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.

Can’t find your reading glasses? A new eye drop out Thursday could be a game-changer for millions of aging Americans who struggle to see up close.

“It’s definitely a life changer,” Toni Wright, one of the 750 participants in a clinical trial to test the drops, told CBS News national correspondent Jericka Duncan.

Vuity, the first eye drop for sharpening near vision, hit the market this week after the Food and Drug Administration approved it in October. The new medicine is meant to be used once a day and can improve vision for up to six hours at a time.

The eye drops will work best for people between the ages of 40 and 55, a Vuity spokesperson told CBS. That age group comprised two clinical trials and is most likely to notice the onset of near vision loss. 

Presbyopia, or age-related blurred near vision, typically sets in after age 40, according to the American Optometric Association. Around 1.8 billion people around the world have presbyopia, according to a 2018 estimate, and the condition affects almost half of US adults per earlier estimates.

For this group, Vuity offers a potential alternative to reading glasses. The eye drops might be easier to keep track of, but they are pricier at about $80 for a 30-day supply, according to a press release from biopharmaceutical giant AbbVie. The drops must be prescribed by a physician and are not currently covered by insurance.

The medicine works by causing the pupil to constrict, which naturally allows the eye to focus at different ranges. About 15 minutes after administering one drop in each eye, participants in clinical trials could see three additional lines on a reading chart.

The drops are not meant to be used for night driving, although they worked in low-light conditions for at least three hours after application in the trials. Side effects detected during the three-month trial period included headaches and red eyes, and some users had difficulty adjusting their focus between near and far objects.

A newly-approved eye drop could change the lives of millions of Americans with age-related blurred near vision, a condition affecting mostly people 40 and older, CBS News reported. Vuity, which was approved by the Food and Drug Administration (FDA) in October, would potentially replace reading glasses for some of the 128 million Americans who have trouble seeing close-up.

The new medicine takes effect in about 15 minutes, with one drop on each eye providing sharper vision for six to 10 hours, according to the company, the CBS News report said. Toni Wright, one of the 750 participants in a clinical trial to test the drug, said she liked what she saw. “It’s definitely a life changer,” she told the media.

Before the trial, the only way Wright could see things clearly was by keeping reading glasses everywhere — in her office, bathroom, kitchen and car. “I was in denial because to me that was a sign of growing older, you know, needing to wear glasses,” she said.

It was in 2019 that her doctor told her about a new eye drop with the potential to correct her vision problems, temporarily. The 54-year-old online retail consultant, who works from her farm in western Pennsylvania, instantly noticed a difference, the report said. “I would not need my readers as much, especially on the computer, where I would always need to have them on,” she said.

Vuity is the first FDA-approved eye drop to treat age-related blurry near vision, also known as presbyopia. The prescription drug utilizes the eye’s natural ability to reduce its pupil size, said George Waring, the principal investigator for the trial. “Reducing the pupil size expands the depth of field or the depth of focus, and that allows you to focus at different ranges naturally,” he said.

A 30-day supply of the drug will cost about $80 and works best in people 40 to 55 years old, a Vuity spokesperson said. Side effects detected in the three-month trial included headaches and red eyes, the company said. “This is something that we anticipate will be well tolerated long term, but this will be evaluated and studied in a formal capacity,” the CBS News report quoted Waring as saying.

Vuity is by no means a cure-all, and the maker does caution against using the drops when driving at night or performing activities in low-light conditions. The drops are for mild to intermediate cases and are less effective after age 65, as eyes age. Users may also have temporary difficulty in adjusting focus between objects near and far.

Vaccine makers say they are in the midst of testing their shots’ effectiveness against the newly discovered omicron coronavirus variant, and they remain optimistic that a new variant-specific vaccine could be produced and rolled out quickly if needed.

When asked about the new omicron variant that was first detected in southern Africa, Paul Burton, Moderna’s chief medical officer, told ABC News’ “Good Morning America” on Monday that vaccine manufacturers around the world, including Moderna, “are testing samples from people who have received our vaccines against the strains.”

Burton said that while the company thinks “vaccine effectiveness may come down, based on the mutation seen in this in this virus,” he added that with booster shots of the existing version of the vaccine, “We should be able to get antibody levels up, so that’s a very important initial line of defense.”

Burton said that researchers will know just how effective the vaccines are against this variant “in the next couple of weeks.” If manufacturers need to make an omicron variant-specific vaccine, it should take approximately “two to three months” to test and manufacture it, he said.

Fellow coronavirus vaccine maker Pfizer similarly expressed confidence that it could produce a new vaccine quickly if needed. Pfizer’s CEO Albert Bourla told CNBC’s “Squawk Box” on Monday that he is very optimistic the company will be able to speedily switch production to a new vaccine, if the research merits, without losing any volume.

Johnson & Johnson also said in a statement Monday that it is evaluating its current COVID-19 vaccine against the omicron variant.

“In addition, the company is pursuing an omicron-specific variant vaccine and will progress it as needed,” it said.

Scientists suspect the omicron variant could partially chip away protection from current vaccines due to its mutations, but they are still waiting on testing to learn if, and to what extent, that could be the case.

Vaccine experts have told ABC News that the current COVID-19 vaccines, which rely on genetic technology, could easily be updated to better combat emerging variants. This has not been necessary so far, as the original vaccines have been effective against the dominant variants that have spread in the past, but companies are preparing to tweak vaccines to respond to the omicron variant just in case.

The good news is that these novel vaccines employing genetic technology mean updates can be made to the vaccines easily — unlike vaccines based on older technology, which used a piece of the virus or a killed virus to mimic infection.

The new vaccines, which use the genetic technology, introduces an instruction manual of sorts into your body. This introduction manual tells your cells to start churning out a protein normally found on the outside of the virus, and your body activates an immune response when your body senses that viral protein.

In remarks on Monday, President Joe Biden assured Americans that the omicron variant “is a cause for concern, not a cause for panic.”

“We have the best vaccine in the world. The best medicines, the best scientists, and we’re learning more every single day,” the president said. “And we’ll fight this variant with scientific and knowledgeable actions and speed. Not chaos and confusion.”

A new strain of COVID-19 first discovered in South Africa was declared a variant of concern by the World Health Organization on Friday. Here’s how the pharmaceutical industry plans to address the latest coronavirus curve ball.

Vaccine makers are already pivoting their efforts to combat the new variant: testing higher doses of booster shots, designing new boosters that anticipate strain mutations, and developing omicron-specific boosters.

In a statement sent to NPR, Moderna said it has been working on a comprehensive strategy to predict variants of concern since the beginning of 2021. One approach is to double the current booster from 50 to 100 micrograms. Secondly, the vaccine maker has been studying two booster vaccines that are designed to anticipate mutations like those found in the omicron variant. The company also said it will ramp up efforts to make a booster candidate that specifically targets omicron.

“From the beginning, we have said that as we seek to defeat the pandemic, it is imperative that we are proactive as the virus evolves,” said Moderna CEO Stéphane Bancel. “The mutations in the Omicron variant are concerning and for several days, we have been moving as fast as possible to execute our strategy to address this variant.”

Pfizer and BioNTech told Reuters that they expect more data about the omicron variant to be collected within two weeks. That information will help determine whether or not they need to modify their current vaccine. Pfizer and BioNTech said a vaccine tailored for the omicron variant, if needed, could be ready to ship in approximately 100 days.

Johnson & Johnson said in a statement sent to NPR that it too is already testing its vaccine’s efficacy against the new variant.

The omicron variant was first reported to the WHO on Nov. 24, the WHO said. Preliminary evidence indicates the variant poses an increased risk for reinfection due to the large number of mutations. Until recently, cases across South Africa have predominantly been from the delta variant, an earlier strain that has pushed health care systems to the max since early summer. But omicron infections have been on the rise in recent weeks, the WHO reported.

More concerning, omicron cases have emerged across the globe. Cases have been confirmed in Botswana, the United Kingdom, Italy, Germany, Belgium, Israel, the Netherlands, Australia and Hong Kong.

News of the rapidly spreading variant led to a new set of air travel restrictions from South Africa and seven other countries, implemented by President Joe Biden, that go into effect Monday. The president made the announcement the day after Thanksgiving, one of the busiest travel periods of the year.

Unlike last year, when millions of people traveled against the advice of health experts, the Centers for Disease Control and Prevention and chief medical adviser to the president, Dr. Anthony Fauci, more or less condoned Thanksgiving get-togethers for vaccinated Americans. And, according to an American Automobile Association travel forecast, over 53 million people were expected to travel for Thanksgiving — an 18% jump compared to last year — including more than 4 million by air.

As of Friday, the CDC said that no cases of the omicron variant had been identified in the United States. However, Fauci said on Saturday that he would not be surprised if the variant is already here.

“We have not detected it yet, but when you have a virus that is showing this degree of transmissibility and you’re already having travel-related cases that they’ve noted in Israel and Belgium and other places … it almost invariably is ultimately going to go essentially all over,” he said in an interview on the Today show.

As Americans prepare to transition from one busy holiday to the next, the CDC is predicting that coronavirus cases, hospitalizations and deaths will increase over the next four weeks. More than 776,000 people in the U.S. have died of COVID-19 to date, according to Johns Hopkins University’s tracker, and the country is projected to surpass 800,000 deaths by Christmas.

The Ministry of Ayush in India has decided to re-examine the matter pertaining to the use of Ashwagandha — Withania somnifera — leaves in Ayurveda, Siddha and Unani (ASU) drugs by constituting an expert group to this end.

The Ayush Ministry earlier had directed ASU drug manufacturers to refrain from the usage of Ashwagandha (Withania somnifera) leaves, saying that no substantial evidence and literature is available to endorse the efficacy of crude drug or extract of Ashwagandha.

The Ministry also issued an advisory to all ASU Drugs Manufacturers Associations seeking the manufacturers of the crude drug/extracts, sellers, ASU drug manufacturing companies, ASU drug exporters not to use Withania somnifera leaves either in crude or extract or any other form for therapeutic purposes under the ambit of ASU drugs.

“No substantial evidence and literature is available to endorse the efficacy of crude drug/extract of Withania somnifera leaves. Considering this, it would not be appropriate to consider the Withania somnifera leaves as ASU medicine at this stage,” the ministry had said in its advisory.

However, after industry’s intervention, the Ayush Ministry invited the stakeholders to discuss their concerns about utilization of Ashwagandha leaves in ASU products.

After the discussion with the ASU industry partners, the Ministry of Ayush has decided to set up an expert group to re-examine the advisory issued to the drug manufacturers to refrain from using Ashwagandha leaves.

