Category: Science

The Ludhiana-based institution, which played a pivotal role during the Green Revolution to make India surplus in foodgrains by developing high-yielding strains, has bred a new wheat variety with high amylose starch content, known to reduce risks of type-2 diabetes and cardiovascular diseases.

From “quantity” to “quality” and from “food security” to “nutritional security” — this seems to be the new research focus of the Punjab Agricultural University (PAU).

The Ludhiana-based institution, which played a pivotal role during the Green Revolution to make India surplus in foodgrains by developing high-yielding strains, has bred a new wheat variety with high amylose starch content, known to reduce risks of type-2 diabetes and cardiovascular diseases.

Eating chapatis made from this wheat — called PBW RS1, with RS being short for resistant starch — won’t cause an immediate and rapid rise in glucose levels. The high amylose and resistant starch, instead, ensure that glucose is released more slowly into the bloodstream. Being slower to digest also increases a feeling of satiety; a person consuming 4 chapatis from normal wheat would now feel full after having just two.

It has total starch content, almost the same as the 66-70 per cent in other wheat varieties. But it has 30.3 per cent resistant starch content as against only 7.5-10 per cent for other varieties including PBW 550, PBW 725, HD 3086 and PBW 766, show trials conducted by PAU over four years. The other varieties have 56-62 per cent non-resistant starch content which is nearly half (37.1 per cent) in PWB RS1. Similarly, PBW RS1 has 56.63 per cent amylose compared to only 21-22 per cent in other varieties.

“Chapatis and biscuits made from its whole grain flour also have lower glycemic index (a value used to measure how specific foods increase blood sugar levels), which is linked to the decreased digestibility of the starch. So, it can help bring down the prevalence of diet-related diseases, including obesity and diabetes (especially type 2),” said Achla Sharma, principal wheat breeder at PAU, which was rated the country’s top state agricultural university in 2023 as per the National Institute Ranking Framework.

The variety has been developed over a period of 10 years by a team of wheat breeders led by Dr V S Sohu, head, department of plant breeding and genetics. PAU is the first to combine five novel alleles (genes) affecting resistant starch levels for developing this variety.

Earlier, PAU had released two varieties – PBW Zn1 with high zinc content, and PBW1 Chapati whose flour had premium chapati quality that remained fresh for long – on nutritional lines but none had features as PBW RS1.

Sharma noted that millets are considered healthy because they don’t lead to a spike in blood sugar levels. Dieticians even recommend that diabetic and obese persons give up wheat altogether. “But the fact is that both production and consumption of wheat are much higher and not everyone can have millets on a daily basis. Our idea was, therefore, to breed a wheat variety which feels and tastes like normal wheat, but has higher RS and lower glycemic index,” she said.

But PBW RS1 has a significant drawback that might come in the way of its cultivation by farmers. The average grain yield from the variety at PAU’s field trials has been recorded at 43.18 quintals per hectare. This is below Punjab’s average yield of 48 quintals, which has touched 52 quintals in some years with many farmers harvesting 60 quintals or more.

PAU vice-chancellor Dr Satbir Singh Gosal, however, felt that a beginning towards ushering in nutritional security had to be made. He has urged the Punjab government to promote PBW RS1 flour as a product with “high medicinal and nutritional value”. With proper marketing, the wheat could “fetch higher price” from buyers, similar to the premium that millers are paying for basmati paddy over regular parmal varieties.

“Yes, lower productivity is a challenge. But then, PBW RS1 should be identified as a special-trait variety that will be priced high enough to incentivise farmers to grow it. We have pitched the idea for marketing it as a special quality flour to Markfed (the Punjab State Cooperative Supply & Marketing Federation),” Gosal told The Indian Express, adding that PBW RS1 is the country’s first ever improved wheat variety bred for quality, and not just quantity.

Sharma said seeds for the new variety will be made available to farmers in September to enable them sow in the upcoming rabi season. Apart from its nutritional attributes, PBW RS1 is “completely resistant” to yellow rust and “moderately resistant” to brown rust fungal diseases.

“Chapatis and biscuits from its flour taste just like normal wheat. The high amylose/resistant starch content, translating into increased total dietary fibre, would also be advantageous to bakers and food processors. They can produce products without incorporating fibre or additives from other sources to their formulas,” she said.

The MIT group needed to check whether they could expand that finding into domains all the more usually connected with inventiveness, for example, narrating. They also wanted to find out if they could control what people’s dreams contained and how that controlled content might affect the creative process.

“One of the objectives of our gathering is to give individuals more bits of knowledge into how their mind functions, and furthermore what their mental state is and the way that they might have the option to impact it,” Maes says.

Toward that end, Horowitz worked with a group of individual MIT Media Lab understudies in fostering a gadget called Dormio that could be utilized for designated dream brooding. Changes in muscle tone, heart rate, and skin conductance are three physiological sleep markers that are measured by the glove and sent to an app for a smartphone or laptop.

As somebody wearing the glove enters the N1 express, the application prompts them to dream about a particular point. When the wearer enters the next stage of sleep after a few minutes, the app wakes them up, asks them to describe their dream, and records their response.

According to Esfahany, who is majoring in computation and cognition, a program offered jointly by MIT’s departments of Brain and Cognitive Science and of Electrical Engineering and Computer Science, “Before that device, there were no causal studies where people could guide dreams toward certain topics and then look at post-sleep behavior.”

In a 2020 paper, the researchers first demonstrated that they could utilize the Dormio device for targeted dream incubation. In their new review, they utilized this way to deal with investigate how dreaming, and designated dreaming specifically, impacts imagination.

In a 2020 paper, the researchers first demonstrated that they could utilize the Dormio device for targeted dream incubation. They used this strategy to investigate how creativity is influenced by dreaming, and specifically by targeted dreaming, in their new study.

The researchers divided 49 participants into four groups for this study. One group was given 45 minutes to sleep while the Dormio device asked them to dream of a tree and recorded their dreams. The wearer was again prompted to dream about a tree and encouraged to go back to sleep each time a dream was reported.

A different group of people napped while using the device, but they were only told to watch what they were thinking. Throughout the 45-minute period, two additional groups remained awake: The other was instructed to observe their thoughts, while one of these were given prompts to consider trees.

Subjects were asked to complete three tasks that have previously been shown to correlate with creativity after napping or being awake for 45 minutes. First was a narrating task, where the members were approached to compose an innovative story including “tree.”

Human raters who read the stories and were unaware of which participants were in each group determined that study participants who were instructed to dream about trees produced the most inventive stories. In addition, those who took a break without being prompted to do so displayed greater creativity than those who had remained awake throughout the experiment.

Divergent thinking tasks, two additional measures of creativity, gave the highest scores to those who were instructed to have dreams about trees. In one task, participants were required to think of as many inventive uses for a tree as possible. In the second, individuals were presented with a list of nouns and asked to respond with the first verb that came to mind for each one.

At the point when the specialists broke down each of the three errands, members who snoozed with designated dream brooding performed 43% more imaginatively than members who rested without designated dream hatching, and 78 percent more innovatively than the people who remained alert without brooding.

The scientists likewise found that inside the gathering told to dream about trees, the people who had a bigger number of dreams about trees likewise showed greater imagination in their accounts. These individuals additionally consolidated a large part of the substance of their fantasies in their accounts.

“That proof recommends that it’s not simply being in the N1 rest express that makes individuals more imaginative. According to Esfahany, “people are more creative because they are also utilizing the dreams that are occurring in that sleep state.”

Outfitting the psyche

The analysts likewise found that individuals who rested had the best execution on one more measure connected with inventiveness, known as semantic distance. The difference in meaning between two words or concepts is known as semantic distance. Mother and frog, for instance, would be further apart, while father and mother would be closer together.

The researchers found that people who napped produced word combinations with a much greater semantic distance than those who stayed awake in the verb generation and alternative use tasks. This supports the hypothesis that during rest beginning, the mind unites ideas that it probably won’t interface during waking hours.

“In the event that we guide your reasoning during that period, that amazing chance to look for farther separated ideas is additionally directed,” Esfahany says. ” If we direct you to have a dream about a tree, you’ll develop much broader associations with trees, which you can use to come up with creative responses.

The Dormio device is not required for targeted dream incubation, the researchers emphasize; It can be done with any device that can play and record sound, as well as track sleep. Additionally, they have developed a simpler version of their protocol that is accessible online to anyone who wishes to use it and makes use of a timer rather than tracking sleep states.

“That is actually our objective with a ton of this work: to give individuals more devices to figure out how to bridle their own personalities,” Maes says.

The analysts are presently investigating whether they can grow their fantasy brooding convention to later rest stages, like REM. They are also looking into ways to make the protocol easier to use and use it in other areas, like helping to treat distress caused by nightmares.

When Leo Tolstoy, a Russian philosopher, wrote the opening line of Anna Karenina, he might have been right. Blissful families are indistinguishable; each troubled family is miserable in its own specific manner.”

A new report distributed in Mental Science and drove by a researcher now at the USC Dornsife School of Letters, Expressions and Sciences, recommends that with regards to their cerebrums handling data, individuals who are not forlorn are similar, yet every desolate individual cycles the world in their own, peculiar way.

Overflowing examination shows that forlornness is inconvenient to prosperity and is many times joined by self-announced sensations of not being perceived by others. A new report from the US Top health spokesperson’s office alluded to depression as a general wellbeing emergency in response to the developing number of grown-ups experiencing this condition. Indeed, even before the beginning of the Coronavirus pandemic, around half of U.S. grown-ups revealed encountering quantifiable degrees of depression.

Forlornness is peculiar

While she was a postdoctoral individual at UCLA, Elisa Baek, partner teacher of brain research at USC Dornsife, looked to all the more likely comprehend what adds to such sensations of separation and being misconstrued. Baek and her group utilized a neuroimaging procedure called practical attractive reverberation imaging (fMRI) to look at the cerebrums of 66 first-year understudies while they watched a progression of video cuts. The videos covered a wide range of topics, from melodramatic music videos to party scenes and sporting events, giving researchers a wide range of scenarios to examine.

The UCLA Loneliness Scale, a survey that measures a person’s subjective feelings of loneliness and feelings of social isolation, was given to the participants, whose ages ranged from 18 to 21, prior to being scanned.

In view of the review results, the analysts isolated the members into two gatherings: desolate and “nonlonely” (those not encountering depression). After that, they used fMRI to scan each participant’s brain as they watched the videos.

Contrasting the cerebrum imaging information between the two gatherings, the analysts found that lonelier people displayed more different and eccentric mind handling designs than their non-desolate partners.

This finding is critical in light of the fact that it uncovers that brain comparability, which alludes to how comparable the mind movement examples of various people are, is connected to a common perspective of the world. This common perspective is significant for laying out friendly associations. Individuals who experience the ill effects of depression are not just less like society’s standard of handling the world, yet each desolate individual varies in novel ways, also. The feelings of loneliness and a lack of social connections may be exacerbated by this individuality.

Baek said, “It was amazing for observe that desolate individuals were even less like one another.” The way that they don’t track down shared trait with desolate or nonlonely individuals makes accomplishing social association considerably more challenging for them.

Dejection isn’t tied in with having or not having companions

All in all, does peculiar handling in forlorn people cause dejection, or is it a consequence of depression?

The specialists saw that people with elevated degrees of depression – ; regardless of the number of social connections or friends they had -; were bound to have eccentric cerebrum reactions. This raised the likelihood that being encircled by individuals who see the world uniquely in contrast to oneself might be a gamble factor for depression, regardless of whether one mingles routinely with them.

The study also suggests that a person’s idiosyncratic way of processing the world may be influenced by the degree to which social connections or disconnections change over time.

Looking forward, Baek said she is keen on analyzing individuals who have companions and are socially dynamic yet at the same time feel forlorn. In addition, the researchers are examining how lonely people react to specific situations in different ways. For instance, do desolate individuals show mannerisms while handling unforeseen occasions or questionable social settings in which things can be deciphered in an unexpected way?

United Nations Secretary General Antnio Guterres on the eve of International Day of Yoga said that benefits of this ancient practice (Yoga) are precious in today’s dangerous and divided world.

“In a dangerous and divided world, the benefits of this ancient practice (Yoga) are particularly precious. Yoga offers a heaven of calm,” he said in a message on Tuesday, on the eve of the International Day of Yoga, which is observed on June 21 every year.

He further added that, “On this International Day of Yoga, let us embrace the spirit of unity, and resolve to build a better, more harmonious world for people, planet and ourselves.”

Prime minister Narendra Modi is set to lead a yoga session at UN headquarters in New York on Wednesday during the course of his ongoing US visit.

Following is UN Secretary-General António Guterres’ message for the International Day of Yoga, observed on 21 June:

The International Day of Yoga celebrates the restorative healing and inner peace provided by this ancient practice.

This year’s theme — Yoga for Humanity — reminds us how yoga is truly universal.

With roots in India, yoga is now practiced worldwide, giving people of all faiths and walks of life the tools and practices they need to enhance and balance their physical, spiritual and mental wellbeing.

For hundreds of millions of people worldwide, yoga has also been an essential lifeline during the COVID-19 pandemic, providing an important means of coping with the challenges of social isolation and stress.

And in a world beset by disaster and division, yoga’s values of mindfulness, balance, moderation and discipline are essential as we seek out a new relationship with one another and with our planet.

On this important day, let us be inspired by this timeless practice and its values.

The United States Food and Drug Administration (US FDA) has recently uncovered a series of regulatory failures in Indian pharmaceutical factories, raising concerns about the quality of drugs manufactured in the country. India is one of the largest producers of generic drugs, supplying approximately 40% of generic medicines consumed in the United States. Consequently, any lapses in manufacturing standards could have far-reaching implications for both the Indian pharmaceutical industry and patients relying on these medications.

The US FDA’s inspection reports reveal several instances of inadequate quality control measures, lack of data integrity, and improper sanitation practices in various Indian pharmaceutical plants. These issues have led to multiple warnings and import alerts from the regulatory body, which could potentially damage the reputation and export prospects of Indian drug manufacturers.

One such case involved Lupin Ltd., India’s third-largest drugmaker by sales, which received a warning letter from the FDA in November 2017. The warning cited significant violations of current good manufacturing practice (CGMP) regulations at two of the company’s facilities. Issues raised included insufficient oversight of suppliers, poor laboratory controls, and a lack of proper documentation.

Similarly, Dr. Reddy’s Laboratories, another major Indian pharmaceutical firm, faced an FDA warning in 2015 for CGMP violations at three of its manufacturing plants. The regulatory agency observed inadequate quality control systems, incomplete investigations into product failures, and a lack of data integrity in the company’s records.

These findings have prompted the Indian government to take action to improve the compliance of domestic pharmaceutical companies with international standards. The Central Drugs Standard Control Organization (CDSCO), India’s national regulatory body for pharmaceuticals and medical devices, has initiated efforts to strengthen its inspection processes and enhance collaboration with the US FDA.

To address the issue of data integrity, CDSCO is working on guidelines that will clarify expectations for Indian pharmaceutical companies regarding data management and record-keeping. The organization is also focusing on capacity-building initiatives, such as training programs for drug inspectors and regulatory staff to improve their understanding of CGMP requirements.

The Indian pharmaceutical industry has acknowledged the need to enhance its manufacturing standards and maintain transparency in its operations. Industry representatives have expressed their commitment to working closely with regulators to address these concerns and ensure the safety and efficacy of their products.

US FDA’s findings have highlighted significant shortcomings in the quality control measures employed by some Indian pharmaceutical factories. These revelations underscore the importance of stringent regulatory oversight and adherence to international manufacturing standards to safeguard public health. As the Indian pharmaceutical industry continues to expand its global presence, it must prioritize compliance with CGMP regulations and work collaboratively with regulatory bodies to uphold the highest standards of drug quality and safety.

The US Food and Drug Administration (FDA) has granted approval for a new vaccine that can help fight respiratory syncytial virus (RSV), an illness that leads to the death of thousands of people each year in America. The vaccine, named Arexvy by the UK-based manufacturer GSK, has been hailed as a significant breakthrough that could save many lives. However, it still needs evaluation from the US Centers for Disease Control and Prevention (CDC) before it can be made available to the public.

Dr Peter Marks, who leads the Center for Biologics Evaluation and Research at the FDA, said, “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening.”

RSV is a respiratory disease that typically causes cold-like symptoms for adults. However, it can prove dangerous for young children, those with underlying health conditions, and older adults aged over 65 who suffer from the virus. On average, it kills between 100 and 300 children under the age of 5 in America every year, and causes between 6,000 to 10,000 fatalities among adults over 65 annually, leading to between 60,000 to 120,000 hospitalisations.

According to the CDC, the quickest way to prevent RSV is through vaccination. Arexvy is the first vaccine capable of preventing RSV anywhere in the world, having been in development for over 60 years. Arexvy has an efficacy rate of 82.6%, according to a study by GSK in February.

The most common side effects are “mild or moderate,” such as discomfort around the injection site or fatigue, typically subsiding within two days. Officials say the vaccine could be available to people aged over 60 within the next few months.

Dr Susanna Naggie, an infectious disease specialist, at Duke University School of Medicine, in Durham, North Carolina said, “This is a very important and long-awaited advance for an infection that causes significant morbidity and mortality, particularly in older adults.”

