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October 22, 2021

Health Law Weekly

FDA Authorizes Moderna, J&J Boosters; OKs “Mix and Match” Doses

  • October 22, 2021

The Food and Drug Administration (FDA) authorized October 18 booster shots of the Moderna Inc. and Johnson & Johnson (J&J) COVID-19 vaccines.

The FDA is amending Moderna’s emergency use authorization (EUA) to allow a booster shot six months after the two-dose regimen for those 65 and older and for high-risk populations, including those with frequent institutional or occupational exposure to COVID-19.

Under the revisions to the J&J EUA, a booster shot of the vaccine may now be administered at least two months after the first dose in those 18 and older.

In addition, the FDA authorized a “mix and match” booster dose in eligible individuals after completing their primary vaccinations with a different COVID-19 vaccine.

The move follows a decision in September to authorize a booster dose of the Pfizer-BioNTech COVID-19 vaccines in those 65 and older and in high-risk populations.

"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,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

On October 21, a Centers for Disease Control and Prevention advisory panel voted unanimously to recommend the Moderna and J&J booster shots as well. CDC Director Rochelle Walensky, M.D., M.P.H signed off on the panel's recommendations the same day.  

  • Coronavirus Pandemic