The group will make appropriate recommendations to the Centre on the use of Ashwagandha leaves and Panchanga of Ashwagandha in ASU products based on scientific evidence. (IANS)

An influential U.S. advisory panel will discuss expanding eligibility for COVID-19 vaccine booster shots to all adults Friday, a move that could make the shots available nationwide as early as this weekend.

Some cities and states already allow all adults to get boosters of Pfizer’s vaccine, but it is not yet official U.S. policy. In the last week, California, New Mexico, Arkansas, West Virginia and Colorado expanded the shots to all adults. New York City made a similar move.

Pfizer asked U.S. regulators last week to allow boosters of its COVID-19 vaccine for anyone 18 or older. The Food and Drug Administration is expected to sign off on Pfizer’s application before the advisory panel meets Friday. The final step — CDC’s official recommendation — could come soon after the meeting.

The move would greatly expand who is eligible. Boosters are now recommended for people who initially received their second Pfizer or Moderna shots at least six months ago if they’re 65 or older or are at high risk of COVID-19 because of health problems or their job or living conditions. Boosters are also recommended for people who received the single-dose Johnson & Johnson vaccine at least two months ago.

Nearly 31 million Americans have already received a dose beyond their original vaccination, including those with weakened immune systems, such as cancer patients and organ transplant recipients who need an extra dose to be fully vaccinated.

While all three vaccines used in the U.S. continue to offer strong protection against severe COVID-19 illness and death, the shots’ effectiveness against milder infection can wane over time.

Pfizer has submitted early results of a booster study in 10,000 people to make its case that it’s time to further expand the booster campaign. The study found that a booster could restore protection against symptomatic infection to about 95%, even as the extra-contagious delta variant was surging. Side effects were similar to those seen with the company’s first two shots.

Members of the panel, the Advisory Committee on Immunization Practices, have debated in prior meetings whether there is sufficient evidence that boosters are currently needed for all adults.

We’ve all heard talk about “the new normal,” whatever that even is. CNN’s chief medical correspondent Dr. Sanjay Gupta has his own ideas, and despite the harsh realities of nearly 3 years living through a pandemic — quarantines, hospital staffing shortages, massive loss of life — he remains optimistic. In his new book World War C, he says, COVID is something we’ll likely live with… forever. But that doesn’t mean it has to control our lives. He sat down with NPR’s Rachel Martin to talk about it in today’s episode.

CNN chief medical correspondent Sanjay Gupta, MD, offers an accessible, data-packed answer to our biggest questions about Covid-19: What have we learned about this pandemic and how can we prepare for—or prevent—the next one?
As America’s favorite frontline Covid-19 health journalist, Dr. Sanjay Gupta has barely left his primetime seat in his makeshift studio basement since the pandemic began (other than to perform brain surgery). He’s had the insider of insider access to the drama’s unfolding, including exclusive conversations with the world’s top public health experts and behind-the-scenes scientists racing to find treatments and cures. And now he’s sharing what he’s learned in a book that will answer not only all our questions about what happened, but also about how our world will change in the years ahead, even once we’re back to “normal.”
Gupta argues that we need to prepare for a new era where pandemics will be more frequent, and possibly even more deadly. As the doctor who’s been holding America’s hand through the crisis with compassion, clarity, and well-earned wisdom, he gives you the unvarnished story behind the pandemic, including insights about the novel virus’s behavior, and offers practical tools to ready ourselves for what lies ahead. He answers critical questions: Can we stamp out the virus for good (and if not, how do we live with it)? Should we put our parents in a nursing home? Where should we live? What should we stockpile? What should we know before taking a trip? Does it make sense to spend more on health insurance to deal with any long-term effects? How do you decide when it’s safe to go to a public pool or schedule elective surgery? What should Covid survivors know about protecting their future health? What if you become a long-hauler with chronic health challenges stemming?
Dr. Sanjay Gupta is CNN’s Emmy Award–winning chief medical correspondent and the host of the acclaimed podcast Chasing Life (formerly Coronavirus: Fact vs Fiction), America’s go-to resource for expert advice on how to stay healthy and safe. The #1 New York Times bestselling author of Chasing Life, Cheating Death, Monday Mornings, and Keep Sharp, Dr. Gupta lives in Atlanta, where he works as an associate professor of neurosurgery at the Emory University School of Medicine. World War C will give you hope for the future along with real information that leaves you more resilient and secure.

(San Antonio, TX: November 12, 2021) “It is with great pleasure that we announce that the 40th American Association of Physicians of Indian origin (AAPI) Annual Convention and Scientific Sessions will be held from June 23-26, 2022 in the beautiful city of San Antonio, Texas,” Dr. Anupama Gotimukula, President of AAPI announced here at the virtual kick off meeting on Sunday, November 7th, 2021.

In her welcome remarks, Dr. Anupama Gotimukula, the 4th woman President of AAPI in the history of AAPI, who has been leading AAPI to newer heights with her dynamic leadership, provided a brief history of AAPI, stating how AAPI’s mission has evolved in the past 40 years. “Today, AAPI is strong representing over 100,000 Indian American physicians, 130 local Chapters, who make up of 10% of total physicians in the US and  nearly 50% of International Medical Graduates, rooted in every corner of the nation, who serve every 7th patient in the US. We are proud of our achievements and our contributions to the healthcare industry and the millions of people we serve.”

“We invite you to the AAPI 40th Annual Convention in the beautiful city of San Antonio, Texas,” Dr. Jayesh Shah, past President of AAPI and Chair of AAPI Convention 2022 said. Welcoming the delegates to his “Home city of San Antonio,” which is hosting the 2nd national convention, Dr. Shah said, “We have convened a fantastic group of people to meet the needs of the 2022 convention and are very excited about this year. Please reach out to any one of the representatives from the San Antonio team with questions or comments.”

The convention will be held at the Henry B. Gonzales Convention Center in San Antonio, TX located on the River Walk. This world-class facility will afford an intimate setting that will facilitate our ability to convey cutting-edge research and CME, promote business relationships, and display ethnic items. Vendor satisfaction and comfort are our top priorities.

Dr. Jayesh Shah introduced the strong and dedicated team of Convention Committee members, including Mr. Venky Adivi, Chief Executive Officer of the Convention; Dr. Aruna Venkatesh, Convention Treasurer; Dr. Vijay Koli, Past President of AAPI & Convention Advisor; Dr. Rajam Ramamurthy, Convention Advisor; Dr. Rajeev Suri, President of TIPS & Co-Chair of the Convention, Dr. Shankar Sanka, Co-Chair of the Convention; Dr. Hetal Nayak, Co-Chair of the Convention; Kiran Cheruku, Co-Chair of the Convention; and Chief Operating Officers, R. Reddy Yeluru and Ram Joolukuntla.

In his felicitation address, Honorable Aseem Mahajan, Consul General of India in Houston, said, “Honored to be part of the virtual Curtain Raiser.” Mr. Mahajan referred to the significance of “India and the United States, the two most vibrant democracies, representing two great multicultural societies with shared values, who are natural partners” working together in several areas of interest to both the nations.  Pointing to the immense opportunities for collaboration in healthcare between the US and India, as India is working towards “Expanding on the MedTech sector for global presence & position India as a global hub for medical devices, an attractive destination for medical devices by encouraging manufacturing, innovation, and R&D based on emerging technological landscapes, and transforming India into a hub for medical devices & emerge as the “diagnostic capital” of the world.”

Welcoming AAPI delegates to San Antonio, The mayor of the City, Mr. Ron Nirenberg said, “2022 is most exciting time to be in San Antonio, which hosts one of the largest Diwali celebrations in the United States. We are honored to host the largest gathering of Indian American physicians in our vibrant city, home to some of the best healthcare facilities in the nation.”

Confirming his presence at the Convention, “Little Master” Sunil Gavaskar told AAPI members as being part of the “greatest profession in the world,” and said, “It’s a unique honor to be part of the important AAPI convention in Texas. I am looking forward to meeting you all in Texas.” Mr. Gavakar referred to his association with the “Heart to Heart Foundation” and how the Foundation is touching many hearts around the world.

“Our physician members have worked very hard during the covid 19 pandemic as the 2022 convention is a perfect time to heal the healers with a special focus on wellness,” said Dr. Jayesh Shah. Accordingly, some of the major themes at the convention include: Yoga and Meditation practices, Welcome kit with books & self-care supplies, A Personal Reflexology Session, Take home wellness routine, Ailment based yoga therapy sessions, Workshop on Spiritual well-being, Book talk with Yoga Gurus, including on the science of Yoga & Lifestyle medicine, as well as a unique opportunity to visit first of its kind in San Antonio, Aum Ashram as part of the Wellness session.

In addition to colorful entertainment, exquisite authentic Indian cuisine, esteemed yoga gurus and experts, who are planned to share their wisdom and leading the Wellness Sessions include: Paramguru Sharatha Jois, Sadhvi Bhagawati, Saraswati Eddie Stern,  Dr. Sat Bir Khalsa, Dr. Dilip Sarkar, Dr. Pankaj Vij, and  Dr. Param Dedhia.

The American Association of Physicians of Indian Origin Convention offers an exciting venue to interact with leading physicians, health professionals, academicians, and scientists of Indian origin. The physicians and healthcare professionals from across the country will convene and participate in the scholarly exchange of medical advances, to develop health policy agendas, and to encourage legislative priorities in the coming year.

Planned to have a limited number of attendance due to the ongoing covid pandemic and taking into account the safety of the participants, including Physicians, Academicians, Researchers and Medical students, “The annual convention offers extensive academic presentations, recognition of achievements and achievers, and professional networking at the alumni and evening social events,” Dr. Gotimukula added.   For more information, please visitwww.aapiconvention.org  and www.aapiusa.org

Seeking “additional clarifications” for a final “risk-benefit assessment” in order to grant emergency use listing (EUL) to Bharat Biotech’s Covid-19 vaccine, Covaxin, the technical advisory group (TAG) of the World Health Organisation (WHO) has held back approval for the indigenously developed vaccine, till at least one more week, if not longer. This, after the TAG convened on Tuesday specifically to discuss granting EUL to Covaxin.

The TAG — which is an independent advisory group that recommends to WHO on whether a Covid-19 vaccine fulfils criteria for EUL or not — will meet next on November 3.

This increases the uncertainty about the vaccination status of millions of people who received the two jabs of Covaxin as several regions, including North America and the European Union, only consider those people fully vaccinated who have received their full course of WHO-approved vaccines.