The breakthrough vaccine could potentially save numerous lives, and its approval by the FDA is a critical step in the fight against RSV.

Recognizing the Signs of Respiratory Syncytial Virus (RSV) in Children

RSV typically begins with a stuffy or runny nose, followed by a dry cough, fever, and occasionally, difficulty breathing. In most cases, it is mild and can be managed with infant paracetamol or ibuprofen. If your child is not drinking enough fluids, having difficulty breathing or has a temperature that won’t go down, consult your doctor or seek medical attention. If your little one is having trouble breathing to the point of exhaustion – muscles around their ribs are prominently drawing in as they take each breath and they are pale and sweaty – immediately call emergency services.

Researchers at the Grossman School of Medicine at NYU have discovered new evidence as to why human hair loses its natural colour over time, which they believe can also be applied to preventing the greying of human hair. The study examined the melanocyte stem cells (McSCs) that control hair colour, and found that earlier in life, these cells can be remarkably dynamic. However, with age, these cells tend to slow down, getting trapped in what is known as the hair follicle bulge, meaning they do not get a chance to finish the job they were created to do. Reinforcing these cells could mean the end of grey hair, according to the team at NYU.

“The newfound mechanisms raise the possibility that the same fixed positioning of melanocyte stem cells may exist in humans. If so, it presents a potential pathway for reversing or preventing the graying of human hair by helping jammed cells move again,” said study leader, Qi Sun,a postdoctoral fellow at NYU Langone Health

Lab mice that had their hair “physically aged” by plucking and forced regrowth were observed to have a 15% higher concentration of McSCs stuck in that follicle bulge before their hairs were pulled. Following the intervention, the percentage of hairs that no longer had pigment generating abilities rose to nearly 50%. With the greater understanding of the stalled-out cells and their probable responsibility for loss of hair colour, researchers are now focusing on how to get the McSCs back on track.

The next research step will be “to investigate means of restoring motility of McSCs or of physically moving them back to their germ compartment, where they can produce pigment,” according to lead researcher Professor Mayumi Ito,PhD

Dr Doris Day, a dermatologist affiliated with Lenox Hill Hospital in New York City, commented that although the new study is interesting and needed, it is still “early days” for any human hair solution.

Dr. Dattatreyudu Nori, a world renowned Indian-American oncologist, has been appointed as the senior advisor to the Chennai-center of the Memorial Sloan Kettering Cancer Center from New York. The Padma Shri awardees was named one of the top doctors in America for the treatment of cancers, especially in women. Memorial Sloan Kettering Cancer Center (MSKCC), a cancer treatment and research institution in the borough of Manhattan in New York City is one of the world’s top cancer centers.

The center’s Chennai facility is its first overseas center, which opened last year. Dr. Nori stated that the opening of the center in India is a big deal and aims to bring the best practices of cancer treatment from the United States to India. He also emphasized the importance of providing the best treatment for cancer patients. The center’s presence in India will help to increase awareness in the fight against the deadly disease and save a large number of lives.

Speaking to the media, Nori said that he gets a lot of patients from India whom he treats at MSKCC. He noted that Indian patients look out for different hospitals and opinions, and they spend a lot of money going to different centers before reaching MSKCC. And therefore, he had aimed to have one of its centers open in India.

According to him the India centre will make a second opinion option available to Indians within the country, eliminating the need to travel to the US. Nori emphasized that the first treatment for cancer cure should be the best. “There is no room for catching up,” the doctor said.

A MSKCC centre was opened in Chennai, India in 2020. However, Nori mentioned that good cancer centers are coming up in the country in the last ten years, but they are not able to cater to the needs of all cancer patients. He recommended the Indian government to focus on controlling the incidents of cancer through screening and early detection. The doctor is also trying to introduce new programs in India that were successful in the US.

Speaking on the importance of early screening, Nori said that in the US it has reduced the occurrence of cervical cancer by 24 per cent, mammography has reduced the mortality of breast cancer, and awareness programs about smoking caused a downward trend of lung cancer. He revealed that he will be introducing some of these programs in India.

The Padma Shri awardee who hails from Andhra Pradesh obtained his medical degree from Kurnool Medical College and a postgraduate degree from Osmania Medical College. He is known for the development and application of brach.

The vaccine technology America learned about during the pandemic was originally aimed at cancer, but its use against infectious diseases took off in the pandemic. Now a new study suggests specially designed mRNA shots can help prevent recurrences of melanoma, a dreaded skin cancer.

The study, presented Sunday at a research conference, showed that after nearly two years, patients who received a personalized mRNA vaccine made by Moderna and Merck were 44% more likely to be alive and avoid new tumors than those who received only the standard of care.

If the results hold up in a larger, longer study planned to start later this year, it will mark a dramatic turnaround for cancer vaccines, which have been tested and failed for decades.

“It’s probably the first real data that suggests that this personalized approach to vaccination may be worth exploring further,” said Dr. Ryan Sullivan, an oncologist at Mass General Cancer Center, who was a co-author on the study.

Instead of using a vaccine to try to prevent or shrink a tumor, the new mRNA vaccines are aimed at reducing the chances of a high-risk cancer recurring.

“This represents a big shift in how we’re using cancer vaccines,” said Dr. Robert Vonderheide, who was not involved in the study but is the program committee chair of the American Association for Cancer Research’s annual meeting, where the study was presented.

The pandemic proved that mRNA vaccines, already in development for cancer, could be used safely and developed quickly, said Vonderheide, who also directs the Abramson Cancer Center at the University of Pennsylvania.

Benefits seen in melanoma, a cancer known to be controlled by the immune system, are likely to hold up in other cancers that are affected by the immune system, he and several other experts said. The next one to be tested will be non-small-cell lung cancer, which kills about 100,000 Americans a year.

But it made sense to try first in melanoma.

“No cancer is as immunotherapy sensitive as melanoma is,” said Dr. Rodabe Amaria, a melanoma oncologist at MD Anderson Cancer Center in Houston, who was not involved in the study. “You have to prove it in melanoma before you try it in other cancers.”

How would an mRNA cancer vaccine work?

These vaccines are designed to prevent cancer recurrences, not an initial run-in with the disease.

After surgical removal of a tumor or a separate biopsy, scientists send a sample of tissue and blood for genetic sequencing, looking for proteins that are unique to the cancer and not present in healthy tissue.

The mRNA vaccine is then designed to target 34 of these distinctive proteins, getting the immune system to recognize them and hopefully kill the cells that make them without damaging healthy tissue.

Because there are so many possible neoantigens, resulting from a patient’s own genetics and the evolution of their tumor cells, the vaccine must be bespoke, designed specifically for each person.

Researchers aren’t sure how many neoantigens to target or which are likely to offer the most benefit, “so we cram in as many potential neoantigens as possible,” said Dr. Eliav Barr, chief medical officer of Merck, which supported the trial.

Each vaccine takes about eight weeks to manufacture and is based on tumor cells removed during surgery. While the patient waits for their personalized vaccine, they start taking the drug pembrolizumab (brand name Keytruda), made by Merck, which unleashes the immune system to attack cancer.

Pembrolizumab is given as a 30-minute infusion every three weeks for a year. Patients receive two or three doses of pembrolizumab and then, when their vaccine is ready, they get nine doses along with their next nine infusions, before completing pembrolizumab.

According to findings released Sunday by the researchers, but not yet peer reviewed, among 107 volunteers who received both the experimental vaccine and pembrolizumab, the cancer returned in 24 (22%) within two years. There were 20 recurrences (40%) among the 50 people who received only pembrolizumab.

(Keytruda sells for a list price of $185,000 a year, although most people will not pay the list price, according to Merck. It’s too soon to know how much companies will charge for mRNA vaccines.)

Melanoma is diagnosed in about 100,000 Americans per year. If caught early, nearly everyone survives for at least five years, but only one-third of patients whose cancer has spread widely survive that long.

“Pembro” already dramatically decreased recurrences, but the new study showed a 44% extra benefit with the addition of the mRNA vaccine, called mRNA-4157/V940.

“We’re already reaping those benefits (from pembro), and now, in such a short period of time to have an additional therapeutic agent that builds on that progress is a very exciting thing,” Amaria said.

Side effects of mRNA vaccine for cancer

The addition of the mRNA vaccine did not seem to add substantially to the side effects already seen with pembrolizumab.

Pembro often affects the endocrine system, Amaria said, causing diabetes and potentially permanent thyroid problems. Other common side effects include exhaustion, muscle pain, rash, diarrhea, fever, cough, decreased appetite, itching, shortness of breath, constipation and nausea.

As more patients live longer with melanoma, these side effects are becoming more noticeable, Amaria said. “In some patients, the benefit goes hand-in-hand with the toxicity,” so side effects may be a sign the treatment is working.

“In some patients, we’re fundamentally changing their quality of life,” she said, but “most people do have normal lives, recovered from side effects.”

What is mRNA?

Messenger RNA carries instructions from a cell’s DNA code to the cellular machinery that manufactures proteins, telling it what to make. Delivered as a vaccine, the short-lived mRNA turns cells into factories that produce desired proteins.

With COVID, mRNA vaccines produce the spike protein found on the surface of the SARS-CoV-2 virus, training the immune system to recognize and wipe out viral cells.

In the case of these cancer vaccines, the mRNA triggers the body to produce the 34 neoantigens, training the immune system to recognize and target them.

In cancers that have spread beyond an initial tumor, surgeons can’t remove all the cancerous cells. In people with Stage 2 melanoma or above, this dangerous spread has already begun and the risk of recurrence after surgery is very high.

The vaccine should help prevent these dangerous recurrences, Barr said.

The mRNA vaccine can’t be used to prevent disease, as it is with COVID, because the neoantigens don’t exist until the tumor does, Barr said. But it appears to work well when designed to target a specific person’s cancer and hopefully providing long-term memory, so even future cancer cells will be killed.

BioNTech, the German company that helped develop the other mRNA vaccine against COVID, is also working on cancer vaccines, including against ovarian and lung cancer, as are several other companies.

It’s not really clear why an mRNA vaccine would be effective against cancer when so many other approaches have failed, several experts said. The technology may simply spur more reaction from tumors, Sullivan said.

What happens next?

The new study, launched in 2018, was relatively small and only lasted a few years, so Merck hopes to start a large, Phase 3 trial later this year. It will be open to people with Stage 2 or Stage 3 melanoma.

Amaria said she and her colleagues at MD Anderson are considering participating. Patients often come to her asking for an mRNA vaccine against their cancer, she said.

Dr. Jeffrey Weber, who led the new study and is the deputy director of the Perlmutter Cancer Center at NYU Langone, said he’s optimistic about the future of mRNA vaccines against cancer.

“It’s got a ways to go, but I do believe that these results will hold up over time,” he said.

The Huanan seafood and wildlife market in China has been a focal point in the search for the origin of the coronavirus that has impacted the world as none other in the past three years. People around the world have been seeking to identify the origin of the deadly virus.

Now a research team in China has published analysis of samples taken more than three years ago from the market linked to the outbreak of Covid-19. This is the first peer-reviewed study of biological evidence gathered from the market back in 2020.

By linking the virus with animals sold in the market, it could open new lines of inquiry into how the outbreak began. The research reveals swabs that tested positive for the virus also contained genetic material from wild animals.

Some scientists say this is further evidence that the disease was initially transmitted from an infected animal to a human. But others have urged caution in interpreting the findings and it remains unclear why it took three years for the genetic content of the samples to be made public.

Another theory has centered on the suggestion that the virus accidentally leaked from a laboratory in Wuhan.

No definitive proof

The Chinese research team posted an early version of their study online back in February 2022, but they did not publish the full genetic information that was contained in the samples gathered from the market.

In March this year, another international group of researchers shared their own assessment of what those crucial market swabs had revealed, after spotting that the genetic sequences had been posted on a scientific data-sharing website.

This new analysis, which has been validated by other scientists before being published in the journal Nature, includes more important detail about the content of those samples, which were collected from stalls, surfaces, cages and machinery inside the market.  Before the 2020 outbreak, scientists took photos of animals, including racoon dogs, being sold in the Huanan market

The Chinese research team’s paper showed that some samples – collected from areas where wildlife was being sold – had tested positive for the virus.  Their analysis also showed that animals now known to be susceptible to the virus, particularly raccoon dogs, were being sold alive in those locations.

But the Chinese researchers have pointed out that their discoveries fall short of definitive proof of how the outbreak started. “These environmental samples cannot prove that the animals were infected,” the paper explains.  The possibility remains, it adds, that the virus was brought into the market by an infected person, rather than an animal.

Prof David Robertson, from the University of Glasgow, is a virologist who has been involved in the genetic investigation into the origin of SARS-CoV-2 since it emerged in 2020. He told BBC News: “The most important thing is that this very important dataset is now published and available for others to work on.”

But he added that the contents of the samples were “compelling evidence that animals there were probably infected with the virus. It’s the whole body of evidence that’s important,” he said. “When you bring this together with the fact that the early Covid-19 cases in Wuhan are linked to the market, it’s strong evidence that this is where a spillover from an animal in the market occurred.”

According to BBC, the published findings come amid signs that the lab leak theory is gaining ground among authorities in the US. The Chinese government has strenuously denied suggestions that the virus originated in a scientific facility, but the FBI said it now believes that scenario is the “most likely”, as does the US Department of Energy.

Various US departments and agencies have investigated the mystery and produced differing conclusions, but on March 1^st, the FBI’s director accused Beijing of “doing its best to try to thwart and obfuscate”, and disclosed the bureau had been convinced of the lab leak theory “for quite some time now”.

The FBI has not made their findings public, which has frustrated some scientists. The lead researcher of the new report, from the Chinese Center for Disease Control and Prevention (China CDC) in Beijing, has been contacted by the BBC for comment.

Northwestern University researchers have discovered a previously unknown mechanism that drives aging. In a new study, researchers used artificial intelligence to analyze data from a wide variety of tissues, collected from humans, mice, rats, and killifish. They discovered that the length of genes can explain most molecular-level changes that occur during aging.

All cells must balance the activity of long and short genes. The researchers found that longer genes are linked to longer lifespans, and shorter genes are linked to shorter lifespans. They also found that aging genes change their activity according to length. More specifically, aging is accompanied by a shift in activity toward short genes. This causes the gene activity in cells to become unbalanced.

Surprisingly, this finding was near universal. The researchers uncovered this pattern across several animals, including humans, and across many tissues (blood, muscle, bone, and organs, including liver, heart, intestines, brain, and lungs) analyzed in the study.

The new finding potentially could lead to interventions designed to slow the pace of — or even reverse — aging. The study was published December 9 in the journal Nature Aging.

“The changes in the activity of genes are very, very small, and these small changes involve thousands of genes,” said Northwestern’s Thomas Stoeger, who led the study. “We found this change was consistent across different tissues and in different animals. We found it almost everywhere. I find it very elegant that a single, relatively concise principle seems to account for nearly all of the changes in activity of genes that happen in animals as they age.”

“The imbalance of genes causes aging because cells and organisms work to remain balanced — what physicians denote as homeostasis,” said Northwestern Engineering’s Luís A.N. Amaral, a senior author of the study. “Imagine a waiter carrying a big tray. That tray needs to have everything balanced. If the tray is not balanced, then the waiter needs to put in extra effort to fight the imbalance. If the balance in the activity of short and long genes shifts in an organism, the same thing happens. It’s like aging is this subtle imbalance, away from equilibrium. Small changes in genes do not seem like a big deal, but these subtle changes are bearing down on you, requiring more effort.”

An expert in complex systems, Amaral is the Erastus Otis Haven Professor of Chemical and Biological Engineering at the McCormick School of Engineering. Stoeger is a postdoctoral scholar in Amaral’s laboratory.

Looking across ages

To conduct the study, the researchers used various large datasets, including the Genotype-Tissue Expression Project, a National Institutes of Health-funded tissue bank that archives samples from human donors for research purposes.

The research team first analyzed tissue samples from mice — aged 4 months, 9 months, 12 months, 18 months, and 24 months. They noticed the median length of genes shifted between the ages of 4 months and 9 months, a finding that hinted at a process with an early onset. Then, the team analyzed samples from rats, aged 6 months to 24 months, and killifish, aged 5 weeks to 39 weeks.

It seems that, at a young age, our cells are able to counter perturbations that would lead to an imbalance in gene activity. Then, suddenly, our cells are no longer able to counter it. Thomas Stoeger Postdoctoral Scholar, Northwestern University

“There already seems to be something happening early in life, but it becomes more pronounced with age,” Stoeger said. “It seems that, at a young age, our cells are able to counter perturbations that would lead to an imbalance in gene activity. Then, suddenly, our cells are no longer able to counter it.”

After completing this research, the researchers turned their attention to humans. They looked at changes in human genes from ages 30 to 49, 50 to 69 and then 70 and older. Measurable changes in gene activity according to gene length already occurred by the time humans reached middle age.

“The result for humans is very strong because we have more samples for humans than for other animals,” Amaral said. “It was also interesting because all the mice we studied are genetically identical, the same gender and raised in the same laboratory conditions, but the humans are all different. They all died from different causes and at different ages. We analyzed samples from men and women separately and found the same pattern.”

‘Systems-level’ changes

In all animals, the researchers noticed subtle changes to thousands of different genes across samples. This means that not just a small subset of genes that contributes to aging. Aging, instead, is characterized by systems-level changes.

