New FDA Covid vaccine policy raises access, transparency questions

Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen on Signal at hbranswell.01.

WASHINGTON — Food and Drug Administration Commissioner Marty Makary promised stakeholders last week that the agency’s new Covid-19 vaccine framework would answer all of their questions. 

But the framework has perhaps created as much confusion as clarity. Broadly, the FDA said it will limit approval of Covid-19 vaccines to people 65 and older and to those at risk for severe Covid outcomes, and will require vaccine makers to conduct clinical trials investigating whether the shots benefit healthy adults and children. 

At a public webinar on Tuesday, top vaccine regulator Vinay Prasad described the approach as a “compromise” allowing Covid-19 vaccine access for millions of Americans while still generating evidence. He answered some questions, asked by Makary, about his rationale.