The WHO last week said that it “cannot cut corners” in granting EUL to the vaccine. It had also put the onus of the delay on Bharat Biotech, saying that the timeframe for granting EUL depends on how quickly a company can submit all the data required in order to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries.

The company, which has been submitting clinical trial data of its vaccine on a rolling basis to the WHO, had earlier in May said that it had applied for WHO’s EUL that was expected between July to September. Later in June, it claimed that it had held a “pre-submission” briefing with the world health body regarding EUL approval for Covaxin. Last month, in a statement, it said that “all data was submitted for EUL Application to WHO in early July.”

A pre-submission briefing provides an opportunity to the company to receive advice and guidance before submission of the final dossier, as well as an opportunity to meet WHO assessors who will be involved in examining their product. This implies that it should be held before submitting the application — and not after it.

Even earlier this month, the Strategic Advisory Group of Experts on Immunisation (SAGE) of the WHO had held back on giving EUL to Covaxin, which has demonstrated 77.8% efficacy against symptomatic Covid-19 and 65.2% efficacy against the Delta variant.

Millions of Americans are now eligible for Moderna and Johnson & Johnson booster shots and also they that they can choose a different company’s vaccine for that next shot, after the nation’s top public health official endorsed recommendations from expert advisers that the shots are safe and effective at bolstering protection against the coronavirus.

Certain people who received Pfizer vaccinations months ago already are eligible for a booster and now the Centers for Disease Control and Prevention says specific Moderna and Johnson & Johnson recipients qualify, too. And in a bigger change, the agency is allowing the flexibility of “mixing and matching” that extra dose regardless of which type people received first.

The green light on October 20^th from Rochelle Walensky, director of the Centers for Disease Control and Prevention, means that eligible Americans at risk of severe disease can choose any of the three boosters now authorized in the United States regardless of their original shot.

“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe — as demonstrated by the over 400 million vaccine doses already given,” Walensky said in a statement Thursday night, several hours after receiving unanimous recommendations from the expert panel, called the Advisory Committee on Immunization Practices. “And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating delta variant.”

Walensky’s action — following authorization from federal regulators — largely fulfills the administration’s August pledge to make boosters of all three vaccines available to Americans, albeit a month later than promised and for a smaller group. The administration’s focus on boosters came as the highly contagious delta variant sickened millions and killed tens of thousands, and also reflected concern about waning immunity from the vaccines.

CDC’s sign-off on the additional boosters as well as the flexibility to mix and match the shots gives greater leeway to consumers, as well as to clinicians and pharmacies administering them to vulnerable populations. Health officials have repeatedly sought ways to make it easier for people to get a booster dose, especially those who have had side effects from one brand, or who worry about risks associated with a particular shot.

The availability of boosters will be particularly welcome to the 15 million recipients of the Johnson & Johnson vaccine, many of whom have been particularly fearful of breakthrough infections given that shot’s lower level of protection compared with the messenger RNA vaccines.

“I agree that those who received a [Johnson & Johnson] vaccine should receive a second dose — I would prefer that those individuals get an mRNA vaccine” rather than a second Johnson & Johnson shot, said advisory panel member Pablo J. Sanchez, a pediatrician at Ohio State University.

Interchangeability of shots is also likely to speed booster vaccination in nursing homes and other institutional settings where residents received different shots during the early rollout. The Pfizer-BioNTech booster is already in use since it was authorized and recommended last month.

“I think the opportunity for these [mix and match] boosts [is] priceless,” said Helen Keipp Talbot, an infectious-disease doctor at Vanderbilt University and panel member.

The CDC plans to release guidance early next week with more detailed information about who might benefit from choosing one booster over another, as the panel requested. CDC advisers and agency officials are still working out whether to recommend that some people stick to their original vaccine if possible.

“A really important aspect of all of this is being clear and not dancing on the head of a pin so that we don’t confuse the American people,” said Beth Bell, a global health professor at the University of Washington.

The advisory panel’s recommendation was similar to Wednesday’s action by the Food and Drug Administration. The FDA did not take a position on whether people should stay with the original vaccine or switch to another one, saying it did not have the data to make such judgments.

The FDA has authorized a third shot of Moderna or Pfizer-BioNTech for anyone 65 and older, or any adults at high risk of severe illness because of underlying conditions, job exposure or because they are in institutional settings, and who have gone at least six months since their second dose.

It broadened eligibility much further for those who received the single-shot Johnson & Johnson vaccine to anyone 18 and older who has gone at least two months since getting the shot — criteria reflecting the lower protection afforded by that vaccine compared with the others.

Advisers to the CDC suggested in their all-day meeting Thursday that mixing and matching booster shots may appeal to consumers concerned about possible risks associated with their first vaccine.

“A lot of what our efforts are centered around is trying to mitigate risk as much as possible, both from disease as well as vaccination,” said Grace Lee, a professor of pediatrics at Stanford University School of Medicine and chair of the panel.

More data on the safety of booster shots for specific groups may help determine “whether or not a different boost would be appropriate, for example, for young women” who first received Johnson & Johnson, Lee added.

Some panel members questioned the wisdom of administering a second Johnson & Johnson shot to women of childbearing age, for instance, because of rare but serious risk of blood clots associated with that vaccine. Analyses of data for those who have received that shot suggest an increased risk of a rare type of clot, especially for women 18 to 49 years old.

About 105 million fully vaccinated people have received the two-shot Pfizer series, according to the CDC. About 70 million fully vaccinated people have received the Moderna shots. Only 15 million Americans were vaccinated with Johnson & Johnson shots, which arrived later and were delayed by an investigation of a rare adverse event, as well as a manufacturing problem. More than 11 million people have received a booster or an additional dose of a vaccine to date.

There still are restrictions on who qualifies and when for a booster. Starting six months past their last Pfizer or Moderna vaccination, people are urged to get a booster if they’re 65 or older, nursing home residents, or at least 50 and at increased risk of severe disease because of health problems. Boosters also were allowed, but not urged, for adults of any age at increased risk of infection because of health problems or their jobs or living conditions. That includes health care workers, teachers and people in jails or homeless shelters. Moderna’s booster will come at half the dose of the original two shots.

As for recipients of the single-shot J&J vaccine, a COVID-19 booster is recommended for everyone at least two months after their vaccination. That’s because the J&J vaccine hasn’t proved as protective as the two-dose Moderna or Pfizer options.

About two-thirds of Americans eligible for COVID-19 shots are fully vaccinated, and the government says getting first shots to the unvaccinated remain the priority. While health authorities hope boosters will shore up waning immunity against milder coronavirus infections, all the vaccines still offer strong protection against hospitalizations and death, even as the extra-contagious delta variant burned through the country.

Newswise — A novel approach to treating type 2 diabetes is being developed at the Technion. The disease, caused by insulin resistance and reduction of cells’ ability to absorb sugar, is characterized by increased blood sugar levels. Its long-term complications include heart disease, strokes, damage to the retina that can result in blindness, kidney failure, and poor blood flow in the limbs that may lead to amputations. It is currently treated by a combination of lifestyle changes, medication, and insulin injections, but ultimately is associated with a 10-year reduction in life expectancy.

Led by Professor Shulamit Levenberg, Ph.D. student Rita Beckerman from the Stem Cell and Tissue Engineering Laboratory in the Technion’s Faculty of Biomedical Engineering presents a novel treatment approach, using an autograft of muscle cells engineered to take in sugar at increased rates. Mice treated in this manner displayed normal blood sugar levels for months after a single procedure. The group’s findings were recently published in Science Advances.

Muscle cells are among the main targets of insulin, and they are supposed to absorb sugar from the blood. In their study, Prof. Levenberg’s group isolated muscle cells from mice and engineered these cells to present more insulin-activated sugar transporters (GLUT4). These cells were then grown to form an engineered muscle tissue, and finally transported back into the abdomen of diabetic mice. The engineered cells not only proceeded to absorb sugar correctly, improving blood sugar levels, but also induced improved absorption in the mice’s other muscle cells, by means of signals sent between them. After this one treatment, the mice remained cured of diabetes for four months – the entire period they remained under observation. Their blood sugar levels remained lower, and they had reduced levels of fatty liver normally displayed in type 2 diabetes.

“By taking cells from the patient and treating them, we eliminate the risk of rejection,” Prof. Levenberg explained. These cells can easily integrate back into being part of the body and respond to the body’s signalling activity.

Currently around 34 million Americans, just over 1 in 10, suffer from diabetes, 90% of them from type 2 diabetes. An effective treatment – and one that is a one-time treatment rather than daily medication – could significantly improve both quality of life and life expectancy of those who have diabetes. The same method could also be used to treat various enzyme deficiency disorders.

This work was funded by Rina and Avner Schneur as part of the Rina and Avner Schneur Center for Diabetes Research.

Unvaccinated people are about six times more likely to test positive for COVID-19 and 11 times more likely to die from the illness compared to people who are vaccinated, though there are slight differences in risk based on vaccine type, according to newly released CDC data. 

The CDC published data Oct. 15 that breaks down the rate of COVID-19 cases and deaths by vaccination status and vaccine type. The rates are based on data from 16 public health departments — representing about 30 percent of the U.S. population — and cover April through the end of August. 

Five notes: 

1. Overall, unvaccinated people had the highest COVID-19 case and death rates. 

2. The COVID-19 case and death rates were slightly higher among Johnson & Johnson vaccine recipients, followed by Pfizer recipients and then Moderna.

3. As of Aug. 15, there were about 737 cases per 100,000 population among unvaccinated people — the highest rate during the period for which data was collected.

4. The case rates as of Aug. 15 for J&J recipients were about 172 cases per 100,000, followed by about 136 cases per 100,000 among Pfizer recipients, and 86 cases per 100,000 among Moderna recipients. 

5. The death rates as of Aug. 15 were nearly 13 per 100,000 among unvaccinated people, 3 per 100,000 for J&J recipients, about 1.4 per 100,000 for people who got Pfizer’s shot, and 0.69 per 100,000 for Moderna recipients.

Anthony Fauci, the chief medical advisor to President Joe Biden, said American drug regulator will consider whether those who have been inoculated with one dose of Johnson & Johnson (J&J) vaccine should be administered an mRNA-based vaccine, like Moderna or Pfizer as a booster shot to help induce a higher number of antibodies.

“If you boost people who have originally received J&J with either Moderna or Pfizer, the level of antibodies that you induce in them is much higher than if you boost them with the original J&J,” Fauci told reporters during a television interview.

Fauci’s comment comes after a second dose of the J&J vaccine was recommended by the Food and Drug Administration (FDA) for 18 years and above as a booster shot. FDA also recommended a third dose of the Modern vaccine as a booster shot to high-risk adults.

