Category: Health

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.

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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.”

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.

Alzheimer’s-like changes seen in COVID-19 patients’ brains

People who die of severe COVID-19 have brain abnormalities that resemble changes seen in Alzheimer’s disease – accumulation of a protein called tau inside brain cells, and abnormal amounts of the protein beta-amyloid that accumulates into amyloid plaques – small studies have found.

At Columbia University, Dr. Andrew Marks and colleagues studied the brains of 10 COVID-19 patients and found defects in proteins called ryanodine receptors that control the passage of calcium into cells. In Alzheimer’s disease, defective ryanodine receptors are linked to accumulation of tau into so-called neurofibrillary tangles. These tangles were present in high levels in the COVID-19 patients’ brains, the Columbia team reported on Thursday in Alzheimer’s & Dementia. Other research teams have looked for – and found – abnormal amyloid levels in brains of COVID-19 patients, according to reports posted online ahead of peer review on bioRxiv and on The Lancet’s preprint server.

In all the studies, patients had experienced the most severe forms of COVID-19. If similar changes are occurring in the brains of patients with milder illness, that might help explain the “brain fog” associated with long COVID, Marks said. Patients with severe COVID-19 might be at higher risk for dementia later in life, but it is too soon to know, he added. His advice: Get a booster vaccine and avoid the virus. “If you get COVID-19, you probably won’t die, but we still don’t know a lot about the long-term effects.”

Seniors can get flu shot, mRNA COVID-19 booster together

Seniors can safely get the high-dose flu vaccine and an mRNA COVID-19 booster dose at the same time, a new study confirms.

The study’s 306 participants, all older than 65, were randomly assigned either to receive Sanofi’s Fluzone High-Dose Quadrivalent influenza vaccine and a third shot of Moderna’s mRNA vaccine at the same time, or either of the vaccines alone. Blood samples obtained before and 21 days after vaccination showed that giving the two vaccines together did not affect the resulting immune response, with similar antibody levels generated in participants in each of the three groups, according to a report published on Tuesday in The Lancet Respiratory Medicine.

A spokesperson for Sanofi said combined administration of the COVID-19 and influenza vaccines “did not raise any safety concerns and the study team is continuing to follow study participants through 6 months after vaccination.”

Fluid in some rapid COVID tests could be deadly for kids

In some COVID-19 rapid test kits, the small bottle of “reagent” fluid contains sodium azide, a powerful poison that is particularly dangerous for small children, experts warn.

In adults, small amounts can quickly cause dangerously low blood pressure, dizziness, fainting, or even heart attacks or strokes, said Dr. Kelly Johnson-Arbor, Co-Medical Director of the National Capital Poison Center in Washington, D.C. Higher doses can be fatal, she and her colleagues wrote in The American Journal of Emergency Medicine. Sodium azide levels in COVID-19 rapid test kits are not always high enough to cause low blood pressure in adults, and the iHealth kits being sent out by the U.S. government do not contain any sodium azide at all, Johnson-Arbor said. “However… since children are typically much smaller than adults, they are at a higher risk of experiencing poisonous effects after swallowing any amount,” she said.

Poison control hotlines have been getting reports of accidental exposures to the reagent fluid. “Some people have swallowed the solution, some have spilled it onto their skin, and others have put it in their eyes,” mistaking the bottle for eye drops, Johnson-Arbor said. “If you or a loved one swallows the reagent fluid or gets the fluid in their eyes or on the skin, contact Poison Control right away.” (In the U.S., at www.poison.org or 1-800-222-1222; in the UK at https://www.npis.org/).

The Food and Drug Administration (FDA) on Monday, January 31^st granted full approval to Moderna’s COVID-19 vaccine, giving an additional vote of confidence in its safety and effectiveness.

The full approval for people ages 18 and older was based on follow-up data showing “high efficacy and favorable safety approximately six months after the second dose.”

The vaccine had already been available since December 2020 under an emergency use authorization, but full approval provides an extra emphasis.

Acting FDA Commissioner Janet Woodcock said she hoped the move gives some people additional confidence in the vaccine.

