Wednesday, October 27, 2021
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FDA Panel Recommends Authorizing Moderna Booster Vaccine

A key Food and Drug Administration panel voted Thursday to recommend booster doses of Moderna’s COVID-19 vaccine for a large portion of the population.

Members of the Vaccines and Related Biologicals Advisory Committee (VRBPAC) voted unanimously, 19-0.

The agency’s vaccine advisory committee said boosters should be recommended for people 65 and older, people between the ages of 18 and 64 who are at high risk for severe COVID, as well as people who are at risk for severe COVID because of their jobs. .

The recommended population for the Moderna booster is the same population for which the Pfizer booster was authorized last month.

The Biden administration has made boosters a priority for all Americans, although experts are divided on whether the general population will actually benefit. Ultimately, the way to end the COVID-19 pandemic is by injecting vaccines into the unvaccinated, rather than empowering those who are already protected.

Unlike Pfizer, Moderna proposes using a half dose of the vaccine for a booster given at least six months after the main dose, rather than an additional full dose.

That difference may make Moderna’s enhancers less likely to trigger side effects than the first two doses in their series.

The company argued that the potency of its vaccine decreases over time, with neutralizing antibody levels falling six to eight months after a second dose. FDA reviewers found that while a booster did increase antibody levels, it was unclear whether the protection from the initial vaccination had been substantially decreased.

Some panelists questioned whether there was a justification for recommending boosters for people at risk because of their jobs, as there was no data showing an increased risk of exposure equivalent to an increased risk of severe COVID-19.

The FDA representative said the language was intended to be flexible and that it would also result in less confusion due to what was previously licensed for Pfizer.



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