This view differs from prevailing biological approaches that study the effects of single genes. Since the onset of modern genetics in the early 20th century, many researchers expected to be able to attribute many complex biological phenomena to single genes. And while some diseases, such as hemophilia, do result from single gene mutations, the narrow approach to studying single genes has yet to lead to explanations for the myriad changes that occur in neurodegenerative diseases and aging.

“We have been primarily focusing on a small number of genes, thinking that a few genes would explain disease,” Amaral said. “So, maybe we were not focused on the right thing before. Now that we have this new understanding, it’s like having a new instrument. It’s like Galileo with a telescope, looking at space. Looking at gene activity through this new lens will enable us to see biological phenomena differently.”

Lengthy insights

After compiling the large datasets, many of which were used in other studies by researchers at Northwestern University Feinberg School of Medicine and in studies outside Northwestern, Stoeger brainstormed an idea to examine genes, based on their length.

The length of a gene is based on the number of nucleotides within it. Each string of nucleotides translates to an amino acid, which then forms a protein. A very long gene, therefore, yields a large protein. And a short gene yields a small protein. According to Stoeger and Amaral, a cell needs to have a balanced number of small and large proteins to achieve homeostasis. Problems occur when that balance gets out of whack.

Although the researchers did find that long genes are associated with increased lifespans, short genes also play important roles in the body. For example, short genes are called upon to help fight off pathogens.

“Some short genes could have a short-term advantage on survival at the expense of ultimate lifespan,” Stoeger said. “Thus, outside of a research laboratory, these short genes might help survival under harsh conditions at the expense of shortening the animal’s ultimate lifespan.”

Suspected ties to long COVID-19

This finding also may help explain why bodies take longer to heal from illnesses as they age. Even with a simple injury like a paper cut, an older person’s skin takes a longer time to recover. Because of the imbalance, cells have fewer reserves to counteract the injury.

“Instead of just dealing with the cut, the body also has to deal with this activity imbalance,” Amaral hypothesized. “It could explain why, over time with aging, we don’t handle environmental challenges as well as when we were younger.”

And because thousands of genes change at the system-level, it doesn’t matter where the illness starts. This could potentially explain illnesses like long COVID-19. Although a patient might recover from the initial virus, the body experiences damage elsewhere.

“We know cases where infections — predominantly viral infections — lead to other problems later in life,” Amaral said. “Some viral infections can lead to cancer. Damage moves away from the infected site and affects other areas of our body, which then is less able to fight environmental challenges.”

Hope for medical interventions

The researchers believe their findings could open new venues for the development of therapeutics, designed to reverse or slow aging. Current therapeutics to treat illness, the researchers argue, are merely targeting the symptoms of aging rather than aging itself. Amaral and Stoeger compare it to using Tylenol to reduce a fever instead of treating the illness that caused the fever.

“Fevers can occur for many, many reasons,” Amaral said. “It could be caused by an infection, which requires antibiotics to cure, or caused by appendicitis, which requires surgery. Here, it’s the same thing. The issue is the gene activity imbalance. If you can help correct the imbalance, then you can address the downstream consequences.”

Other Northwestern co-senior authors include Richard Morimoto, a professor of molecular biosciences in the Weinberg College of Arts and Sciences; Alexander Misharin, an associate professor of medicine at Feinberg; and G.R. Scott Budinger, the Ernest S. Bazley Professor of Airway Diseases at Feinberg and chief of pulmonary and critical care at Northwestern Medicine.

The global exchange of information and best practices in health would be best achieved in cooperation with doctors around the world, India’s Minister of Health said at the 13th annual conference of the Global Association of Physicians of Indian Origin (GAPIO) which took place Feb. 11-12, 2023, in Gandhinagar, Gujarat.

More than 500 doctors from 57 countries, including doctors of Indian origin practicing in the United States, the UK, and Australia among others, attended.

India’s Health Minister Mansukh Mandavia speaking at the Feb. 11-12, 2023, conference of the Global Association of Physicians of Indian Origin in Gandhinagar. Photo GAPIO

“The healthcare sector in India and across the world is going through transformative changes, especially after the onset of the COVID-19 pandemic,” Dr Mansukh Mandaviya, India’s Minister of Health & Family Welfare and Chemicals & Fertilizers, Government of India, said at the opening session.  “Indian doctors practicing anywhere in the world have created a name for themselves. In order to further strengthen the healthcare system of the country, exchange of knowledge and information amongst doctors about global best practices is key.”

Chief Minister of Gujarat Bhupendra Patel, speaking at the Feb. 11-12, 2023, conference of GAPIO, held in Gandhinagar, Gujarat. Photo: GAPIO

Chief Minister of Gujarat Bhupendra Patel said, “While India has successfully come out of the shadows of the COVID-19 pandemic, there are greater challenges ahead in the healthcare sector due to the growing burden of non-communicable diseases such as cancer, heart diseases, and diabetes. The way forward is to provide innovative solutions which are also cost-effective and can be availed by all sections of society. Doctors have a significant role in coming up with these solutions and serving mankind.”

Founder President of GAPIO and Chairman Apollo Hospitals Group Dr. Prathap C. Reddy, said “The spirit of the physicians of Indian origin to excel in India and overseas is what we are striving to recognize. Their laudable efforts and path breaking work across the globe has made every Indian proud. The awardees’ exemplary work is an inspiration for others to emulate.”

Dr Anupam Sibal, outgoing president of GAPIO and Group Medical Director, Apollo Hospitals Group, and Senior Consultant Pediatric Gastroenterologist and Hepatologist, said, “GAPIO provides a platform to doctors of Indian origin practicing anywhere in the world to share their knowledge and exchange ideas on clinical skill development, solutions to contemporary health issues, and modernizing the approach to delivering healthcare.”

Dr Nandakumar Jairam, incoming president of GAPIO said, “Research and innovation can improve the delivery of quality healthcare in India to the last mile. As the country braces to overcome its myriad health challenges, this conference will help identify methodologies most suitable to skill and scale the healthcare workforce in the country.”

Dr. Sudhir Parikh, vice president of GAPIO speaking at the two-day conference of the organization Feb. 11-12, 2023, in Gandhinagar, Gujarat. Photo GAPIO

Dr Sudhir Parikh, vice president of GAPIO and Chairman and Publisher of Parikh World Wide Media and ITV Gold 24×7 TV Channel in United States commented, “With our presence among 57 countries, GAPIO is committed to its vision of Improving Health Worldwide. GAPIO serves to establish collaborations, bringing 1.4 million physicians of Indian origin under one umbrella platform. In the coming year, our activities will be enhanced to build a stronger well connected physician community.”

Dr. Rohini Sridhar, secretary general of GAPIO, speaking at the Feb. 11-12 conference in Gandhinagar, Gujarat. Photo: GAPIO

Dr Ramesh Mehta, past president of BAPIO (British Association of Physicians of Indian Origin) and Past President GAPIO, said, “The conference has gone beyond discussing hard-core medical specialities. Other important issues discussed such as tragedy of avoidable childhood blindness: What GAPIO can do? The evolution of Genomics: Reaching beyond the unseen, Climate change and its impact on human health, Navigating Change and Preparing for the Future – The Nursing perspective, Reversal of NCD’s, LEADS for healthcare in India, Leadership mantras, Women in Medicines make this conference really unique.”

Dr Sanku Rao, Past President, GAPIO expressed his happiness about the academic component of this conference. With around 500+ delegates, many doctors attending virtually and having more than 150 faculty members from all over the world including USA, UK, Australia and India, the conference is truly labelled as “Global” he noted.

Over two days, physicians discussed public health and the latest innovations in cardiac sciences, neurosciences, nephrology, oncology, kidney and liver transplants, gastroenterology, nutrition, and nursing among others.

A dedicated session on the use of robotics and artificial intelligence was also held. It focused on colorectal surgery, pushing the envelope by complex myomectomy with robotics, robotic upper CI surgery benefits, robotic arthroplasty, AI in cardiac disorders, artificial intelligence simplified, the role of robotics in thoracic surgery, and established and evolving indication of proton therapy in the Indian context.

During the conference, winners of the Annual GAPIO Awards to Indian physicians for noteworthy contributions to the field of medicine were also announced.

Award winners in the distinguished category:

GAPIO Lifetime Achievement Award: Prof. Dhavendra Kumar, Spire Cardiff Hospital, UK

Prathap C Reddy Philanthropy Award: Dr Rayapu Ramesh Babu, Blood Donors Organization for Social Service, Tirupati

IA Modi Award: Prof. Ajay Kumar Duseja, PGIMER, Chandigarh

GAPIO Surgical Excellence Award: Prof. Devendra Kumar Gupta, AIIMS, New Delhi

GAPIO Excellence in Diagnostic Award: Prof. Anita Borges, SL Raheja Hospital, Mumbai

GAPIO Excellence in Radiology/ Radiation Therapy Award: Prof. Akshay Kumar Saxena, PGIMER, Chandigarh

Award winners in the Young Category:

Dr IA Modi Award: Dr Sanjith Saseedharan, SL Raheja Hospital, Mumbai

GAPIO Surgical Excellence Award: Dr. Saurabh Jain, MGMMC, Indore

GAPIO Excellence in Diagnostic Award: Dr. Tushar Sehgal, AIIMS, New Delhi

GAPIO Excellence in Radiology/ Radiation Therapy Award: Dr. Chandrashekhara S H, AIIMS, New Delhi

Established in 2011, GAPIO aims to bring 1.4 million physicians of Indian origin across the world under one professional platform.  Members belong to various medical specialties and super specialties, and several are recipients of distinguished awards.

On the occasion of Republic Day, India achieved yet another milestone on the global stage as it launched the world’s first intranasal COVID-19 vaccine. Bharat Biotech’s iNCOVACC was unveiled by Dr Mansukh Mandaviya, Union Minister of Health & Family Welfare  in the presence of Union Minister of State (IC) for Science and Technology, Dr Jitendra Singh, officials from the union government, co-founder and executive chairman, Bharat Biotech Dr Krishna Ella and co-founder and MD, Bharat Biotech Suchitra Ella.

World’s 1st intranasal
• iNCOVACC® is the world’s first Intranasal vaccine for COVID to receive approval for the primary 2-dose schedule, and as a heterologous booster dose, administered as nasal drops.
• iNCOVACC® is a cost effective COVID vaccine which does not require syringes, needles, alcohol wipes, bandage, etc, saving costs related to procurement, distribution, storage, and biomedical waste disposal, that is routinely required for injectable vaccines.
• iNCOVACC® utilizes a vector-based platform, which can be easily updated with emerging variants leading to large-scale production, within a few months. These rapid response timelines combined with the ability of cost-effective and easy intranasal delivery, makes it an ideal vaccine to address future infectious diseases.
• A rollout of iNCOVACC® is expected to begin in private hospitals that have placed advance orders. Initial manufacturing capacity of several million doses per annum has been established, this can be scaled up to a billion doses as required. iNCOVACC® is priced at INR 325/dose for large volume procurement by State Governments and Govt of India.
• Phase III trials (as a 2-dose regimen) were conducted for safety, immunogenicity in ~3100 subjects, in 14 trial sites across India.
• Heterologous booster dose studies were conducted for safety and immunogenicity in ~875 subjects, with BBV154 intranasal vaccine administered in those previously completing a regimen of the commonly administered COVID vaccines. The trials were conducted in 9 trial sites across India.
• iNCOVACC® recipients demonstrated significant levels of Mucosal IgA antibody levels (measured in the saliva). Mucosal IgA antibodies in the upper respiratory tract may provide benefits in reducing infections and transmission. New Delhi/Hyderabad, Jan 26, 2023: Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, today dedicated iNCOVACC® (BBV154) to the nation, world’s 1st COVID intranasal vaccine for Primary series and Heterologous booster.

iNCOVACC® was launched by Dr. Mansukh Mandaviya, Hon’ble Minister for Health and Family Welfare, in the presence of Dr. Jitendra Singh, Hon’ble Minister for Science & Technology, on the occasion of Republic Day. Product development and clinical trials for iNCOVACC® were funded in part by the Government of India, through the Department of Biotechnology’s, COVID Suraksha Program.
Bharat Biotech received approval from the Central Drugs Standard Control Organization (CDSCO) for iNCOVACC® to be administered for primary series and as heterologous booster doses.

Amid growing COVID- 19 cases and emerging variants of the highly transmissible virus, a booster dose of the vaccine becomes imperative. iNCOVACC® is now available on CoWIN, and priced at INR 800 for private markets and INR 325 for supplies to Govt of India and State Governments.

iNCOVACC® is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results.

This vaccine has been specifically formulated to allow intranasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries. As a needleless vaccination, Bharat Biotech’s iNCOVACC® will be the world’s first such booster dose. India will now have more options when it comes to third doses or precautionary doses.

Clinical trials and extensive humoral and cell mediated responses were conducted to evaluate iNCOVACC® as a primary dose schedule, and as heterologous booster dose for subjects who have previously received two doses of the two commonly administered COVID-19 vaccines in India. The intranasal vaccine is stable at 2- 8°C for easy storage and distribution and has been designed for efficient distribution and easy pain free administration.

iNCOVACC® was developed in partnership with Washington University, St. Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated in preclinical studies for efficacy.

The director of the George Washington University School of Medicine argues that the brain of an older person is much more practical than is commonly believed.  At this age, the interaction of the right and left hemispheres of the brain becomes harmonious, which expands our creative possibilities.  That is why among people over 60 years of age you can find many personalities who have just started their creative activities.

Of course, the brain is no longer as fast as it was in youth.  However, it gains in flexibility.  Therefore, with age, we are more likely to make the right decisions and are less exposed to negative emotions.  The peak of human intellectual activity occurs around the age of 70, when the brain begins to function at full strength.

Over time, the amount of myelin in the brain increases, a substance that facilitates the rapid passage of signals between neurons.  Due to this, intellectual abilities increase by 300% compared to the average.

Also interesting is the fact that after 60 years, a person can use 2 hemispheres at the same time.  This allows you to solve much more complex problems.

Professor Monchi Uri, from the University of Montreal, believes that the old man’s brain chooses the path that consumes less energy, eliminates the unnecessary and leaves only the right options to solve the problem.  A study was conducted involving different age groups.  Young people were very confused when passing the tests, while those over 60 years of age made the right decisions.

Now, let’s look at the characteristics of the brain between the ages of 60 and 80.  They are really pink.  *CHARACTERISTICS OF THE BRAIN OF AN ELDERLY PERSON.*

1. Neurons in the brain do not die, as everyone around you says.  The connections between them simply disappear if one does not engage in mental work.
2. Distraction and forgetfulness arise due to an overabundance of information.  Therefore, it is not necessary for you to concentrate your whole life on unnecessary trifles.
3. From the age of 60, a person, when making decisions, does not use one hemisphere at the same time, like young people, but both.
4. Conclusion: if a person leads a healthy lifestyle, moves, has viable physical activity and is fully mentally active, intellectual abilities do NOT decrease with age, they simply GROW, reaching a peak at the age of 80-90 years .

So do not be afraid of old age.  Strive to develop intellectually.  Learn new crafts, make music, learn to play musical instruments, paint pictures!  Dance!  Take an interest in life, meet and communicate with friends, plan for the future, travel as best you can.  Do not forget to go to shops, cafes, shows.  Don’t shut up alone, it’s destructive to anyone.  Live with the thought: all good things are still ahead of me! (SOURCE: New England Journal of Medicine)

A team of Indian scientists has developed a breakthrough output in collaboration with Atlanta’s Emory University—a coronavirus countering unique monoclonal antibody that effectively neutralizes a wide range of COVID-19 variants.

The collaboration between the scientists at the Delhi-based International Centre for Genetic Engineering and Biotechnology (ICGEB), funded by the ICMR and Emory Vaccine Center (EVC) effectively neutralizes a wide range of SARS-CoV-2 variants including Alpha, Beta, Gamma, and the different Omicron sub-lineages including, BA.1, BA.2 and others., Dr. Rafi Ahmed, Director, Emory Vaccine Center, told NRI Pulse. The antibody has been tagged 002-S21F2.

002-S21F2 is a dream come true for scientists and researchers who, since the emergence of the pandemic, have been in pursuit of a single antibody that can fight not only one strain of the virus but subsequent variants.

Dr. Ahmed says, is a result of research carried out on patients in India who had mild cases of the original Wuhan strain of Covid-19. The collaborative research was carried out by ICGEB in partnership with the National Institute of Malaria Research (ICMR-NIMR, New Delhi) working with the Emory Vaccine Center (Atlanta, USA).  Dr. Ahmed credits the discovery to Dr. Anmol Chandele, who serves as the Group Lead at ICGEB and resides in Delhi and Dr. Murali-Krishna Kaja, who splits his research time between Atlanta and New Delhi.

The screening of single-cell Memory B cells, the organisms that create lifelong immunity to infecting pathogens, derived from covid-19 recovered patients from India was the base of the research and discovery.

Antibodies target particular cell surfaces and either destroy the infected cell or eradicate the virus from the host. Monoclonal antibody (protein) is produced from a cell line made by cloning a unique white blood cell.

“Scientists at ICGEB generated a batch of over 300 different antibodies that came from different patients in India who were affected by the original Wuhan strain,” Dr Ahmed says. “At the time, there were no new variants. So most of the antibodies that were generated by our lab were able to neutralize the Wuhan strain, and not surprisingly, did not react effectively with other strains, because typically antibodies are very effective against the strain the infected them.”