“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” she said in a statement. “While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.”

Pfizer’s vaccine already received full approval in August.

“Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death,” Moderna CEO Stéphane Bancel said in a statement. “The totality of real-world data and the full [approval] for Spikevax in the United States reaffirms the importance of vaccination against this virus. This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the U.S.”

A booster shot of the Moderna vaccine is also recommended five months after the second shot.

About 74 percent of adults are now fully vaccinated, according to Centers for Disease Control and Prevention data. The numbers are much lower for boosters, which are crucial for achieving higher protection against the omicron variant, with 44 percent of fully vaccinated adults having received a booster, according to the public health agency.

In the other big COVID-19 vaccine news, Maryland-based Novavax finally applied for emergency use authorization for its vaccine in adults.

The request was based in part on results from two large clinical trials of approximately 30,000 participants in the U.S. and Mexico. The company said two doses of the vaccine given three weeks apart demonstrated an overall efficacy of approximately 90 percent, though the trials took place before the omicron variant became dominant.

Novavax was one of the six companies the U.S. invested in as part of Operation Warp Speed. The company originally wanted to ask the FDA for authorization by May 2021, but had to delay the request multiple times due to numerous development and manufacturing setbacks.

The protein-based vaccine could provide an alternative to the mRNA shots available from Pfizer and Moderna, as there is a small risk the mRNA vaccines cause heart inflammation in certain adults.

The authorization process from FDA could take several months, though the vaccine is available under emergency use from the European Commission, and the World Health Organization.

The Novavax vaccine is given in two doses spaced 21 days apart; the company recently announced plans to test a booster shot.

For decades, a small group of cutting-edge medical researchers have been studying a biochemical, DNA tagging system, which switches genes on or off. Many have studied it in bacteria and now some have seen signs of it in, plants, flies, and even human brain tumors. However, according to a new study by researchers at the Icahn School of Medicine at Mount Sinai, there may be a hitch: much of the evidence of its presence in higher organisms may be due to bacterial contamination, which was difficult to spot using current experimental methods. 

To address this, the scientists created a tailor-made gene sequencing method which relies on a new machine learning algorithm to accurately measure the source and levels of tagged DNA. This helped them distinguish bacterial DNA from that of human and other non-bacterial cells. While the results published in Science supported the idea that this system may occur naturally in non-bacterial cells, the levels were much lower than some previous studies reported and were easily skewed by bacterial contamination or current experimental methods. Experiments on human brain cancer cells produced similar results.

“Pushing the boundaries of medical research can be challenging. Sometimes the ideas are so novel that we have to rethink the experimental methods we use to test them out,” said Gang Fang, PhD, Associate Professor of Genetics and Genomic Sciences at Icahn Mount Sinai. “In this study, we developed a new method for effectively measuring this DNA mark in a wide variety of species and cell types. We hope this will help scientists uncover the many roles these processes may play in evolution and human disease.”

The study focused on DNA adenine methylation, a biochemical reaction which attaches a chemical, called a methyl group, to an adenine, one of the four building block molecules used to construct lengthy DNA strands and encode genes. This can “epigenetically” activate or silence genes without actually altering DNA sequences. For instance, it is known that adenine methylation plays a critical role in how some bacteria defend themselves against viruses.

For decades, scientists thought that adenine methylation strictly happened in bacteria whereas human and other non-bacterial cells relied on the methylation of a different building block—cytosine—to regulate genes. Then, starting around 2015, this view changed. Scientists spotted high levels of adenine methylation in plant, fly, mouse, and human cells, suggesting a wider role for the reaction throughout evolution.

However, the scientists who performed these initial experiments faced difficult trade-offs. Some used techniques that can precisely measure adenine methylation levels from any cell type but do not have the capacity to identify which cell each piece of DNA came from, while others relied on methods that can spot methylation in different cell types but may overestimate reaction levels.

