FDA authorizes Moderna and J&J COVID-19 boosters

The Food and Drug Administration yesterday authorized administering a single booster dose of the Moderna and Johnson & Johnson COVID-19 vaccines to eligible individuals, and authorized eligible recipients of all three authorized COVID-19 vaccines to receive a different COVID-19 vaccine for their initial and booster doses. 

Specifically, FDA authorized for adults age 65 and older, adults at high-risk for severe COVID-19, and adults with frequent occupational or institutional exposure to the SARS-CoV-2 virus a single booster dose of the Moderna COVID-19 vaccine at least six months after completing a primary dose series. It also authorized adults who received a single dose of the J&J vaccine to receive a booster dose at least two months later; FDA clarified that adults under age 65 who have frequent institutional or occupational exposure to SARS-CoV-2 may receive a Pfizer booster.

“The amendments to the emergency use authorizations to include a single booster dose in eligible populations are based on the available data and information and follows the input from the members of our advisory committee who were supportive of the use of a booster dose of these vaccines in eligible populations,” said Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “We are also taking action today to include the use of mix and match boosters to address this public health need. We will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the healthcare community and public with our determination in the coming weeks.”