FDA advisers favor retiring original covid shot in favor of newer version
Advisers to the Food and Drug Administration on Thursday unanimously endorsed retiring the original coronavirus shot in favor of one that targets both the original strain of the coronavirus and the omicron variant.
The recommendation, if adopted by the FDA, will have minimal impact on most people, affecting unvaccinated people who have not yet received any doses of the vaccine; they were still being offered two initial shots of a vaccine based on the original form of the virus. The bivalent shot that is replacing the original formulation has been used as a booster since September.
"Speaking with colleagues, friends, families, the questions I'm answering from the community, there's so much confusion about these different formulations that … anything we can do to ease up on that confusion and simplify is going to be a good thing," said Archana Chatterjee, dean of the Chicago Medical School and a member of the FDA advisory committee.
The FDA also sought input from its advisers on several complicated topics, including whether the agency should switch to a once-a-year vaccine schedule that is akin to the annual shot for the influenza vaccine. Many committee members favored simplifying the shot regimen but called for more data to understand whether additional doses should be given to young children who have never been vaccinated along with people who are older and immunocompromised.
Representatives from three vaccine companies - Moderna, Novavax and Pfizer - indicated they would need advance notice of 100 days to six months to launch a vaccine based on a new variant. Messenger RNA shots made by Moderna and Pfizer can be manufactured quickly, but several committee members argued that too little attention had been paid to the potential role of protein-based shots such as the one made by Novavax, which take longer to manufacture but provide excellent protection.
Many experts cautioned that while following a flu vaccine model might be a practical option, the coronavirus has yet to settle into a reliable seasonal pattern.
"We have to keep reminding ourselves this is not influenza and keep paying attention to make sure we don't follow that dogma because we're used to doing it. We'll try this this time," said Bruce Gellin, chief of Global Public Health Strategy for the Rockefeller Foundation. "I don't think we're setting it in stone."
Many scientists are dissatisfied about a vaccine policy that is always two steps behind the virus and hope to have better options in the future.
John Beigel, associate director for clinical research at the National Institutes of Health's Division of Microbiology and Infectious Diseases, outlined the public health need for next-generation, variant-proof vaccines that provide durable protection and limit the spread of the coronavirus.
But Beigel said identifying promising vaccine candidates now will require more scientific work than at the dawn of the pandemic, when it was more obvious which experimental vaccines to fast-track.
"For Operation Warp Speed, there was good data to support which vaccines to advance," Beigel said, referring to the government campaign early in the pandemic to develop vaccines and treatments. For next-generation vaccines, it's far less clear which vaccine candidates are most likely to succeed - or even how to measure whether they're working.
"Which vaccines are likely to increase the breadth of protection and durability is not clear," Beigel said. "How do you define the vaccines or pick the vaccines that will limit asymptomatic transmission?"
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