COVID vaccine strategy to get an overhaul by FDA : Shots

Licensed vocational nurse Denise Saldana vaccinates Pri DeSilva, deputy director of Personal and Corporate Charity, with the fourth Pfizer COVID-19 booster shot at the Medical Center Dr. Kenneth Williams in Los Angeles, November 1, 2022.

Damian Dovarganes/AP

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Damian Dovarganes/AP

Licensed vocational nurse Denise Saldana vaccinates Pri DeSilva, deputy director of Personal and Corporate Charity, with the fourth Pfizer COVID-19 booster shot at the Medical Center Dr. Kenneth Williams in Los Angeles, November 1, 2022.

Damian Dovarganes/AP

The Food and Drug Administration is considering a major shift in the nation’s COVID-19 vaccine strategy, NPR has learned.

The goal is to simplify vaccination against COVID and be able to adopt a similar approach to that used for influenza vaccines, with annual updates to match any strains of the virus. -Which withdrawals are in circulation. This is according to a federal official who spoke on condition of anonymity because they are not authorized to speak publicly.

The FDA will outline this strategy publicly on Monday when it releases a set of documents ahead of the agency’s Thursday meeting. Advisory Committee on Vaccines and Related Biological Products. The committee will vote on the agency’s proposal.

Currently, people who want to be fully vaccinated against COVID must first get the basic vaccine — two initial shots of the vaccine a few weeks apart. That was followed at least two months later by a booster shot, now a bivalent injection designed to protect against omicrons.

Under the new approach, most people would be advised to simply get any of the latest versions of the vaccine annually each fall just like the flu vaccine. They won’t have to worry about how many pictures they took and when.

Vaccine manufacturers will update the shot every year through a process that begins each spring to try the best-suited vaccine possible with whatever variation is likely to prevail over the winter. next. That’s how the flu vaccine is made every year.

Some immunologists and vaccine researchers say it is appropriate to simplify the process along the lines of flu vaccines at this time of the pandemic. However, many questions remain about the emerging reinforcement strategy.

“Given the tools we have right now, I think it makes the most sense to schedule an annual update as close as possible to the variant currently circulating,” says Deepta Bhattacharya, an immunologist at the University of Arizona. “So I think all of the things the FDA is looking at make sense.”

Questions about the effectiveness of the updated injections

There is a fierce debate about the wisdom of regularly updating the COVID vaccine to try to accommodate new variants. Some researchers question whether that would actually make vaccines more effective. They also argue that low demand for the latest booster vaccine shows that the public is reluctant to continue boosting vaccines, even if they have been updated with new strains.

“The public will vote if you want to and say, ‘No. I won’t understand this. This doesn’t make any sense to us,'” Dr. Gregory Polanda vaccine researcher at the Mayo Clinic.

While advocating continued use of booster shots for people at high risk, such as older adults, some question whether current bivalent vaccines are updated to target omicrons. provide increased protection compared to the original vaccine. They say most people are still well protected from serious illness because of the immunity they already have.

“We don’t have solid data on the performance of divalent boosters,” said John Moore, an immunologist at Weill Cornell Medical College. “Evidence is definitely lacking, and the evidence out there is at least inconclusive and, to me, the tendency to say that divalent boosters are few if not better.”

Moore and others argue that viruses are changing so quickly that it makes no sense to constantly try to adapt vaccines to the latest variations.

“We really shouldn’t go after these variations, these variations will disappear and often disappear by the time you make a vaccine,” Dr. Paul Offit of the University of Pennsylvania, one of the FDA’s advisors.

Offit and others also question whether everyone necessarily needs regular boosters or just those at high risk, like the elderly.

Arguments for alternative vaccine strategies

Critics of the FDA’s proposed new strategy say it would be better to invest in the development of better vaccines that can be more appealing to people and in campaigns to get more people vaccinated. more room. Better vaccines could include those that can keep people from getting the virus in the first place and not just from getting very sick — such as the nasal spray vaccine. Or perhaps vaccines provide longer protection or are taken in pill form, to make them more tolerable for people who don’t like needles.

“Especially now that Congress has not allocated new funding to respond to COVID, we must be especially vigilant in how we spend our money and what will be most cost-effective,” said Dr. speak. Celine Gounder, a senior fellow at the Kaiser Family Foundation. “It’s not clear whether updating fortified formulations and continuously strengthening everyone is the most effective approach to controlling COVID at this stage.”

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

“I think we need to raise the bar and ask for more evidence of clinical efficacy,” Dr. Eric Rubin, professor of immunology and infectious diseases at Harvard, and a member of the advisory committee. For example, Rubin said that the FDA should require proof that updated vaccines actually reduce the risk of infection, illness, hospitalization, and death.

Others say it makes sense to keep vaccines up to date to ensure people are as protected as possible while researchers continue to try to develop new vaccines.

“Even if you don’t have a booster that matches 100% of what’s circulating, you’ll have a booster that matches 75% to 80% to 90% of what’s circulating,” says David Martinez, an immunologist at the University of North Carolina, Chapel Hill. “And that’s good enough. I’ll probably benefit most people.”

FDA looks forward to endemic COVID

Some researchers say it’s too early to rely on annual boosters. They note that COVID has not yet stabilized into a seasonal pattern like influenza, and that the SARS-CoV2 virus is mutating faster than the influenza virus. So people may need to be boosted more often, especially since protection against serious illness may only last about four to six months, they said.

“We’ll get there very soon with the first people on bivalent boosters, like me,” says Dr. Peter Hotez, a vaccine researcher at Baylor College of Medicine. “I don’t know if an annual strategy would cut it.”

The FDA’s plan comes as COVID appears to be moving towards becoming an endemic disease. That doesn’t mean it’s going away or that it’s no longer a threat. Health experts say the disease will continue to be a threat for the foreseeable future, sickening many people and potentially even killing hundreds a day, making it a health problem. large populations and is the leading cause of death.

But unless some more dangerous version of the virus suddenly appears, the world might eventually settle down to coexist with the virus. The goal of the new vaccine strategy is to make a vaccine, the main weapon to protect us, simpler and therefore hopefully more appealing, the NPR federal official said. The latest boosters have found very few participants.

The thinking is that at this point in the pandemic, the vast majority of people have significant levels of immunity, either by being vaccinated and boosted, or by being infected one of several times, or both. And while that immunity seems to protect most people from serious illness, that protection seems to fade over time.

The FDA is also looking into making the injections interchangeable. That way, people won’t have to worry about the brand they’re buying. Again, this change is intended to make the COVID shot more like the flu shot. People usually don’t worry about the brand of flu vaccine they get.

Vaccines will still be used in different doses for different ages. And young children and older adults will still get two shots a year, just like the flu vaccine.

If the FDA advisory committee endorses this approach on Thursday, the FDA will work with vaccine companies and the Centers for Disease Control and Prevention to finalize the details. And FDA advisors will meet again in the spring to select one or more specific strains of the virus that the new shots will target.


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