In this study, Dr. Fang’s team developed a method called 6mASCOPE which overcomes these trade-offs. In it, DNA is extracted from a sample of tissue or cells and chopped up into short strands by proteins called enzymes. The strands are placed into microscopic wells and treated with enzymes that make new copies of each strand. An advanced sequencing machine then measures in real time the rate at which each nucleotide building block is added to a new strand. Methylated adenines slightly delay this process. The results are then fed into a machine learning algorithm which the researchers trained to estimate methylation levels from the sequencing data.

“The DNA sequences allowed us to identify which cells—human or bacterial—methylation occurred in while the machine learning model quantified the levels of methylation in each species separately,” said Dr. Fang.

Initial experiments on simple, single-cell organisms, such as green algae, suggested that the 6mASCOPE method was effective in that it could detect differences between two organisms that both had high levels of adenine methylation.

The method also appeared to be effective at quantifying adenine methylation in complex organisms. For example, previous studies had suggested that high levels of methylation may play a role in the early growth of the fruit fly Drosophila melanogaster and of the flowering weed Arabidopsis thaliana. In this study, the researchers found that these high levels of methylation were mostly the result of contaminating bacterial DNA. In reality, the fly and the plant DNA from these experiments only had trace amounts of methylation.

Likewise, experiments on human cells suggested that methylation occurs at very low levels in both healthy and disease conditions. Immune cell DNA obtained from patient blood samples had only trace amounts of methylation.

Similar results were also seen with DNA isolated from glioblastoma brain tumor samples. This result was different than a previous study, which reported much higher levels of adenine methylation in tumor cells. However, as the authors note, more research may be needed to determine how much of this discrepancy may be due to differences in tumor subtypes as well as other potential sources of methylation.

Finally, the researchers found that plasmid DNA, a tool that scientists use regularly to manipulate genes, may be contaminated with high levels of methylation that originated from bacteria, suggesting this DNA could be a source of contamination in future experiments. 

“Our results show that the manner in which adenine methylation is measured can have profound effects on the result of an experiment. We do not mean to exclude the possibility that some human tissues or disease subtypes may have highly abundant DNA adenine methylation, but we do hope 6mASCOPE will help scientists fully investigate this issue by excluding the bias from bacterial contamination,” said Dr. Gang. “To help with this we have made the 6mASCOPE analysis software and a detailed operating manual widely available to other researchers.”

This work was supported by the National Institutes of Health (GM139655, HG011095, AG071291); the Icahn Institute for Genomics and Multiscale Biology; the Irma T. Hirschl/Monique Weill-Caulier Trust; the Nash Family Foundation; and the Department of Scientific Computing at the Icahn School of Medicine at Mount Sinai. Methods validation using Mass Spectrometry was supported by the collaborators at the Chinese Academy of Sciences (XDPB2004) and the National Natural Science Foundation of China (22021003).

About the Mount Sinai Health System

The Mount Sinai Health System is New York City’s largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai advances medicine and health through unrivaled education and translational research and discovery to deliver care that is the safest, highest-quality, most accessible and equitable, and the best value of any health system in the nation. The Health System includes approximately 7,300 primary and specialty care physicians; 13 joint-venture ambulatory surgery centers; more than 415 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. The Mount Sinai Hospital is ranked on U.S. News & World Report’s “Honor Roll” of the top 20 U.S. hospitals and is top in the nation by specialty: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. Mount Sinai Kravis Children’s Hospital is ranked in U.S. News & World Report’s “Best Children’s Hospitals” among the country’s best in four out of 10 pediatric specialties. The Icahn School of Medicine is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report’s “Best Medical Schools,” aligned with a U.S. News & World Report “Honor Roll” Hospital, and No. 14 in the nation for National Institutes of Health funding. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and YouTube.

The Omicron variant has raised long-awaited hopes that Covid-19 is starting to shift from a pandemic to a more manageable endemic illness like seasonal flu.

The Omicron variant has moved the Covid-19 pandemic into a new phase and could bring it to an end in Europe, the WHO Europe director said Sunday.

“It’s plausible that the region is moving towards a kind of pandemic endgame,” Hans Kluge told news agency AFP in an interview, adding that Omicron could infect 60 percent of Europeans by March.

