FDA expands COVID-19 booster emergency use authorization

The U.S. Food and Drug Administration (FDA) amended the emergency use authorizations for booster doses of novel coronavirus (COVID-19) vaccinations in eligible populations to include the Moderna and Johnson & Johnson vaccines, as well as allowing for “mix and match” booster dosing, according to an announcement made yesterday evening by the agency.

According to the announcement, the use of a single booster dose of the Moderna COVID-19 vaccine may be administered at least six months after completion of the primary series to individuals 65 years and older; 18 to 64 years old who are at high risk of severe COVID-19; and 18 to 64 years old with frequent institutional or occupational exposure to SARS-CoV-2, the virus that causes COVID-19.

Additionally, the use of a single booster dose of Johnson & Johnson COVID-19 vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years and older.

The FDA also expanded the guidance to allow for use of each of the available COVID-19 vaccines as a heterologous or “mix and match” booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine. A panel of experts from the U.S. Centers for Disease Control and Prevention (CDC) will meet to discuss whether this is an effective strategy, as well as to evaluate which populations need these booster doses. 

The Pfizer-BioNTech vaccine was previously granted emergency use authorization for boosters in some populations, and those guidelines remain intact, agency representatives said. A single booster dose of the Pfizer-BioNTech COVID-19 vaccine may be 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.