But the team was lucky. “Two, out of the 300 or so monoclonals we discovered, were broadly cross-reactive, and one antibody, in particular, is a very rare one as described anywhere. It not only neutralized the Wuhan strain but the Delta, Beta and also Omicron and its sub-lineages including, BA.1, BA.2 and many others. And then a group of structural biologists at Emory in Atlanta, with Dr. Anamika Patel and Dr. Eric Ortlund researched reasons to find out why the antibody was so successful in neutralizing all the variants.”

“It turned out that this (antibody) is seeing a very unique part of the spike protein (the spike you see in the pictures everywhere) is what binds to the cellular receptor. So, if that is blocked, the binding is blocked. This monoclonal was seeing it from an angle which was common to all variants and not limited to any one type. It is actually a better monoclonal in terms of any of the other licensed monoclonals across the world. They are not as effective as this one,” Dr. Ahmed elaborated.

Unlike other monoclonal antibodies that target the (virus) areas that are a hotspot for mutation, 002-S21F2 attacks the protein spikes (portion of the virus) that remain the same across all variants. It targets a highly conserved area on the outer surface of the receptor binding domain of the virus, and with 002-S21F2 being broad-spectrum, neutralizes all the known variants. And since it is derived from human strains, tolerance is not an issue.

“We are now hoping is that the Indian government will work with the appropriate pharmaceutical companies in India. This antibody is patented in India, so it can be used in India and produced by a pharmaceutical company in India and we want to ensure that it is not expensive to buy for patients,” Dr. Ahmed notes.

“If produced quickly it could be of great value, particularly in immuno-compromised patients, or someone who is really sick or for people with cancers related to immune systems, lymphoma, multiple myeloma, or transplant patients who are on immunosuppressive regimen who cannot be given vaccines,” he added.

Antibodies cannot be administered to everybody. They have a short half life – meaning they disappear from the body after a few weeks because there is nothing to produce it. While vaccines can be made available to everyone, antibody treatments are the solution to specialized cases with immediate requirements such as immunocompromised cases mentioned above.

Newswise — When the U.S. Food and Drug Administration gave controversial accelerated approval to the first Alzheimer’s drug in nearly 20 years, it had a surprising impact on attitudes about research into the disease. A survey by University of California, Irvine neuroscientists has found news coverage of the FDA’s decision made the public less willing to volunteer for Alzheimer’s pharmaceutical trials.

The study was conducted by the UCI Institute for Memory Impairments and Neurological Disorders, known as UCI MIND. It appears in the Journal of Alzheimer’s Disease. (Link to abstract: https://content.iospress.com/articles/journal-of-alzheimers-disease/jad220801)

The UCI team performed the survey in tandem with the FDA’s spring 2021 consideration of aducanumab. The monoclonal antibody reduces brain plaques, an Alzheimer’s hallmark, in people with the condition. A panel of outside experts advised the FDA against approval, saying aducanumab’s ability to decrease plaques hadn’t shown an impact on the disease’s clinical progression. The agency’s controversial go-ahead and further disaccord over the drug’s labeling and price captured widespread media attention.

The UCI MIND researchers conducted their study among people aged 50 to 79 who had expressed willingness to take part in drug research. Two weeks before the FDA’s decision, UCI MIND asked respondents if they would be interested in enrolling in a hypothetical four-year study of a plaque-reducing monoclonal antibody and a plaque-preventing drug known as a BACE inhibitor. Eight days after the FDA gave aducanumab the green light, UCI MIND sent survey participants a similar questionnaire with a new section about the monoclonal antibody and its approval.

“We found those who had heard about the FDA decision before our follow up became less willing to take part in a drug trial,” said neurobiology & behavior graduate student Marina Ritchie, corresponding author of the paper. “The people who learned about it from our materials demonstrated absolutely no change in their willingness.”

UCI MIND Director Joshua Grill added: “This is surprising, because it goes against some of our previous data showing people are generally more willing to take part in studies involving approved drugs compared to investigational ones. We believe it could be evidence of the powerful influence of media coverage of science.”

The survey’s findings may offer important insights for Alzheimer’s disease researchers. “Alzheimer’s is the most important medical condition society faces and we need an army of citizen volunteers to participate in drug trials,” said Grill, a professor of neurobiology & behavior and psychiatry & human behavior. “Anything that diminishes credibility in scientific research impedes our progress. Media coverage has the potential to influence people’s choices. That can hold us back or push us forward.”

The findings also show researchers need to be aware of sample bias. It occurs when people with certain characteristics participate in a study at a higher rate than others without those traits or if some research population segments are not fairly represented.

“It’s crucial for trial participants to reflect the scope of people affected by the disease,” Ritchie said. “One thing we don’t know is whether the impact of media attention may be more or less important for particular groups, especially groups underrepresented in research.”

The UCI MIND team plans to conduct further research into the issue, with emphasis on learning how to better ensure diverse populations are part of Alzheimer’s clinical trials. “We need to understand what barriers to trust may exist and overcome them so our research is inclusive and applicable to everyone,” Grill said. Funding for the project was provided by the UCI Alzheimer’s Disease Research Center.

A toddler is thriving after doctors in the U.S. and Canada used a novel technique to treat her before she was born for a rare genetic disease that caused the deaths of two of her sisters.

Ayla Bashir, a 16-month-old from Ottawa, Ontario, is the first child treated as fetus for Pompe disease, an inherited and often fatal disorder in which the body fails to make some or all of a crucial protein.

Today, she’s an active, happy girl who has met her developmental milestones, according to her father, Zahid Bashir and mother, Sobia Qureshi.

“She’s just a regular little 1½-year-old who keeps us on our toes,” Bashir said. The couple previously lost two daughters, Zara, 2½, and Sara, 8 months, to the disease. A third pregnancy was terminated because of the disorder.

In a case study published Wednesday in the New England Journal of Medicine, doctors describe an international collaboration during the COVID-19 pandemic that led to the treatment that may have saved Ayla’s life – and expanded the field of potential fetal therapies. The outlook for Ayla is promising but uncertain.

“It holds a glimmer of hope for being able to treat them in utero instead of waiting until damage is already well-established,” said Dr. Karen Fung-Kee-Fung, a maternal-fetal medicine specialist at The Ottawa Hospital who gave the treatment and delivered Ayla.

Fung-Kee-Fung was following a new treatment plan developed by Dr. Tippi MacKenzie, a pediatric surgeon and co-director of the Center for Maternal-Fetal Precision Medicine at the University of California, San Francisco, who shared her research after the pandemic prevented Ayla’s mother from traveling for care. “We were all motivated to make this happen for this family,” MacKenzie said.

Doctors have treated fetuses before birth for three decades, often with surgeries to repair birth defects such as spina bifida. And they’ve given blood transfusions to fetuses through the umbilical cord, but not medicines. In this case, the crucial enzymes were delivered through a needle inserted through the mother’s abdomen and guided into a vein in the umbilical cord. Ayla received six biweekly infusions that started at about 24 weeks of gestation.

“The innovation here wasn’t the drug and it wasn’t accessing the fetal circulation,” said Dr. Pranesh Chakraborty, a metabolic geneticist at Childrens Hospital of Eastern Ontario, who has cared for Ayla’s family for years. “The innovation was treating earlier and treating while still in utero.”

The unusual partnership also involved experts at Duke University in Durham, N.C., which has led research on Pompe disease, and University of Washington in Seattle.

Babies with Pompe disease are often treated soon after birth with replacement enzymes to slow devastating effects of the condition, which affects fewer than 1 in 100,000 newborns. It is caused by mutations in a gene that makes an enzyme that breaks down glycogen, or stored sugar, in cells. When that enzyme is reduced or eliminated, glycogen builds up dangerously throughout the body.

In addition, the most severely affected babies, including Ayla, have an immune condition in which their bodies block the infused enzymes, eventually stopping the therapy from working. The hope is that Ayla’s early treatment will reduce the severity of that immune response.

Babies with Pompe disease have trouble feeding, muscle weakness, floppiness and, often, grossly enlarged hearts. Untreated, most die from heart or breathing problems in the first year of life.

In late 2020, Bashir and Qureshi had learned they were expecting Ayla and that prenatal tests showed she, too, had Pompe disease.

“It was very, very scary,” recalled Qureshi. In addition to the girls who died, the couple have a son, Hamza, 13, and a daughter, Maha, 5, who are not affected.

Both parents carry a recessive gene for Pompe disease, which means there’s a 1 in 4 chance that a baby will inherit the condition. Bashir said their decision to proceed with additional pregnancies was guided by their Muslim faith.

“We believe that what will come our way is part of what’s meant or destined for us,” he said. They have no plans for more children, they said.

Chakraborty had learned of MacKenzie’s early stage trial to test the enzyme therapy and thought early treatment might be a solution for the family.

The treatment could be “potentially very significant,” said Dr. Brendan Lanpher, a medical geneticist at the Mayo Clinic in Rochester, Minn., who was not involved in the research.

“This is a progressive disease that builds up over time, so every day a fetus or baby has it, they’re accumulating more of the material that affects muscle cells.”

Still, it’s too early to know whether the protocol will become accepted treatment, said Dr. Christina Lam, interim medical director of biochemical genetics at the University of Washington and Seattle Children’s Hospital in Seattle.

“It’s going to take some time to really be able to establish the evidence to definitively show that the outcomes are better,” she said.

In the winter of 2019, a number of children living in India’s Jammu region began falling sick with what many thought was a mysterious illness. 

The children, suffering from cough and cold, had been prescribed a cough syrup by local doctors. Instead of recovering, they fell seriously ill, vomiting, running high fever and kidneys shutting down. By the time the mystery was solved, 11 children, aged between two months and six years, had died.

Tests found that three samples of the cough syrup, made by an Indian drug company called Digital Vision, contained diethylene glycol or DEG, an industrial solvent used in the making of paints, ink, brake fluids. Kidney failure is common after consuming this poisonous alcohol. 

India production halted after Gambia child fatalities

Earlier this month, the World Health Organization (WHO) put out a global warning over four India-made cough syrups thought to be linked to the deaths of 66 children in The Gambia. Lab analysis of the samples of a syrup made by a 32-year-old firm called Maiden Pharmaceuticals Limited confirmed the presence of “unacceptable amounts” of diethylene glycol and another toxic alcohol called ethylene glycol. 

The tainted drugs and the tragic deaths again shone a spotlight on India’s $42bn – half of the revenues come from exports – drug manufacturing industry. 

Some 3,000 firms operate 10,000 pharmaceutical factories making generics (copies of branded medicines that usually sell for a fraction of their price), over-the-counter medicines, vaccines and ingredients in what is one of the world’s largest drug-making countries. Although India imports 70% of the active ingredient chemicals for its medicines from China, it is trying to make more of them at home. 

Prime Minister Narendra Modi has championed India as the “pharmacy of the world”. India’s traditional expertise in making generics has helped make it a formidable low-cost maker of drugs and become a global manufacturing base. 

Some 40% of over-the-counter and generic medicines sold in the US and a quarter of all medicines dispensed in the UK come from India. The country supplies some two-thirds of anti-retroviral drugs globally to fight HIV. Outside the USA, India has the most number of drug making plants – 800 – that are compliant with the US health and safety requirements. 

Yet such breathless growth – the industry has been running at a clip of over 9% every year for nearly a decade – has been clouded by allegations of problems of quality and weak regulation. 

Gambia cough syrup scandal: Mothers demand justice

Many believe that India has always battled a flood of counterfeit drugs, mostly sold in small towns and villages. But analysts say the physicians and patients are possibly conflating sub-standard drugs with what they think are fake medicines. State-run drug testing labs in many states are under-funded, short-staffed and poorly equipped. Regulatory oversight and enforcement is unsurprisingly spotty, analysts say. In 2014, India’s top drug regulator famously told a newspaper: “If I follow US standards I will have to shut almost all drug facilities.” 

More than 70 people, mostly children, have died in five separate mass poisoning incidents related to drugs spiked with DEG since 1972. 

In 2013, after a seven-year long investigation, top Indian drug maker Ranbaxy Laboratories was ordered to pay a record $500m fine in the US, the biggest handed down to a generic drug maker for improper manufacturing, storing and testing of drugs. 

Official government records reveal that between 2007 and 2020, more than 7,500 drugs sampled in just three of India’s 28 states and three union territories had failed quality tests and had been declared drugs “not of standard quality” or inferior, research by Dinesh Thakur, a former Indian drug executive-turned-public health expert, found. 

These drugs failed tests for not having enough of ingredient chemicals, impaired ability to dissolve in the patients’ blood or were found to be contaminated. 

Each failed sample typically represents a batch of the medicine, which in turn could run into hundreds of thousands of tablets, capsules and injections. “The total number of patients affected by such inferior drugs possibly runs into hundreds of thousands, perhaps millions over the last decade,” says Mr Thakur, co-author of The Truth Pill, a piercing look at drug regulation in India. 

Cough-syrup scandal: How did it end up in The Gambia?

Mr Thakur says he worries that many Indian firms are not following “good manufacturing practices” or GMP, a drug industry term to refer to testing for quality control. He believes that the DEG-related incidents had occurred at home – and now abroad – because some firms “quite often fail to test either the raw materials or the final formulation before shipping it to the market”. 

“Given the sheer quality of drugs detected as “not of standard quality” over the last decade from the open market it is obvious that a large number of manufacturing facilities are completely flouting quality and process control procedures that form the core of ‘good manufacturing practices'” says Mr Thakur. 

That’s not all. Using right to information law, Mr Thakur found many of India’s state-owned drug testing labs lacked key equipment. Drug sampling practices, he noted, date back to a colonial 1875 law where inspectors pick up a small number of random samples from the market. 

India has been debating a law to recall drugs that have been found to be inferior from the market since nearly half a century. “All it has are guidelines, which many state regulators seem to be unaware of. Have you ever heard of a drug recalled in India?” says Mr Thakur. 

It is difficult to understand the scale of the problem – many of India’s drug factories are indeed world-class. Physicians say they largely trust India-made drugs. 

Dr Rahul Baxi, a Mumbai-based diabetologist, told me that only once in recent years he became suspicious about a drug when glucose levels of a patient shot up after he switched off from branded drug to a cheaper generic. 

But he suspects that there could be counterfeit or inferior drugs being sold in small towns and villages. “Many of my patients that come from far flung parts of India buy six months of prescribed drugs from pharmacies in the city because they say they don’t trust drugs available in their areas,” Dr Baxi said.

After the deaths of the children in The Gambia, India claimed that its federal regulator was “robust” and sought more details from the WHO on the causality of the deaths with the exported cough syrup. 

Food and Drug Administration (FDA), which regulates medical products in the US, posts inspection status of firms supplying drugs to the US and warning letters. A spokesperson told me that its policies ensure that “companies – regardless of where the are located – meet the FDA’s strict standards for producing medicines for US patients that are high quality, safe and effective”.

A pharmaceutical industry leader, insisting on anonymity, told me that “although some countries do have very rigid quality standards”, India’s drugs were completely safe. “We are not defending the mishaps,” he said, “but these are aberrations”. Mr Thakur says: “An aberration should only happen once. You can’t play with people’s lives”.  (BBC.COM)

A new study led by a neuroscientist from the Centre for Brain Research at the Indian Institute of Science (IISc) reveals cells that span brain hemispheres to coordinate activity in visual processing centres, and shows that Alzheimer’s degrades their structure and therefore their function.

The results of the study, published in Neuron by a research team based at The Picower Institute for Learning and Memory in Cambridge, MA, come from experiments in mice, but provide a physiological and mechanistic basis for prior observations in human patients: the degree of diminished brain rhythm synchrony between counterpart regions in each hemisphere correlates with the clinical severity of dementia.

“We demonstrate that there is a functional circuit that can explain this phenomenon,” said lead author Chinnakkaruppan Adaikkan, a former Picower Institute postdoc who is now an assistant professor in the Centre for Brain Research at the Indian Institute of Science (IISc) in Bangalore. “In a way, we uncovered a fundamental biology that was not known before.”

Specifically, Adaikkan’s work identified neurons that connect the primary visual cortex (V1) of each hemisphere and showed that when the cells are disrupted, either by genetic alterations that model Alzheimer’s disease or by direct laboratory perturbations, brain rhythm synchrony becomes reduced and mice become significantly less able to notice when a new pattern appeared on a wall in their enclosures. Such recognition of novelty, which requires visual memory of what was there the prior day, is an ability commonly disrupted in Alzheimer’s.

“This study demonstrates the propagation of gamma rhythm synchrony across the brain hemispheres via the cross hemispheric connectivity,” said study senior author Li-Huei Tsai, Picower Professor and director of The Picower Institute and MIT’s Aging Brain Initiative. “It also demonstrates that the disruption of this circuit in AD mouse models is associated with specific behavioral deficits.”

In the study, Adaikkan, Tsai, Thomas McHugh and co-authors discovered and traced V1 neurons that extended their axons all the way through the corpus callosum, which connects the brain’s hemispheres, to cells in the V1 on the brain’s other side. There, they found, the cross-hemispheric (CH) neurons forged connections, or synapses, with target cells, providing them with “excitatory” stimulation to drive their activity.

