Category: Health

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

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

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

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

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

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

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

What you need to know:

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

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

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

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

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

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

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

Data Supporting the Moderna COVID-19 Vaccine, Bivalent Authorization

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What is this deficiency, and how was it cured?

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

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

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

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

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

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

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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.”