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August 31, 2020

Health Law Daily

FDA Commissioner Promises Transparent Review Of Potential Coronavirus Vaccine

  • August 31, 2020

Bloomberg (8/30, Armstrong) reports FDA Commissioner Stephen Hahn “promised that the review of a potential Covid-19 vaccine in the U.S. will be transparent to the public, with any clearance by the agency driven by data alone.” During an interview on Sunday, Hahn “responded to questions about the different ways the FDA could clear a vaccine for use: either under an emergency authorization, likely based on more limited data and for use in a narrow group, or a broader approval that could lead to wider use.” Hahn said, “We’ve said all along we’re not going to pre-judge what mechanism we’re going to use to authorize or approve a vaccine. ... We’re going to let the data dictate that. The data will dictate what kind of decision is made on the vaccine.”