FDA Authorizes ‘Mix and Match’ Approach, Moderna and J&J COVID-19 Boosters

The FDA yesterday authorized boosters of both the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines for emergency use. The agency also authorized a “mix and match” approach for emergency use that allows people to receive a booster with a different drugmaker’s product to the one they received in their initial vaccination.

The FDA said the known and possible benefits of a mix and match approach outweigh any known or potential risks in the eligible populations.

The mix and match approach was supported by data from the National Institutes of Health (NIH), which suggested that using different COVID-19 vaccines as boosters is safe and effective.

The FDA stipulated a Moderna booster may be given six months following completion of a two-dose primary series for those age 65 years and older, adults at high-risk of contracting severe COVID-19 and adults at high-risk of contracting the disease based on their workplace. But the FDA allowed a booster of the J&J shot in all adults two months following a single-dose regimen.

“The available data suggest waning immunity in some populations who are fully vaccinated,” said Acting FDA Commissioner Janet Woodcock, noting that “the availability of these authorized boosters is important for continued protection against COVID-19 disease.”

With Pfizer’s booster previously authorized for emergency use, the FDA’s announcement means individuals may mix and match with any of the authorized or approved COVID-19 shots in the U.S. And a Centers for Disease Control and Prevention (CDC) expert panel will convene today to determine booster recommendations for use, paving the way for Americans to start mixing and matching jabs in the coming days (DID, Sept. 23).

Peter Marks, director of the FDA’s Centers for Biologics Evaluation and Research, noted that the agency’s updated Moderna and J&J booster authorizations were in line with its own vaccine advisory committee’s findings last week. However, that committee did not vote on whether to support a mix and match approach to boosting and the panelists were split on that issue (DID, Oct. 18). ― Jason Scott