FDA advisory group votes against COVID-19 vaccine booster dose
A Food and Drug Administration advisory panel overwhelmingly voted in favor of Pfizer-BioNTech's COVID-19 booster shots on Friday for people ages 65 and up as well as those at high risk of severe illness, after initially rejecting boosters for everyone ages 16 and up.
“We’re being asked to approve this as a three-dose vaccine for people 16 years of age and older, without any clear evidence if the third dose for a younger person when compared to an elderly person is of value,” said committee member Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.Such feedback led to further debate among the committee members about specific age groups or populations that may be most appropriate for a third dose of vaccine.
Though three COVID vaccines are in use, Friday’s vote focused on the Pfizer vaccine only, and would only apply to those who originally received the Pfizer shots. It does not apply to people who have received the Moderna or Johnson & Johnson vaccines. The booster question will now go to a group of advisers to the CDC, which will take up the issue in a two-day meeting next week.
But data from the United States, presented by the CDC, found the vaccines continued to provide high protection against severe disease, hospitalization and death. The FDA advisory committee also raised questions about the safety of an additional dose, particularly in regard to the risk ofIsraeli researchers reported Friday that among 2.8 million people who had been given a third dose, only one case of myocarditis had been reported. However, it’s only been two weeks since younger adults have been given a booster in Israel, and may not reflect the full scope of cases.
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