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Moderna’s COVID-19 Vaccine To Get Real-Time Data Assessment By US FDA

 
• By Derrick Gingery and Sarah Karlin-Smith

Commissioner Hahn says FDA will see data as it is compiled to speed review; enrollment criteria raises some eyebrows since Moderna plans to exclude patients with known history of SARS-CoV-2 infection from Phase III. The agency’s guidance on COVID-19 vaccine trials says that such exclusions are not necessary since screening is unlikely when a product would be delivered post-market.

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Moderna commences a late-stage study of its COVID-19 vaccine 27 July • Source: Shutterstock

Assessors at the US Food and Drug Administration will see the Phase III and other data on Moderna, Inc.’s coronavirus vaccine candidate before application submission in order to ensure an approval decision can be made as soon as possible.

FDA Commissioner Stephen Hahn said on 27 July that the agency would employ its real-time assessment mechanism for the candidate, which began its Phase III trial that day

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