FDA clears Pfizer, Moderna Covid booster shots for all adults

Background: The agency did not convene a meeting of its independent advisory committee prior to expanding booster use, as it concluded that the data submitted by both companies did not raise issues that would benefit from additional discussion.

The agency examined safety concerns about the risks of a rare side effect of inflammation of the heart muscle or its outer skin. It found that the benefits of vaccinations outweigh the possible risks, based on additional real-world data collected after approval for both vaccines and current Covid-19 cases.

Previously, all adults over 65 and adults with high Covid-19 exposure and those at high risk of developing severe Covid-19 were entitled to a booster vaccination as long as they were six months or more away from their final dose. All adults who had received the Johnson & Johnson single-dose vaccine two months or more previously could also receive a booster vaccine. Over 32 million adults in the United States have received booster injections.

Despite the fact that federal health officials had not officially endorsed booster vaccinations for the remaining adult population, many state and local health officials had already recommended it for their communities. They fear that with the cold weather ahead, vacation travel, and a possible diminishing immunity from starting doses, hospitals could be overwhelmed with an influx of cases.

What’s next: The CDC’s External Vaccine Advisory Committee is due to meet Friday afternoon to discuss whether it will recommend both booster vaccinations for all adults.

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