Adaikkan also found that CH neurons were much more likely to be activated by a novelty discrimination task than V1 neurons in general or neurons in other regions heavily involved in memory such as the hippocampus or the prefrontal cortex.

Curious about how this might differ in Alzheimer’s disease, the team looked at the activity of the cells in two different Alzheimer’s mouse models. The found that CH cell activity was significantly lessened amid the disease. Unsurprisingly, Alzheimer’s mice fared much poorer in novelty discrimination tasks.

The team examined the CH cells closely and found that they gather incoming input from a variety of other cells within their V1 and other regions in their hemisphere that process visual information. When they compared the incoming connections of healthy CH neurons to those in CH cells afflicted with Alzheimer’s, they found that cells in the disease condition had significantly less infrastructure for hosting incoming connections (measured in terms of synapse-hosting spines protruding from the vine-like dendrites that sprawl out of the cell body).

Given the observations correlating reduced brain rhythm synchrony and memory performance in Alzheimer’s, the team wondered if that occurred in the mice, too.

To find out, they custom-designed electrodes to measure rhythmic activity simultaneously in all cortical layers of each hemisphere’s V1. They observed that cross-hemispheric synchrony increased notably between the V1s when mice engaged in novelty discrimination but that the synchrony, both at high “gamma” and lower “theta” frequency rhythms, was significantly lower in the Alzheimer’s mice than it was in healthy mice.

Adaikkan’s evidence at that point was strong, but still only suggestive, that CH neurons provided the means by which the V1 regions on each side of the brain could coordinate to enable novelty discrimination, and that this ability became undermined by Alzheimer’s degradation of the CH cells’ connectivity. To more directly determine whether the CH circuit played such a causal, consequential role, the team directly intervened to disrupt them, testing what effect targeted perturbations had.

They found that chemically inhibiting CH cells disrupted rhythm synchrony between V1s, mirroring measures made in Alzheimer’s model mice. Moreover, disrupting CH activity undermined novelty discrimination ability. To further test whether it was the cells’ cross-hemispheric nature that mattered specifically, they engineered CH cells to be controllable with flashes of light (a technology called “optogenetics”). When they shined the light on the connections, they forged in the other hemisphere to inhibit those, they found that doing so again compromised visual discrimination ability.

All together, the study results show that CH cells in V1 connect with neurons in the counterpart area of the opposite hemisphere to synchronize neural activity needed for properly recognizing novelty, but that Alzheimer’s disease damages their ability to do that job.

The U.S. Food and Drug Administration has authorized updated COVID-19 booster shots from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna that target the dominant BA.4 and BA.5 Omicron subvariants, as the government prepares for a broad fall vaccination campaign that could begin within days.

The new vaccines also include the original version of the virus targeted by all the previous COVID shots. The FDA authorized the shots for everyone ages 12 and older who has had a primary vaccination series and is at least two months out from a previous booster shot, shorter than prior recommended intervals.

Dr. Peter Marks, a senior FDA official overseeing vaccines, said he hopes the shots will restore the very good protection against symptomatic disease that the original vaccines offered when launched in late 2020 and early 2021.

The Washington Post (8/31, McGinley) reports, “New Omicron-targeting coronavirus booster shots are poised for rollout after being authorized Wednesday by the Food and Drug Administration – a move designed to improve protection against severe illness and death during a potential rise in COVID-19 cases this fall and winter.” These bivalent “boosters, reformulated to take aim at the BA.4 and BA.5 Omicron subvariants dominant in the United States, are scheduled to be reviewed by advisers to the” CDC and if approved, “some boosters may be available starting this weekend, with more showing up in pharmacies, [physicians’] offices and clinics after Labor Day.”

The AP (8/31, Neergaard) reports, “The updated boosters are only for people who have already had their primary vaccinations, using the original vaccines.” The shots “made by Pfizer and its partner BioNTech are for anyone 12 and older while Moderna’s updated shots are for adults – if it has been at least two months since their last primary vaccination or their latest booster.”

The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.

The monovalent COVID-19 vaccines that are authorized or approved by the FDA and have been administered to millions of people in the United States since December 2020 contain a component from the original strain of SARS-CoV-2.

What you need to know:

• The authorized bivalent COVID-19 vaccines, or updated boosters, include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant.
• The BA.4 and BA.5 lineages of the omicron variant are currently causing most cases of COVID-19 in the U.S. and are predicted to circulate this fall and winter. In June, the agency’s Vaccines and Related Biological Products Advisory Committee voted overwhelmingly to include an omicron component in COVID-19 booster vaccines.
• For each bivalent COVID-19 vaccine, the FDA based its decision on the totality of available evidence, including extensive safety and effectiveness data for each of the monovalent mRNA COVID-19 vaccines, safety and immunogenicity data obtained from a clinical study of a bivalent COVID-19 vaccine that contained mRNA from omicron variant BA.1 lineage that is similar to each of the vaccines being authorized, and nonclinical data obtained using a bivalent COVID-19 vaccine that contained mRNA of the original strain and mRNA in common between the BA.4 and BA.5 lineages of the omicron variant.
• Based on the data supporting each of these authorizations, the bivalent COVID-19 vaccines are expected to provide increased protection against the currently circulating omicron variant. Individuals who receive a bivalent COVID-19 vaccine may experience side effects commonly reported by individuals who receive authorized or approved monovalent mRNA COVID-19 vaccines.
• With today’s authorization, the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older.
• The agency will work quickly to evaluate future data and submissions to support authorization of bivalent COVID-19 boosters for additional age groups as we receive them.

Who is eligible to receive a single booster dose and when:

• Individuals 18 years of age and older are eligible for a single booster dose of the Moderna COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
• Individuals 12 years of age and older are eligible for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said FDA Commissioner Robert M. Califf, M.D. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”

The Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent contain mRNA from the SARS-CoV-2 virus. The mRNA in these vaccines is a specific piece of genetic material that instructs cells in the body to make the distinctive “spike” protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical.

“The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants. We sought input from our outside experts on the inclusion of an omicron component in COVID-19 boosters to provide better protection against COVID-19. We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently. The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization.”

For each of the bivalent COVID-19 vaccines authorized today, the FDA evaluated immunogenicity and safety data from a clinical study of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages. Furthermore, data pertaining to the safety and effectiveness of the current mRNA COVID-19 vaccines, which have been administered to millions of people, including during the omicron waves of COVID-19, contributed to the agency’s evaluation.

Data Supporting the Moderna COVID-19 Vaccine, Bivalent Authorization

To evaluate the effectiveness of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for individuals 18 years of age and older, the FDA analyzed immune response data among approximately 600 individuals 18 years of age and older who had previously received a two-dose primary series and one booster dose of monovalent Moderna COVID-19 Vaccine. These participants received a second booster dose of either the monovalent Moderna COVID-19 Vaccine or Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1) at least 3 months after the first booster dose. After 28 days, the immune response against BA.1 of the participants who received the bivalent vaccine was better than the immune response of those who had received the monovalent Moderna COVID-19 Vaccine.

The safety of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for individuals 18 years of age and older is supported by safety data from a clinical study which evaluated a booster dose of Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1), safety data from clinical trials which evaluated primary and booster vaccination with the monovalent Moderna COVID-19 Vaccine, and postmarketing safety data with the monovalent Moderna COVID-19 Vaccine.

The safety data accrued with the bivalent vaccine (original and omicron BA.1) and with the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

The clinical study that evaluated the safety of a booster dose of the bivalent vaccine (original and omicron BA.1) included approximately 800 participants 18 years of age and older who had previously received a two dose primary series and one booster dose of the monovalent Moderna COVID-19 Vaccine, and then at least 3 months later, received a second booster dose with either the monovalent Moderna COVID-19 Vaccine or Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1).

Among the study participants who received the bivalent vaccine, the most commonly reported side effects included pain, redness and swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, swelling of the lymph nodes in the same arm of the injection, nausea/vomiting and fever.

The fact sheets for both bivalent COVID-19 vaccines for recipients and caregivers and for healthcare providers include information about the potential side effects, as well as the risks of myocarditis and pericarditis.

With the authorization, the FDA has also revised the EUA of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to remove the use of the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for individuals 18 years of age and older and 12 years of age and older, respectively. These monovalent vaccines continue to be authorized for use for administration of a primary series for individuals 6 months of age and older as described in the letters of authorization. At this time, the Pfizer-BioNTech COVID-19 Vaccine remains authorized for administration of a single booster dose for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine.

The compound in psychedelic mushrooms helped heavy drinkers cut back or quit entirely in the most rigorous test of psilocybin for alcoholism, reports here stated. Psilocybin, found in several species of mushrooms, can cause hours of vivid hallucinations. Indigenous people have used it in healing rituals and scientists are exploring whether it can ease depression or help longtime smokers quit. It’s illegal in the U.S., though Oregon and several cities have decriminalized it. Starting next year, Oregon will allow its supervised use by licensed facilitators.

The new research, published last week in JAMA Psychiatry, is “the first modern, rigorous, controlled trial” of whether it can also help people struggling with alcohol, said Fred Barrett, a Johns Hopkins University neuroscientist who wasn’t involved in the study.

In the study, 93 patients took a capsule containing psilocybin or a dummy medicine, lay on a couch, their eyes covered, and listened to recorded music through headphones. They received two such sessions, one month apart, and 12 sessions of talk therapy.

The Associated Press reports, “The compound in psychedelic mushrooms helped heavy drinkers cut back or quit entirely in the most rigorous test of psilocybin for alcoholism,” investigators concluded in a study in which “93 patients took a capsule containing psilocybin or a dummy medicine, lay on a couch, their eyes covered, and listened to recorded music through headphones.” Participants “received two such sessions, one month apart, and 12 sessions of talk therapy.”

NBC News reports the study revealed that “more than 80% of those who were given the psychedelic treatment had drastically reduced their drinking eight months after the study started, compared to just over 50% in the antihistamine control group,” according to findings published online Aug. 24 in JAMA Psychiatry. In fact, “at the end of the trial, half of those who received psilocybin had quit drinking altogether, compared to about one-quarter of those who were given the antihistamine.”

Mary Beth Orr, 69, of Burien, Washington, said her psilocybin-induced hallucinations — flying over breathtaking landscapes and merging telepathically with creative people throughout history — taught her she wasn’t alone. Before enrolling in the study in 2018, Orr had five or six drinks every evening and more on weekends. “The quantity was unacceptable and yet I couldn’t stop,” she said. “There was no off switch that I could access.”

During her first psilocybin experience, she saw a vision of her late father, who gave her a pair of eagle eyes and said, “Go.” She told the therapists monitoring her: “These eagle eyes can’t see God’s face, but they know where it is.”

She stopped drinking entirely for two years, and now has an occasional glass of wine. More than the talk therapy, she credits psilocybin. “It made alcohol irrelevant and uninteresting to me,” Orr said. Now, “I am tethered to my children and my loved ones in a way that just precludes the desire to be alone with alcohol.”

Patients receiving psilocybin had more headaches, nausea and anxiety than those getting the dummy drug. One person reported thoughts of suicide during a psilocybin session. In an experiment like this, it’s important that patients don’t know or guess if they got the psilocybin or the dummy drug. To try to achieve this, the researchers chose a generic antihistamine with some psychoactive effects as the placebo. Still, most patients in the study correctly guessed whether they got the psilocybin or the dummy pill.

A study published this week in the Lancet Psychiatry showed increased risks of some brain disorders two years after infection with the coronavirus, shedding new light on the long-term neurological and psychiatric aspects of the virus.

The analysis, conducted by researchers at the University of Oxford and drawing on health records data from more than 1 million people around the world, found that while the risks of many common psychiatric disorders returned to normal within a couple of months, people remained at increased risk for dementia, epilepsy, psychosis and cognitive deficit (or brain fog) two years after contracting covid. Adults appeared to be at particular risk of lasting brain fog, a common complaint among coronavirus survivors.

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The study was a mix of good and bad news findings, said Paul Harrison, a professor of psychiatry at the University of Oxford and the senior author of the study. Among the reassuring aspects was the quick resolution of symptoms such as depression and anxiety.

“I was surprised and relieved by how quickly the psychiatric sequelae subsided,” Harrison said.

David Putrino, director of rehabilitation innovation at Mount Sinai Health System in New York, who has been studying the lasting impacts of the coronavirus since early in the pandemic, said the study revealed some very troubling outcomes.

“It allows us to see without a doubt the emergence of significant neuropsychiatric sequelae in individuals that had covid and far more frequently than those who did not,” he said.

Because it focused only on the neurological and psychiatric effects of the coronavirus, the study authors and others emphasized that it is not strictly long-covid research.

“It would be overstepping and unscientific to make the immediate assumption that everybody in the [study] cohort had long covid,” Putrino said. But the study, he said, “does inform long-covid research.”

Between 7 million and 23 million people in the United States have long covid, according to recent government estimates – a catchall term for a wide range of symptoms including fatigue, breathlessness and anxiety that persist weeks and months after the acute infection has subsided. Those numbers are expected to rise as the coronavirus settles in as an endemic disease.

The study was led by Maxime Taquet, a senior research fellow at the University of Oxford who specializes in using big data to shed light on psychiatric disorders.

The researchers matched almost 1.3 million patients with a diagnosis of covid-19 between Jan. 20, 2020, and April 13, 2022, with an equal number of patients who had other respiratory diseases during the pandemic. The data, provided by electronic health records network TriNetX, came largely from the United States but also included data from Australia, Britain, Spain, Bulgaria, India, Malaysia and Taiwan.

The study group, which included 185,000 children and 242,000 older adults, revealed that risks differed according to age groups, with people age 65 and older at greatest risk of lasting neuropsychiatric affects.

For people between the ages of 18 and 64, a particularly significant increased risk was of persistent brain fog, affecting 6.4 percent of people who had had covid compared with 5.5 percent in the control group.

Six months after infection, children were not found to be at increased risk of mood disorders, although they remained at increased risk of brain fog, insomnia, stroke and epilepsy. None of those affects were permanent for children. With epilepsy, which is extremely rare, the increased risk was larger.

The study found that 4.5 percent of older people developed dementia in the two years after infection, compared with 3.3 percent of the control group. That 1.2-point increase in a diagnosis as damaging as dementia is particularly worrisome, the researchers said.

The study’s reliance on a trove of de-identified electronic health data raised some cautions, particularly during the tumultuous time of the pandemic. Tracking long-term outcomes may be hard when patients may have sought care through many different health systems, including some outside the TriNetX network.

“I personally find it impossible to judge the validity of the data or the conclusions when the data source is shrouded in mystery and the sources of the data are kept secret by legal agreement,” said Harlan Krumholz, a Yale scientist who has developed an online platform where patients can enter their own health data.

Taquet said the researchers used several means of assessing the data, including making sure it reflected what is already known about the pandemic, such as the drop in death rates during the omicron wave.

Also, Taquet said, “the validity of data is not going to be better than validity of diagnosis. If clinicians make mistakes, we will make the same mistakes.”

The study follows earlier research from the same group, which reported last year that a third of covid patients experienced mood disorders, strokes or dementia six months after infection with the coronavirus.

While cautioning that it is impossible to make full comparisons among the effects of recent variants, including omicron and its subvariants, which are currently driving infections, and those that were prevalent a year or more ago, the researchers outlined some initial findings: Even though omicron caused less severe immediate symptoms, the longer-term neurological and psychiatric outcomes appeared similar to the delta waves, indicating that the burden on the world’s health-care systems might continue even with less-severe variants.

Hannah Davis, a co-founder of the Patient-Led Research Collaborative, which studies long covid, said that finding was meaningful. “It goes against the narrative that omicron is more mild for long covid, which is not based on science,” Davis said.

“We see this all the time,” Putrino said. “The general conversation keeps leaving out long covid. The severity of initial infection doesn’t matter when we talk about long-term sequelae that ruin people’s lives.”

The US has approved a new type of eye drop which they say could eliminate the need for reading glasses, media reports here say. The FDA (Food and Drug Administration) recently approved the use of an eye drop designed to improve age-related near-vision, reports Express.co.uk.

Called Vuity, the drop is applied to each eye once a day and starts working within 15 minutes of application. The makers say each drop lasts for at least six hours. As per the report, the drug is a formulation of a well-known compound known as pilocarpine.

The prescription medication Vuity treats age-related blurry vision, also known as presbyopia.  It’s a condition common enough to affect approximately 128 million people in the United States as the muscles in the eyes require more effort to focus.

Although the condition is common, it doesn’t mean we have to live with it. For people tired of always looking for reading glasses or squinting their eyes trying to read a product label, a daily dose of Vuity could help.

The researchers behind Vuity designed it to allow for the eye drop to rapidly adjust to the pH of the tear film. What the drop does is take advantage of the eye’s ability to reduce pupil size, improve near-vision whilst maintaining distance vision.

The drop has been found to be most effective for those between the ages of 40 and 55. Results have come from two randomized control trials on 750 subjects, the report said.

It was during these studies that Vuity was observed to start working within 15 minutes of application.

In a positive piece of news, the drops were found to result in no serious side effects. However, some patients experienced mild headaches and eye redness. (IANS)

World’s first trial, led by an Indian American doctor, on a mRNA-based vaccine for pancreatic cancer has shown promise for remission.

