FDA Expected to Authorize Heterologous COVID-19 Vaccine Boosters


The decision comes after supporting data from a "mix and match" trial last week, and may align with emergency authorizations for the Moderna and Janssen booster doses.

FDA Expected to Authorize Heterologous COVID-19 Vaccine Boosters

The US Food and Drug Administration (FDA) is anticipated to advise that Americans may receive a different COVID-19 vaccine as a booster dose than the one they were initially administered.

The report from outlets including The New York Times comes just days after the FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) deliberated on the provided data of the Moderna and Janssen Pharmaceuticals booster doses—a pair of day-long discussions which both concluded with supporting panel votes but notes of criticism on the strategic distribution of COVID-19 vaccine booster doses.

But more importantly, the report comes after data from a “mix and match” clinical trial showed that patients initially administered a single-dose Janssen COVID-19 adenovirus-based vaccine reported significantly greater antibody titers from a booster dose of Moderna’s mRNA-1273 than a homologous booster dose.

Now, the FDA is anticipated to significantly expand the subpopulation eligible for booster doses—which currently includes persons aged ≥65 years old, those who may be immunocompromised, and those who work in areas of high-risk for SARS-CoV-2 infection—as early as this week. According to the Times, they are also anticipated to grant emergency use authorization (EUA) for the Moderna and Janssen booster doses by Wednesday evening.

Currently, Pfizer-BioNTech’s mRNA vaccine BNT162b2 is the lone COVID-19 vaccine granted EUA as a booster dose by the FDA.

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