Both Pfizer-BioNTech SE and Moderna vaccines are based on mRNA technology while the J&J shot uses adenovirus like India’s Covishield. Experts opine that mix-and-match of vaccines if sanctioned will give individuals greater flexibility in deciding which booster shot they should opt for to help battle waning immunity against the virus.

The infectious disease expert had said towards the end of September that efficacy data on the pairing of vaccines will be available in the first two weeks of October, months after the National Institutes of Health started a mix-and-match trial of Pfizer, Moderna, and J&J shots on roughly 150 adults on June 1. All the participants were given a booster shot of a different vaccine three to four months after completing their first vaccine regimen.

Fauci also said individuals will have the freedom to choose which booster shot they would like to go for. “I believe there’s going to be a degree of flexibility of what a person who got the J&J originally can do, either with J&J or with the mix-and-match from other products,” he said.

More COVID-19 boosters are likely on the horizon: Last week, a U.S. Food and Drug Administration (FDA) advisory committee recommended a half-dose of Moderna’s vaccine for those over 65, as well as younger adults with certain health conditions and those who work in high-risk settings.

Subsequently, the committee unanimously voted to recommend boosters for Janssen/Johnson & Johnson recipients who are 18 or older, at least two months after their first dose. The FDA, which previously green-lit Pfizer boosters, is expected to follow both of the committee’s recommendations.

But when it comes to booster shots, one big question lingers: should people be mixing and matching by getting an extra dose of a vaccine other than the one they initially received?

A highly anticipated study of “mixing and matching” Covid-19 vaccines found the approach to be safe and effective, although the Moderna and Pfizer-BioNTech vaccines were found to spark stronger immune system responses than Johnson & Johnson’s vaccine. “Mixing and matching” refers to giving a booster dose of a vaccine different from the vaccine type that was used for the initial vaccination series.

According to the findings from the study by the National Institutes of Health, which was released last week, but has yet to be peer reviewed, participants who received a booster of a different vaccine than the one they originally got experienced antibody increases similar to or higher than those who received another dose of the same vaccine they were previously given.

The study found that people who received the Johnson & Johnson vaccine produced stronger antibody levels after they got booster shots made by Moderna or Pfizer, compared to boosters from Johnson & Johnson. Those who were originally vaccinated with the Pfizer or Moderna vaccines and received either company’s booster shot produced similarly strong immune responses, the researchers found.

Mixing and matching could help the booster rollout in the U.S., since people could receive whatever vaccine their pharmacy had on hand, rather than seeking out the shot they were originally given. As Alice writes, “The findings are encouraging because they suggest that it’s safe for providers to mix and match doses when it comes to boosters. … The ability to get any of the three vaccines will ensure that more people will get the additional shot.” However, at least for now, the FDA and CDC aren’t even considering whether to approve mixing and matching.

The World Health Organization (WHO) has said that it has recommended widespread use of the world’s first malaria vaccine called RTS,S/AS01 (RTS,S) for children in sub-Saharan Africa. According to the WHO, the vaccine is the result of 30 years of research and development by British pharmaceutical company GlaxoSmithKline (GSK) in partnership with the international non-profit organization Program for Appropriate Technology in Health (PATH) and with a network of research centers in Africa.

The WHO said on Wednesday its recommendation is based on results from more than 2.3 million doses of the vaccine that have been administered to more than 800,000 children in pilot countries Ghana, Kenya and Malawi since 2019, Xinhua news agency reported.

According to the WHO, more than two-thirds of children in the three countries who were not sleeping under a bednet were benefiting from the vaccine, bringing about a 30 percent drop in severe malaria, even when introduced in areas where insecticide-treated nets were widely used and there was good access to diagnosis and treatment.

The vaccine has a favorable safety profile, the WHO said, with no negative impact on the uptake of bednets, other childhood vaccinations, or health seeking behavior for febrile illness. “It’s safe, it significantly reduces life-threatening severe malaria, and we estimate it to be highly cost-effective,” WHO Director General Tedros Adhanom Ghebreyesus said at a press briefing.

According to the WHO, “the vaccine should be provided in a schedule of four doses in children from five months of age for the reduction of malaria disease and burden.” Malaria is a life-threatening disease caused by parasites that are transmitted to people through the bites of infected female Anopheles mosquitoes. It is preventable and curable.

The WHO’s records show that malaria remains a primary cause of childhood illness and death in sub-Saharan Africa. More than 260,000 African children under the age of five die from the disease annually. “This long-awaited malaria vaccine is a breakthrough for science, child health and malaria control,” said Tedros. “This vaccine is a gift to the world, but its value will be felt most in Africa, because that’s where the burden of malaria is greatest.” (IANS)

Newswise — Researchers at Johns Hopkins Medicine have found that a drug first developed to treat Alzheimer’s disease, schizophrenia and sickle cell disease reduces obesity and fatty liver in mice and improves their heart function — without changes in food intake or daily activity.

These findings, published online Oct. 7 in the Journal of Clinical Investigation, reveal that a chemical inhibitor of the enzyme PDE9 stimulates cells to burn more fat. This occurred in male mice and in female mice whose sex hormones were reduced by removing their ovaries, thus mimicking menopause. Postmenopausal women are well known to be at increased risk for obesity around their waist as well as at risk for cardiovascular and metabolic disease. Inhibiting PDE9 did not cause these changes in female mice that had their ovaries, so female sex hormone status was important in the study.

“Currently, there isn’t a pill that has been proven effective for treating severe obesity, yet such obesity is a global health problem that increases the risk of many other diseases,” says senior investigator David Kass, M.D., Abraham and Virginia Weiss Professor of Cardiology at the Johns Hopkins University School of Medicine. “What makes our findings exciting is that we found an oral medication that activates fat-burning in mice to reduce obesity and fat buildup in organs like the liver and heart that contribute to disease; this is new.”

This study follows work reported by the same laboratory in 2015 that first showed the PDE9 enzyme is present in the heart and contributes to heart disease triggered by high blood pressure. Blocking PDE9 increases the amount of a small molecule known as cyclic GMP, which in turn controls many aspects of cell function throughout the body. PDE9 is the enzyme cousin of another protein called PDE5, which also controls cyclic GMP and is blocked by drugs such as Viagra. Inhibitors of PDE9 are experimental, so there is no drug name yet.

Based on these results, the investigators suspected PDE9 inhibition might improve cardiometabolic syndrome (CMS), a constellation of common conditions including high blood pressure; high blood sugar, cholesterol and triglycerides; and excess body fat, particularly around the waist. CMS is considered a pandemic by medical experts and a major risk factor for heart disease, stroke, type 2 diabetes, cancers and COVID-19.

While PDE9 inhibitors remain experimental, they have been developed by several pharmaceutical companies and tested in humans for diseases such as Alzheimer’s and sickle cell. The current mouse study used a PDE9 inhibitor made by Pfizer Inc. (PF-04447943) that was first tested for Alzheimer’s disease, though eventually abandoned for this use. Between the two reported clinical trials, over 100 subjects received this drug, and it was found to be well tolerated with no serious adverse side effects. A different PDE9 inhibitor is now being tested for human heart failure.

To test the effects of a PDE9 inhibitor on obesity and cardiometabolic syndrome, the researchers put mice on a high-fat diet that led to doubling their body weight, high blood lipids and diabetes after four months. A group of female mice had their ovaries surgically removed, and most of the mice also had a pressure stress applied to the heart to better mimic cardiometabolic syndrome. The mice were then assigned to receive either the PDE9 inhibitor or a placebo by mouth over the next six to eight weeks.

In female mice without their ovaries (a model of postmenopause), the difference in median percent weight change between the drug and placebo groups was -27.5%, and in males it was -19.5%. Lean body mass was not altered in either group, nor was daily food consumption or physical activity. The PDE9 inhibitor lowered blood cholesterol and triglycerides, and reduced fat in the liver to levels found in mice fed a normal diet. The heart also improved with PDE9 inhibition, with ejection fraction (which measures the percentage of blood leaving the heart each time it contracts) relatively higher by 7%–15% and heart mass (hypertrophy) rising 70% less compared with the placebo. An increase in heart mass is evidence of abnormal heart stress. However, having this lowered by the inhibitor indicates stress on the heart was reduced.

The investigators found PDE9 inhibition produces these effects by activating a master regulator of fat metabolism known as PPARa. By stimulating PPARa, levels of genes for proteins that control fat uptake into cells and their use as fuel are broadly increased. When PPARa was blocked in cells or the whole animal, the effects from PDE9 inhibition on obesity and fat-burning were also lost. They found estrogen normally plays this role of PPARa on fat regulation in females, but when its levels fall like they do after menopause, PPARa becomes more important to regulate fat and so PDE9 inhibition has a greater effect.

“The finding that the experimental drug did not benefit female mice that had their ovaries shows that these sex hormones, particularly estrogen, had already achieved what inhibiting PDE9 does to stimulate fat-burning,” notes Sumita Mishra, the research associate who performed much of the work. “Menopause reduces sex hormone levels, and their control over fat metabolism then shifts to the protein regulated by PDE9, so the drug treatment is now effective.” According to the U.S. Centers for Disease Control and Prevention, more than 40% of people living in the U.S. are obese; and 43% of American women over the age of 60 — long past menopause — are considered obese. Kass notes that if his lab’s findings in mice apply to people, someone weighing 250 pounds could lose about 50 pounds with an oral PDE9 inhibitor without changing eating or exercise habits.

“I’m not suggesting to be a couch potato and take a pill, but I suspect that combined with diet and exercise, the effects from PDE9 inhibition may be even greater,” says Kass. The next step would be testing in humans to see if PDE9 inhibitors produce similar effects in men and postmenopausal women. “PDE9 inhibitors are already being studied in humans, so a clinical obesity study should not be that far away,” Kass says. The other researchers involved in the study include Nandhini Sadagopan, Brittany Dunkerly-Ering, Susana Rodriguez, Dylan Sarver, Sean Murphy, Hildur Knutsdottir, Vivek Jani, Deepthi Ashok, Christian Oeing, Brian O’Rourke and G. William Wong from Johns Hopkins Medicine; Ryan Ceddia and Sheila Collins from Vanderbilt University; and John Gangoiti and Dorothy Sears from the University of California San Diego.

The Johns Hopkins University has filed a patent on behalf of investigators Kass, Mishra and a prior member of the Kass laboratory, D.I. Lee, for the use of PDE9 inhibitors to treat cardiometabolic syndrome.

