FDA OKs Boosters for COVID-19 Vaccines

The US Food and Drug Administration is amending emergency use authorizations for COVID-19 vaccines by Moderna and Johnson & Johnson to allow for booster doses in certain eligible populations. The agency also authorized mixed booster regimes of the Moderna, J&J, and Pfizer/BioNTech COVID-19 vaccines. Pfizer/BioNTech had previously received authorization for a booster of their COVID-19 vaccine in certain populations.

The FDA authorized use of a single booster dose of Moderna’s COVID-19 vaccine, administered at least six months after completion of the primary series, to individuals: (1) 65 years of age and older; (2) 18 through 64 years of age at high risk of severe COVID-19; or (3) 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2, the virus that causes COVID-19.

The FDA authorized use of a single booster dose of J&J’s COVID-19 vaccine, administered at least two months after completion of the single-dose primary regimen, to individuals 18 years of age and older.

The agency also authorized use of each of the available COVID-19 vaccines (Moderna’s, J&J’s, and Pfizer’s/BioNTech’s) as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.

The agency had previously authorized a booster dose of Pfizer’s/BioNTech’s COVID-19 vaccine, administered at least six months after completion of the primary series, to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.

Source: The FDA