Category: Corona Virus Vaccine

A new announcement from vaccine company Valneva indicates its experimental COVID-19 vaccine is effective at neutralizing the Omicron variant. The vaccine is at the tail-end of Phase 3 trials and is the first inactivated whole-virus vaccine to be trialed in Europe.

French company Valnevas vaccine candidate is dubbed VLA2001 and it works a little differently to most currently approved COVID-19 vaccines.

Most current vaccines focus on presenting a persons immune system with the spike protein of SARS-CoV-2. But VLA2001 is what is known as an inactivated whole-virus vaccine. These vaccines actually contain complete copies of the whole virus grown in a lab and then inactivated (or "killed") using chemicals or heat.

This process is one of the more traditional ways to make a vaccine. It has been utilized successfully for decades, going back to Jonas Salks landmark polio vaccine and has been more recently used to develop annual influenza vaccines.

Adam Taylor, a researcher from Australias Griffith University, explained last year that there is hope inactivated whole-virus vaccines could be more effective against SARS-CoV-2 variants because they help the body learn how to target more viral antigens beyond just the spike protein.

This type of inactivation is expected to preserve the structure of the viral proteins, as they would occur in nature, Taylor explained in a piece for The Conversation. This means the immune system will be presented with something similar to what occurs naturally, and mount a strong immune response.

Valneva

VLA2001 is currently deep in Phase 3 human trials. Ongoing trial data has been consistently supplied to regulatory bodies in Europe and approvals are expected to come over the next few months.

The latest announcement from Valneva reports on lab studies looking at how effective antibodies induced by the vaccine are at neutralizing both the Delta and Omicron SARS-CoV-2 variants. The research isolated antibodies from human trial subjects who had been given three shots of VLA2001.

All samples tested were effective at neutralizing the original strain of SARS-CoV-2 and the Delta variant. Against Omicron the research found 87 percent of samples presented neutralizing antibodies.

The findings are certainly promising, however, it is still unclear what kind of real-world protection may be generated by VLA2001 in the face of Omicron.

Valneva is not the first inactivated whole-virus vaccine to be developed for COVID-19. In fact, Chinas Sinovac and Sinopharm vaccines use similar technology and have already been administered to billions of people.

However, recent research has indicated current whole-virus vaccines may not be performing well against the Omicron variant. Studies have found immune responses to Omicron after two shots of many currently available whole-virus vaccines are sub-optimal.

What this means for Valneva is unclear. It could be that whole-virus vaccines require a standard three-dose protocol to be effective, or maybe Valenevas unique combination of adjuvants added to the vaccine help prompt better immune responses. Or possibly these lab studies measuring antibody neutralization simply dont translate into real-world protection against Omicron.

What we do know is that Valnevas vaccine demonstrates a good safety profile and should be relatively easy to manufacture. Over the coming months its approval should help amplify vaccine supplies to countries struggling for doses and offer well-vaccinated countries new options for booster programs.

This is very encouraging data and adds to the positive Phase 3 data, said Clive Dix, former lead on the UK Vaccine Taskforce. Hopefully this vaccine will be approved soon and should become an important vaccine in both this pandemic in countries still behind the curve and as a vaccine for boosting during the winter of 2022/23.

Source: Valneva

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New whole-virus COVID vaccine may be effective against Omicron

WASHINGTON/GENEVA March 15 (Reuters) - The United States, European Union, India and South Africa have reached a consensus on key elements of a long-sought intellectual property waiver for COVID-19 vaccines, according to a proposed text reviewed by Reuters.

Sources familiar with the talks described the text as a tentative agreement among the four World Trade Organization members that still needs formal approvals from the parties before it can be considered official. Any agreement must be accepted by the WTO's 164 member countries in order to be adopted.

Some elements of the consensus deal, including whether the length of any patent waivers would be three years or five years, still need to be finalized, according to the text. It would apply only to patents for COVID-19 vaccines, which would be much more limited in scope than a broad proposed WTO waiver that had won backing from the United States, according to the document.

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The document authorizes use of "patented subject matter required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic".

It said IP rights would also be waived for ingredients and processes necessary for COVID-19 vaccine manufacture, a move aimed at granting critical know-how to many countries lacking expertise, especially for advanced mRNA-type vaccines.

The text contained several limitations, including that the waiver is only available to WTO member countries that exported less than 10% of global exports of COVID-19 vaccine doses in 2021.

The tentative agreement does not include COVID-19 treatments or tests, and the limitations would likely exclude China from any waiver, a source familiar with the negotiations said.

The text, which was produced in negotiations last week, was being circulated to officials in Brussels, Washington, Johannesburg and New Delhi before being presented to other WTO members. Adoption of the IP waiver by the consensus-driven organization is far from certain.

'PROMISING PATH'

USTR spokesman Adam Hodge said the informal discussions among the four principal parties had not yet resulted in agreement, but had produced a promising compromise and consultations were continuing.