Somewhere in India last October, a person—likely immunocompromised, perhaps taking drugs for rheumatoid arthritis or with an advanced case of HIV/AIDS—developed COVID-19. Their case might have been mild, but because of their body’s inability to clear the coronavirus it lingered and multiplied. As the virus replicated and moved from one cell to another, parts of the genetic material copied itself incorrectly. Maybe the person lived in a crowded home or went out to buy food in a busy market, but wherever it happened, the altered virus was spread to others. Experts believe this singular situation in one individual is likely how the Delta variant now wreaking havoc in the U.S. and around the world was born.

In the course of the COVID-19 pandemic, thousands of variants have been identified, four of which are considered “variants of concern” by the World Health Organization—Alpha, Beta, Gamma, and Delta, all closely tracked by scientists on websites such as GiSAID and CoVariants. Delta is by far the most contagious—some 97 percent more sothan the earliest circulating virus, according to European researchers. But is it the worst the world might see? Understanding how mutations develop can help us grasp whether more concerning versions may yet appear.

That turn of events in India—or others that may come in other places—was expected by microbiologists who study viruses, although they could not have predicted where it would happen, exactly when, and which lines of genetic code would shift inside the germ. “Every single time the virus gets in a cell it replicates its genome so it can spread to other cells, and this has the potential to make an error,” says Bethany Moore, chair of the microbiology and immunology department at the University of Michigan.

Mutations generally appear randomly and spontaneously, rather than in a systematic way.

Most mutations either kill the virus or they die out from lack of spread, victims of an infected person isolating or passing the germs to a small number of others who then stay home. But when enough mutations are created, some will get lucky (from the virus’s perspective) and catch hold, perhaps when an infected person attends a crowded sporting event or a large indoor gathering such as a wedding. “It’s like there’s an evolutionary windstorm over many smoldering embers of little hopeful mutants that might normally go extinct, but when you have rampant infection, natural selection gains the upper hand,” says Vaughn Cooper, professor of microbiology and molecular genetics at the University of Pittsburgh School of Medicine.

Coronaviruses more prone to mutations than other germs

Scientists always expected to see variants with SARS-CoV-2 because coronaviruses inevitably copy their genomes more sloppily than humans and animals, or even some other pathogens, replicate their own genetic codes. Rather than a double-helixed deoxyribonucleic acid (DNA) carrying their genes, coronaviruses contain single-stranded ribonucleic acid (RNA). “Due to very ancient accidents of history, the enzymes that make new copies of RNA are more error-prone,” Cooper says, although he notes that coronaviruses don’t spin out as many mutations as other RNA viruses such as influenza because of a proofreading enzyme tasked with double-checking its work. “The majority of viruses that go into a patient and come out from that patient is the same,” Cooper says. For coronaviruses, the estimate is that one mistake happens in a million or more replicated units of RNA, Moore says.

But it doesn’t take many slipshod copies of a virus to wreak havoc on the world. “There’s a reason health professionals have always worried about pandemic respiratory threats,” says Sten Vermund, an infectious disease epidemiologist at the Yale School of Public Health. Germs transmitted when we breathe or talk spread faster than those requiring touch or sex or bad sanitation. The threat from this coronavirus is compounded by the fact that we can pass it, and its mutated versions, before we even know we have it.

So far, the genome, or complete set of genetic material, of more than a million SARS-CoV-2 viruses have been sequenced by scientists, who are keen to stay on top of how the virus is evolving in order to determine how best to protect people from it. Earlier this year the United Kingdom, a leader in this endeavor, launched a $3.5 million effort to study the effects of emerging mutations. Sequencing got off to a slow start in the U.S., but in fall of 2020 the Centers for Disease Control and Prevention launched the National SARS-CoV-2 Strain Surveillance (NS3)  program that contracts with universities and private laboratories to sequence the coronaviruses circulating here. Hundreds of thousands of genomes have already been sequenced under this program.

Sets of the random mutations found in a virus are classified as variants only when they give the pathogen an advantage, Moore says. Within each variant are subvariants (as indicated in the alternative naming system known as Pango, where Delta is known as B.1.617.2, the later numbers indicating sub-lineages). Still, the overall blueprint of the genome remains the same. Were SARS-CoV-2 to mutate in a way that changes its essential nature, it could become a new species, perhaps SARS-CoV-3, she notes.

Convergent evolution

Mutations that take hold survive for a reason, Cooper says, such as by helping the virus increase transmissibility, infectivity, virulence, or the ability to escape our immunity. But scientists are less concerned about any specific mutation than about similar changes arising in multiple independent variants, Cooper says, “because that suggests they make the virus more evolutionarily fit.” This phenomenon is known in evolutionary biology as convergent evolution.

For example, in all of the variants of concern, a common mutation occurs in one section of the spike protein, the protrusions dotting the surface of the virus that help it infect human cells. In position 614, one type of amino acid (called aspartic acid) has been swapped for another (glycine). This mutation, known as D614G, makes the virus more transmissible and infectious.

Another common mutation, L452R, flips the amino acid leucine to arginine, again on the spike protein. The fact that mutations in L452 are seen in more than a dozen separate lineages indicates that this mutation confers an important advantage to the coronavirus, researchers recently noted after sequencing hundreds of virus samples around the U.S. In addition to providing the virus with a stronger attachment to our cells, it may be that L452R helps infect people with some immunity.

Because the spike protein has been critical for developing vaccines and treatments, more research has gone into studying mutations there compared with other proteins in the coronavirus. But it’s important to pay attention beyond this area, says Nash Rochman, an evolutionary virology expert at the N.I.H.’s National Library of Medicine. Rochman coauthored a recent paper that concludes that while the spike protein is an important site, so is another part of the virus called the nucleocapsid protein, which makes up the coating that surrounds the virus’s RNA genome.

In fact, the two areas might be working together, Rochman says. “A variant with a mutation in the [spike protein] without any change in the nucleocapsid protein might behave very differently than another variant that has mutations in both regions.” Groups of mutations working in concert is a concept known as epistasis, and modeling by Rochman and colleagues show that a small group of mutations in various spots could collectively have the major impact of helping the virus evade antibodies and thus making vaccines less effective.

The mutations that appeared in the U.S. this year are the reason the pandemic is not under control. “Just as we were making progress with vaccination, Delta comes along,” Vermund says, and rather than the expected case reductions from the vaccine, rates rose because of Delta’s increased transmissibility. “If we had only circulation of Alpha at that time, the rise in cases would not have occurred,” he says.

That the virus could obtain mutations that help it escape vaccines is of course everyone’s biggest concern. Currently, all three vaccines authorized in the U.S. remain protective. (Mu, the newest “variant of interest” does seem to weaken vaccine effectiveness, but it is not widely spreading at this time.) Some people think the small percentage of vaccinated people testing positive or developing symptoms is a sign the virus is outsmarting the shots, but Vermund says that’s not so. “I hate the term ‘breakthrough infection,’ because it’s misleading on the science,” he says. Vaccines are not like power shields that deflect the Klingons, he says. Instead, they allow the enemy to get on the ship (hence the positive tests) but they are immediately surrounded by a well-armed crew.

With such a small part of the world’s population vaccinated (some 43 percent have gotten at least one shot, but only 2 percent of those in low-income countries have), the virus doesn’t yet have much incentive to outwit the immune system of those who’ve been innoculated. “Vaccine evasion isn’t what the virus is looking for right now,” Cooper says. It’s easier for the germs to seek new and improved ways to infect the billions of people who don’t yet have this immunity.

Still, no one knows what mutations lie ahead and how much damage they might do. Vermund points out that 95 percent of people on Earth can visit another place within 48 hours—within the incubation period of COVID-19—which is why a variant emerging even in a remote, low-population area can become a global problem.

“Mutations happen when there is viral replication. So the best way to stop future variants is to severely limit the amount of viral replication that is occurring in the world,” says David Peaper, a Yale Medicine pathologist who directs the Yale New Haven Hospital Clinical Microbiology Laboratory. That’s why getting everyone in the U.S. and the world vaccinated is the most important thing we can do, he says. “As long as there is SARS-CoV-2 anywhere in the world, there’s an opportunity for dangerous variants to emerge.”

New evidence on breakthrough infections indicates people who tested positive for SARS-CoV-2 after 1 or 2 vaccine doses had significantly lower odds of severe disease, hospitalization, or Long COVID than unvaccinated. http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00460-6/fulltext

• After two vaccines doses, the odds of hospitalisation were reduced by more than two-thirds and breakthrough infections were almost two times more likely to be completely asymptomatic.
• The odds of long COVID-19 (symptoms continuing for 28 days or more after testing positive) were also reduced by more than half for people who received two vaccine doses.
• People over age 60 who were frail or had underlying conditions had higher odds of a breakthrough infection, especially after only one dose.
• The findings could have implications for health policies around timing between vaccine doses, potential COVID-19 vaccine booster shots, and for continuing personal protective measures, including mask-wearing and social distancing.

People who tested positive for SARS-CoV-2 after one or two vaccine doses had significantly lower odds of severe disease or hospitalisation than unvaccinated people, according to a large-scale study investigating COVID-19 breakthrough infections published in The Lancet Infectious Diseases journal.   Researchers also found that the odds of experiencing long COVID (illness lasting 28 days or more after a positive test) were cut in half for people who received two vaccines doses.

People most vulnerable to a breakthrough infection after their first vaccine dose included frail older adults (60 years and older), and older adults living with underlying conditions such as obesity, heart disease, kidney disease, and lung disease. In all age groups, people living in deprived areas, such as densely populated urban settings, were more likely to experience a breakthrough infection. These factors were most significantly associated with a post-vaccination infection after receiving the first vaccine dose and before receiving a second dose.

“We are at a critical point in the pandemic as we see cases rising worldwide due to the delta variant. Breakthrough infections are expected and don’t diminish the fact that these vaccines are doing exactly what they were designed to do—save lives and prevent serious illness. Other research has shown a mortality rate as high as 27% for hospitalised COVID-19 patients.

We can greatly reduce that number by keeping people out of the hospital in the first place through vaccination. Our findings highlight the crucial role vaccines play in larger efforts to prevent COVID-19 infections, which should still include other personal protective measures such as mask-wearing, frequent testing, and social distancing,” says study co-lead author Dr Claire Steves of King’s College London, UK. [1]

Well-known Mumbai-based neurosurgeon Dr. B.K. Misra has been conferred the prestigious American Association of Neurological Surgeons’ ‘International Lifetime Achievement Award in Neurosurgery’, an official said here Aug. 26. Misra is the head of the Department of Surgery and Division of Neurosurgery and Gamma Knife Radiosurgery at the P.D. Hinduja Hospital here. He received the International Lifetime Achievement Award from the American Association of Neurological Surgeons (AANS) at its Annual Scientific Meeting 2021, Orlando. He is the first Indian ever to be bestowed with this award. The felicitation ceremony was conducted through an online event amidst the pandemic. AANS is the world’s apex body of neurosurgeons. “We have the best of tech, infrastructure and skills at par with the best in the world to treat the most complex neurosurgical conditions and even have the potential to become the destination for neurological treatment,” Misra said on receiving the award.

