FDA Advisory Panel Rejects Biden Plan for Pfizer Booster Shots, But Approves Them for Elderly and High-Risk Individuals
An advisory panel at the Food and Drug Administration rejected on Friday a plan to offer booster shots of the Pfizer-BioNTech coronavirus vaccine to Americans age 16 and older.
The final vote tally of the Vaccines and Related Biological Products Advisory Committee was 16 to 2. The vote is nonbinding. A final FDA decision is expected soon.
“Over several hours of discussion, members of the Food and Drug Administration panel of outside experts voiced frustration that Pfizer had provided little data on safety of extra doses,” reported the Associated Press. “And they complained that data provided by Israeli researchers about their booster campaign might not be suitable for predicting the U.S. experience.”
The Biden administration announced about a month ago a plan to make booster shots available starting Sept. 20. The panel’s decision will likely delay the plan.
“It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” said committee member National Institutes of Health official Michael Kurilla.
CDC advisers are scheduled to meet next week for two days over booster shots.
Nonetheless, emergency booster shots are available for those immunocompromised.
UPDATE: The panel subsequently voted to unanimously recommend booster shots for Americans over 65 and for people who are at high risk.
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