"The difficult and protracted process has resulted in a compromise outcome that offers the most promising path toward achieving a concrete and meaningful outcome," Hodge said in an emailed statement.

A WTO spokesperson did not immediately respond to a Reuters query on the talks.

The tentative deal comes after months of negotiations over how to accelerate COVID-19 vaccine production in developing countries, where vaccination rates have lagged far behind wealthy countries.

In talks brokered by WTO Director General Ngozi Okonjo-Iweala, the United States, EU, India and South Africa broke away from negotiations among the organization's 164 members to try to craft an agreement.

Objections from some countries with large pharmaceuticals sectors, including Switzerland and Britain, had stalled progress in negotiations among the larger group. India and South Africa had first proposed the WTO vaccine IP waiver in 2020 as the COVID-19 pandemic exploded.

A spokesperson for pharmaceutical industry trade group PhRMA said efforts to waive intellectual property commitments are unnecessary and harm efforts to end the pandemic. Voluntary technology transfer and partnerships have helped vaccine makers to target production of 20 billion doses in 2022, more than enough for the world, she said.

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Reporting by Andrea Shalal and David Lawder in Washington, Emma Farge in Geneva and Phil Blenkinsop in Brussels, additional reporting by Caroline Humer; Writing by David Lawder; Editing by Tim Ahmann and Richard Pullin

Our Standards: The Thomson Reuters Trust Principles.

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U.S., EU, India, S.Africa reach compromise on COVID vaccine IP waiver text - Reuters

Several times during this pandemic, I have written essays about America as if the country was my patient. The current situation has me thinking along those lines again.

Doctors, like anyone else, love to give good news. We see the value of hope but also recognize that honesty must be our North Star. I would love to be the good guy here and tell my patient that it's time to be discharged from this chapter of our lives. But a doctor's job is to fully assess the situation and lean into the nuance, as opposed to simple axioms.

Time for a physical

So let's examine America, the patient. On the one hand, the numbers are going down. Cases of Covid-19 are more than a third lower this week than they were last week and the lowest they've been since July, according to the latest data from Johns Hopkins University. And the number of people hospitalized is about a fifth of what it was during the country's mid-January peak. Even deaths, the so-called lagging indicator, have been falling; they're at their lowest point in two months.

A closer look

But in medicine, we cannot rely on lab results and a medical history. We need to perform a thorough and detailed exam. And when we do that, a more complete picture of the patient emerges.

Truth is, America, my patient still has an active infection. Although the numbers are falling, they are still painfully high: The country is averaging just under 37,000 new cases of Covid-19 a day. It's as if saying the patient used to have a very high fever but now only has a moderately high fever. The point is, it's still too high. We wouldn't stop treating the patient's infection at this point but rather complete the course of treatment and care.

There's also the issue of understanding the effects the illness may have on my patient in the future. In this case, it means acknowledging an entirely new disease: long Covid.

Many Americans are enduring the lingering effects of a past infection, battling health conditions like fatigue, brain fog, shortness of breath, cardiac issues. The list of long Covid symptoms is lengthy and varied; there are no answers as to who and why, nor are there easy, one-size-fits-all treatments.

And, even more important, there are still about 30,000 Americans hospitalized for Covid and, on average, more than 1,250 deaths a day. That's the equivalent of about two jumbo jets dropping out of the sky every day.

My patient still needs lots of care.

Other factors at play

Despite the less red and inflamed transmission map, it still shows there's a lot of virus out there. If the virus came in the form of a raindrop, parts of our country would still be getting drenched.

I have often imagined how different things would be if we could have actually seen the virus -- little green particles circulating around people's noses and mouths and becoming airborne. What if we had been able to witness its destruction and journey into blood vessels and lungs? This invisible enemy circumvented our basic human ability to detect a threat and, as a result, made us more likely to ignore and even deny it.

I would remind my patient we have been here before. We experienced moments of genuine hope earlier and then witnessed how quickly things can change. In the summer of 2021, the Delta variant surprised us, and in December, Omicron blindsided us. Both times, the spikes caused by these variants followed declarations of victory heralding the end of the pandemic.

And while studies suggest that BA.2 is not more likely to lead to hospitalization than BA.1, another patient that I've been keeping an eye on, the United Kingdom, is seeing cases and hospitalizations starting to trend up again after declining steadily since mid-January. Sometimes, doctors gain a lot of information from watching how other patients are faring.

Again, I get it. I would love to look at these past two years in the rearview mirror as well, but we need to learn the lessons of this pandemic and apply that knowledge in real time. Today. Now.

Delta and Omicron represent two cautionary tales in the span of a few months. It would be shortsighted to ignore that reality, believing it will never happen again.

A blend of science and judgment

The International Epidemiology Association's Dictionary of Epidemiology defines a pandemic as "an epidemic occurring worldwide, or over a very wide area, crossing international boundaries and usually affecting a large number of people."

