FDA Takes Action to Expand the Use of a Booster Dose for Moderna and Janssen COVID-19 Vaccines

The U.S. Food and Drug Administration (FDA) amends the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose in eligible populations.

The use of a single booster dose of the Moderna (NASDAQ: MRNA) vaccine, which may be administered at least 6 months after completion of the primary series to 65 years of age and older individuals, 18 through 64 years of age individuals at high risk of severe COVID-19, and 18 through 64 years of age individuals with frequent institutional or occupational exposure to SARS-CoV-2.

Use of a single booster dose of the Janssen (Johnson and Johnson) (NYSE: JNJ) vaccine may be administered at least 2 months after completion of the single-dose primary regimen to 18 years of age and older individuals.

According to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, FDA also takes action to include the use of mix and match boosters and will work to collect additional data as fast as possible to further assess the benefits and risks of the use of booster doses in additional populations. Marks said FDA plans to update the healthcare community and public with its determination in the coming weeks.

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