Once the current surge of Omicron currently sweeping across Europe subsides, “there will be for quite some weeks and months a global immunity, either thanks to the vaccine or because people have immunity due to the infection, and also lowering seasonality.”

“We anticipate that there will be a period of quiet before Covid-19 may come back towards the end of the year, but not necessarily the pandemic coming back,” Kluge said. Top US scientist Anthony Fauci expressed similar optimism on Sunday.

He told ABC News talk show “This Week” that with Covid-19 cases coming down “rather sharply” in parts of the United States, “things are looking good”.

While cautioning against over confidence, he said that if the recent fall in case numbers in areas like the US’s northeast continues, “I believe that you will start to see a turnaround throughout the entire country”.

The WHO regional office for Africa also said last week that cases of Covid had plummeted in that region and deaths were declining for the first time since the Omicron-dominated fourth wave of the virus reached its peak.

The Omicron variant, which studies have shown is more contagious than Delta but generally leads to less severe infection among vaccinated people, has raised long-awaited hopes that Covid-19 is starting to shift from a pandemic to a more manageable endemic illness like seasonal flu.

But Kluge cautioned that it was still too early to consider Covid-19 endemic. “There is a lot of talk about endemic but endemic means…that it is possible to predict what’s going to happen. This virus has surprised (us) more than once so we have to be very careful,” Kluge said. With Omicron spreading so widely, other variants could still emerge, he warned.

Focus On ‘Minimising Disruption’

The European Commissioner for Internal Markets, Thierry Breton, whose brief includes vaccine production, said Sunday that it will be possible to adapt existing vaccines to any new variants that may emerge.

“We will be able to better resist, including to new variants”, he told French television LCI.

“We will be ready to adapt the vaccines, especially the mRNA ones, if necessary to adapt them to more virulent variants”.

In the WHO Europe region, which comprises 53 countries including several in Central Asia, Omicron represented 15 percent of new cases as of January 18, compared to 6.3 percent a week earlier, the health body said.

Omicron is now the dominant variant in the European Union and the European Economic Area (EEA, or Norway, Iceland and Liechtenstein), the EU health agency ECDC said last week.

Because of the very fast spread of the variant across Europe, Kluge said emphasis ought to be on “minimising disruption of hospitals, schools and the economy, and putting huge efforts on protecting the vulnerable”, rather than measures to stop transmission.

He, meanwhile, urged people to exercise personal responsibility. “If you don’t feel well, stay home, take a self test. If you’re positive, isolate,” he said.

Kluge said the priority was to stabilise the situation in Europe, where vaccination levels range across countries from 25 to 95 percent of the population, leading to varying degrees of strain on hospitals and health-care system.

“Stabilising means that the health system is no longer overwhelmed due to Covid-19 and can continue with the essential health services, which have unfortunately been really disrupted for cancer, cardiovascular disease, and routine immunisation.”

President Joe Biden’s chief medical adviser expressed optimism that the omicron surge that has pushed Covid-19 infections and hospitalizations to records will soon peak, though that decline won’t be uniform throughout the U.S.“Things are looking good,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on ABC’s “This Week” on Sunday. “We don’t want to get overconfident, but they look like they’re going in the right direction right now.”

Infections are “starting to come down rather sharply” in the U.S. Northeast and Midwest, Fauci said, in line with the variant’s trajectory in South Africa and other places. He said he expected that states in the South and West where cases are still rising will soon follow the same downward path, depending in part on vaccination rates.

“I believe that you will start to see a turnaround throughout the entire country,” he said. “There may be a bit more pain and suffering with hospitalizations in those areas of the country that have not been fully vaccinated or have not gotten boosters.”

Fauci sketched out two longer-term scenarios for Covid-19 as the pandemic enters its third year.

The first is that Covid-19 becomes “less virulent” and can be controlled.

“You’re not eradicating it but it gets down to such a low level, that it’s essentially integrated into the general respiratory infections that we have learned to live with,” he said.

The worst-case scenario is the emergence of a still-more dangerous variant, he said. He said this possibility is more reason for people to get vaccinated and receive booster shots, and to make testing and medical treatment more widely available.