Two years ago, when we made the decision to use the word pandemic on CNN, before the CDC or WHO, it was fairly straightforward -- fundamentally, it was an exercise in math and data analysis. My producers and I spent a lot of time looking at whiteboards where we kept tabs on the growing numbers and locations of Covid-19 cases. One day, I remember thinking, "If this isn't the very definition of a pandemic, I don't know what is. So why is no one else calling it that?"

And so we did.

Although the line was clear entering the pandemic, it will be much fuzzier as we approach endemicity. A disease is considered endemic when it is a "constant presence ... within a given geographic area or population group." It would also be predictable in its rate of spread without causing the level of disruption it does in a pandemic.

But what is considered disruptive may be very different in one country compared with another, even from one person to the next. Progressing into this next phase will be based on a blend of science and judgment.

What the exam reveals

So if America were my patient, the question I would be asking: Is it really time to downgrade the country's present-day condition from pandemic to endemic?

It's analogous in some ways to deciding when to discharge my surgical patients to the general care floor from the intensive care unit.

I make rounds in the intensive care unit, carefully reviewing each patient's chart -- full of lab results, metrics and data. And then I sit at the bedside, watching, examining and understanding how they really feel. Can they stand on their own, put a fork to their mouth and a comb through their hair? Are their basic bodily functions returning to normal, and can they get by independently? It is a judgment call. Two people can have the same vital signs but be in very different places.

If America were my patient, what would I see when I sit at its bedside? Beyond 1,300 people dying a day, I would make note that almost 60,000 people died of Covid-19 during the month of February alone. In other words, more people died of Covid-19 in one month than die of the flu during a bad year.

So the question ultimately is: What is too disruptive? What are we willing to tolerate? At what point do we as a society throw up our hands and say, "We can't do any better than this," so let's call this level of sickness and death "endemic," accept the numbers and move on with our lives?

And of course, my patient, America, lives on a planet with lots of other patients, all part of an intricate ecosystem. We must realize that America's health is dependent on the health of all the other patients on the planet: When any one of us is at risk, we are all at risk.

Finding a measure of peace and quiescence

None of this is easy. It's why epidemiologist and author Dr. Larry Brilliant said that "endemic" is a terrible word.

"Smallpox was 'endemic' when it killed somewhere between a third and half a billion people in the 20th century. Malaria is endemic, and it's killing millions. Tuberculosis is endemic. And HIV/AIDS was sort of thrown out of people's consciousness by just labeling it 'endemic,' " he said.

Brilliant, who is CEO of Pandefense Advisory anda senior adviser at the Skoll Foundation, was a key player on the WHO team that eradicated smallpox.

He pointed out that the technical definition of "endemic" is a disease that is generating an expected number of cases, to the expected community and the expected time. "And because [Covid-19] is a baby of a disease ... it's way too early to try to figure out what is endemicity. We have to wait for it to become a teenager and see how it behaves," he said.

Brilliant prefers the term "quiescent." "We want this thing to be quiet," he said.

He recalled that in the early days of 2020, he and other epidemiologists and public health experts speculated that the illness would come in waves.

"A wave is a really good metaphor to think about this. Sometimes, the waves come in a bunch at a time, and sometimes there's not a wave for hours, even days. Some waves are too small to really be called waves. But every once in a while, there's a rogue wave, this tsunami."

He explained, "what we want is the interval [between waves] to be long and the water in the waves to be quiescent. And that's what we're trying to say when people use the word 'endemic.' ... To say that the pandemic has gone endemic is failure -- it's not success. We haven't put it where we want it. So it's the wrong way of thinking about it."

Plus, said Brilliant, saying that the pandemic is over means "we give up our duty of care."

He believes we still have a duty of care to the immunocompromised, the elderly, the vulnerable and, yes, even the unvaccinated, because they are the ones disproportionately dying.

Life with an endemic disease

Humans are increasingly living side by side with pathogens that were once in the wild but then took hold among us. We might not like it, and sometimes the pathogen comes too close for comfort, but we learn to live with it.

Take the parasite malaria. For millennia, it killed off wide swaths of the global population. In fact, the mosquito, which transmits the parasite that causes disease, is one of the most prolific killers of humans worldwide.

Inarguably, the course of humanity has been shaped by malaria: It's believed to have contributed to the fall of Rome, and for hundreds of years, it helped protect Africa from European colonization even as it infected the local population. (And it's why the gene for sickle cell anemia, which is protective against malaria, never died off evolutionarily.) In this country, Presidents George Washington and Abraham Lincoln grappled with it. The disease stunted the physical and economic growth of the rural South through the 1930s, and it is why the precursor to the CDC was founded.

It's an understatement to say man has been living with malaria for a very long time. And although we may not have eradicated it from the face of the Earth or completely tamed it, we have learned to coexist with it and reduced it to an endemic disease in a shrinking number of countries. The United States eradicated it in 1951.

How did we do that? By arming ourselves with knowledge. Through scientific research, we learned about where malaria comes from and how it is spread. We developed mitigation strategies and medications to blunt its impact.