The hospital’s CEO, Gautam Khanna, lauded Misra’s medical accomplishments and accolades as a testament to his dedication and treating thousands of patients under his care. Misra, president of the Asian Australasian Society of Neurological Surgeons and the World Federation of Skull Base Societies, is also first vice president of the World Federation of Neurosurgical Societies. AANS, the world’s most prestigious apex body of neurosurgeons, has bestowed its highest international distinction honoring Dr. Misra’s lifetime of achievements in neurosurgery in India and globally. Dr. Misra is Honorary President of Asian Australasian Society of Neurological Surgeons (AASNS), is the 1st Vice President of World Federation of Neurosurgical Societies (WFNS), and President of the World Federation of Skull Base Societies, all leading international neurosurgical societies.

Dr. Misra has a long list of “firsts” to his name. He was the first to execute Image-Guided Aneurysm Microsurgery globally and the first in South Asia to perform Gamma Knife Radiosurgery. Acoustic Neuroma Surgery, Vascular Neurosurgery (Aneurysm, AVM), Skull Base Surgery, Pituitary Surgery, Gamma Knife Radiosurgery, Awake Craniotomy, Minimally Invasive Neurosurgery, and Surgery of Complex Brain and Spine Disorder are among Dr. B. K. Misra’s areas of expertise in neurosurgical patient care. He was the first neurosurgeon to do Awake Craniotomy for brain tumours in India. He’s also the recipient of the prestigious Dr. B C Roy National Award as Eminent Medical Person of the Year, 2018 (the Highest Medical Award in India).

On the occasion of receiving the award, Dr. B K Misra said, “It’s my privilege and honor to receive the International Lifetime Achievement award from AANS. A recognition like this, from peers, means a lot to me personally and professionally and inspires me further. I would like to express my gratitude to my family and P.D Hinduja Hospital for their constant support and to my patients for having bestowed their trust on me. Today in India, we have the best of technology, infrastructure and skills, at par with the best in the world, to treat the most complex neurosurgical conditions. We have the potential to become a destination for neurological treatment .” With a long string of credits and firsts, he was the first in the world to execute an Image-Guided Aneurysm Microsurgery, first in South Asia to perform a Gamma Knife Radiosurgery, and first in India to perform an Awake Craniotomy for brain tumors. Earlier, Misra received the Dr. B.C. Roy National Award-2018, and contributes through numerous publications to improve the quality of education in neurosurgery and facilitate spreading the treatment for neurosurgical patients in poor countries globally.

The US intelligence community has failed to reach a consensus on the origin of Covid-19 disease, while ruling out the possibility that China developed the virus as a biological weapon, according to key takeaways from a classified report delivered to President Joe Biden this week. Biden had, in May, ordered the country’s intelligence community “redouble their efforts” and report the origins of the pandemic within 90 days. Their report was delivered to the White House on Tuesday. While most of the new information gathered remains classified, some was released this week as an unclassified summary of assessment on Covid-19 origins.

The intelligence community “assesses that SARS-CoV-2, the virus that causes Covid-19, probably emerged and infected humans through an initial small-scale exposure that occurred no later than November 2019,” said the unclassified summary, compiled by the Office of the Director of National Intelligence. “We judge the virus was not developed as a biological weapon,” it added. Majority of agencies also assessed with low confidence that SARS-CoV-2 probably was not genetically engineered; however, two agencies believe there was not sufficient evidence to make an assessment either way.

One intelligence agency said it assessed with moderate confidence that the first human infection with SARS-CoV-2 most likely was the result of a laboratory-associated incident, while four agencies noted with low confidence that the initial SARS-CoV-2 infection was caused naturally. The report did not name the agencies. “After examining all available intelligence reporting and other information, the IC remains divided on the most likely origin of Covid-19. All agencies assess that two hypotheses are plausible: natural exposure to an infected animal and a laboratory-associated incident,” the report said.

The report also noted that China’s officials did not have foreknowledge of the virus before the initial outbreak of Covid-19 emerged. At the same time the agencies also noted a lack of clinical samples or a complete understanding of epidemiological data from the earliest Covid cases. “If we obtain information on the earliest cases that identified a location of interest or occupational exposure, it may alter our evaluation of hypotheses,” the agencies added in the report. The agencies asked for more cooperation from China to reach a conclusive assessment of the origins of Covid-19. Beijing, however, continues to hinder the global investigation, resist sharing information and blame other countries, including the US.

“These actions reflect, in part, China’s government’s own uncertainty about where an investigation could lead as well as its frustration that the international community is using the issue to exert political pressure on China,” the agencies wrote in the report. Meanwhile, China’s foreign minister has dismissed the report as “anti-science”. In a statement after the report was published, Biden criticized China for not cooperating with the investigation. “Critical information about the origins of this pandemic exists in the People’s Republic of China, yet from the beginning, government officials in China have worked to prevent international investigators and members of the global public health community from accessing it,” Biden was quoted as saying. “The world deserves answers, and I will not rest until we get them,” he added.

The stigma encompassing marijuana has been steadily declining with states legalizing it for both medical and recreational use. On March 31st, New York became the 15th state to legalize cannabis. There are currently 18 states in the U.S. that legalized recreational cannabis and the number of states are only expected to increase with time. As cannabis continues to grow in popularity, it’s important to understand the potentially harmful consequences that come along with the drug.

According to Fiona Clement, a health-policy researcher at the University of Calgary’s Cummings School of Medicine, multiple studies have shown associations between marijuana and possible adverse effects. These side effects include the risk of impaired driving, increased chance of stroke and testicular cancer, brain development changes that may affect learning and memory, and mental illnesses involving psychosis.

After the legalization of marijuana in Colorado, cases of acute injuries and various illnesses linked to cannabis use began to rise. Research shows that cannabis-related visits to hospitals in Colorado increased around 40%, from 824 per 100,000 visits to 1,146 per 100,000, in the years between 2012 and 2014. Many of those cases were related to mental illnesses, which were found to be diagnosed in individuals who use cannabis five times more than those who choose to abstain.

Mental illnesses were not the only concerning cases related to cannabis use that the Colorado hospitals had to handle. Unfortunately, cases of marijuana use leading to cyclic vomiting syndrome also increased, with some hospitals doubling in these diagnoses. There have also been several occurrences where children, under the age of 10, were accidentally poisoned by cannabis. These incidents of marijuana-related visits to the children’s hospital nearly doubled after the legalization of cannabis, suggesting that there are real risks even to individuals who are not consuming the drug.

The potential adverse outcomes have evidently not abated the popularity of cannabis. However, the age restriction for the use of marijuana should be strictly adhered to. Minors are prone to sustaining long-term damage as their brains are still in the process of developing. THC binds to cannabinoid receptors in the brain, which play an important role in neurotransmitter release. These receptors should increase during adolescence, as they are vital for the genetic expression of neural (brain) development. Regular use of marijuana could significantly alter these neurodevelopmental systems, leading to poor cognitive and emotional outcomes in adulthood.

There are clear risks with cannabis use and it’s important to be transparent about these consequences. “Cannabis is not the root of all evil, nor is it the cure for all diseases,” Monte says. “You’ve got to understand what the good is and what the bad is, and then make a balanced decision.”

Johnson & Johnson’s COVID-19 vaccine helps prevent severe disease among those infected with the Delta variant, according to a trial involving almost 480,000 health workers in South Africa. The study, known as Sisonke, provides the first large-scale evidence that the J&J vaccine works against this dominant variant, according to trial co-lead Glenda Gray. It’s probably more protective against Delta than it was with the earlier beta strain, she said in a presentation Friday.

The single-dose shot was 71% effective against hospitalization and as much as 96% effective against death, she said. It also demonstrated durability of eight months. “These results show there is no need for a booster yet,” said Gray, who is president of the South African Medical Research Council.

While the J&J vaccine is a key element to South Africa’s vaccination plan, the country temporarily paused its use in April after the U.S. decided to suspend the shot because of its link to rare blood clots. Other data have raised questions about how well the shot holds up against the highly contagious strain that has driven renewed outbreaks in countries including the U.S. and China.

One U.S. study released last month showed the J&J shot produced relatively low levels of antibodies against Delta. J&J said that analysis, which hasn’t been published in a peer-reviewed journal, had examined only one aspect of protection and didn’t consider long-lasting responses among immune cells stimulated by the vaccine. The drugmaker’s researchers have said their own data indicated that the vaccine neutralizes the variant and that additional doses weren’t needed.

Africa’s Rollout

Earlier this year J&J agreed to supply as many as 400 million vaccines to the African Union through the end of 2022, delivering a boost to a continent trailing most of the world in the race to inoculate. The dose’s requirement for just a single shot is seen as beneficial for Africa, where vaccine distribution to more than 1 billion widely dispersed people is likely to present a challenge.

In the study, the vaccine was administered to the health workers at 120 sites in both urban and rural areas from Feb. 17 to May 17. Analysis of a third data set is expected in coming days. There were two cases of the rare clotting disorder thrombocytopenia thrombosis syndrome among participants, with both making a complete recovery, Gray said.

News wise — If you check the Centers for Disease Control and Prevention COVID-19 data tracker, which tracks cases in each state, much of the country is colored bright red, indicating a high rate of transmission of COVID.

A large chunk of the population is still unvaccinated against COVID-19, fewer people are wearing masks, and more people are getting together—all while the highly contagious Delta variant of the coronavirus continues to spread.

Last week, the CDC recommended that even vaccinated people wear masks indoors in areas with substantial or high rates of transmission to try to turn the tide and reduce cases. That recommendation was based in part on data gathered from a July 4th holiday COVID outbreak in Provincetown, MA that seemed to indicate that even vaccinated people could spread the virus. The news left many confused and concerned about just how well they are protected.

There is danger in reading too much into this case, however, said Adam Lauring, M.D. Ph.D., an infectious disease specialist at Michigan Medicine.  “While this is clearly something to pay attention to, in the CDC report, they are pretty clear in the discussion about the limitations and what they are saying and not saying. Of course, not everyone made it that far,” noted Lauring. For example, as more people are vaccinated, it follows that more cases detected will be in vaccinated individuals.

