COVID Vaccine Strategy to Get Overhaul by FDA: Shot

On November 1, 2022, at Dr. Kenneth Williams Health Center in Los Angeles, Denise Saldana, a licensed vocational nurse, delivered the fourth Pfizer COVID-19 vaccine booster to Pri, Associate Director of Personal and Corporate Giving. Inoculate DeSilva.

Damien Devargans/AP

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Damien Devargans/AP

Denise Saldana, Licensed Professional Nurse, Associate Director of Personal and Corporate Giving Using the Fourth Pfizer COVID-19 Vaccine Booster at Dr. Kenneth Williams Health Center in Los Angeles, November 1, 2022 vaccinate Pri DeSilva, who is

Damien Devargans/AP

Updated at 10:30 AM ET

The Food and Drug Administration is considering major changes to the country’s COVID-19 vaccine strategy.

The goal is to simplify vaccination against COVID, possibly with approaches similar to those used for influenza vaccines. This is according to federal officials who spoke on condition of anonymity because they were not authorized to speak publicly.

NPR reported the proposed shift early Monday morning, and FDA later Monday. publicly outlined it in a series of published documents before the agency’s Thursday meeting Vaccines and Related Biologics Advisory Committee (VRBPAC). The Commission shall Vote on agency proposals.

Currently, anyone wishing to be fully vaccinated against COVID must first receive the primary vaccination. He gets two doses of the original vaccine several weeks apart. A booster followed at least two months later and now his bivalent shot calibrated to protect against omicron.

Under the new approach, most people are encouraged to get the latest version of the vaccine each fall, like the flu vaccine. They don’t have to worry about how many shots they’ve already taken or when they got which one. For those who need her two doses first, such as young children and the elderly, use the same formulation for all three doses.

Vaccine manufacturers update their annual inoculations through a process that begins each spring, trying vaccines that are as close as possible to those that are likely to prevail next winter.

“FDA expects to conduct SARS-CoV-2 strain assessments at least annually and engage VRBPAC around early June each year regarding strain selection for the fall season,” the FDA said in a briefing document. , an updated vaccine will be available by September of each year.

Officials say they may reconsider vaccine strains at other times of the year “urgently if necessary” if more dangerous COVID variants emerge

Some immunologists and vaccine researchers say it’s appropriate at this point in the pandemic to simplify the process, much like the flu vaccine. However, many questions remain about the new booster strategy.

“For the tools we have today, I think it makes the most sense to plan to update them every year as close as possible to the current variants,” he says. Deepta Bhattacharya, an immunologist at the University of Arizona. “So I think everything the FDA is looking at makes sense.”

Questions about the validity of the updated shot

There is fierce debate about the wisdom of regularly updating the COVID vaccine to match new variants. They also argue that low demand for the latest boosters indicates little public appetite for continued boosters with vaccines, even as they are updated with new strains.

“The public folded their arms and voted and said, ‘No. I’m not going to get this. This doesn’t mean anything to us.'” Gregory Polanda vaccine researcher at the Mayo Clinic.

Whether the current bivalent vaccine, updated to target Omicron, provided enhanced protection compared to the original vaccine, while supporting continued boosters for high-risk populations such as the elderly. Most people, they say, are well protected against serious illnesses by the immunity they already have.

“There are no hard data about the performance of the bivalent booster John Moore, an immunologist at Weill Cornell Medical College. “The hard evidence is lacking, and the evidence out there is at least inconclusive, and I tend to say that, for me, the bivalent boosters weren’t that good.”

Moore and others argue that the virus is changing so quickly that it makes no sense to constantly try to adapt the vaccine to the latest variant.

“You really shouldn’t be chasing these variants. They’re transient and often gone by the time a vaccine is created,” said Dr. Paul Offitt A professor at the University of Pennsylvania and one of the FDA’s advisors.

Ofit et al. also question whether everyone should receive regular boosts, or only those at high risk, such as the elderly.

Discussion of alternative vaccine strategies

Critics of the FDA’s proposed new strategy say it would be better off investing in developing better vaccines that are more attractive to people, or in campaigns to get more people vaccinated. . A better vaccine could include something like Nasal Spray his vaccine that could not only get you seriously ill, but prevent people from contracting the virus in the first place. Alternatively, it could be a vaccine that offers longer protection or is administered in pill form to make it more acceptable to people who dislike injections.

“Especially now, when Congress has not allocated new funding for the COVID response, we must be especially careful about how we spend the money and what is most cost-effective. . celine gounder, Senior Fellow of the Kaiser Family Foundation. “It is unclear at this stage whether updating the booster formulation and repeatedly boosting people is the most effective approach for him to control COVID.”

Another concern some researchers have is that the FDA continues to rely on antibody levels to test vaccine efficacy.

“I think we need to raise the bar and look for more evidence of clinical efficacy,” said Dr. Eric RubinProfessor of Immunology and Infectious Diseases at Harvard University and a member of the Advisory Board. For example, Rubin says the FDA needs to prove that updated vaccines actually reduce the risk of infection, illness, hospitalization and death.

Some say that while researchers continue to develop new vaccines, it makes sense to update them to make sure people are as well protected as possible.

“Even if there is no booster that matches 100% of what is in circulation, there will be boosters that match 75% to 80% to 90% of what is in circulation,” he said. David Martinez, an immunologist at the University of North Carolina at Chapel Hill. “And that’s enough. I’ll probably benefit most people.”

FDA stays ahead of endemic COVID

Some researchers think it’s too early to rely on annual boosters. They note that COVID does not fit perfectly into seasonal patterns like flu, and the SARS-CoV2 virus is changing more rapidly than the flu virus. As such, more frequent boosters may be needed, especially since protection against severe disease may only last about four to six months, they say.

“Early adopters of bivalent boosters like myself will soon reach that goal,” Dr. Peter Hotes, a vaccine researcher at Baylor College of Medicine. “I don’t know if an annual strategy will cut it.”

The FDA’s plan comes out when COVID appears to be heading towards becoming endemic. The disease will continue to be a threat in the near future, with many people getting sick and potentially even hundreds of deaths a day, becoming a major public health problem and leading cause of death, health experts say. says.

But unless a more dangerous version of the virus suddenly emerges, the world may eventually settle on a more predictable coexistence with the virus. It is about making vaccines, our main weapon for protecting ourselves, simpler and hopefully more attractive. The latest booster found very few takers.

At this point in the pandemic, the vast majority of people are believed to have had significant levels of immunity, either through vaccination and boosting, or one or more infections, or both. appears to protect most people from serious illness, but that protection seems to wear off over time.

The FDA is also considering making the shots interchangeable. That way people don’t have to worry about which brand they’re getting. People usually don’t worry about the brand of flu vaccine they receive.

Vaccines are given at different doses for different ages. And very young children and the elderly are vaccinated twice a year, just like the flu vaccine.

If an FDA advisory panel approves the approach on Thursday, the FDA will work with vaccine companies and the Centers for Disease Control and Prevention to finalize the details. Select a specific strain of virus to