And our work is still not done: In 2020, malaria killed an estimated 627,000 people, the vast majority of them children in sub-Saharan Africa.

Early detection, rapid response

Many experts, including Brilliant, are pretty sure that Covid-19 is here to stay. Like the common cold (also often caused by a coronavirus) or the flu, it's expected to be part of our lives for the next 10, 50 or 100 years, and life will never be quite the same again.

But we can improve the situation and learn to live with it.

"We want the disease to occur in places that we expect it, in the numbers that we expect, so we know how to deal with it," Brilliant said. "You can go to Hawaii on vacation and not worry. Your kids can go to school. And you don't need to worry about going to dinner with your parents or your grandparents. Maybe it's quiet and you have to still wear masks. Maybe it's quiet and you still have to be tested before you go someplace. But it's not on the front page every day."

The key, said Brilliant, is two-part: early detection and rapid response.

For that to happen, we have to have good monitoring tools and be nimble going into and out of protective mode. Maybe that means we carry a mask in our coat pocket during wintertime, just like we take an umbrella when the forecast predicts rain; maybe we keep a box of rapid tests and a packet of antivirals in the bathroom cabinet for when we are under the weather; maybe we close a school but like we do with the flu -- with surgical precision, using a scalpel instead of a chainsaw.

The good news, Brilliant said, is that moving forward, our tools -- vaccines, surveillance, tests, treatments, prophylactics -- will only get better.

The inescapable fact is that we live in the era of pandemics. There are simply more and more opportunities for a pathogen, like the SARS-CoV-2 virus, to come in contact with the human population, make the jump and take hold. It's a dance we are increasingly doing because we are infringing more and more on the microbes' territory. Population growth, deforestation, climate change all contribute to this.

These pathogens are going to keep emerging in humans, but pandemics are not inevitable. Humans have evolved to create remarkable public health tools to prevent that, just as long we are smart and humane enough to use them.

My patient -- America -- is still in precarious health and will have to be careful moving forward to maintain all of the gains and continue making progress. Both the patient and doctors will have to remain vigilant and act quickly if there's any new infection.

It's just not time for my patient to completely drop their guard, however much we would all like that to happen. We can and should be hopeful, but honesty must lead the way, full and transparent.

CNN's Andrea Kane contributed to this report.

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Dr. Sanjay Gupta: Is America ready to take the next step in its Covid-19 recovery? - CNN

United Airlines, which was one of the first major businesses to mandate vaccination against the coronavirus, will allow workers who were granted religious or medical exemptions from receiving a shot to return to their jobs at the end of this month.

About 2,200 United employees received exemptions last year. They were placed on unpaid leave or were moved to roles that did not involve in-person contact with customers. Those employees will be able to return to their normal positions on March 28.

We expect Covid case counts, hospitalizations and deaths to continue to decline nationally over the next few weeks, and, accordingly, we plan to welcome back those employees, Kirk Limacher, Uniteds vice president for human resources, said in a note to employees on Thursday.

The airlines plans were reported earlier by The Wall Street Journal.

United announced its vaccine mandate in early August, one of the first major corporations to do so. By October, nearly all of the airlines 67,000 employees had been inoculated in one of the largest and most successful corporate vaccination efforts at the time. About 200 employees were later fired for failing to comply with the policy, and all new hires are required to be vaccinated.

Since the beginning of the pandemic, Scott Kirby, the airlines chief executive, had written letters to the families of employees who had died from the virus, a practice that he once described as the worst thing that I believe I will ever do in my career. As the Delta variant began its spread over the summer, he decided to do something about it.

We concluded enough is enough, he said in an interview with The New York Times last year. People are dying, and we can do something to stop that.

In January, Mr. Kirby said the vaccine mandate had saved the lives of an estimated eight to 10 United employees since late September. In his note on Thursday, Mr. Limacher said vaccinated employees were remarkably safe compared with those who had been approved for an exemption, five of whom had died since November.

The nation is easing pandemic restrictions as the Omicron virus wave recedes. If a new variant emerges or case counts rise again, the airline may adjust course, Mr. Limacher said.

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United Airlines Workers With Vaccine Exemptions Can Return to Jobs - The New York Times

Estimating excess mortality due to the COVID-19 pandemic: a systematic analysis of COVID-19-related mortality, 202021  The Lancet

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Estimating excess mortality due to the COVID-19 pandemic: a systematic analysis of COVID-19-related mortality, 202021 - The Lancet

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POLL: DO ANY OF THE COVID VACCINES STOP OR EVEN HINDER the ...

G. Douaud, in collaboration with Anderson Winkler and Saad Jbabdi, University of Oxford and NIH.

CNN

People who have even a mild case of Covid-19 may have accelerated aging of the brain and other changes to it, according to a new study.