Lauring also noted that a nasal swab COVID test measures how much viral RNA is present in a person’s nose but can’t measure how much of that virus is infectious. “The amount of genome present is a marker, but it is not the same thing as saying these people are equally as infectious,” said Lauring.

Another important point is that a swab is taken at one moment in time. “You could picture a situation where vaccinated people with Delta have a really steep rise and then a really steep fall in the amount of virus shed, whereas an unvaccinated person would have a steep rise that would remain high for longer.”

Even with all the unknowns, what was true before Delta is true now: the majority of cases will be in unvaccinated people. But, he added, “the big change is before, we were thinking vaccinated people would not transmit that often, whereas it appears that vaccinated people with the Delta variant will transmit more often than with other variants,” said Lauring.

What does this mean practically? This means that it will take additional measures, like wearing masks in certain situations—such as indoor spaces with a lot of local cases—in addition to vaccines to stop the spread of COVID.

Early data show that the vaccines are still more than 80% effective at preventing severe illness and death and are still reducing transmission. As far as boosters go, said Lauring, “I’m more concerned about people who have not been vaccinated at all.” And in the U.S., case counts continue to be highest in areas with low vaccination rates, evidence that the vaccines are working against all variants.

What about kids under 12 who don’t yet have an approved COVID vaccine?

Lauring noted that the risk of severe illness and death is low for children and that hasn’t changed, even with Delta. But as more adults become vaccinated, more of any future cases will be in unvaccinated people, including kids.

“The more transmissible the virus is, the higher the percentage of immune people you’ll need to shut down transmission.”

The best thing to do to protect kids, immunocompromised individuals and to reduce the chance for the emergence of even more transmissible variants remains to get as many people vaccinated against COVID-19 as possible to safely approach herd immunity.

Lauring noted that COVID is probably here to stay.

“My sense is people are coming to grips with what that means. From a policy level, we’ll have to figure out what level of circulation and hospitalization we are comfortable with,” he said.

The Food and Drug Administration (FDA) has begun accelerating the process to fully approve the Pfizer-BioNTech COVID-19 vaccine, facing pressure to add resources from those who believe the lack of full approval is hampering efforts to get more Americans vaccinated.

“We recognize that for some, the FDA approval of COVID-19 vaccines may bring additional confidence and encourage them to get vaccinated,” Abigail Capobianco, a spokeswoman at the FDA, said in a statement on Aug. 4. “Acknowledging the urgency related to the current state of the pandemic, we have taken an all-hands-on-deck approach, including identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities, in order to complete our review to help combat this pandemic surge.”

President Joe Biden said last week he expects a fully approved vaccine by the early fall, but the FDA would not comment on the time frame.

Data show that being vaccinated dramatically reduces the risk of hospitalization or death following a COVID-19 infection. More than 192 million Americans have gotten at least one dose of the three vaccines that have been given emergency use authorization (EUA) in the U.S., made by Pfizer-BioNTech, Moderna and Janssen/Johnson & Johnson, without widespread side effects, data show. But now the number of Americans fully vaccinated against COVID-19 has begun to stall with about 92 million people over age 12 still unvaccinated, according to U.S. Centers for Disease Control and Prevention (CDC) data. Meanwhile, the more contagious Delta variant of the virus is spreading rapidly among the unvaccinated population.

The spike in COVID-19 cases in states that have low vaccination rates has threatened to claw the U.S. back into the worst of the pandemic, and it creates a looming political liability for Biden. On Aug. 3, Biden gave a sober speech from the East Room of the White House, saying the country’s “best line of defense” against the virus “is the vaccine.” “It’s as simple as that. Period. The vaccine,” he said.

But as Biden attempts to mount more aggressive vaccination efforts to stave off the spread of the highly transmissible Delta variant, the fact that the FDA has yet to fully approve any of the vaccines is threatening to slow progress. About 30% of unvaccinated people say they would be more likely to get a shot with full FDA approval, according to recent polls from the Kaiser Family Foundation. While the pollsters warn that may be a “proxy for more general concerns,” some doctors and public health experts in areas with low vaccination rates also say they frequently hear the FDA’s emergency authorization cited as a reason people remain hesitant to get the shot.

The Biden Administration has said all civilian federal employees must be vaccinated against COVID-19 or submit to regular testing, and many hospital systems and universities, as well as a number of large private employers like Walmart, Google, and Disney, have begun to follow suit.

The Justice Department’s Office of Legal Counsel recently released an opinion saying federal law does not prohibit companies from requiring vaccines even if they are under emergency authorization, and courts have generally upheld vaccine mandates.

But some employers and organizations have been reluctant to make similar requirements while the vaccines are still under emergency authorization. A number of public educational institutions—including the State University of New York and Colorado State University systems—have said they will mandate vaccination for students once a vaccine is fully approved. In other parts of the country, Republican politicians have used the lack of full approval to block vaccine requirements from being put into place. In Texas, for example, Republican Gov. Greg Abbott signed an executive order on July 29 preventing any organization that receives state funds, including public universities, from requiring vaccines under emergency use authorization.

Health systems have also taken a mixed approach. Mass General Brigham, which employs 80,000 workers in Massachusetts, said it will require employees to get vaccinated once the FDA issues its full approval for at least one of the vaccines, as did Beaumont Health, the largest health care system in Michigan. Other large health systems like Cleveland Clinic, Intermountain Health, and Christus Health have not put in place vaccine requirements and say they are still monitoring the situation.

“We need to see a full approval before we’ll do another evaluation of thinking about a requirement in the future,” says Dr. Sam Bagchi, executive vice president and chief clinical officer at Christus. He notes that the health system is already facing “unprecedented staffing challenges” due to many health care workers quitting or taking early retirement during the pandemic. If his hospitals required workers to get vaccinated now, he fears it would push workers away at a time when they need more staff due to rising COVID-19 cases.

Long-term care facilities are in a particularly precarious position. LeadingAge, the national trade group for non-profit nursing homes and other aging services, recently called for its members to require employees to get vaccinated against COVID-19 as vaccination efforts have stalled in places where the virus devastated residents and staff last year. But Katie Smith Sloan, the group’s president and CEO, says she knows many of her member facilities can’t afford to lose staff who aren’t ready to get vaccinated. “We’re already facing acute shortages, particularly nursing assistants and nurses in long-term care, home health, nursing homes, and assisted living,” she says. She hopes that an FDA approval will make more workers volunteer to get vaccinated and encourage more facilities to require it.

Even the U.S. military is still weighing what to do. It has not yet required that its 1.3 million active duty personnel be vaccinated, and senior military medical officials are watching the FDA approval process closely. Secretary of Defense Lloyd Austin is consulting with medical experts and still weighing whether to request approval from Biden to require vaccines, Pentagon spokesman John Kirby said on Aug. 3.

The FDA typically completes a priority review, like it is conducting for Pfizer, in six to eight months. Pfizer says it submitted a rolling application in May and Moderna—which manufactures one of the other approved COVID-19 vaccines—says it submitted a rolling application in June, meaning both companies could turn in portions of their applications while continuing to collect data. The process is “moving forward as rapidly as possible in keeping with the high-quality complete assessment that the public expects from the FDA,” said FDA spokeswoman Capobianco.

The COVID-19 pandemic was the first time that the FDA granted emergency use authorization to a vaccine for widespread use. The EUA designation was developed after the Sept. 11 attacks and originally intended for potentially lifesaving medicines or other products during an emergency like a terrorist attack or a more acute disease outbreak. To get an EUA for the COVID-19 vaccines, manufacturers had to follow special guidelines that included submitting two months of clinical trial data, along with information about the quality and consistency of the vaccines—and the FDA had to establish that the “potential benefits outweigh the known and potential risks” of the vaccine.

For full approval, the FDA must review significantly more data and make a larger determination that a vaccine is ready to be licensed, according to Dr. Jesse Goodman, former chief scientist at the FDA and a professor at Georgetown University. This involves analyzing hundreds of thousands of pages of material about the clinical trials, manufacturing processes and how the vaccines have functioned in the real world since the agency authorized it for emergency use. Regulators will check the vaccine manufacturer’s data and perform their own analyses to verify the vaccine’s efficacy, how that efficacy might decline over time and any evidence of potential side effects. They will also inspect manufacturing plants to ensure high levels of quality control—a particularly complex job given that these vaccines used new technology, Goodman says. He notes the FDA “has historically been under-resourced” and that there are a limited number of people with the appropriate expertise to review these new vaccines.

While all that can take time, public health experts are calling for more transparency from the agency as the U.S. struggles to convince a significant portion of its population to take the lifesaving shot. “It’s been a black box,” says Dr. William Schaffner, an infectious disease professor at Vanderbilt University Medical Center. “Particularly since we’re dealing with a pandemic and the taxpayers of the United States are paying for this vaccine, I think having the leadership of the FDA be more explicit about what the process is, and why it’s taking so long, would be at the very least instructive.”

But some worry hastening the approval process could backfire. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, warned in a letter to the New York Times last month that “any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy.”

Dr. Arnold Monto, a professor of epidemiology at University of Michigan who chairs the committee of outside experts that advises the FDA on vaccines, including for COVID-19, agrees. “They’re trying as hard as they can,” he says, “given the constraints that they’re working under.”

The U.S. government’s top infectious disease expert, Dr. Anthony Fauci, said last week that he was hopeful the Food and Drug Administration will give full approval to the coronavirus vaccine by month’s end and predicted the potential move will spur a wave of vaccine mandates in the private sector as well as schools and universities.

Moderna said its COVID-19 vaccine remained 93% effective through six months after the second shot, as it reported second-quarter earnings and revenue that beat expectations. A final analysis of the company’s late-stage study, described in a statement on Thursday, suggests the vaccine’s protection remains stable for long after recipients complete the standard two-dose regimen. The 93% effectiveness level is just short of the shot’s initial efficacy of 94%.

Concern that the effectiveness of COVID-19 vaccines could wane has stoked talk of booster shots, and some countries have begun to offer vulnerable people third doses. However, World Health Organization Director-General Tedros Adhanom Ghebreyesus called for a moratorium on such measures on Wednesday until more people in the developing world are inoculated. The recommendation could limit the reach of Moderna’s shot, called Spikevax.

The shares fell 2.9% as of 8:28 a.m. before U.S. markets opened Thursday. COVID-19 vaccine-maker Pfizer lost 0.6%, while its partner BioNTech shed 3.8%.

