FDA Panel Recommends Moderna Booster Shot EUA For Certain People

A Food and Drug Administration advisory panel has unanimously recommended granting emergency use authorization for a third Moderna shot, though only some people would be eligible for the booster shot. The recommendation follows Moderna's second-quarter financial details shared in August, which included information on the COVID-19 vaccine's efficacy six months after the second dose, as well as the booster for its booster shots to help protect against SARS-CoV-2 variants.

The recommendation comes from advisers with the FDA, paving the way for an Emergency Use Authorization and a second COVID-19 booster shot option in the US. The regular Moderna COVID-19 vaccination protocol involves administering 100-microgram doses over two shots. The booster shot, should it get the authorization, will cover a single 50-microgram booster dose to help protect those whose immunity may be faltering.

Only certain people would be eligible for the Moderna booster shot similar to that of the currently available Pfizer booster dose. Only adults ages 18 to 64 would be eligible, assuming they face a high risk of developing a severe COVID-19 infection. As well, the same age group would be eligible if their jobs or other settings put them at risk of developing a severe infection or complications from an infection.

This authorization would expand the number of people in the US who are eligible for a third dose to beyond only those who have compromised immune systems. With that said, the FDA panel also noted that the evidence that a third booster shot is necessary or useful isn't entirely solid. However, given the severe nature of the disease and the "imperfect" data currently available, the panel unanimously recommended the booster shot.

With the advisers' recommendation in place, it is likely that we'll see an emergency use authorization granted by the FDA in the near future. In a separate announcement, the FDA said it will soon hold another meeting with advisers over a potential EUA for Ridgeback and Merck's oral COVID-19 treatment.