Anthony Fauci, top US infectious disease expert, has said he is confident that most states in the country will reach a peak of Omicron infection cases by mid-February.

“You never want to be overconfident when you’re dealing with this virus,” Fauci added on Sunday in an interview with ABC News.

“Things are looking good. We don’t want to get overconfident, but they look like they’re going in the right direction right now,” he said.

Fauci added that there are states in the northeast and in the upper midwest where cases have already peaked and declined “rather sharply.” But cases are still rising in southern and western states, Xinhua news agency reported.

“There may be a bit more pain and suffering with hospitalisations in those areas of the country that have not been fully vaccinated or have not gotten boosters,” he warned.

The recent Covid-19 surge in the US driven by the Omicron variant is leading to record high cases, hospitalisations and critical shortage of healthcare staff.

The country has recorded over 70 million Covid-19 cases and nearly 866,000 deaths as of Sunday afternoon, according to real-time data from Johns Hopkins University.(IANS)

A new international study offers a clearer picture of the impact of COVID-19 infection and the risk of severe outcomes on young people around the world.

The study was co-led by a team of researchers from the University of Calgary’s Cumming School of Medicine (CSM), Ann & Robert H. Lurie Children’s Hospital of Chicago, and University of California-Davis Medical Center.  It followed more than 10,300 children at 41 emergency departments in 10 countries including Canada and United States, Italy, Spain and Australia.

Researchers followed more than 3,200 children who visited hospital emergency departments and tested positive for COVID-19. Approximately 3 percent (107 total) of those diagnosed with COVID-19 experienced severe outcomes within two weeks of their visit to an emergency room. In addition, 23 percent (735 total), were hospitalized for treatment. Severe outcomes included cardiac or cardiovascular complications, such as myocarditis (inflammation of the heart), as well as neurologic, respiratory, or infectious problems. Four children died. The study was published in JAMA Network Open.

“The study sought to quantify the frequency of and risk factors for severe outcomes in children with COVID-19,” says study co-lead Stephen Freedman, MD, a paediatrician and professor at the CSM.  “We found that older age, having a pre-existing chronic condition and symptom duration were important risk factors for severe outcomes.”

Researchers also found children deemed healthy at an initial emergency department visit rarely deteriorated significantly after the first visit.

“Fortunately, the risk of developing severe disease in children with COVID-19 discharged from the emergency department is very low,” says study co-lead Todd Florin, MD, MSCE, director of Research in Emergency Medicine at Ann & Robert H. Lurie Children’s Hospital of Chicago and associate professor of Pediatrics at Northwestern University Feinberg School of Medicine. “Our findings can provide reassurance to parents and clinicians for children well enough to be managed in the community, while also providing important insights on which children may be at particular risk for severe outcomes.”

Although asthma has previously been suggested as a risk factor for severe outcome, this study was not able to confirm a link. It also did not find that very young infants were at a higher risk for severe outcomes.

“With emergency departments across the world seeing an influx of patients due to the COVID-19 pandemic and stressing capacity, this study will help address the surge by providing an estimate of the risk among pediatric COVID-19 patients screened in emergency department,” said Nathan Kuppermann, MD, MPH, chair of Emergency Medicine at University of California Davis Medical Center and co-lead of the study. “It will support emergency physicians triage of pediatric patients more efficiently by knowing who has risk factors for severe outcomes and focus advanced level care to those who do.”

The study occurred within the Pediatric Emergency Research Network, a global consortium of the world’s major pediatric emergency care research networks. It received support from the Canadian Institutes of Health Research, Alberta Innovates, Alberta Health Services and the University of Calgary. It also received COVID grant funding from the University of California Davis, Cincinnati Children’s Hospital Medical Center and Ann and Robert H. Lurie Children’s Hospital of Chicago. Dr. Anna Funk, PhD, an epidemiologist and UCalgary postdoctoral fellow, was lead author of the study.

“There are no specific evidence-based treatments and therapies for children at this time and detailed research data describing outcomes in young people with COVID-19 has been lacking, so this study offers important insights that we believe will be helpful to front-line care providers treating children with COVID-19,” adds Freedman.

