WASHINGTON — WASHINGTON (AP) — The Trump administration said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else — raising questions about whether some people who want a vaccine this fall will be able to get one.
Top officials for the Food and Drug Administration laid out new standards for updated COVID shots, saying they’d continue to use a streamlined approach to make them available to adults 65 and older as well as children and younger adults with at least one high-risk health problem.
But the FDA framework, published Tuesday in the New England Journal of Medicine, urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people. It’s a stark break from the previous federal policy recommending an annual COVID shot for all Americans six months and older. In the paper and a subsequent online webcast, the FDA’s top vaccine official said more than 100 million Americans still should qualify for what he termed a booster under the new guidance.
Dr. Vinay Prasad described the new approach as a “reasonable compromise” that will allow vaccinations in high-risk groups to continue while generating new data about whether they still benefit healthier people.
“For many Americans we simply do not know the answer as to whether or not they should be getting the seventh or eighth or ninth or tenth COVID-19 booster,” said Prasad, who joined the FDA earlier this month. He previously spent more than a decade in academia, frequently criticizing the FDA’s handling of drug and vaccine approvals.
It’s unclear what the upcoming changes mean for people who may still want a fall COVID-19 shot but don’t clearly fit into one of the categories.
“Is the pharmacist going to determine if you’re in a high-risk group?” asked Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. “The only thing that can come of this will make vaccines less insurable and less available.”
The nation’s leading pediatrics group said FDA’s approach will limit options for parents and their children.
“If the vaccine were no longer available or covered by insurance, it will take the choice away from families who wish to protect their children from COVID-19, especially among families already facing barriers to care,” said Dr. Sean O’Leary of the American Academy of Pediatrics.
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