FDA advisors vote to standardize COVID vaccines as bivalent, stump for more data

FDA vaccine advisors have recommended the United States move to standardize COVID-19 vaccines, making them all bivalent—targeting both the original coronavirus and circulating variants.

Such a move would sideline the original primary series formulations, which are still in use for those who have not been vaccinated. 

While that vote of the 21 members of the Vaccines and Related Biological Products Advisory Committee on Thursday was unanimous, there was disagreement on many other topics and often the same conclusion: More data is needed.

The advisory committee, made up of independent doctors and scientists, makes vaccine recommendations to the FDA. While the agency takes the input into consideration, FDA officials and others at the Centers for Disease Control and Prevention have the final say on U.S. vaccine policy.

One area of discussion during Thursday's VRBPAC meeting was whether younger people who are healthy need to be vaccinated. Another topic centered around annual booster administration. 

The answer for both: More data is needed.

“We need the CDC to tell us exactly who is getting hospitalized and dying of this virus—the ages, vulnerability, the type of immune compromise, and whether they were treated with antivirals. And we need immunological data to indicate who’s at risk,” said Paul Offit, M.D., of the Children’s Hospital of Philadelphia, as quoted by Kaiser Health News. “Only then can we decide who gets vaccinated with what and when.”

As for annual boosters, the experts were open to the idea, The Wall Street Journal reports. Going forward, the FDA suggested that it would meet annually in May or June to decide which variants to target, similarly to how it manages the development of annual flu shots.

Representatives from vaccine makers Pfizer and Moderna said that this would allow them enough time to develop an updated bivalent vaccine ready for the traditional fall booster season, according to reports. And it’s roughly the timeline they used in 2022 to develop their most recent versions of their mRNA vaccines.

This schedule would be problematic for Novavax however. A company representative said on Thursday that it needed six months to adapt its protein-based vaccine to circulating variants.