The study, published Monday in the journal Nature, is believed to be the largest of its kind. It found that the brains of those who had Covid-19 had a greater loss of gray matter and abnormalities in the brain tissue compared with those who didnt have Covid-19. Many of those changes were in the area of the brain related to the sense of smell.

We were quite surprised to see clear differences in the brain even with mild infection, lead author Gwenalle Douaud, an associate professor of neurosciences at the University of Oxford, told CNN in an email.

Douaud and her colleagues evaluated brain imaging from 401 people who had Covid-19 between March 2020 and April 2021, both before infection and an average of 4 months after infection. They compared the results with brain imaging of 384 uninfected people similar in age, socioeconomics and risk factors such as blood pressure and obesity. Of the 401 infected people, 15 had been hospitalized.

The 785 participants were between the ages of 51 and 81 and were all part of the UK Biobank, an ongoing government health database of 500,000 people begun in 2012.

Douaud explained that it is normal for people to lose 0.2% to 0.3% of gray matter every year in the memory-related areas of the brain as they age, but in the study evaluation, people who had been infected with the coronavirus lost an additional 0.2% to 2% of tissue compared with those who hadnt been infected.

In addition to imaging, the participants were tested for their executive and cognitive function using the Trail Making Test, a tool used to help detect cognitive impairments associated with dementia and test a persons brain processing speed and function. The researchers found that those who had the greatest brain tissue loss also performed the worst on this exam.

Although the areas of the brain most affected appear to be related to the olfactory system, Douaud said it wasnt clear why that was the case.

Since the abnormal changes we see in the infected participants brains might be partly related to their loss of smell, it is possible that recovering it might lead to these brain abnormalities becoming less marked over time. Similarly, it is likely that the harmful effects of the virus (whether direct, or indirect via inflammatory or immune reactions) decrease over time after infection. The best way to find out would be to scan these participants again in one or two years time, she said.

Douaud added that the researchers anticipate reimaging and testing the participants in one or two years.

And while the study finds some association between infection and brain function, its still not clear why. Previous studies have shown people with significant and repeated loss of smell also have an associated loss of gray matter. However, this study did not evaluate whether people actually had a loss of smell.

The authors cautioned that the findings were only of a moment in time but noted that they raise the possibility that longer-term consequences of SARS-CoV-2 infection might in time contribute to Alzheimers disease or other forms of dementia.

The findings were noticeable, but they werent enough to cause alarm, said Dr. Richard Isaacson, a neurologist and director of the Florida Atlantic University Center for Brain Health. Isaacson was not involved in the study.

Isaacson said the findings were noticeable for clinicians, but he added that the overall impact on individuals was difficult to determine and could be small. Its really hard to know the long-term clinical impact and quality of life impact in a situation like this, he said.

The brain may be affected by other mechanisms such as immune, inflammatory, vascular or psychological/behavioral change but not direct infection, said Dr. Alan Carson, a professor of neuropsychiatry at the Center for Clinical Brain Sciences at the University of Edinburgh, who was not involved in the study.

What this study almost certainly shows is the impact, in terms of neural changes, he said. But I dont think it helps us understand the mechanisms underpinning cognitive change after Covid infection.

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Study links even mild Covid-19 to changes in the brain - CNN

The coronavirus vaccine made by Pfizer-BioNTech is much less effective in preventing infection in children ages 5 to 11 years than in older adolescents or adults, according to a large new set of data collected by health officials in New York State a finding that has deep ramifications for these children and their parents.

The Pfizer vaccine is the only Covid shot authorized for that age group in the United States. It still prevents severe illness in the children, but offers virtually no protection against infection, even within a month after full immunization, the data, which were collected during the Omicron surge, suggest.

The sharp drop in the vaccines performance in young children may stem from the fact that they receive one-third the dose given to older children and adults, researchers and federal officials who have reviewed the data said.

The findings, which were posted online on Monday, come on the heels of clinical trial results indicating that the vaccine fared poorly in children aged 2 to 4 years, who received an even smaller dose.

Experts worried that the news would further dissuade hesitant parents from immunizing their children. Other studies have shown the vaccine was not powerfully protective against infection with the Omicron variant in adults, either.

Its disappointing, but not entirely surprising, given this is a vaccine developed in response to an earlier variant, said Eli Rosenberg, deputy director for science at the New York State Department of Health, who led the study. It looks very distressing to see this rapid decline, but its again all against Omicron.

Still, he and other public health experts said they recommend the shot for children given the protection against severe disease shown even in the new data set.

We need to make sure we emphasize the doughnut and not the hole, said Dr. Kathryn M. Edwards, a pediatric vaccine expert at Vanderbilt University.

In their study, Dr. Rosenberg and his colleagues analyzed data from 852,384 newly fully vaccinated children aged 12 to 17 years and 365,502 children aged 5 to 11 years between Dec. 13, 2021, and Jan. 31, 2022, the height of the Omicron surge.

The vaccines effectiveness against hospitalization declined to 73 percent from 85 percent in the older children. In the younger children, effectiveness dropped to 48 percent from 100 percent. But because few children were hospitalized, these estimates have wide margins of error.