The new shot is developed by BioNTech based on the same technology used by the German biotech company along with its US partner Pfizer to develop vaccines against Covid-19.

The groundbreaking trial led by Dr Vinod Balachandran at the Memorial Sloan Kettering Cancer Center (MSK) in New York, showed that half of the patients remained cancer-free 18 months after having their tumours removed and receiving the jabs.

The key to these vaccines appears to be proteins in the pancreatic tumours, called neoantigens, which alert the immune system to keep the cancer at bay, according to MSK. The promising results were also presented at the American Society of Clinical Oncology conference in Chicago.

In 8 of 16 patients studied, the vaccines activated T cells that recognise the patient’s own pancreatic cancers. These patients also showed delayed recurrence of their pancreatic cancers, suggesting the T cells activated by the vaccines may be having the desired effect to keep pancreatic cancers in check.

According to Balachandran, mRNA vaccines could stimulate the immune system to recognise and attack pancreatic cancer cells.

“Unlike some of the other immunotherapies, these mRNA vaccines do appear to have the ability to stimulate immune responses in pancreatic cancer patients,” Balachandran said of the promising preliminary results.

“So we’re very excited about that, and the early results suggest that if you have an immune response, you may have a better outcome.”

Balachandran added the results should be welcome news for other cancer patients too, as pancreatic cancer has been very difficult to treat with traditional chemotherapies and immunotherapies.

The phase-I trial was also heralded as “encouraging” by BioNTech.

“We are committed to taking up this challenge by leveraging our long-standing research in cancer vaccinology and are trying to break new ground in the treatment of such hard-to-treat tumours,” BioNTech co-founder and chief medical officer Prof Ozlem Tureci said.

In a medical trial, 12 patients in the US were completely cured of rectal cancer without requiring any surgery or chemotherapy. A look at the study, and its results

In a medical trial, results of which were published in The Indian Express on Wednesday, 12 patients in the United States were completely cured of rectal cancer without requiring any surgery or chemotherapy.

The trial used a monoclonal antibody called dostarlimab every three weeks for six months for the treatment of a particular kind of stage two or three rectal cancer. The study was done by doctors from the Memorial Sloan Kettering Cancer Centre in New York, and its results have been published in the New England Journal of Medicine.

The trial showed that immunotherapy alone – without any chemotherapy, radiotherapy, or surgery that have been staples of cancer treatment – could completely cure the patients with a particular kind of rectal cancer called ‘mismatch repair deficient’ cancer”.

All 12 patients had completed the treatment and were followed for six to 25 months after. “No cases of progression or recurrence had been reported during the follow-up,” the study said. The response too was rapid, with symptoms resolving in 81% of the patients within nine weeks of starting the therapy.

What is this deficiency, and how was it cured?

‘Mismatch repair deficient’ cancer is most common among colorectal, gastrointestinal, and endometrial cancers. Patients suffering from this condition lack the genes to correct typos in the DNA that occur naturally while cells make copies.

The immunotherapy belongs to a category called PD1 blockades that are now recommended for the treatment of such cancers rather than chemotherapy or radiotherapy. PD1 is a type of protein that regulates certain functions of the immune system, including by suppressing T cell activity, and PD1 blockade therapy looks to release the T cells from this suppression.

“The anomalies in the DNA result in cancerous growths in patients with mismatch repair deficient cancers. If you imagine the immune system to be a car, PD1 acts as the brakes for the T cells of the immune system. By giving the PD1 blockades, we release the brakes and allow the T cells to destroy the cancerous growth,” said Dr P K Julka, former professor of radiotherapy at the All India Institute of Medical Sciences, New Delhi and the current chairman for Max Oncology Daycare Centre. Dr Julka did the first immunotherapy treatment in India while at AIIMS in 2015. He was not involved in the US study.

India has a couple of PD1 blockades available, although not the one used for this study. If PD1 therapy was already in use, what’s new in the trial? Earlier, this therapy was used post-surgery, but the study has shown that a surgery may not be required.

“Although the therapy is usually used for cancers that have metastasised (spread to locations other than where the cancer formed), it is now recommended for all mismatch repair deficient cancers as they result in quicker improvement and lesser toxicity as compared to traditional chemo and radiotherapy. So far, we have been using the therapy after a patient undergoes surgery; it is used for 10 to 15 indications. This study shows that even the surgery was not needed in these patients,” Dr Julka said.

Speaking about his own practice, Dr Julka said that in all tumours, they now look for mismatch repair deficiency to see whether immunotherapy can be used. Eliminating other treatments can improve a patient’s quality of life by preserving fertility, sexual health, and bladder and bowel functions.

Also read |New study recommends next-generation sequencing for extending lung cancer treatment to more patients

When can such a treatment be accessible in India?

Cost is believed to be a major hurdle. Dr M D Ray, professor of surgical oncology at AIIMS-Delhi, who disagrees with the immunotherapy approach, said: “These patients can be well managed with chemotherapy and radiotherapy as well. Around 10 to 15% of cancer patients actually do not need surgeries. The problem with immunotherapies is that they are expensive and unaffordable for most people in India, and certainly for those coming to AIIMS. A genetic test can also cost up to Rs 30,000, the patients here cannot afford all this.”

He added that precision medicine, such as using particular immunotherapy drugs for particular types of cancers, is still at a nascent stage in India. “Precision medicine for cancer treatment is happening in India, but it is still in nascent stages. It would take at least ten years for it to become commonplace,” he said.

An immunotherapy treatment can cost around Rs 4 lakh per month, with patients needing the treatment for six months to a year.

“People may end up using their life-savings for the treatment. We usually end up giving the treatment only to those who can bank on schemes such as CGHS for sponsoring their treatment or receive free doses from the companies as part of their assistance programme,” said Dr Julka.

However, he added: “One day, cancer will be like any other chronic disease. Like people with diabetes go to work after taking a tablet, cancer patients would too. The future of cancer treatment is molecular oncology – you find a mutation in one gene, you give a particular medicine for it; you find it in another, you give another medicine.”

More than one million people have now died of Covid-19 in the US since the pandemic’s start, according to Tuesday data from Johns Hopkins University — a reminder the pandemic is not over even as much of the country pushes to move away from Covid-19 measures.

The US Centers for Disease Control and Prevention estimates that the number of Covid-19 deaths in the US was about 32% higher than reported between February 2020 and September 2021. Provisional data from the CDC also shows the US surpassed the death milestone during the week ending on May 14, and a CNN analysis of data released by the agency shows that severe outcomes disproportionately affected older Americans and minority populations.

About three-quarters of all Covid-19 deaths have been among seniors, including more than a quarter among people 85 and older, according to CDC data. And while racial and ethnic disparities have lessened over the course of the pandemic, the risk of dying from Covid-19 has been about two times higher for Blacks, Hispanics and American Indians compared to Whites in the US.

Last week, President Joe Biden issued a proclamation marking a million deaths and ordered the American flag to fly half-staff, writing that the nation “must not grow numb to such sorrow.”

“To heal, we must remember,” the President said in a statement. “We must remain vigilant against this pandemic and do everything we can to save as many lives as possible.”

And it all comes as Covid-19 cases are rising again across the country, with reported infections more than doubling over the past month in the US overall. New York City reached the “high” Covid-19 alert level, indicating high community spread and “substantial pressure on the health care system,” officials said, and encouraged people to wear high-quality masks in all public indoor settings and crowded outdoor spaces, regardless of whether vaccination status is known.

Across the world, there have been more than 524 million cases reported of the virus since the pandemic’s start — more than 82 million of which have been in the US.

Grim milestones throughout the pandemic

The World Health Organization declared Covid-19 a pandemic on March 11, 2020.

• The US reported its first 100,000 deaths about two and a half months later, by May 23, 2020, according to Johns Hopkins.
• There had been 200,000 deaths reported about four months after that, by September 22, 2020.
• There were 300,000 deaths reported less than three months after that, by December 12, 2020.
• There were 400,000 deaths reported about a month later, by January 17, 2021.
• There were 500,000 deaths reported about another month after that, by February 21, 2021.
• There were 600,000 deaths reported about four months later, by June 16, 2021.
• There were 700,000 deaths reported about three and half months after that, by October 1, 2021.
• There were 800,000 deaths reported about two and a half months after that, by December 13, 2021.
• Less than two months later on February 4, the US reported a total of 900,334 deaths.

Overall, death rates have been higher in the Northeast region of the country and lowest in the West, according to JHU data.

But at the state level, death rates have been highest in Mississippi, Arizona and Oklahoma — each with more than 400 total Covid-19 deaths for every 100,000 people — compared with Vermont and Hawaii, which have had about 100 deaths for every 100,000 people.

Globally, there have been more than 6.2 million reported Covid-19 deaths, according to Johns Hopkins data.

Vaccinations have saved millions of lives

Vaccinations for the virus have saved millions of lives, but about half of all Covid-19 deaths in the US have happened over the past year — when vaccines were already widely available for everyone age 5 and older.

And though the government has not shared an official estimate of how many vaccinated people have died of Covid-19, a CNN analysis of CDC data shows that deaths in recent months have been much more evenly split between vaccinated and unvaccinated people as highly transmissible variants take hold, vaccine protection wanes and booster uptake stagnates.

But the risk of dying from Covid-19 is still about five times higher for unvaccinated people than it is for vaccinated people, according to the CDC.

And evidence continues to build around the critical importance of booster shots.

Of those vaccinated people who died from a breakthrough case of Covid-19 in January and February, less than a third had gotten a booster shot, according to a CNN analysis of data from the CDC. The remaining two-thirds had only received their primary series.

The Food and Drug Administration (FDA) on Monday gave its first full approval for a COVID-19 treatment for children under 12.  The agency granted approval to the treatment remdesivir, also known as Veklury, made by Gilead Sciences, which has already been approved as a treatment for adults.

The treatment was earlier under emergency use authorization for children. Full approval from the FDA provides a more formal and higher level of endorsement than emergency authorization.

Still, the FDA stressed that remdesivir is not a replacement for vaccination, and there is still no authorized vaccine for children under 5, a source of stress and disappointment for some parents.

Rep. James Clyburn (D-S.C.), the chair of the House Select Subcommittee on the Coronavirus Crisis, earlier on Monday requested an FDA briefing on the agency’s progress on authorizing a vaccine for children under five.

Authorization for the Pfizer vaccine for young kids could come in June, though previous timelines have been pushed back before.

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While the virus is generally less dangerous in children, the FDA noted severe illness can still result.   “As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”

The approval covers children 28 days and older who weigh at least 3 kilograms and are either hospitalized or at high-risk of severe illness.

Tags also known as Veklury Coronavirus COVID-19 FDA Food and Drug Administration Gilead Sciences James Clyburn made by Gilead Sciences Pandemic Remdesivir The agency granted approval to the treatment remdesivir Veklury

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New research shows that a treatment for retinal vein occlusion yields long-lasting vision gains, with visual acuity remaining significantly above baseline at five years. However, many patients require ongoing treatment. Retinal vein occlusion is one of the most common blinding conditions in the United States; without treatment, central retinal vein occlusion (CRVO), the most severe type of retinal vein occlusion often leads to significant and permanent vision loss. A report on five-year outcomes of the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2), was published April 21 in American Journal of Ophthalmology. SCORE2 was funded in part by the National Eye Institute (NEI), a part of the National Institutes of Health.

Retinal vein occlusion is caused by a blockage of the veins carrying blood away from the retina, the light-sensitive tissue at the back of the eye. This blockage can lead to macular edema where fluid becomes trapped within and under the retina, leading to rapid and severe loss of visual acuity. Without treatment, this condition typically leads to permanent loss of vision. The most effective treatment, injections of anti-vascular endothelial growth factor (VEGF) drugs, helps control blood vessel leakage and swelling in the retina.

“While anti-VEGF therapy is associated with significant improvement in both retinal swelling and visual acuity in patients with central or hemi-retinal vein occlusion, our findings show that most of the patients followed still required treatment to control the macular edema for at least five years,” said Ingrid U. Scott, M.D., M.P.H., Penn State College of Medicine, Hershey, chair of the study. “This demonstrates the importance of continued monitoring of these patients.”

In 2017, SCORE2 clinical trial investigators reported that two types of anti-VEGF treatment were equally effective at improving visual acuity in people with macular edema due to CRVO or hemi-retinal vein occlusion (HRVO). CRVO affects the entire retina, while HRVO generally affects about half of the retina. Half of the study participants had been given Avastin (bevacizumab) while the other half received Eylea (aflibercept). Both drugs were administered by injection once per month for six months. At the six-month mark, the vision of participants in both groups had, on average, improved over three lines on an eye chart.

As detailed in this new report, the study investigators followed SCORE2 participants for five years, collecting information about their visual acuity, treatments, and whether their macular edema had resolved. After the initial 12-month study period, participants were treated at their physician’s discretion. Most physicians reduced the frequency of anti-VEGF injections and some switched their patients to the other anti-VEGF drug. At five years, many participants had lost some visual acuity when compared to their acuity at the 12-month mark; however, they retained on average three lines of improvement, compared to their acuity at the beginning of the study.

“It was surprising to us that despite many participants still needing treatment after five years, their visual acuity outcome remained very good,” said Michael Ip, M.D., co-chair of the study from Doheny Eye Institute, University of California Los Angeles. “In comparison to this treatment for wet age-related macular degeneration, where initial vision improvements fade over time, these results are quite favorable.”

“This five-year study tells us a lot about what’s happening with retinal vein occlusion patients in the real world,” said Scott. “Prior to this study, retinal vein occlusion was widely considered an acute illness. This study shows that RVO is a chronic disease. It also underscores the importance of disease monitoring and individualized treatment to achieve the best possible vision.”

“The SCORE2 study provides invaluable data to guide clinicians and their patients toward informed decisions regarding treatment for retinal vein occlusion,” said NEI Director Michael F. Chiang, M.D.

The SCORE2 study was funded by NEI and Research to Prevent Blindness. Study drugs were provided by Regeneron, Inc and Allergan, Inc. Clinical trial number: NCT01969708.

Reference: Scott IU, VanVeldhuisen PC, Oden NL, Ip MS, Blodi BA, for the SCORE2 Investigator Group. “Month 60 Outcomes after Treatment Initiation with Anti-VEGF Therapy for Macular Edema due to Central or Hemi-Retinal Vein Occlusion.” American Journal of Ophthalmology. April 21, 2022 DOI: 10.1016/j.ajo.2022.04.001

NEI leads the federal government’s research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visit https://www.nei.nih.gov.

The Food and Drug Administration (FDA) announced on Thursday that it had authorized the first test to detect COVID-19 through breath for emergency use.

The InspectIR COVID-19 Breathalyzer is able to identify five volatile organic compounds tied to the coronavirus in a person’s breath by using a technique known as gas chromatography gas mass-spectrometry, delivering results in less than three minutes, according to the FDA.

The agency said that in a study of 2,409 people, which included both people with and without symptoms, the test had a 99.3 percent specificity rate, which measures the percent of correctly identified negative test samples.

The FDA also noted that the InspectIR COVID-19 Breathalyzer had a 91.2 percent sensitivity rate, which measures the percent of correctly identified positive test samples.

Still, the health agency said that a molecular test should be used to confirm positive test results returned by the COVID-19 breath test.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

Bloomberg (4/14, Muller) reports, “A COVID-19 breathalyzer test with the ability to provide diagnostic results in three minutes has won emergency-use authorization from the U.S. Food and Drug Administration, the agency announced Thursday.” The test made by InspectIR Systems “is authorized for those 18 and older and in settings where samples are both collected and analyzed, such as doctor’s offices, hospitals or mobile testing sites.” The FDA “said the test was validated in a study of 2,409 people, where it correctly identified 91.2% of positive samples and 99.3% of negative samples.”

The global center will the first-of-its-kind institution in the world to combine scientific research with ancient traditional methods of medicine.

The World Health Organization(WHO) and Government of India signed an agreement to establish the WHO Global Centre for Traditional Medicine(GCTM) in Gujarat, India to promote traditional medicine backed by science and reasearch to improve the health of people all over the world.

With India set to establish WHO Global Centre for traditional medicine in Jamnagar, Gujarat, Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region has called it a “game-changer.”

Traditional medicines, she said have been around for millennia and pointed out that nearly 80 per cent of people, in 170 of 194 WHO member countries use them.

“Despite their widespread use, traditional medicine lack robust evidence, data and a standard framework preventing their integration into the mainstream healthcare delivery system,” Dr Singh said in an exclusive interview with ANI.

“WHOs Global Centre for traditional medicine could be a game-changer by focusing on evidence and learning, data and analytics, sustainability and equity, innovation and technology to help harness the ancient wisdom and power of traditional medicine, and to advance the SDG 3 target of ensuring health and promoting wellbeing for all of all ages,” she added.

The center backed by an investment of USD 250 million from the Government of India, will be located at Jamnagar, Gujarat. The groundbreaking ceremony for the GCTM will take place on April 19, 2022, in the presence of Prime Minister Narendra Modi and the Director-General of WHO Tedros Ghebreyesus.

Dr Singh said that Prime Minister Narendra Modi spoke to Director-General of the World Health Organization (WHO), Dr Tedros Ghebreyesus and expressed India’s keenness in establishing and hosting the GCTM in India so as to harness the potential of traditional medicine from across the world through modern science and technology to improve the health of people and the planet.

