FDA Authorizes Moderna and J&J Booster Shots
, with subtle caveats. While the CDC recommends Pfizer-BioNTech boosters for people over age 65 and those with health conditions that might put them at higher risk of developing severe COVID-19, the agency stopped short of recommending them for younger people. CDC director Dr. Rochelle Walensky instead decided to allow younger people in higher risk jobs or settings to get an additional dose if they so choose.
The FDA’s recommendation on the Moderna and Johnson&Johnson-Janssen boosters follows the guidance the agency made for the Pfizer-BioNTech booster, with a few exceptions. The Pfizer-BioNTech booster is another dose of the same shot that people already received twice, while the Moderna booster is half the dose of the original shot.
J&J-Janssen’s vaccine is the only one that requires a single dose. Unlike both the Pfizer-BioNTech and Moderna boosters, which are recommended at least six months after the initial vaccination, J&J-Janssen’s booster is recommended starting two months after the first dose. It is also recommended for anyone who received the shot, without any restrictions, because of its lower efficacy initially in protecting against COVID-19 compared to the Pfizer-BioNTech and Moderna vaccines.
Woodcock and Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, acknowledged that rolling out boosters, with their different dosing schemes and target populations, will be complicated.
It’s now up to the CDC’s Advisory Committee on Immunization Practices, which meets on Oct. 21, to iron out the details of how the boosters will be administered. Once the committee reviews and discusses the data and the FDA’s decision, Walensky will issue a final recommendation. The White House has said that the federal government, which will pay for booster shots as it did for the original COVID-19 vaccinations, is ready to start shipping doses so eligible people will have access soon.
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