The numbers for protection from infection are more reliable. Vaccine effectiveness against infection in the older children decreased to 51 percent from 66 percent. But in the younger children, it dropped sharply to just 12 percent from 68 percent.

The numbers change drastically between ages 11 and 12. During the week ending Jan. 30, the vaccines effectiveness against infection was 67 percent in 12-year-olds but just 11 percent in 11-year-old children.

The difference between the two age groups is striking, said Florian Krammer, an immunologist at the Icahn School of Medicine at Mount Sinai.

The biological difference between the two ages is likely to be minimal, but while 12-year-old children got 30 micrograms of the vaccine the same dose given to adults children who were 11 received only 10 micrograms, he noted.

This is super interesting because it would almost suggest that its the dose that makes the difference, he added. The question is how to fix that.

There have been at least 851 deaths involving Covid-19 in children under 17, and nearly 7,000 cases of multisystem inflammatory syndrome in children, a rare but serious condition associated with Covid. More children were hospitalized during the Omicron surge than at any other point in the pandemic.

The findings underscore the need to gather more information on the best dose, number and timing for the shots given to children, Dr. Rosenberg said. They also underscore vaccines as just one measure of protection from the virus, along with masks and social distancing, he said.

March 5, 2022, 7:14 p.m. ET

Dr. Rosenbergs research was posted just days after the Centers for Disease Control and Prevention released new recommendations that would allow the majority of Americans to stop wearing masks, including in schools.

The new data also raises important questions about the Biden administrations strategy for vaccinating children. Only about one in four children aged 5 to 11 years has received two doses of the vaccine. (The C.D.C. has not yet recommended booster doses for this age group.)

The vaccine has not yet been authorized for children younger than 5. Scientific advisers to the Food and Drug Administration were scheduled to meet on Feb. 15 to evaluate two doses of the vaccine for the youngest children, while three doses were still being tested. But the meeting was postponed after Pfizer submitted additional data suggesting two doses were not strongly protective against the Omicron variant of the virus.

Dr. Rosenberg briefed top C.D.C. officials, including Dr. Rochelle P. Walensky, the agencys director, with findings in early February. F.D.A. leaders learned of the data around the same time. Some federal scientists pushed for the data to be made public ahead of the F.D.A. expert meeting scheduled for Feb. 15, viewing it as highly relevant to the discussion about dosing in children under 5, federal officials and others familiar with their responses to it said.

The data is generally consistent with a report from Britain showing that vaccine effectiveness against symptomatic infection in adolescents aged 12 to 17 years drops to 23 percent after two months. The C.D.C. has been compiling its own data on the vaccines effectiveness in younger children and is expected to release at least some of it as early as this week, according to people familiar with the agencys plans.

Israeli researchers have also been assessing the vaccines performance in young children since the country made it available to them in November.

We continue to study and assess real-world data from the vaccine, Amy Rose, a spokeswoman for Pfizer, said in response to queries about the new data.

Mask guidance. The Centers for Disease Control and Prevention released updated data that suggests 90 percent of the U.S. population are in a location with low or medium Covid-19 community levels and can now stop wearing masks.

N.F.L. drops protocols. The National Football League and the players union agreed to suspend all Covid-19 protocols, effective immediately. The league, which is not in season, is the first of the major professional sports leagues in the United States to halt its coronavirus-related policies

Dr. Philip Krause, who recently retired from the F.D.A. as a senior vaccine regulator, said assumptions about certain antibody levels being predictive of vaccine effectiveness should be re-evaluated in light of the new results.

It certainly weakens the argument for mandating that people get that lower dose, he said.

It is not unusual for experts to revisit the dosing and interval for pediatric vaccines as more evidence becomes available. But in this case, giving the children a higher dose to kick up the immune response may not be an option because some data suggest that it may cause too many fevers, an unwelcome and potentially dangerous side effect in young children.

There are other alternatives that may improve immunity in young children, said Deepta Bhattacharya, an immunologist at the University of Arizona.

Pfizer and BioNTech are testing a third dose in children under 5, as well as in those aged 5 to 11, with the idea that, as in adults, an extra shot may significantly augment immunity. Results from these trials are expected in several weeks. Studies in adults suggest that three doses of the vaccine were more protective against the Omicron variant than two doses.

Dr. Bhattacharya said he and his wife spaced the two doses for their children, who are 8 and 10, by eight weeks rather than the currently recommended three, based on studies suggesting that a longer gap between doses may improve protection. The C.D.C. last week encouraged some people older than 12, especially boys and men between 12 to 39 years, to wait eight weeks between the first and second shot.

Another option may be a version of the vaccine designed to thwart the Omicron variant, or one that has a mix of several variants. Pfizer-BioNTech, Moderna and Johnson and Johnson are all testing Omicron-specific versions of their vaccines.

