Covid vaccine strategy to get overhaul by FDA: Shots

Licensed occupational nurse Denise Saldana inoculates Pree DeSilva, Associate Director of Individual and Corporate Giving, with the fourth Pfizer COVID-19 vaccine booster at Dr. Kenneth Williams Health Center on November 1, 2022 in Los Angeles.

Damien Doverganes/AP

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Damien Doverganes/AP

Licensed occupational nurse Denise Saldana inoculates Pree DeSilva, Associate Director of Individual and Corporate Giving, with the fourth Pfizer COVID-19 vaccine booster at Dr. Kenneth Williams Health Center on November 1, 2022 in Los Angeles.

Damien Doverganes/AP

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

The goal is to make vaccination against COVID easier and perhaps adopt a similar approach to that used for the flu vaccine, with annual updates to match any strain of the virus. That’s according to a federal official who spoke under the condition of anonymity because he was not authorized to speak publicly.

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

Currently, people who want to be fully vaccinated against COVID must first get their primary vaccination – two shots of the core vaccine spaced weeks apart. This is followed at least two months later by a booster, currently a bivalent shot designed to protect against Omicron.

Under the new approach, most people will be advised to get the latest version of the vaccine annually, at the same time as the flu vaccine. He will not have to worry about how many shots he has got and when he has got which shot.

Vaccine makers will update the annual shot through a process that begins each spring to try to match the vaccine to one potentially effective in the coming winter. This is how the flu vaccine is prepared every year.

Some immunologists and vaccine researchers say that simplifying the process along the lines of the flu vaccine is appropriate at this point in the pandemic. However, many questions remain about the emerging booster strategy.

Dipti Bhattacharya, an immunologist at the University of Arizona, says, “As far as the equipment we have now, I think it makes the most sense to plan to update every year, to keep up with the variants we’re currently running.” Can do close to.” “So I think all the things the FDA is considering make a lot of sense.”

Questions about the efficacy of update shots

There is intense debate about the wisdom of regularly updating COVID vaccines to try to match new variants. Some researchers question whether this actually makes vaccines more effective. They also argue that the low demand for the latest boosters suggests that the public has little appetite for continued increases with vaccines, even when they are updated with new strains.

Dr. Gregory Poland, a vaccine researcher at the Mayo Clinic, says, “If you will, the public is voting with their hands and saying, ‘No. I’m not getting it. It doesn’t make sense to us.’ ” ,

While supporting continued boosters for those at high risk, such as the elderly, some question whether current bivalent vaccines updated to target the omicron have increased protection compared to the original vaccines. They say most people are still protected from severe disease because they already have immunity.

“We have no solid data about the performance of bivalent boosters,” says John Moore, an immunologist at Weill Cornell Medical College. Hard evidence is lacking, and the evidence that is out there is at least inconclusive and the trend for me to say bivalent boosters were less if not better.”

Moore and others argue that the virus is changing so rapidly that it is futile to continually try to match vaccines to the latest variants.

“We really shouldn’t be chasing these forms, which are transitory and often gone by the time you make the vaccine,” says Dr. Paul Offit of the University of Pennsylvania, one of the FDA’s advisors.

Offit and others also question whether everyone will need a routine boost, or only those at high risk, such as the elderly.

Arguments for alternative vaccine strategies

Critics of the FDA’s proposed new strategy argue that it would be better off investing in the development of better vaccines that might be more attractive to people, and in campaigns to vaccinate more people. Better vaccines could include those that prevent people from catching the virus not only before they become seriously ill – such as the nasal spray vaccine. Or perhaps vaccines that provide longer protection or are administered in pill form to make them more acceptable to avoid needles.

Dr. Celine Gunder, a senior fellow at the Kaiser Family Foundation, says, “Especially now that Congress is not allocating new funds for the COVID response, we have to be especially prudent in how we spend our money and whether will be most cost-effective.” , “It is not clear that updating booster formulations and boosting people more frequently is the most effective way to control COVID at this stage.”

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

“I think we need to raise the bar and have more evidence of clinical efficacy,” says Dr. Eric Rubin, professor of immunology and infectious diseases at Harvard, who is also a member of the advisory committee. For example, Rubin says the FDA should require proof that the updated vaccines are actually reducing the risk of getting infected, getting sick, being hospitalized, and dying.

Others say updating vaccines makes sense to ensure people are protected as much as possible while researchers continue to try to develop new vaccines.

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

FDA looks forward to endemic COVID

Some researchers think it’s too early to rely on annual boosters. COVID is not quite organized into a seasonal pattern like the flu, they note, and the SARS-CoV2 virus is changing more quickly than the flu virus. So people may need a more frequent boost, especially since protection from severe disease may only last for four to six months, he says.

A vaccine researcher at Baylor College of Medicine, Dr. “We’re going to arrive soon with early adopters of bivalent boosters,” says Peter Hotez. “I don’t know if any annual strategy is going to reduce it.”

The FDA’s plan comes as COVID moves toward 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 remain a threat for the foreseeable future, sickening many people and potentially killing hundreds, making it a major public health problem and a leading cause of death .

But unless a more dangerous variant of the virus suddenly emerges, the world may eventually settle into a more predictable coexistence with the virus. Federal officials NPR said the new vaccine strategy aims to make vaccines, the key weapon to protect ourselves, simpler and hopefully therefore more attractive. The latest booster has found very few takers.

The thinking is that at this point in the pandemic the vast majority of people have a significant level of immunity, either from being vaccinated and boosted, or from being infected more than once, or both. And while this immunity appears to protect most people from serious illness, that protection appears to wane over time.

The FDA is also considering making the shots interchangeable. This way people will not have to worry about which brand they are getting. Again, the change aims to make COVID shots more like flu shots. People usually don’t worry about the brand of flu vaccine they receive.

The vaccine will still be given in different doses for different ages. And very young children and the elderly will still get two vaccines each year, just like the flu vaccine.

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

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