FDA scientists neutral on Moderna Covid-19 vaccine booster ahead of key meeting

Stat News | 12 Oct 2021

Food and Drug Administration scientists did not take a clear position as to whether the agency should authorize booster doses of the Moderna Covid-19 vaccine in documents released Tuesday.

Posted ahead of a two-day meeting convened by the FDA on booster shots of both the Moderna and Johnson & Johnson vaccines, the documents laid out the case for authorizing Moderna’s proposed booster — a half dose of the existing vaccine — but also noted that data so far make it unclear that the third dose is needed.

“Some real world effectiveness studies have suggested declining efficacy of Moderna COVID-19 Vaccine over time against symptomatic infection or against the Delta variant, while others have not,” FDA scientists wrote in a briefing document. However, they wrote, current data suggest that Covid vaccines that are available in the U.S. still protect against severe Covid-19 disease and death.

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