FDA Authorizes Moderna and J&J Booster Shots

The Food and Drug Administration (FDA) today followed the advice of its advisory committee and recommended booster shots of COVID-19 vaccines from Moderna and Johnson&Johnson-Janssen. Mixing or matching booster doses was also permitted by the FDA. People can receive a second dose or booster of the original vaccine. More than 150 million doses of the Moderna vaccine and 15 million of the J&J-Janssen vaccine have been administered in the U.S.

In a briefing discussing the agency’s decision, acting FDA director Dr. Janet Woodcock said the primary reason behind recommending boosters is growing evidence that immunity provided by the original COVID-19 immunizations is starting to wane. “The availability of authorized boosters will be important for continued protection against COVID-19 disease,” she said. “The actions taken today help address waning immunity.”
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The decision means that anyone who has been vaccinated against COVID-19—with one of the three available vaccines in the U.S.—could eventually get a booster shot. Until today’s decision, only people who were initially vaccinated with Pfizer-BioNTech’s shot, or those with weakened immune systems, could get an extra dose. According to the FDA, those who were vaccinated by Moderna or Pfizer BioNTech before today are still eligible for boosters. This includes public transport workers and other essential health-care or front-line workers as well as teachers and homeless shelters and prison inmates. Anyone previously vaccinated with J&J-Janssen’s vaccine is eligible for a booster, however, given the lower initial efficacy of that vaccine compared to the other two.

September 22nd, saw the FDA authorize booster shots for Pfizer BioNTech shot-immunized people. The Centers for Disease Control and Prevention supported the decision with some caveats. Although the CDC suggests Pfizer BioNTech boosters be given to older people and for those who have health problems that could increase their risk of severe COVID-19 (e.g., people 65+), the agency did not recommend the shots for younger individuals. Instead, Dr. Rochelle Walensky, director of the CDC decided that younger adults in high-risk jobs and settings could get additional doses if they wanted.

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. Moderna booster contains half of the amount of the original shot. The Pfizer BioNTech booster gives people another shot. Moderna’s scientists showed that the lower dose produced a strong enough immune response and generated fewer potential side effects; they noted that the half dose would also double the number of people who could get a booster 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. Due to its low effectiveness at protecting against COVID-19, it is highly recommended that anyone who has received the shot be given the booster, regardless of restrictions.

Woodcock and Peter Marks (director of the Center for Biologics Evaluation and Research) acknowledged that it will prove difficult to roll out boosters with different dosing plans and target groups. That’s why the agency authorized the mixing and matching of booster doses, to allow providers the flexibility of boosting people with any COVID-19 vaccine if people can’t recall which one they were immunized with, or if it’s not practical for mobile vaccination teams or pharmacies or hospitals to carry all three vaccines.

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. According to the White House, the Federal Government will cover booster shots in the same way it paid for COVID-19 vaccines. It will also ship doses soon for eligible patients.


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