Research at Ann & Robert H. Lurie Children’s Hospital of Chicago is conducted through the Stanley Manne Children’s Research Institute. The Manne Research Institute is focused on improving child health, transforming pediatric medicine and ensuring healthier futures through the relentless pursuit of knowledge. Lurie Children’s is ranked as one of the nation’s top children’s hospitals by U.S. News & World Report. It is the pediatric training ground for Northwestern University Feinberg School of Medicine.

Two new British studies provide some early hints that the omicron variant of the coronavirus may be milder than the delta version. Scientists stress that even if the findings of these early studies hold up, any reductions in severity need to be weighed against the fact omicron spreads much faster than delta and is more able to evade vaccines. Sheer numbers of infections could still overwhelm hospitals.

Still, the new studies released Wednesday seem to bolster earlier research that suggests omicron may not be as harmful as the delta variant, said Manuel Ascano Jr., a Vanderbilt University biochemist who studies viruses. “Cautious optimism is perhaps the best way to look at this,” he said.

An analysis from the Imperial College London COVID-19 response team estimated hospitalization risks for omicron cases in England, finding people infected with the variant are around 20% less likely to go to the hospital at all than those infected with the delta variant, and 40% less likely to be hospitalized for a night or more.

That analysis included all cases of COVID-19 confirmed by PCR tests in England in the first half of December in which the variant could be identified: 56,000 cases of omicron and 269,000 cases of delta.

A separate study out of Scotland, by scientists at the University of Edinburgh and other experts, suggested the risk of hospitalization was two-thirds less with omicron than delta. But that study pointed out that the nearly 24,000 omicron cases in Scotland were predominantly among younger adults ages 20-39. Younger people are much less likely to develop severe cases of COVID-19.

“This national investigation is one of the first to show that Omicron is less likely to result in COVID-19 hospitalization than Delta,” researchers wrote. While the findings are early observations, “they are encouraging,” the authors wrote.

The findings have not yet been reviewed by other experts, the gold standard in scientific research.

Ascano noted the studies have limitations. For example, the findings are specific to a certain point in time during a quickly changing situation in the United Kingdom and other countries may not fare the same way.

Matthew Binnicker, director of clinical virology at Mayo Clinic in Rochester, Minnesota, said that in the Scottish study, the percentage of younger people was almost twice as high for the omicron group compared with the delta group, and that “could have biased the conclusions to less severe outcomes caused by omicron.”

He nonetheless said the data were interesting and suggest omicron might lead to less severe disease. But he added: “It’s important to emphasize that if omicron has a much higher transmission rate compared to delta, the absolute number of people requiring hospitalization might still increase, despite less severe disease in most cases.”

Data out of South Africa, where the variant was first detected, have also suggested omicron might be milder there. Salim Abdool Karim, a clinical infectious disease epidemiologist in South Africa, said earlier this week that the rate of admissions to hospitals was far lower for omicron than it was for delta.

“Our overall admission rate is in the region of around 2% to 4% compared to previously, where it was closer to 20%,” he said. “So even though we’re seeing a lot of cases, very few are being admitted.”

A New South African Study

A new South African study found the omicron variant could be significantly less severe than previous strains of the novel coronavirus.

The study found people with omicron infections had an 80 percent lower chance of being hospitalized, compared to other COVID-19 cases.

The researchers cautioned, though, that it is unclear to what extent omicron is intrinsically less severe than earlier strains, and to what extent the drop is due to more immunity in the population, from both prior infection and vaccination, than there was in earlier waves.

“It is difficult to disentangle the relative contribution of high levels of previous population immunity versus intrinsic lower virulence to the observed lower disease severity,” the study, which has not yet been peer-reviewed, states.  Still, the findings could provide some good news.

“New pre-print from South Africa suggests that, at least among those vaccinated and/or previously infected, Omicron is much less severe than Delta,” tweeted Tom Frieden, former director of the Centers for Disease Control and Prevention. “Will that hold true in the US with an older population? We’ll find out in the coming weeks.” The South African study adds to earlier indications that omicron could be less severe, though researchers are still gathering data.

