The U.S. Food and Drug Administration (FDA) is preparing to issue new guidance for vaccine manufacturers in the coming days as part of a new “radical framework.” The guidance will likely focus on the COVID-19 shots, The Washington Post reported Thursday, citing comments by FDA Commissioner Marty Makary earlier this week.
The Post published its story earlier Thursday, before The Wall Street Journal reported that unnamed sources at the U.S. Department of Health and Human Services (HHS) said HHS is expected to announce within days that it will no longer recommend COVID-19 shots for children, teens and pregnant women.
Speaking at the Food & Drug Law Institute’s conference in Washington, Makary gave few specifics about the upcoming new framework but said it will help ensure the pharmaceutical industry understands “exactly what we’re thinking,” Endpoints News reported.
According to the Post, this may entail “guidance to companies so that they know the agency’s approach to vaccine approvals.”
“We want to be very transparent, and we want to create a framework for vaccine makers that they can use so they have a predictable FDA where they don’t have to worry, ‘How is this going to be received?’” Makary said at the conference.
The announcement comes just a month before government regulators are set to review COVID-19 vaccines for the next cold and flu season.
James Lyon-Weiler, Ph.D., president and CEO of the Institute for Pure and Applied Knowledge and editor-in-chief of the journal Science, Public Health Policy & the Law, said the new framework is “long overdue” and “may represent an inflection point — if it goes beyond mere optics and addresses the core systemic failures that have plagued vaccine policy for decades.”
Hellbound and Down 