FDA proposing it treat the COVID vaccine like the flu shot.
In addition, SARS-CoV-2 continues to evolve and spread in an unpredictable manner, including examples of regional dominance of virus variants that do not lead to worldwide prevalence (e.g., XBB1.5). Currently, it remains impossible to predict which virus VOC [varint of concern] will gain dominance in any particular region of the world and how long a VOC will remain dominant. As such, whether or when the epidemiology of SARS-CoV-2 will adopt a pattern that makes a regular cadence of globally coordinated recommendations for updating COVID 19 vaccine composition obvious or needed remains to be seen. Neither is it clear whether or when most areas of the world will have similar levels of pre-existing immunity (be it from vaccination or infection), susceptibility to clinically significant COVID-19, nor access to the same types and quantities of COVID-19 vaccines. With these uncertainties taken together, the FDA and VRBPAC may need to consider a change in COVID-19 strain composition for U.S. vaccines without a prior WHO strain recommendation.
Officials will operate the vaccine the same as they do the flu shot. They will choose the COVID strain in the spring for consumption in September.
The briefing recommends one shot for healthy people, mainly those with “‘sufficient preexisting immunity,’ through prior infection, vaccination, or combination thereof.”
Older people and those with compromised immune systems might need two shots. The FDA described these people as having “insufficient preexisting immunity.”
A few people told The New York Times the proposal surprised them, especially since they don’t have much “research to support the suggested plan”:
“I’m choosing to believe that they are open to advice, and that they haven’t already made up their minds as to exactly what they’re going to do,” Dr. Paul Offit, one of the advisers and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said of F.D.A. officials.
“I’d like to see some data on the effect of dosing interval, at least observational data,” said Dr. Eric Rubin, one of the advisers and editor in chief of the New England Journal of Medicine. “And going forward, I’d like to see data collected to try to tell if we’re doing the right thing.”
Still, Dr. Rubin added, “I’d definitely be in favor of something simpler, as it would make it more likely that people might take it.”
Dr. Offit offered a few important questions: “How old are they? What are their comorbidities? When was the last dose of vaccine they got? Did they take antiviral medicines?”
He dismissed the “present national strategy” because it’s like “‘OK, well, let’s just dose everybody all the time.’ And that’s just not a good reason.”
Infectious disease physician Dr. Céline Gounder thinks the majority of “people are ‘well protected against severe Covid disease with a primary series and without yearly boosters.'”
The advisers hope Thursday’s meeting will answer some of these questions.
Dr. Gounder is not optimistic because the actual “voting questions ‘are framed in such a way as to force a certain outcome.'”
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