The Government of India last month signed the ‘Host Country Agreement’ with WHO for establishing WHO Global Centre for Traditional Medicine in India at Jamnagar, Gujarat, with its interim office at the Institute of Training and Research in Ayurveda in Gujarat. “Indian Government has generously agreed to support the setting up of the GCTM and its activities for the first ten years,” Dr Singh said.

Noting that the COVID-19 pandemic is stretching and impacting the health systems across the world, Dr Singh pointed out many countries felt the need to mobilize all available resources to recover from the pandemic and accelerate progress towards SDG 3 goals.

“The emerging burden of NCDs and mental illnesses have also created a demand for integrating evidence-based traditional medicine into the healthcare delivery system to promote health and wellbeing,” she said.

A burst of high-profile COVID-19 cases in Washington, D.C., is highlighting the lingering threat of the virus, media reports here stated. House Speaker Nancy Pelosi (D-Calif.), Cabinet members including Attorney General Merrick Garland, and a string of lawmakers, have all tested positive in recent days.

The cases are reminders that the virus is still circulating even as much of America moves forward from the pandemic. In fact, experts are bracing for cases to increase in the coming weeks, given an even more highly transmissible subvariant of omicron, known as BA.2, that is circulating widely.

“I do think we’re going to see an uptick nationally,” said Crystal Watson, senior scholar at the Johns Hopkins Center for Health Security. “The question is really how high it will get.”  Washington, as well as New York and other parts of the northeast, are already seeing upticks in cases.

The high-profile DC cases, “may be a reflection” of a new spike, Watson said, though she noted it is “hard to tell” exactly how wide a conclusion to draw from them.  “I do think we’re generally seeing an uptick in cases in D.C.,” she said.

Still, there are important ways in which any coming increase in cases will likely not be as bad as previous surges. People who are vaccinated, especially those who are boosted, have strong protection against severe disease, meaning that while they may still get infected, the symptoms are likely to be mild.

In addition to the protection offered by vaccination, many people across the country were infected during the first omicron wave over the winter, which means much of the population still has additional immunity.

“We now have a lot of immunity both from vaccines and from infection,” said Jennifer Nuzzo, an epidemiologist at Brown University. “It’s hard to imagine we will see quite the levels of severe illness that we saw in earlier phases.”

Some experts now say that hospitalizations are a more important metric than sheer case numbers. With a highly transmissible virus and vaccines that protect against severe disease, the goal has shifted more towards preventing hospitals from being overwhelmed, rather than trying to prevent mild cases from occurring.

Notably, even as cases have gone up in Washington, D.C., and New York City, hospitalizations continued to decrease, though they tend to lag behind cases.

Anthony Fauci, President Biden’s chief medical adviser, said on Bloomberg TV this week that he hopes the higher levels of immunity in the population help blunt the worst effects of any coming increase in cases.

“I would not be surprised if we see an uptick in cases, whether that uptick becomes a surge where there are a lot more cases is difficult to predict,” Fauci said. “But the one thing that I hope, and I believe there’s reason that this will not happen, is that we won’t get a very large increase proportionately in hospitalizations because of the background immunity.”

Many of the high-profile D.C. cases have appeared to stem from the Gridiron Dinner, a gathering of many top officials. Gridiron organizers said Friday that 53 attendees had been infected.

Leana Wen, a public health professor at George Washington University, argued in a Washington Post op-ed this week that events like the dinner can still go on in this new phase of “living with COVID-19,” especially if they use safeguards like proof of vaccination and rapid testing beforehand.

“There are those who would argue it’s irresponsible to hold parties that could turn into super-spreader events,” Wen wrote. “That was true before vaccines were widely available, but it’s no longer realistic. We need to use a different paradigm — one that’s based on individuals being thoughtful about their own risks and the risks they pose to others.”

Even for President Biden, the White House acknowledged on Friday that he might get the virus, but stressed the protection from he has vaccines and boosters, saying the country is “in a very different place.”

“It is possible he will test positive for COVID at some point and we’re in a very different place than we were…which is to say we have vaccines, we have treatments,” White House Communications Director Kate Bedingfield said on CNN. “The president is vaccinated and double boosted so, you know, protected from severe COVID.”

While there is a risk of a new uptick, the current situation is also greatly improved. Cases, at about 29,000 per day, according to a New York Times tracker, are at their lowest point since last summer.

Hospitalizations have plummeted to about 15,000, and are at their lowest point since the early days of the pandemic in 2020.  There are still about 500 people dying every day from the virus, concentrated among the unvaccinated.

While treatments and vaccines have put the country in a far better place, experts warn that Congress’s failure to provide more funding to fight the virus risks the progress.

The White House says testing capacity will decline in the coming months, and treatments will run out, if more funding is not provided. And if fourth vaccine doses are needed for all Americans, there is not currently enough money to purchase them.

The United States is also lagging other developed countries in its rates of booster doses.   “We have not done a good enough job on that front,” Nuzzo said, noting there should be a particular focus on reaching the remaining elderly who are not boosted.

About half of eligible adults and a third of eligible seniors are not boosted, according to CDC data.   Making sure people are boosted and protected is key, Nuzzo said, because “this virus isn’t going away.”

Newswise — With any highly infectious disease, time can be a killer. It is crucial to get a test result for a pathogen quickly, lest someone continue in their daily lives infecting others. And delays in testing have undoubtedly exacerbated the COVID-19 pandemic.

Unfortunately, the most accurate COVID-19 test often takes 24 hours or longer to return results from a lab.

At-home test kits offer results in minutes but are far less accurate or sensitive.

Researchers at the University of Florida, however, have helped developed a COVID-19 testing device that can detect coronavirus infection in as little as 30 seconds as sensitively and accurately as a PCR, or polymerase chain reaction test, the gold standard of testing. They are working with scientists at National Yang Ming Chiao Tung University in Taiwan.

The device, researchers said, could transform public health officials’ ability to quickly detect and respond to the coronavirus — or the next pandemic.

UF has entered into a licensing agreement with a New Jersey company, Houndstoothe Analytics, in hopes of ultimately manufacturing and selling the device, not just to medical professionals but also to consumers.

Like PCR tests, the device is 90% accurate, researchers said, with the same sensitivity, according to a recent peer-reviewed study published by the UF group.

“There is nothing available like it,” said Josephine Esquivel-Upshaw, D.M.D., a professor in the UF College of Dentistry’s Department of Restorative Dental Sciences and member of the research team that developed the device. “It’s true point of care. It’s access to care. We think it will revolutionize diagnostics.”

The device is not yet approved by the U.S. Food and Drug Administration. First, researchers said, they have to ensure that test results are not thrown off by cross-contamination with other pathogens that might be found in the mouth and saliva. These include other coronaviruses, staph infections, the flu, pneumonia and 20 others. That work is ongoing.

The hand-held apparatus is powered by a 9-volt battery and uses an inexpensive test strip, similar to those used in blood glucose meters, with coronavirus antibodies attached to a gold-plated film at its tip. The strip is placed on the tongue to collect a tiny saliva sample.

The strip is then inserted into a reader connected to a circuit board with the brains of the device.

If someone is infected, the coronavirus in the saliva binds with the antibodies and begins a dance of sorts as they are prodded by two electrical pulses processed by a special transistor. A higher concentration of coronavirus changes the electrical conductance of the sample. That, in turn, alters the voltage of the electrical pulses.

The voltage signal is amplified a million times and converted to a numerical value — in a sense, the sample’s electrochemical fingerprint. That value will indicate a positive or negative result, and the lower the value, the higher the viral load. The device’s ability to quantify viral and antibody load makes it especially useful for clinical purposes, researchers said.

The product can be constructed for less than $50, Esquivel-Upshaw said. In contrast, PCR test equipment can cost thousands.

The research team also is studying its ability to detect specific proteins that could be used to diagnose other illnesses, including cancer, a heart attack and immune health. 

Fan Ren, Ph.D., a distinguished professor in the Herbert Wertheim College of Engineering’s Department of Chemical Engineering, and his team had been developing semiconductor-based sensor devices long before COVID-19 for nonmedical purposes.

He noted that he is inspired in his work by the recent death of his wife, which was unrelated to COVID-19. He connects his grief to the mourning of the world at large.

“Almost a million people have died of COVID” in the United States, Ren said. “Those are so many tragedies. Old people. Young people. You name it. I said, ‘No, that’s it.’ That is too much.”

He said several institutions have worked on devices using a field effect transistor, or FET, like that found in the COVID-19 testing device his team is developing. But those devices are basically one-offs — a sample is applied directly to the FET, which means the transistor is not reusable and must be discarded.

That makes those devices expensive and impractical for mass testing, Ren said. Then he hit on the idea of separating transistor from sample, like blood glucose meters that use test strips to collect a drop of blood after a lancet pierces a finger. This innovation, Ren said, makes the UF device unique, affordable and easy to use.

Ren said the device could be used for venues with large crowds, such as concerts, sporting events, classrooms, in addition to medical settings. Researchers say the unit would also provide access to accurate, inexpensive testing in rural areas or in developing nations.

And the personal uses, researchers say, are limitless — parties, baby showers and other small gatherings. “Yes or no. You’re infected or not infected. You get the answer right away,” said Ren.

The rollout of the Covid-19 vaccines by India in collaboration with leading global institutions has “rescued the world” from the deadly coronavirus and the contributions by the country must not be underestimated, a top American scientist has said.

India is called the pharmacy of the world during the Covid-19 pandemic with its vast experience and deep knowledge in medicine. The country is one of the world’s biggest drug-makers and an increasing number of countries have already approached it for procuring coronavirus vaccines.

Dr Peter Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine (BCM) in Houston during a recent webinar said that the two mRNA vaccines may not impact the world’s low- and middle-income countries, but India’s vaccines, made in collaboration with universities across the world such as BCM and the Oxford University, have “rescued the world” and its contributions must not be underestimated.

During the webinar, “Covid-19: Vaccination and Potential Return to Normalcy – If and When”, Dr Hotez, an internationally-recognised physician-scientist in neglected tropical diseases and vaccine development, said that the Covid-19 vaccine rollout is “India’s gift” to the world in combating the virus.

India’s drugs regulator gave emergency use authorisation to Covishield, produced by Pune-based Serum Institute of India after securing licence from British pharma company AstraZeneca, and Covaxin, indigenously developed jointly by Hyderabad-based Bharat Biotech and Indian Council of Medical Research scientists.

Sleeping for only one night with a dim light, such as a TV set with the sound off, raised the blood sugar and heart rate of healthy young people participating in a sleep lab experiment, a new study found.

The dim light entered the eyelids and disrupted sleep despite the fact that participants slept with their eyes closed, said study author Dr. Phyllis Zee, director of the Center for Circadian and Sleep Medicine at Northwestern University Feinberg School of Medicine.

Heart rate typically drops at night, slowing down as the the brain is busy repairing and rejuvenating the body. An elevated heart rate at night has been shown in numerous studies to be a risk factor for future heart disease and early death.

High blood sugar levels are a sign of insulin resistance, where the body stops using glucose properly and the pancreas goes into overdrive, flooding the body with extra insulin to overcompensate until it eventually loses its ability to do so. Over time, insulin resistance can ultimately lead to Type 2 diabetes.

Sleeping with eyes closed

Prior research has shown an association between artificial light at night and weight gain and obesity, disruptions in metabolic function, insulin secretion and the development of diabetes, and cardiovascular risk factors.

“Why would sleeping with your lights on affect your metabolism? Could that explain why there is a higher prevalence of diabetes or obesity (in society)?” Zee asked.

Zee and her team took 20 healthy people in their 20s and had them spend two nights in a sleep lab. The first night was spent in a darkened room where “you wouldn’t be able to see much, if anything, when your eyes were open,” Zee said.

All of the study participants were connected to devices monitoring a number of objective measures of sleep quality. So data could be gathered with minimal interference, they slept with an IV with long tubes that snake across the room and through a hole to the researcher’s side of the lab. The blood was drawn without ever touching the slumbering participants.

“We recorded the brainwaves and could tell what sleep stage the person was in,” Zee said. “We recorded their breathing, their heart rate, their EKG, and we also drew blood from them to measure melatonin levels while they were sleeping.” Melatonin is a hormone that regulates the body’s circadian rhythm, or sleep and wake body clock.

A randomized portion of the group repeated that same light level for a second night in the lab, while another group slept with a dim overhead light with a glow roughly equivalent to “a very, very dark, cloudy day or street lights coming in through a window,” Zee said.

“Now these people were asleep with their eyelids closed,” she explained. “In the literature the estimation is that about 5% to 10% of the light in the environment would actually get through the closed lid to the eye, so this is really not a lot of light.”

Yet even that tiny amount of light created a deficit of slow wave and rapid eye movement sleep, the stages of slumber in which most cellular renewal occurs, Zee said.

In addition, heart rate was higher, insulin resistance rose, and the sympathetic (fight or flight) and parasympathetic (rest and relax) nervous systems were unbalanced, which has been linked to higher blood pressure in healthy people.

The light was not bright enough, however, to lower levels of melatonin in the body, Zee added. The study was published Monday in the journal of the Proceedings of the National Academy of Sciences.

What to do?

What advice would Zee give people based on her study and existing research in the field? Close your blinds and curtains, turn off all the lights, and consider using a sleep mask.

“I think the strength of the evidence is that you should clearly pay attention to the light in your bedroom,” she said. “Make sure that you start dimming your lights at least an hour or two before you go to bed to prepare your environment for sleep.”

Check your bedroom for sources of light that are not necessary, she added. If a night light is needed, keep it dim and at floor level, “so that it’s more reflected rather than right next to your eye or bed level,” she suggested.

Also be aware of the type of light you have in your bedroom, she added, and ban any lights in the blue spectrum, such as those emitted by electronic devices like televisions, smartphones, tablets and laptops.

“Blue light is the most stimulating type of light,” Zee said. “If you have to have a light on for safety reasons change the color. You want to choose lights that have more reddish or brownish tones.”  LED lights can be purchased in any color, including red and brownish tones.

Kal Penn, Winner of AALDEF Justice In Action Award, Tapped To Star In ‘The Santa Clause’

The Asian American Legal Defense and Education Fund (AALDEF) presented this year’s Justice in Action Awards to Hollywood actor Kal Penn and to Thomas S. Kim, Chief Legal Officer and Company Secretary at Thomson Reuters on March 9th.

Penn was honored for his advocacy for representation in media and his service on behalf of Asian Americans and Pacific Islanders, a press release from AALDEF said.

In a video, award-winning filmmaker Mira Nair, who cast Penn as the lead in her 2006 film “The Namesake,” said, “As an activist and an artist, Kal has never shied away from his roots. He is unapologetic about who he is, and yet is an incredible bridge builder, creating a strong sense of allyship and solidarity with other communities.”

The awards ceremony, held at the Lighthouse at Chelsea Piers in New York City,  was the highlight of AALDEF’s 2022 Lunar New Year Gala, celebrating the Year of the Tiger.

Penn is venturing into Bollywood in a big way. He is the Executive Producer of “Hot Mess Holiday” to be released soon, and is quoted in media reports saying he is interested in doing more in Bollywood.

Penn, known for his role in the ‘Harold and Kumar’ film franchise, is set to star as a lead opposite Tim Allen and Elizabeth Mitchell in Disney Plus’s upcoming limited series, ‘The Santa Clause’, from creator Jack Burditt.

According to Deadline, Allen will be reprising his role as Scott Calvin from the Walt Disney Pictures holiday franchise. The sequel series will show Scott on the brink of his 65th birthday and realizing that he cannot be Santa forever. He has suddenly started to lose his Santa magic, and more importantly, he’s got a family, who could benefit from a life in the normal world, especially his two kids who grew up in the North Pole.

Accompanied by a lot of elves, children and family to please, Scott sets out to find a suitable replacement Santa while preparing his family for a new adventure in a life south of the pole.

Penn will portray an ambitious game inventor and product developer and a devoted single father named Simon Choksi. He’s capable of talking the tech-mogul talk but is unable to walk the walk, and his dreams of being the next Bezos falls drastically short. However, after a visit to the North Pole, all that changes.

Mitchell would be reprising her role as Mrs Clause from the films, as was previously announced.

As per Deadline, this project will be directed and executive produced by Jason Winer along with Jon Radler for Winer’s Small Dog Picture Company. Burditt will executive produce and serve as showrunner.

Allen will also executive produce with Kevin Hench, Richard Baker and Rick Messina. The Disney Branded Television series is a production of 20th Television, a part of Disney Television Studios.

Newswise — Investigators at Cedars-Sinai have identified a potential new therapy for COVID-19: a biologic substance created by reengineered human skin cells.   Scientists found the substance stopped SARS-CoV-2, the virus that causes COVID-19, from reproducing itself and also protected infected cells when tested in human lung cells. Although still in the early stages, the findings open the possibility of having a new therapy for COVID-19 patients. The details of the potential therapy are published in the journal Biomaterials and Biosystems.

“We were surprised to find this potential therapy shuts down a novel pathway for viral replication and also protects infected cells,” said Ahmed G. Ibrahim, PhD, MPH, assistant professor in the Smidt Heart Institute at Cedars-Sinai and first author of the study.

Few treatments currently exist for COVID-19 and the ones that do primarily focus solely on preventing the virus from replicating. This new potential treatment inhibits replication but also protects or repairs tissue, which is important because COVID-19 can cause symptoms that affect patients long after the viral infection has been cleared.

