FDA panel recommends authorizing Moderna booster shot

A key Food and Drug Administration panel on Thursday voted in favor of recommending booster doses of Moderna’s COVID-19 vaccine for a large swath of the population.

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

The agency’s vaccine advisory committee said boosters should be recommended for people over 65, people between the ages of 18 and 64 who are at high risk of severe COVID-19, as well as people who are at risk of serious COVID-19 because of their jobs.

The population recommended for Moderna’s booster is the same population that Pfizer’s booster was authorized for last month.

The Biden administration has made boosters for all Americans a priority, even though experts are divided on whether the general population will really benefit. Ultimately, the way to end the COVID-19 pandemic is by getting shots to the unvaccinated, rather than boosting those who are already protected.

Unlike Pfizer, Moderna is proposing to use a half-dose of the vaccine for a booster given at least six months after the prime dose, rather than an additional full dose.

That difference may make Moderna boosters less likely to trigger side effects than the first two doses in its series.

The company argued that the potency of its vaccine wanes over time, with neutralizing antibody levels dropping six to eight months after a second dose. FDA reviewers found that while a booster did increase antibody levels, it wasn’t clear whether the protection of the initial vaccination had dropped substantially.

Some panel members questioned whether there was a justification for recommending boosters for people at risk because of their jobs, since there wasn’t data to show higher exposure risk equated to a higher risk of severe COVID-19.

FDA’s representative said the language was meant to be flexible, and would also result in less confusion because of what was previously authorized for Pfizer. 

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