The Food and Drug Administration is considering a major shift in the nation’s COVID-19 vaccine strategy.
The goal is to streamline COVID vaccination and perhaps adopt a similar approach to the one used for the flu vaccine, with annual updates to accommodate any strain of the circulating virus. This was said by a federal official who spoke on condition of anonymity because he was not authorized to speak publicly.
NPR reported the proposed shift early Monday morning and the FDA following Monday he outlined this publicly in a series of released documents ahead of an agency meeting on Thursday Advisory Committee on Vaccines and Related Biological Products (VRBPAC). The committee will vote on the agency’s proposal.
Currently, people who want to be fully vaccinated against COVID must first get their primary shots: two doses of the original vaccine weeks apart. This was followed at least two months later by a booster, currently the bivalent injection tailored to protect against omicron.
With the new approach, most people would be advised to simply get the latest version of the vaccine every year every fall like the flu shot. They shouldn’t have to worry about how many shots they’ve already gotten and which one they’ve gotten when. Those who still need to receive two doses initially, such as young children and the elderly, would use the same formulation for all three injections.
Vaccine makers would update the annual injection through a process that would begin each spring to try to match the vaccine as closely as possible to whichever variant is likely to be dominant next winter. This is how the flu vaccine is formulated every year.
“The FDA plans to conduct a SARS-CoV-2 strain evaluation at least annually and to engage VRBPAC in early June each year regarding strain selection for the fall season,” the FDA wrote. FDA in its disclosure document, adding that updated vaccines would be ready for use by September of each year.
The agency notes that if a more dangerous COVID variant emerges, it may reconsider the vaccine strain at other times of the year “on an emerging and necessary basis.”
Some immunologists and vaccine researchers say streamlining the process along the lines of the flu shot is appropriate at this point in the pandemic. However, many questions remain about the emerging recall strategy.
“As far as the tools we have right now, I think it makes more sense to plan to update every year as close to the variant currently in circulation as possible,” he says Deepta Bhattacharya, an immunologist at the University of Arizona. “So I think all the things that the FDA is considering make a lot of sense.”
Questions about the effectiveness of injections updated
There is intense debate about the wisdom of regularly updating COVID vaccines to try to match new variants. Some researchers question whether this really makes vaccines more effective. They also argue that low demand for the latest booster shows the public has little appetite for continued boosting with vaccines, even as they’ve been updated with new strains.
“The public is voting with their arms if you want and they said, ‘No. I will not understand. This makes no sense to us,” says Dr. Gregory Polanda vaccine researcher at the Mayo Clinic.
While endorsing continued recalls for people at high risk, such as the elderly, some question whether current bivalent vaccines updated to target omicrons have improved protection over the original vaccines. Most people are still well protected against serious disease by the immunity they already possess, they say.
“We don’t have solid data on the performance of bivalent boosters,” he says John Moore, an immunologist at Weill Cornell Medical College. “Hard evidence is lacking and the evidence that is out there is inconclusive to say the least and tended to me to say that the bivalent boosters were little if not better.”
Moore and others argue that the virus is changing so fast that it’s futile to constantly try to match vaccines to the latest variants.
“We really shouldn’t be chasing these variants, which are evanescent and often disappear by the time you create the vaccine,” says Dr. Paul Offit of the University of Pennsylvania, one of the advisors to the FDA.
Offit and others also question whether everyone will necessarily need to be boosted regularly, or just those at high risk, such as the elderly.
Arguments for alternative vaccination strategies
Critics of the FDA’s proposed new strategy argue that it would be better to invest in developing better vaccines that might be more attractive to people and in campaigns to get more people vaccinated. Better vaccines might include ones that could prevent people from getting the virus in the first place, not just getting seriously ill, such as a nasal spray vaccine. Or perhaps vaccines that provide longer protection or are given in pill form, to make them more acceptable to needle averse people.
“Especially now that Congress isn’t allocating new funds for the COVID response, we need to be especially cautious about how we spend our money and what would be most convenient,” says Dr. Celine Gounder, senior fellow at the Kaiser Family Foundation. “It is unclear whether updating booster formulations and repeatedly boosting people is the most effective approach to controlling COVID at this stage.”
Another concern for 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 demand more clinical efficacy evidence,” says Dr. Eric Ruby, professor of immunology and infectious diseases at Harvard who is also a member of the advisory board. For example, Rubin says the FDA should require proof that updated vaccines are actually reducing the risk of being infected, getting sick, hospitalized and dying.
Others say updating vaccines makes sense to make sure people are as protected as possible as 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,” he says David Martinez, an immunologist at the University of North Carolina, Chapel Hill. “And that will be good enough. It would probably benefit most people.
FDA looks ahead to endemic COVID
Some researchers think it’s too early to rely on annual boosters. COVID hasn’t quite adapted to a seasonal pattern like the flu, they note, and the SARS-CoV2 virus is changing faster than the flu virus. So people may need to be boosted more frequently, especially since protection against serious disease can only last about four to six months, they say.
“We will achieve that very soon with early adopters of bivalent boosters, like me,” says Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children’s Hospital and dean of the National School of Tropical Medicine at Baylor College of Medicine. “I don’t know if an annual strategy is going to cut that.”
The FDA’s plan comes as COVID appears to be moving toward becoming an endemic disease. That doesn’t mean it’s going away or no longer a threat. The disease will continue to pose a threat for the foreseeable future, making many people ill and potentially killing hundreds a day, making it a major public health problem and a leading cause of death, health experts say.
But unless a more dangerous version of the virus suddenly emerges, the world could finally settle into a more predictable coexistence with the virus. The NPR federal official he spoke to says the goal of the new vaccine strategy is to make vaccines, which are the main weapon to protect us, simpler and hopefully therefore more attractive. The latest boosters have found very few buyers.
The idea is that at this point in the pandemic the vast majority of people have significant levels of immunity, either from having been vaccinated and boosted, or infected one or more times, or both. And while that immunity appears to protect most people from serious illness, that protection appears to fade with time.
The FDA is also considering making the shots interchangeable. That way people wouldn’t have to worry about which brand they’re buying. Again, the change aims to make COVID vaccines more like flu shots. People typically don’t care which brand of flu shot they get.
The vaccine would still be given at different doses for different ages. And very young children and the elderly would still get two injections a year, just like the flu shot.
If the FDA’s advisory committee approves the approach on Thursday, the FDA will work with vaccine companies and the Centers for Disease Control and Prevention to finalize the details. And FDA advisers will meet again in the spring to choose the specific strain or strains of the virus that the new shots should target.