The FDA is proposing a new COVID vaccination strategy. Here's what you need to know.
A key advisory committee to the Food and Drug Administration met on Thursday to discuss the future of COVID-19 vaccination in the United States.
The FDA meeting comes at a time when health experts across the globe have acknowledged that COVID-19 appears to be moving toward becoming an endemic disease. This means the virus will not be fully eradicated, but it will become more predictable and manageable. With this in mind, many countries have begun to strategize about how to deal with the virus moving forward.
As the pandemic enters its fourth year, many Americans have returned to pre-COVID routines. In the U.S., COVID-19 cases, hospitalizations and test positivity are down about 20% in the past two weeks, according to data from the New York Times. This winter so far, cases have remained far below prior winter waves, and many experts believe that this is due in part to the U.S. having high rates of population immunity that has been acquired through vaccination, infection or both.
Thanks to this immunity, and to therapeutics such as Paxlovid, most Americans are well protected against severe disease and hospitalization. Given all of these factors, some experts have said it is reasonable for the FDA to begin thinking about a new vaccination plan for this next stage of the COVID pandemic.
What is the FDA proposing?
One of the primary goals of the FDA meeting was to determine a new strategy to make COVID-19 vaccination — an important weapon against the virus — simpler. By making the process less confusing for the public, the FDA said it hoped the shots will be more appealing to the American people.
As part of its strategy, the agency asked members of the Vaccine and Related Biological Products Advisory Committee to vote on a proposal to shift toward only one vaccine composition. Currently, unvaccinated Americans who get their first doses of the mRNA vaccines such as the Pfizer and Moderna shots, also known as the primary series, receive a shot targeting only the ancestral strain of the virus. This type of vaccine is what’s known as monovalent.
The bivalent boosters, on the other hand, which are recommended at least two months after a primary series to restore protection, are formulated to target more than one strain of the virus. The shots, which were developed last year, target the ancestral strain and Omicron subvariants BA.4 and BA.5. However, they have been found to also be effective against the dominant variant in the U.S. right now, known as the XBB.1.5 strain.
In order to improve the process, the committee of experts voted unanimously to make all the doses of COVID-19 vaccines interchangeable and offer anyone receiving a COVID shot, whether as a primary series or as a booster, the same vaccine. This means anyone receiving the vaccine would get the bivalent booster. However, it is not clear yet when this new plan will begin. The FDA and the Centers for Disease Control and Prevention (CDC) must first approve the new strategy.
“I do agree that we need to simplify this vaccine approach,” Dr. Katelyn Jetelina, an epidemiologist and author of the popular Substack column “Your Local Epidemiologist,” told Yahoo News. “It’s been incredibly confusing for the general public, and so this is the first step in the right direction,” she said.
Jetelina said she wasn’t sure why this approach had not been embraced sooner given how well the bivalent boosters are working.
Two new studies suggest the bivalent boosters are more effective at protecting against severe illness, hospitalization and death from COVID-19 than the monovalent vaccines that contain only the ancestral strain of the virus. According to CDC data presented at the FDA meeting, adults who received a bivalent booster had a three times lower risk of hospitalization and a two times lower risk of dying compared to those who were vaccinated but did not receive the bivalent booster.
Despite the reassuring data, the new booster uptake in the U.S. has been depressingly low. Only 15% of the population has received the shot, according to the latest CDC data. Uptake has been higher among people 65 years of age and older. To date, 40% of people in that age group have received their bivalent booster. But experts have said this number is disappointing considering that this group is at higher risk of COVID-19 complications and would benefit the most from the shots.
At the meeting, Hayley Gans, a pediatrics professor at Stanford University and a member of the committee, emphasized that the group’s decision was rooted in data.
“This is not only a convenience thing to increase the number of people who are vaccinated, which I agree with my colleagues is extremely important,” she said. “But I also think moving towards the strains that are circulating is very important, so I would also say the science also supports this move.”
An annual shot like the flu
Following the vote, the committee discussed other ways to improve the U.S. vaccination strategy. The FDA presented the idea of adopting a plan similar to the flu model moving forward. The plan recommends that most healthy people receive one dose every fall. Some Americans, including older people, unvaccinated young children and those who are immunocompromised, may need to be offered two or more doses a year, the agency said.
In order to make this work, the FDA said the committee should meet annually, starting in early June, to select the strains that the COVID-19 vaccines should be targeting that year. After that meeting, the agency would make a formal decision on what the formulation of the shots should be and direct manufacturers to gear up production.
By simplifying the COVID vaccination process, Americans would no longer need to keep track of how many shots they've already received or worry about figuring out the best time to get vaccinated. But not all experts believe this approach would be as effective as the yearly flu shot.
“I think applying the flu model to SARS-CoV-2 is a giant leap of faith that we don't necessarily have a lot of evidence on,” Jetelina said.
Scientists have also noted that COVID-19 hasn’t quite settled into a seasonal pattern like the flu and so it may be too soon to rely on annual boosters.
“I'm optimistic that we're starting to see second-generation variants. ... We’ve had Omicron for more than a year now, [and] it continues, Omicron continues to mutate,” Jetelina said. “And to me, that's a good sign that it’s finally finding its ladder-like evolution patterns like we see with the flu and other coronaviruses.”
But Jetelina told Yahoo News she expects to see a few more waves and thinks it’s going to take five to 10 years to see seasonal trends with COVID-19. “This just takes time,” she said.
Peter Marks, director of the Center for Biologics Evaluation & Research at the Food and Drug Administration, defended the proposed plan.
“We [are] starting to see some seasonality ... and I think we also see the potential advantages to the winter seasonality with a fall campaign because when do we have to worry about the worst overwhelming of the hospitals? It will be when we have influenza, RSV and potentially COVID at the same time,” Marks said.
Another advantage to implementing this strategy, he explained, is that people can get both the COVID-19 vaccine and the influenza vaccine at the same time. “Again, it facilitates a vaccination program that may lead to more people getting vaccinated and protected and reducing the amount of disease we see.”
But there are many unanswered questions and issues to work out for an annual COVID-19 vaccination program to work, Jetelina noted. One concern is that COVID-19 is a rapidly evolving virus, and by the time a new vaccine is developed, there may be new variants circulating that may cause an updated vaccine to be less effective.
“We really just have to be ready to pivot if needed and have a contingency plan if it’s not gonna work. I haven’t seen a discussion around that yet,” Jetelina said.
There’s also a concern about whether vaccine manufacturers would have enough time to produce the updated shots. A Pfizer representative said at the meeting Thursday that it can deliver a vaccine in 100 days. Moderna also said it could work with the FDA’s timeline.
Novavax, however, does not produce an mRNA vaccine and said it may need at least six months to make an updated vaccine.
Finally, experts at the meeting emphasized it was important for scientists and vaccine developers to continue to pursue the development of the next generation of COVID vaccines.
Monica Gandhi, an infectious disease doctor and professor of medicine at the University of California, San Francisco, told Yahoo News that it is crucial that these vaccines receive federal funding in the future.
“We need ongoing funding for new vaccine development, and that is just because this [COVID-19 virus] is here to stay,” Gandhi said. “I absolutely support that, especially at the NIH [National Institutes of Health] level as opposed to any sort of other funding agency. It’s really the NIH that’s gotten good at that kind of research, so yes, I’m very in favor of them funding new vaccine research and I really hope they do,” she added.