Moderna’s latest efficacy data hasn’t been published in a medical journal and further details weren’t released. Despite the apparent endurance of its vaccine, Moderna is exploring options for supplemental shots that could fend off emerging strains of the virus.

All three of the company’s booster candidates produced “robust antibody responses” against delta and other variants of concern in a phase 2 human study, Moderna said in its statement. The boosters are being tested at a 50 microgram dose, or half what is used in the current shot. That data has been submitted to a journal for publication, the company said.

Seeking Approval

Cambridge, Massachusetts-based Moderna also said it expected to complete its submission for full Food and Drug Administration approval for its vaccine this month.

The agency is already reviewing the submission for a rival messenger RNA vaccine from Pfizer Inc. and BioNTech SE, and is under growing pressure to complete the process quickly. With the delta variant sparking a new wave of cases, advocates say an approval could help convince more people to get a shot.

Moderna, which reported its first profit earlier this year, had net income of almost $2.8 billion in the quarter ending June 30 on revenue of $4.4 billion, almost all of which is from its COVID-19 shot. Diluted earnings per share of $6.46 easily beat analysts expectations, according to a survey of analysts by Bloomberg, while revenue only slightly exceeded expectations.

The company said in the release it has signed $20 billion worth of COVID-19 vaccine purchase agreements for 2021, up from the $19.2 billion it announced in May. For 2022, it already has signed agreements for $12 billion in vaccine sales with options for $8 billion more. Moderna didn’t increase its forecast that it will produce 800 million to 1 billion COVID vaccine doses this year.

Seeking Deals

Moderna’s views for total sales of its COVID-19 vaccine pale in comparison to the Pfizer-BioNTech partnership, which has a higher manufacturing capacity for its shot. Last month, Pfizer boosted its vaccine sales forecast for 2021 to $33.5 billion.

Moderna’s shares have quadrupled since the beginning of the year, and the company hit $100 billion in market value for the first time July 14. The stock was made part of the S&P 500 last month and is the index’s best performer this calendar year.

As the biotech seeks to grow further, it will look opportunities to acquire or license technologies that could enhance its platform. Moderna, which has more than $12 billion in cash and investments, will focus on nucleic acid technologies, such as mRNA, gene editing, and gene therapy, the company said in a presentation.

Moderna has also built out its suite of leaders to double down on its commercial franchise. In the last quarter, the company hired Paul Burton, a former Johnson & Johnson executive, to serve as chief medical officer, and Ogilvy’s Kate Cronin as chief brand officer.

In late May, The US Food and Drug Administration (FDA) allowed for Emergency Use Authorization (EUA) to combat the COVID-19 pandemic, resulting in the investigational monoclonal antibody therapy sotrovimab. This new therapeutic weapon allows for the treatment of mild-to-moderate COVID-19 in patients over 12 years of age with positive outcomes. Its widespread use includes patients who are at a higher risk of more severe symptoms of COVID-19 such as individuals who are over 65 years old or those with certain medical conditions.

With a lead over the first-generation monoclonal antibody (mAb) therapies for COVID-19, Sotrovimab is reportedly referred to as super-antibodies due to their broad neutralization capacity when encountered with viral pathogen variants.

Sequencing each version of the virus the patients are suffering from would not only be overly meticulous but also equally painstaking. Therefore, Sotrovimab’s large range in capabilities is enticing to physicians as stated by analysts and researchers.

When a person is infected with COVID-19, antibodies are typically produced to fight against the invading disease. These antibodies are unique to each individual, meaning that some antibodies are better than others at combating the virus. Thus, pharmaceutical companies study thousands of these antibodies to take advantage of the most effective ones with the highest barrier to resistance.

Out of these pharmaceutical companies, Vir Biotechnology and GlaxoSmithKline derived the monoclonal antibody sotrovimab from patients who had SARS in 2003, which targets parts of the COVID-19 virus that it shares with the original SARS virus. By targeting these areas, it lowers the chance for the virus to mutate and should allow for the antibody to work against new variants.

According to data from clinical trials, sotrovimab showed positive results with a 79% reduction in risk of hospitalization or death, appearing to yield activity against the currently known problematic variants of COVID-19.

Sales for these antibody therapies were expected to diminish as vaccination rates continuously rose, however, analysts predict that the market for COVID-19 mAbs will endure to assist in treatments for those who are unable to receive their vaccination shots for medical reasons.

A full course of two of the most widely available coronavirus vaccines is about as effective against the more contagious delta variant as it was against a previously dominant version of the virus, according to a study published in the New England Journal of Medicine.

Two doses of the Pfizer-BioNTech vaccine offer 88 percent protection against symptomatic disease caused by the delta variant, compared to 94 percent against the alpha variant that was first discovered in Britain and became dominant across the globe earlier this year, the study said.

A double dose of the Oxford-AstraZeneca vaccine was 67 percent effective against delta, according to the British researchers, down slightly from an efficacy rate of 75 percent against the alpha variant.

Here are some significant developments:

• China said Thursday that it will not accept the World Health Organization’s suggested plan for the second phase of investigation into the origins of the coronavirus. A senior Chinese health official criticized the agency’s proposal to include the lab-leak hypothesis as a research priority.
• Officials announced that some 200 million people or more than half of all adults in the European Union have now been fully vaccinated.
• The United States has extended restrictions on nonessential travel at the borders with Canada and Mexico until Aug. 21. The Department of Homeland Security said the decision was made because of the “continued transmission and spread of [the virus] within the United States and globally.”
• Australia’s most populous state Thursday reported its highest number of new, locally transmitted cases for the year, even as much of the country remained under lockdown to stem an outbreak of the more contagious delta variant. New South Wales, which includes Sydney, recorded 124 new infections, health authorities said.
• Tunisia’s president has ordered the military to oversee the country’s coronavirus response as the North African nation battles its worst outbreak of the pandemic. Earlier this week, the health minister was fired for bungling Tunisia’s vaccine rollout as the virus spread.
• The Tokyo 2020 Organizing Committee announced 12 new coronavirus cases among accreditation holders, including two unnamed athletes who were living in the Olympic Village. Eight athletes have tested positive since arriving in Tokyo for the Games.

The authors of the new study said a single dose of either the Pfizer-BioNTech or the Oxford-AstraZeneca vaccine was significantly less effective against the delta variant than two doses. One dose of the vaccine developed by U.S. firm Pfizer with German partner BioNTech was just 36 percent effective, the study found, while a single shot of the vaccine from Oxford University and British-Swedish company AstraZeneca offered 30 percent protection.

“Absolute differences in vaccine effectiveness were more marked after the receipt of the first dose,” the authors wrote. The research confirmed earlier data released by Public Health England that suggested the two vaccines offered similar levels of protection against the delta variant when administered as a full course. It also offered some hope to those nations struggling to beat back outbreaks caused by the delta variant, which the World Health Organization says has reached at least 124 countries.

The study stood in contrast to preliminary data made public by Israel’s Health Ministry earlier this month that said the Pfizer-BioNTech vaccine was only 64 percent effective in preventing symptomatic infection caused by the delta variant. Some public health experts warned that the data from Israel was observational and not the result of a controlled study.

Newswise — Australian scientists researching how our immune system responds to COVID-19 have revealed that those infected by early variants in 2020 produced sustained antibodies, however, these antibodies are not as effective against contemporary variants of the virus.

The research is one of the world’s most comprehensive studies of the immune response against COVID-19 infection. It suggests vaccination is more effective than the body’s natural immune response following infection and shows the need to invest in new vaccine designs to keep pace with emerging COVID variants.  Published today in PLOS Medicine, the study was made possible by a partnership between the University of Sydney, Kids Research, Sydney Children’s Hospitals Network, the Kirby Institute at UNSW Sydney, Australian Red Cross Lifeblood, St Vincent’s Hospital and NSW Health Pathology, as well as other local and international collaborators.

The team analysed the serum of 233 individuals diagnosed with COVID-19 over 7 months and uncovered that the level of immunity over time is dependent on disease severity and the viral variant. They show that antibodies developed during the first wave had reduced effectiveness against six variants, ranging from those observed in the second wave in Australia through to three variants of concern that have driven the global pandemic in the UK, Brazil and South Africa.

How do we study the immune response?

The serum of COVID-19 infected individuals was of interest as it is the part of our blood that contains crucial information about our immune system. Analysis of the serum made it possible to create a detailed timeline of the level of ‘neutralising antibodies’ produced against COVID-19 infection, and so to see if there was long-term immunity. 

Neutralising antibodies are part of our immune system’s frontline arsenal that is triggered during infection and vaccination. Their job is to shield cells that are usually the target of a pathogen (such as the SARS-CoV-2 virus which causes the COVID-19 disease) from being infected. The level of neutralising antibody response can be a defining feature of how effectively our body fights off illness.

Interestingly, a rare group of ‘super responders’ was also identified as an exception.  This group of ‘super responders’ had a stable and robust level of antibodies across all COVID-19 variants. The researchers say this group could prove useful for investigating the potential of convalescent plasma (using blood from people who have recovered to treat others) which has so far proven ineffective against severe COVID-19 illness. In addition, key donors could be looked at closely and their antibodies cloned for future therapeutic use.

Why it is important?

Co-senior author Associate Professor FabienneBrilot of the University of Sydney and Kids Research, Sydney Children’s Hospitals Network, and her research team led the analysis branch of the study, using highly sensitive tools they developed to study the antibodies in detail.

“We can learn a great deal from these people who were infected in the first wave in Australia as they were infected with the same variant that our current vaccines are based on,” said Associate Professor Brilot.  “While the approved vaccines are showing good responses, our study highlights the importance of continued vaccine development, especially taking into account the differences in variants.” Co-senior author Associate Professor Stuart Turville of the Kirby Institute said the study was conducted to investigate the level, breadth and longevity of the immunity generated from COVID-19 infection and whether mutation of the virus compromises immunity.

“What this work has shown us is that current observations about vaccines show they offer a much broader protection against COVID-19 and its variants than the body’s natural immune response following infection, which is usually only protective against the variant of the virus that the person was infected with. We, therefore, should not rely on the body’s natural immune response to control this pandemic, but rather the broadly protective vaccines that are available.”

Key findings 

• SARS-CoV-2 antibody responses are sustained for up to seven months post-infection.
• The immune response remained stable in some individuals, and while it decreased in others, no individual showed a negative response during the seven-month period.
• Levels of virus-neutralising antibodies were associated with COVID-19 severity.
• Antibodies generated after early infection displayed a significantly reduced antibody binding and neutralisation potency to globally emerging viral variants.