FDA greenlights mix-and-match booster doses

 The Food and Drug Administration (FDA) amended its emergency use authorization for all COVID-19 vaccines on Wednesday to allow for mix-and-match boosters for patients who initially received a different vaccine.

The federal agency also authorized booster shots for Americans who received the Moderna and Johnson & Johnson inoculations. The FDA had previously authorized boosters for the Pfizer vaccine. 

The decision on Wednesday would allow recipients of all three vaccines to get booster shots of doses from other companies if and when the Centers for Disease Control and Prevention (CDC) issues an official recommendation.

The FDA’s move supporting mixed vaccine doses follows a preprint study from the National Institutes of Health that found that mixing and matching any of the three vaccines authorized in the U.S. was safe and effective. 

State health officials have said such a move would provide doctors with flexibility to administer available shots to patients.

“The FDA has determined that the known and potential benefits of the use of a single heterologous booster dose outweigh the known and potential risks of their use in eligible populations,” a statement by the agency said. 

Pending CDC approval, Moderna’s third shot is expected to be available for those older than 65, adults with underlying conditions, and those with jobs or living situations that put them at risk of contracting the virus at least six months after the initial series. Johnson & Johnson’s extra dose would be available at least two months after vaccination.

A CDC advisory committee plans to consider the data on Moderna and Johnson & Johnson boosters this week, before that federal agency issues its official recommendation. 

The FDA’s advisory panel recommended last week for certain populations to get booster shots of the Moderna and Johnson & Johnson vaccines in order to extend their immunity to the virus.

The FDA panel endorsed another dose of Johnson & Johnson for all adults two months after the initial shot. 

Almost 70 million Americans are fully vaccinated with the Moderna series, while more than 15 million received the Johnson & Johnson shot. The majority of fully vaccinated people, at almost 105 million, received the Pfizer-BioNTech doses, according to CDC data. 

CDC Director Rochelle Walensky signed off on booster doses of the Pfizer-BioNTech vaccine late last month for the same at-risk populations approved for Moderna boosters. The move made a third shot of Pfizer available to millions of eligible booster recipients six months after the second dose. 

https://thehill.com/policy/healthcare/577665-fda-greenlights-mix-and-match-booster-doses