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 uses because it concluded the data submitted by both companies didn’t raise questions that would benefit from additional discussion.

The agency reviewed safety concerns around the risks of a rare side effect of inflammation of the heart muscle or its outer lining. It determined that the benefit of vaccinations outweighed the possible risk based on additional real-world data collected post authorization for both vaccines, and current Covid-19 cases.

Previously, all adults over 65 and adults with high exposure to Covid-19 and those at a high risk of developing severe Covid-19 were eligible to receive boosters as long as they were six months or more away from their final dose. All adults who had received the single-dose Johnson & Johnson vaccine two months or more prior could also receive a booster. Already, over 32 million U.S. adults have received booster shots.

Despite the fact that federal health agencies hadn’t formally endorsed boosters for the remaining adult population, many state and local health officials had already recommended them for their communities. They fear that with upcoming cold weather, holiday travel and potential waning immunity from initial doses, hospitals may be overwhelmed with an influx of cases.

What’s next: The CDC’s external advisory committee on vaccines is slated to meet Friday afternoon to discuss whether it will recommend both booster shots for all adults.