The potential therapy investigated in this study was created by scientists using skin cells called dermal fibroblasts. The investigators engineered the cells to produce therapeutic extracellular vesicles (EVs), which are nanoparticles that serve as a communication system between cells and tissue. Engineering these fibroblasts allowed them to secrete EVs—which the investigators dubbed “ASTEX”—with the ability to repair tissue.

In previous experiments, the investigators demonstrated that ASTEX can repair heart tissue, lung tissue and muscle damage in laboratory mice. When the COVID-19 pandemic hit in 2020, the investigators turned to studying whether ASTEX could be used as treatment against SARS-CoV-2.

The study was done through a collaboration with investigators at UCLA who tested ASTEX by applying it to human lung epithelial cells, cells that line the pulmonary tract and are the targets of SARS-CoV-2 infection.

They discovered that ASTEX prevented cells from launching an inflammatory process that could lead to cell death. Cells treated with ASTEX also made fewer of a type of protein called ACE that SARS-CoV-2 may use to infect cells.

The team then compared the potential treatment with remdesivir, a drug currently used to treat COVID-19, and found that remdesivir did not inhibit production of ACE. Instead, remdesivir stops the virus from latching on to a protein called ACE2. ASTEX, therefore, may present another way to prevent the virus from entering cells.

“Viruses don’t have their own machinery to get into cells, so they use proteins,” Ibrahim said. “We believe targeting ACE proteins is just one way SARS-CoV-2 infiltrates cells, hijacks their genetic information and replicates itself in the body.”

ASTEX appears to have stopped this hijacking process.

“This potential anti-COVID-19 biological therapy is novel in that it has two facets: It protects infected cells, which remdesivir does not do, and also inhibits viral replication,” said senior author Eduardo Marbán, MD, PhD, executive director of the Smidt Heart Institute and the Mark S. Siegel Family Foundation Distinguished Professor at Cedars-Sinai.

Investigators are planning future studies.

During the two-day 12^th Global Conference held on a digital platform Feb. 26 and 27, 2022, the Global Association of Physicians of Indian Origin (GAPIO) presented the annual GAPIO awards for 2021 to doctors who have made noteworthy contributions to improving healthcare.

The award winners in the Distinguished Category are:

• GAPIO Lifetime Achievement Award – Jatin P Shah, Former Chairman, Head and Neck Service, Memorial Sloan-Kettering Cancer Center, New York
• Prathap C Reddy Philanthropy Award – Dr. Srinivas Gosla Reddy, Plastic Surgeon, GSR Institute of Craniofacial Plastic Surgery, Hyderabad and Director, Hyderabad Cleft Society.
• Dr I A Modi Award – Dr. Mahesh Kumar Goenka, Director & Head, Institute of Gastrosciences, Apollo Hospitals, Kolkata, President, Indian Society of Gastroenterology, 2022 -2023
• GAPIO Surgical Excellence Award – Dr. A A Shetty, Emeritus Professor, Orthopaedics, Trauma and Regenerative Medicine Cell therapy, Christ Church University, UK
• GAPIO Excellence in Diagnostics – Dr. Arvind Lal, Chairman, Dr Lal PathLabs Ltd, New Delhi, Managing Trustee, ALVL Foundation
• GAPIO Excellence in Radiology/ Radiation Therapy Awards – Harsh Mahajan,  Founder & Chief Radiologist, Mahajan Imaging, Chairman, Department of Nuclear Medicine & PET-CT, Sir Ganga Ram Hospital, New Delhi.

Each winner receives Rs. 100,000, a citation and a trophy.

GAPIO Special Appreciation Award – Dr. J. S. Tuteja, Pediatrician and Adolescent Health specialist, Indore, for his path breaking work in delivering Pediatric and Adolescent care.

The award winners in Young Category are:

• Dr I A Modi Award – Dr. Harsh Vardhan, Assistant Professor, Nephrology, AIIMS, Patna.
• GAPIO Surgical Excellence Award – Dr. Vishal Kumar, Associate Professor, Orthopedics, PGI, Chandigarh
• GAPIO Excellence in Diagnostics – Dr. Swapnil Rane, Associate Professor, Tata Memorial Centre Advanced Centre for Treatment, Research and Education in Cancer, Mumbai.
• GAPIO Excellence in Radiology/ Radiation Therapy Awards – Dr. Binit Sureka, Associate Professor, Interventional Radiology, AIIMS, Jodhpur.

Each winner receives Rs. 50,000, a citation and a trophy.

Mansukh Mandaviya, India’s Minister for Health & Family Welfare and Chemical and Fertilizers of India Government of India, was the Chief Guest and Dr. Prathap C Reddy, founder President of GAPIO and Chairman Apollo Hospitals Group was the Guest of Honor.

Dr. Anupam Sibal, President of GAPIO and Group Medical Director, Apollo Hospitals Group and Senior Consultant Pediatric Gastroenterologist and Hepatologist said, “The awardees through their immense contribution in clinical care, academics, research in different medical and surgical specialities exemplify the highest standards that Indian physicians have become synonyms with.”

Remarking on the young physicians category, Dr. Nandakumar Jairam, Vice President GAPIO said, “The awardees in the Young category represent the aspirations of the Young Indian Physician who is willing to take on challenges to improve delivery of care, while excelling in academics and research.”

 Dr. Sudhir Parikh, Secretary General of GAPIO and Chairman and Publisher of Parikh World Wide Media and ITV Gold 24×7 TV Channel in USA said, “With a presence in 53 countries, GAPIO serves to establish collaborations, bringing 1.4 million physicians of Indian origin on one platform. In the coming year our activities will be enhanced to build a stronger well connected physician community.

Dr. Prathap C Reddy, Founder President of GAPIO and Chairman Apollo Hospitals Group said, “The exemplary work by the awardees is an inspiration for others to emulate. The spirit of  the physicians of Indian origin to excel in India and overseas is what we hope to recognize. There are countless examples of path breaking work across the globe that would make every Indian proud”.

The U.S. has experienced a brutal winter wave of COVID-19, driven by the highly transmissible Omicron variant. Daily deaths are higher today than they were during the peak of last fall’s Delta wave, and have plateaued at about 2,500 per day. Many hospitals are still under huge strain and are postponing elective surgeries to free up beds for patients with COVID-19. Daily cases have been higher than during the Delta surge, despite multiple eager predictions in the past that we had reached herd immunity and that the pandemic was over.

Nevertheless, there are promising signs that we are turning a corner. New daily cases are falling rapidly—they are down by over 75% from the peak of the Omicron wave. Hospitalizations are also falling. While we are not out in the clear yet, especially in poorly vaccinated regions of the U.S., the sharp downturn in cases is cause for optimism.

The fall in cases is also an opportunity for fundamental preparation, given the high chance of a future wave. To prevent being overwhelmed again, we should be proactive now in putting a preparedness system in place.

Instead, in the face of these receding cases, some pundits are calling for an end to pandemic control measures, such as indoor masking and testing of people with no symptoms. And several states have rolled back mask mandates, even though indoor masks mandates remain popular in public polling (the Biden Administration is being more cautious about easing masking). We fully understand the frustration and impatience behind these calls. Pandemic fatigue is real. Yet this yearning for ‘normal’ ignores the reality that our society before COVID-19 was anything but normal. If it had been, we may not have suffered as devastating a pandemic as we have. Instead it was those very conditions that allowed for terrible inequities and outsized impacts on America’s poor, which still continue today.

We are concerned that the Biden Administration is not taking preparedness seriously enough. It was a welcome step to see the Administration making 400 million N95 masks available for free at pharmacies and community health centers, and we are delighted that Americans can now go online and order four free rapid tests per household. But four rapid tests and a mask will not be enough to end the pandemic. These measures are not commensurate with the size of the problem, and they must be coupled with actual public health strategies for effective roll-out and sustained uptake.

Perhaps the biggest problem is that there is still a huge amount of viral transmission, with around 175,000 new daily cases. Less than two thirds of Americans are fully vaccinated—defined as two doses of Pfizer or Moderna or one dose of Johnson & Johnson—which does not provide as much protection as it did before Omicron. Only a quarter of Americans have received a booster dose, which provides the highest level of protection against infection, hospitalization, and death. There are ongoing inequities in vaccination, including racial inequities, with Black and Hispanic populations being vaccinated at a lower rate compared to white populations. Only 24% of children aged 5-11 and 57% of those aged 12-17 are fully vaccinated. Hospitalizations among the under 5 hit record levels during the Omicron surge, yet vaccines are not yet licensed for this age group.

There is also what the New York Times calls a “pandemic of the forgotten.” Around 7 million Americans have weakened immune systems from transplants, cancer treatment, rheumatoid arthritis medications, or other medical conditions, and they could get very ill if they get COVID-19. Yet this push toward returning to normal seems to matter-of-factly ignore them. And, there is the growing number of people who are suffering from long-term morbidity after surviving infection—the condition now known as Long Covid—which we are only just beginning to understand.

One recurring problem when it comes to pandemics is that we suffer from short term memory. We cross our fingers and hope that this wave is the last. Many of us were surprised when Vice President Kamala Harris said that the Biden Administration “didn’t see Delta coming….didn’t see Omicron coming.” That’s absurd. Viral mutations were entirely expected. There is a serious risk of further variants arising, especially with inequitable and low vaccination coverage in much of the world due to supply hoarding. Distributing a few rapid tests and masks and hoping that this wave disappears and will be the end of the U.S. pandemic is not a sound approach.

Even with the current variants in circulation, we could see further waves, such as was seen in the South in past summers, especially in poorly vaccinated states, and as people move indoors to escape the heat and humidity. We could similarly see future winter waves as we have witnessed in the northeast. With cases of Omicron receding, now is the time to put in place a proper infrastructure, resilient enough to handle further surges. Instead of declaring “mission accomplished,” we must declare a considerable effort toward true preparedness.

In addition to driving up vaccination coverage, what would true preparedness look like?

Instead of a one-off distribution of N95 masks, the government should replenish the stockpile enough to deploy them again in the face of future outbreaks. These should be ubiquitously available, and in different shapes and sizes, placed outside any high-risk venues including public transport or crowded indoor sites of congregation (grocery stores, malls, retail, movie theaters, gyms, offices) during surges.

Serial rapid tests are needed, and they need to reach those unable to order them online. A single test is a snapshot in time—so after a known exposure, having enough tests for daily testing prior to leaving the home is what would actually be needed for 5 to 7 days. Rapid tests identify contagious people before they get symptoms, allowing people to avoid spreading the infection, thus breaking the cycles of transmission. One of us presented similar arguments for both Ebola and Zika in the past. Such rapid tests for SARS-CoV-2 can help keep schools and workplaces open, and they can protect vulnerable people in nursing homes, jails, prisons, and other high-risk congregate settings. High quality masks and rapid tests are particularly critical for protecting front line workers.

With the arrival of new antiviral drugs, such as Paxlovid, and data showing early antiviral use with Remdesivir is more effective, universal access to free tests has become even more urgent. These medicines can reduce your chances of being hospitalized or dying if they are taken soon enough after symptoms begin, but this requires access to testing for early enough diagnosis. Greater access to testing needs to be combined with fair and equitable access to these medications—especially for communities that traditionally have low access to care.

A joined-up preparedness plan would also include paid sick leave. During the 2009 swine flu pandemic, an estimated 3 in 10 people with symptoms in the U.S. went to work, infecting up to 7 million others. The U.S. is the only high-income nation without mandatory federal sick pay, and this will continue to be a huge barrier to controlling COVID-19.

Another way to curb transmission of SARS-CoV-2 is to improve ventilation and air filtration in all buildings, including schools. Congress has allocated up to $170 billion for school infrastructure improvements, including improving air quality. Unfortunately, too much of this money has been left on the table. In some cases, as Joseph Allen and Celine Gounder note, some schools are “already under attack by parents who are opposed to other pandemic-related public health measures, like masking.” Other school districts lack the know-how to make the upgrades—they need better guidance and standards. Some schools say they struggle to pay for upgraded ventilation systems even with federal aid.

Instead of being caught flat-footed by the next wave or variant, we need more comprehensive data and surveillance systems, including wastewater sampling, as well genomic surveillance to identify and track new variants. With better data, we can know when to titrate public health protections up and down. As Megan Ranney, professor of emergency medicine and academic dean of public health at Brown University says, we need “investments in better data systems, now, to signal when a surge is on its way and to provide clear metrics of when to increase protections (like masks)—and clear lines about when these protections can be relaxed.”

With so many people worldwide still unvaccinated, and many Americans without boosters, we should prepare ourselves for future pandemic ebbs and flows. To end the pandemic, the U.S. should do much more to boost global vaccine access including donating several-fold more doses, sharing vaccine technology more urgently, and funding massive global production. Domestically, an important guiding principle is that our policies should be driven by data and not dates—for example, we believe it is better to base the end of mask mandates on metrics such as vaccination coverage, hospitalization rates, and ICU capacity rather than picking an arbitrary end date. Unlike the start of the pandemic, we now have a remarkable array of science-based tools that can turn COVID-19 into something akin to a cold or flu, but to get there we’ll need higher vaccination rates, better data and surveillance systems, data-driven policies on masks and rapid tests, improved ventilation in shared public spaces, and a more resilient preparedness system.

As the spike in coronavirus cases caused by the omicron variant wanes, some experts say it is time to start lifting more restrictions, setting up a heated debate, particularly over mask mandates in schools.

People are exhausted with the pandemic after roughly two years, and health advocates warn that pandemic rules cannot last forever.

“We cannot remain in a perpetual state of emergency,” said Leana Wen, a public health professor at George Washington University. “People burn out.”

Many aspects of life have already returned to something like normal. Bars and restaurants are open and packed across the country, and countless travel restrictions have been lifted.

But some locations, including New York and Washington, D.C., still have mask mandates for the general public, and in schools, mask requirements are more common.

Vaccinations remain as the key source of protection. People who are vaccinated and boosted have strong protection against severe disease, even if there is still a chance they get mild illness.

Wen noted that school-age children 5 and up can now all be vaccinated.

And Pfizer last week began the application for its COVID-19 vaccine for children as young as six months.

Ashish Jha, dean of the Brown University School of Public Health, said that restrictions in general should be lifted as cases come down, but not just yet, given that cases are still high.

“I’ve been saying for weeks that as cases recede we can soon relax public health restrictions,” Jha tweeted. “I think of this like the weather. When it is bucketing rain umbrella, rain coat, boots, are all essential. When the storm turns into a drizzle, those become less critical.”

The possibility of a future variant that has greater ability to evade the vaccines’ protection, or that causes more severe disease, leads some experts to call for loosening restrictions during the coming lull to give people a respite in case they need to return later.

“If we don’t take the off-ramps, nobody will listen when we need to have an on-ramp,” tweeted Jeremy Faust, a professor at Harvard Medical School.

Cases in the U.S. have fallen significantly from the peak during the omicron wave in mid-January, from approximately 800,000 new cases per day to about 350,000 per day, which is still quite high. More experts are putting a focus on hospitalizations, which have now peaked nationally, though again are still at the high level of around 123,000 a day, according to a New York Times tracker.

Asked about people returning to more normal activities, Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky on Wednesday cautioned that hospitalizations “are still quite high and [we are] certainly having hospital capacity challenges in many parts of the country still.”

“We really do have to look to our hospitalization rates and our death rates to look to when it is time to lift some of these mitigation efforts,” she said. “We will continue to reevaluate, and we know people are anxious.”

The matter of lifting restrictions has received a new burst of political attention as Republicans push to scale back measures such as mask mandates.

Virginia’s new Republican governor, Glenn Youngkin, has drawn controversy and an American Civil Liberties Union-backed lawsuit from parents over an order making masks optional in schools in the state.

Senate Minority Leader Mitch McConnell (R-Ky.) more broadly said Wednesday that “it is time for the state of emergency to wind down.”

On the Democratic side, Denver Mayor Michael Hancock this week lifted the city’s mask mandate and proof of vaccination requirement for businesses.

“This virus is something we’re going to have to manage and learn to live with,” Hancock said.

A Monmouth University poll this week found that a large majority of Americans, 70 percent, agreed that “it’s time we accept that Covid is here to stay and we just need to get on with our lives.”

Republicans continue to fight hard against President Biden’s vaccine mandates, which many public health experts have praised as a crucial way to get more people vaccinated and help return to normal.

Advocates have also been pushing the Biden administration and Congress for more funding for global vaccination efforts, which can help prevent new variants from emerging.

Some experts are pushing back against the calls for returning to normal, pointing to more vulnerable people.

“The great, white middle — stretching right and left across the political spectrum and the op-ed pages of the Times — is ready to move on,” Gregg Gonsalves, a professor at the Yale School of Public Health, wrote in The Nation. “The thing is: Those left behind don’t have the choices or the resources that those with privilege do, whether they are poor, living with disabilities or chronic medical conditions — or just too old to matter.”

Wen, a former health commissioner for the city of Baltimore, said the CDC should at least set new benchmarks for under what circumstances masks would no longer be needed.

“It’s precisely because of the threat of future variants that we need to let up on restrictions now,” she said. “I’m not trying to sound the all-clear at all … I’m saying we need to take advantage of the lull that we have coming up.”