The Food and Drug Administration said vaccines cleared in the U.S. currently provide protection against severe disease and death from Covid-19, potentially complicating the Biden administration’s deliberations over the need for booster shots
An outside panel of scientific advisers will review the FDA report on Friday, along with a companion analysis from Pfizer and other information, as part of a discussion over who needs booster shots and when.and bolster signs of waning immunity among the vaccinated. Evidence supporting the need for an extra dose, at least in the general public, hasn’t been conclusive.
“Overall, data indicate that currently U.S.-licensed or authorized Covid-19 vaccines still afford protection against severe Covid-19 disease and death in the United States,” the scientists wrote. No new serious safety concerns were found in people who received the booster shots, the FDA said, and reported side effects such as fatigue or fevers were similar to what was previously reported in trial subjects. The agency said that Pfizer’s analysis of a third dose met its criteria for a safe and effective vaccine.
The FDA released its report on Wednesday, two days ahead of a meeting of the Vaccines and Related Biological Products Advisory Committee, an advisory panel that will decide whether to recommend Americans receive booster shots.
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