The next variant may differ widely from Omicron, much as Omicron did from the Delta variant. But training the body to recognize multiple versions would still offer a better chance at preventing infection with newer forms of the virus. Deciding when and how best to update these vaccines, I think thats really still the key conversation going forward here, Dr. Bhattacharya said.

Newer vaccines that use different approaches than the ones currently authorized in the United States may also work better for children. A protein-based vaccine made by Novavax is under review at the F.D.A., and the pharmaceutical companies Sanofi and GSK said this month that they plan to submit their vaccine for evaluation soon.

Many parents want to vaccinate their children to prevent them from spreading the virus to vulnerable relatives, to keep them in school or to avoid the possibility of long Covid, the poorly understood set of lingering symptoms that can occur even after a mild infection. Experts acknowledged that the vaccines low effectiveness against infection does not ease those concerns.

Still, the vaccines provide more protection than we think, said Jessica Andriesen, a vaccine data expert at the Fred Hutchinson Cancer Research Center in Seattle.

They may also make it so that your kid who brings home Covid isnt shedding virus as much as they would be if they werent vaccinated, and they also may have it for a shorter amount of time, she said.

The virus is here to stay, and childrens risk of severe outcomes increases with age. So inoculating children early is a good idea, said Paul Offit, director of the Vaccine Education Center at Childrens Hospital of Philadelphia and an adviser to the F.D.A.

The argument I make to parents when I talk to them about this vaccine is, your children are going to grow up, he said. Theyre going to need to be protected against this virus for years.

Sharon LaFraniere and Isabel Kershner contributed reporting.

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Pfizer Shot Is Far Less Effective in 5- to 11-Year-Olds Than in Older Kids, New Data Show - The New York Times

Few of Covid-19s peculiarities have piqued as much interest as anosmia, the abrupt loss of smell that has become a well-known hallmark of the disease. Covid patients lose this sense even without a stuffy nose; the loss can make food taste like cardboard and coffee smell noxious, occasionally persisting after other symptoms have resolved.

Scientists are now beginning to unravel the biological mechanisms, which have been something of a mystery: The neurons that detect odors lack the receptors that the coronavirus uses to enter cells, prompting a long debate about whether they can be infected at all.

Insights gleaned from new research could shed new light on how the coronavirus might affect other types of brain cells, leading to conditions like brain fog, and possibly help explain the biological mechanisms behind long Covid symptoms that linger for weeks or months after the initial infection.

The new work, along with earlier studies, settles the debate over whether the coronavirus infects the nerve cells that detect odors: It does not. But the virus does attack other supporting cells that line the nasal cavity, the researchers found.

The infected cells shed virus and die, while immune cells flood the region to fight the virus. The subsequent inflammation wreaks havoc on smell receptors, proteins on the surface of the nerve cells in the nose that detect and transmit information about odors.

The process alters the sophisticated organization of genes in those neurons, essentially short-circuiting them, the researchers reported.

Their paper significantly advances the understanding of how cells critical to the sense of smell are affected by the virus, despite the fact that they are not directly infected, said Dr. Sandeep Robert Datta, an associate professor of neurobiology at Harvard Medical School, who was not involved in the study.

Its clear that indirectly, if you affect the support cells in the nose, lots of bad things happen, Dr. Datta said. The inflammation in the adjacent cells triggers changes in the sensory neurons that prevent them from working properly.

Indeed, many complications of Covid appear to be caused by the immune systems friendly fire as it responds to infection by flooding the bloodstream with inflammatory proteins called cytokines, which can damage tissue and organs.

This might be a general principle: that a lot of what the virus is doing to us is a consequence of its ability to generate inflammation, Dr. Datta said.

March 3, 2022, 9:38 p.m. ET

The new study is based on research carried out at Zuckerman Institute and Irving Medical Center at Columbia University in New York; the New York University Grossman School of Medicine; the Icahn School of Medicine at Mount Sinai in New York; Baylor Genetics in Houston; and the School of Medicine at the University of California, Davis. The research was published online in Cell in early February.

The scientists examined golden hamsters and human tissue specimens from 23 patients who succumbed to Covid. After the hamsters were infected with the original coronavirus, scientists tracked the damage to their olfactory systems over time.

(How do you know a golden hamster has lost its sense of smell? You dont feed it for several hours and then bury Cocoa Puffs in its bedding, said Benjamin tenOever, a professor of microbiology at NYU Langone Health and an author of the new research. Hamsters that can smell will find the cereal in seconds.)

The virus did not invade neurons, the researchers learned, only the cells that play supporting roles in the olfactory system. But that was enough to alter the function of the nearby neurons, leading to a loss of smell.

New Zealands Covid reckoning. For much of the past two years, the coronavirus was a phantom presence in New Zealand. Now, the island nation is being hit by a major outbreak of the Omicron variant, with the virus spreading at an extremely fast rate.

