FDA Set to Authorize Moderna, J&J COVID-19 Boosters
The FDA is poised to authorize booster shots of Moderna’s and Johnson & Johnson’s COVID-19 vaccines and may also allow a “mix and match” approach.
The agency is expected to clear the use of additional boosters ahead of a Centers for Disease Control and Prevention (CDC) expert panel meeting Thursday.
Last week, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously recommended a Moderna COVID-19 half-dose booster six months following a two-jab primary series for those aged 65 years and older, adults at high-risk of severe disease and adults frequently exposed to COVID-19 (DID, Oct. 15).
VRBPAC also unanimously endorsed a booster dose of the Johnson & Johnson (J&J) vaccine for adults at least two months following a single-dose primary series.
In the same meeting, National Institutes of Health (NIH) officials suggested that the preliminary data indicate a “mix and match” approach using different COVID-19 vaccines as boosters is safe and effective. But the FDA’s expert panel failed to reach consensus on whether “mix and match” would be appropriate at this time.
Last month, the FDA authorized a Pfizer booster for some groups just hours before the CDC’s Advisory Committee on Immunization Practices took up the issue and signed off on almost all the FDA’s updated authorizations. CDC Director Rochelle Walensky later overrode the advisory panel to also support a Pfizer COVID-19 booster shot for people at high risk of contracting the disease in the workplace, to align with the FDA’s position (DID, Sept. 27).
In other COVID-19 vaccine news, the CDC yesterday announced that the Pfizer vaccine was 93 percent effective in preventing hospitalization of COVID-19 patients aged 12 to 18 years old from June through September, a time when the Delta variant was the dominant strain. The only shot currently authorized in the U.S. for adolescents, the Pfizer vaccine was cleared by the agency in May to treat adolescents 12 and older. ― Jason Scott