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Pandemic Logistics: US FDA Has Not Verified Some Moderna COVID-19 Vaccine Data And Analyses

 
• By Derrick Gingery

Older patients appear to have lower efficacy in a Moderna application amendment that the agency hasn’t fully digested, but along with the original submission, data still supports evaluation for an emergency use authorization, the FDA said.

The FDA reviewed a planned interim analysis of Moderna vaccine data, but said assessors did not verify all data from a second submission the sponsor sent later. • Source: Shutterstock

A trade-off for the unprecedented speed with which the US Food and Drug Administration is assessing the coronavirus vaccines is evident in the briefing document for the upcoming advisory committee meeting on Moderna, Inc.’s candidate.

Moderna transmitted additional efficacy and safety data to the agency on 4 and 7 December, respectively, a few days after...

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