The Food and Drug Administration on Thursday is asking an expert advisory panel to consider how often people should be boosted against COVID-19 and what those boosters should look like.
The Biden administration has already recommended that healthy young people get annual COVID-19 boosters, just as they get an annual flu shot.
The FDA is looking for the experts’ take on that recommendation, as well as providing twice-annual boosters for people who are immune-compromised or over a certain age to increase their chances of avoiding a potentially dangerous infection.
In an all-day meeting Thursday, which will be webcast live, the committee will also consider simplifying the composition of vaccines and developing a process of selecting variants to be targeted with each round of shots.
Any recommendations made by the committee will have to be ratified by the FDA commissioner and then considered by an advisory committee to the Centers for Disease Control and Prevention and its director.
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Here are the key issues the Vaccines and Related Biological Products Advisory Committee will discuss:
Timing of boosters: Should Americans get annual COVID shots?
The Biden administration, vaccine manufacturers and at least one modeling study suggest that annual fall boosters will help prevent severe disease and minimize the spread of the virus.
Neil Maniar, a professor of public health practice at Northeastern University in Boston, thinks that’s a good idea. Many Americans have skipped boosters because they were unsure whether they were eligible. A simplified schedule, he said, “will increase vaccination rates because it will hopefully make it easier for people to follow.”
But there is little real-world data to show that young, otherwise healthy people who’ve had at least three exposures to the virus – through vaccination or infection – would benefit from additional shots.
“If you’re over 60, absolutely, you need to stay up to date” on boosters, said Dr. Carlos del Rio, president of the Infectious Disease Society of America, on Tuesday during a call with media.
For someone who is under 50 and has been vaccinated and infected, “there’s really not this huge need to be up to date,” he said.
Vaccines will never prevent all cases of COVID-19, noted Dr. Paul Offit, a member of the VRBPAC and a pediatrician who directs the Vaccine Education Center at the Children’s Hospital of Philadelphia.
Protection against severe disease and death seems to be remaining strong among the young and healthy who’ve been triply vaccinated, or vaccinated and infected, he said.
Healthy young people might eventually need boosters to prevent severe disease, but Offit said he hasn’t seen data to convince him the time is now.
Even for the most vulnerable people like his 94-year-old mother, the best bet may be to get her the antiviral Paxlovid when she catches COVID-19, Offit said, rather than constantly boosting her to try to prevent any infection.
FDA wants to simplify the vaccine options
The FDA also recommended that all vaccines — both initial shots and boosters — address the same variants going forward.
Right now, the primary series vaccines are aimed only at the original virus, while boosters are aimed at both the original and the BA.4/BA.5 variants of omicron. Giving everyone the same type of shot will simplify the options.
Novavax vaccine, the fourth approved COVID-19 shot, has not received authorization for a bivalent option but would be allowed to target the same variants as other vaccines under the proposed guidelines.
Maniar said he likes the idea of offering people options of which shot to get: the two mRNA vaccines from Pfizer-BioNTech and Moderna, the viral vector vaccine from Johnson & Johnson, or the protein-based vaccine from Novavax.
“Not only will the folks who are planning to get vaccinated get vaccinated, but hopefully those who have hesitancy right now will gain more confidence in the process … because they have more choice,” he said. “That’s the hope. We’ll have to see how it plays out.”
FDA suggests bivalent boosters are better
The FDA believes taking aim at at least two variants is better than one.
Data from real-world studies, “suggest that bivalent mRNA booster vaccination provides additional protection against symptomatic infection, emergency department/urgent care visits, and hospitalization,” according to a 25-page report the FDA released ahead of the committee meeting.
The current boosters are composed of the original virus — in case it reappeared — and the BA.4 and BA.5 variants of omicron. BA.5 was the prevailing variant in the U.S. last summer when FDA chose the composition of the shot, though it now accounts for just about 2% of COVID-19 cases. BA.4 is virtually gone and the original virus hasn’t been seen for more than a year.
Some are not convinced that original virus should continue to be part of the vaccine.
Including two variants in the vaccine means everyone gets half a dose against each, which might mean less protection rather than more against the prevailing variant, said John Moore, a professor of Microbiology and Immunology at Weill Cornell Medical College in New York.
“You’re protecting against something that is a low-probability event,” Moore said of the unlikely return of the original virus “and you’re compromising what is with you.”
How the FDA wants to update annual COVID vaccines
It’s clear that the virus that causes COVID-19 keeps evolving. Just since Halloween, the dominant variant in the United States has switched from BA.5 to BQ.1.1 to now, in most parts of the country, XBB.1.5.
To remain effective, the vaccine will have to change, too.
The FDA is proposing a committee that would recommend variants for annual vaccines, typically in June. That will enable manufacturers to make doses available by late September, in time to get people boosted before a possible COVID-19 surge around the holidays.
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The report also recommended a process to quickly target new variants in case of “circulation of a more pathogenic vaccine-escape variant of SARS-CoV-2.” A similar process exists to address new, particularly dangerous flu strains.
With the flu, an expert panel meets every spring to pick four strains to target with that fall’s vaccine. They base those targets largely on which strains are then circulating in the southern hemisphere. Flu is typically less lethal in years when the match between the virus and the vaccine is good.
It will be much harder to predict COVID-19’s future, said Dr. Philip Krause, chair of the World Health Organization’s Vaccines Research Expert Group, in a Wednesday call with reporters.
The virus has – at least so far – been evolving rapidly with new variants spreading incredibly fast and varying from country to country.
Other issues likely to come up
Krause said he hopes the committee will discuss what kind of data the FDA needs to proceed in its battle against COVID-19, rather than setting policies that might not make sense later.
The FDA’s current recommendations, for instance, will make it hard for new, better vaccines to come along, said Krause, also former deputy director of FDA’s Office of Vaccines.
Vaccines under development include approaches that have the potential to provide longer-lasting or broader protection, but these wouldn’t fit the annual, every-vaccine-is-the-same paradigm FDA is laying out.
“To the degree that we double-down on the technologies we have,” Krause said, “we may create barriers to others or improved versions.”
How to watch the Vaccines and Related Biological Products Advisory Committee
The Vaccines and Related Biological Products Advisory Committee meeting is 8:30 a.m. to 5:30 p.m. ET on Thursday. You can watch a livestream on Youtube or watch below. More details on the VRBPAC meeting and agenda can be found here.
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Contact Karen Weintraub at kweintraub@usatoday.com.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
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