U.S. health regulators on Wednesday authorized the first pill against COVID-19, a Pfizer drug that Americans will be able to take at home to head off the worst effects of the virus.  The long-awaited milestone comes as U.S. cases, hospitalizations and deaths are all rising and health officials warn of a tsunami of new infections from the omicron variant that could overwhelm hospitals.

The drug, Paxlovid, is a faster way to treat early COVID-19 infections, though initial supplies will be extremely limited. All of the previously authorized drugs against the disease require an IV or an injection.

An antiviral pill from Merck also is expected to soon win authorization. But Pfizer’s drug is all but certain to be the preferred option because of its mild side effects and superior effectiveness, including a nearly 90% reduction in hospitalizations and deaths among patients most likely to get severe disease.

“The efficacy is high, the side effects are low and it’s oral. It checks all the boxes,” said Dr. Gregory Poland of the Mayo Clinic. “You’re looking at a 90% decreased risk of hospitalization and death in a high-risk group — that’s stunning.”

The Food and Drug Administration authorized Pfizer’s drug for adults and children ages 12 and older with a positive COVID-19 test and early symptoms who face the highest risks of hospitalization. That includes older people and those with conditions like obesity and heart disease, though the drug is not recommended for patients with severe kidney or liver problems. Children eligible for the drug must weigh at least 88 pounds (40 kilograms).

The pills from both Pfizer and Merck are expected to be effective against omicron because they don’t target the spike protein where most of the variant’s worrisome mutations reside.

Pfizer currently has 180,000 treatment courses available worldwide, with roughly 60,000 to 70,000 allocated to the U.S. The company said it expects to have 250,000 available in the U.S. by the end of January.

Federal health officials are expected to ration early shipments to the hardest hit parts of the country. Pfizer said the small supply is due to the manufacturing time — currently about nine months. The company says it can halve production time next year.

The U.S. government has agreed to purchase enough Paxlovid to treat 10 million people, and it will be provided free to patients. Pfizer says it’s on track to produce 80 million courses globally next year, under contracts with the U.K., Australia and other nations.

President Joe Biden said the pill marks a “significant step forward in our path out of the pandemic” and said his administration will work with states to ensure equitable distribution.

Health experts agree that vaccination remains the best way to protect against COVID-19. But with roughly 40 million American adults still unvaccinated, effective drugs will be critical to blunting the current and future waves of infection.

The U.S. is now reporting more than 140,000 new infections daily and federal officials warn that the omicron variant could send case counts soaring. Omicron has already whipped across the country to become the dominant strain, federal officials confirmed earlier this week.

Against that backdrop, experts warn that Paxlovid’s initial impact could be limited. For more than a year, biotech-engineered antibody drugs have been the go-to treatments for COVID-19. But they are expensive, hard to produce and require an injection or infusion, typically given at a hospital or clinic. Also, laboratory testing suggests the two leading antibody drugs used in the U.S. aren’t effective against omicron.

Pfizer’s pill comes with its own challenges.

Patients will need a positive COVID-19 test to get a prescription. And Paxlovid has only proven effective if given within five days of symptoms appearing. With testing supplies stretched, experts worry it may be unrealistic for patients to self-diagnose, get tested, see a physician and pick up a prescription within that narrow window.

“If you go outside that window of time I fully expect the effectiveness of this drug is going to fall,” said Andrew Pekosz, a Johns Hopkins University virologist.

The FDA based its decision on company results from a 2,250-patient trial that showed the pill cut hospitalizations and deaths by 89% when given to people with mild-to-moderate COVID-19 within three days of symptoms. Less than 1% of patients taking the drug were hospitalized and none died at the end of the 30-day study period, compared with 6.5% of patients hospitalized in the group getting a dummy pill, which included nine deaths.

Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body.

The U.S. will pay about $500 for each course of Pfizer’s treatment, which consists of three pills taken twice a day for five days. Two of the pills are Paxlovid and the third is a different antiviral that helps boost levels of the main drug in the body.