The FDA is unlikely to ask its outside vaccine advisers to weigh in on whether the agency should authorize Pfizer Covid-19 boosters for all adults, a source says
The US Food and Drug Administration is unlikely to ask its outside vaccine advisers to weigh in on whether the agency should authorize Pfizer Covid-19 boosters for all adults, a source familiar with the situation told CNN.
Pfizer applied to the FDA for emergency use authorization on November 9 to make all adults eligible for boosters. Processing that request could be faster if the agency does not wait for members of the Vaccines and Related Biological Products Advisory Committee to meet. Allowing boosters for all adults has been controversial, as some FDA vaccine advisers are concerned about the risk of myocarditis -- inflammation of the heart muscle -- a rare side effect that occurs mainly in young men.
"I think we need to show why a booster dose is clearly of benefit to 18-29 year-olds, because if it's not clearly of benefit, we have to consider the fact that myocarditis was a second dose phenomenon and may also be a third dose phenomenon. Do the benefits clearly and definitively outweigh risks for 18-29 year old?" Offit said.
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