ARTICLE | Product Development

FDA advisory panel’s Offit opposes COVID vaccine EUA based on interim data

If other committee members agree, timelines for COVID vaccine authorizations could be pushed out

October 27, 2020 9:34 PM UTC

Paul Offit and other members of FDA’s vaccines advisory committee are unlikely to recommend emergency use authorization of COVID-19 vaccines based on interim analyses of Phase III trials, according to Offit. If his view prevails, authorizations could come months later than vaccine sponsors and Operation Warp Speed have suggested. 

Offit did not say how many other members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) support his position. ...