N.F.L. drops protocols. The league and the players union agreed to suspend all Covid-19 protocols, effective immediately. The N.F.L., which is not in season, is the first of the major professional sports leagues in the United States to halt its coronavirus-related policies

The immune response altered the architecture of genes in the neurons, disrupting production of odor receptors, said Marianna Zazhytska, a postdoctoral fellow at the Zuckerman Institute and one of the papers first authors, along with a graduate student, Albana Kodra.

It is not the virus itself causing all this reorganization its the systemic inflammatory response, Dr. Zazhytska said. The nerve cells are not hosting the virus, but they are not doing what they did before.

The ability of the olfactory receptors to send and receive messages is disrupted. But the neurons dont die, and so the system can recover after the illness resolves.

Earlier work at the Zuckerman Institute showed that neurons that detect smells have complex genomic organizational structures that are essential to the creation of odor receptors, and the receptor genes communicate among themselves very intensively, said Stavros Lomvardas, one of the papers corresponding authors.

We saw early on that upon infection, the genomic organization of these neurons changes completely theyre unrecognizable compared to how they normally are, Dr. Lomvardas said.

There is a signal released from the infected cells that is received by the neurons that normally detect odors, and tells them to reorganize and stop expression of olfactory receptor genes, he said.

He suggested this may represent an evolutionary adaptation that offers a form of antiviral resistance and whose main purpose may be to prevent the virus from entering the brain. That was a relief for us, he said. That was one piece of good news.

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How the Coronavirus Steals the Sense of Smell - The New York Times

'Pancorona virus vaccine will combat all corona virus variants: Dr Drew Weissman

Hyderabad, Feb 24 (UNI) BioAsia 2022 Genome Valley Excellence Award recipient, Dr. Weissman on Thursday said we are making a ' pancorona virus' vaccine which will protect against all coronavirus variants.The 19th edition of BioAsia, on its inaugural day held in virtual mode Thursday , held a special fireside chat, which witnessed a revolutionary revelation on the future of the coronavirus vaccination by Dr. Drew Weissman.In a conversation with Apollo Hospitals Managing Director Dr. Sangita Reddy, Dr Wissman elaborate extensively on the pancorona viruses, the state of costs in healthcare, and the future of mRNA in therapeutics.There have been three coronavirus epidemics in last years and there are going to be more. So, we want to create a vaccine that will stop any coronavirus from infecting humans. We are developing a few and they look promising, he said.The future of mRNA technology is noted to be tremendously promising, with an array of uses. It can also be used in therapeutics, he said.Dr. Weissman and his lab envision developing mRNA therapy for neurologic events, strokes, embolic events, as a way for reducing inflammation. My biggest hope is its use in gene therapy. Someday, it might be possible to treat genetic diseases like Cystic fibrosis, he told.Dr. Weissman also indicated an optimistic outlook for India in terms of collaborations to build mRNA production sites. In his closing remarks, he voiced strongly against the misinformation on vaccines.He said On a societal and systematic level, equality of therapeutics is important. Cost being the main problem, government and privately funded research can magnanimously help in bringing down costs and make it accessible across the world.A globally renowned researcher in mRNA technology for the rapid development of effective COVID-19 vaccines, Dr. Weissman, in collaboration with Dr. Katalin Karik, discovered the ability of modified nucleosides in RNA to suppress activation of the innate immune sensors and increase the translation of the nucleoside-modified mRNA. This outstanding discovery was used in the first two approved COVID-19 vaccines by Pfizer and Moderna.The striking result of the modified RNA vaccines was the incredibly high efficacy.Within 12- days of the second dose, the infections in the vaccinated people were extinct, with nearly 95 percent efficacy, he said. When you inject mRNA, it kills the tissue due to severe inflammation. But we developed a new type of RNA that is not inflammatory this RNA used in vaccines is incredibly effective and safe, the researchers said.Over a billion people have received the RNA vaccines so far and there have been almost no adverse events, he said during BioAsia 2022.RNA is a complex molecule that is simple to make, making it an ideal, cost-effective technology to introduce to other vaccine development.Dr. Weissman continues to develop other vaccines to induce potent antibody and T-cell responses with mRNA-based vaccines.Speaking on the development of future vaccines, he said, We are working on many different vaccines for a variety of pathogens including HIV, HCV, HSV, Malaria, Influenza, and pancorona viruses. We are also working on vaccines for food allergies, cancer vaccines, autoimmune diseases, therapeutics and In vivo gene therapy.Dr. Weissman observed that Coronavirus like any other RNA viruses is prone to a lot of mutations. The variants are going to keep coming as long as there's widespread infection. We have only vaccinated 15 percent of Africa and we've immunized low levels of many countries in the world. Until the world is fully vaccinated, the virus will continue to mutate, he stated.There are 2 options here, observes Dr. Weissman, you can keep making new vaccines every time there is a new variant. But it is important to note the low life span of these variants to keep up with this cycle, he added.UNI KNR SY 1531

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'Pancorona virus vaccine will combat all corona virus ...