1. Pink Sheet
  2. >>Regulatory Trackers
  3. >>US FDA Performance Tracker

COVID Vaccines: US FDA Should Play More Activist Role In Development Of Modified Formulations

 
• By Sue Sutter

Advisory committee tells FDA that the agency, not vaccine manufacturers, should dictate the conversation around variants and reformulations; panelists also want better government research on immune correlates of protection ahead of any decision on a composition change.

Dictation
FDA's external experts want the agency, not manufacturers, to dictate the conversation on variants and new formulations for modified vaccines. • Source: Alamy

The US Food and Drug Administration should take a more activist role in the development and evaluation of modified COVID-19 vaccine formulations targeted at new variants, the agency’s external experts said 6 April.

The agency should tell manufacturers which variants and formulation types they should focus their research efforts on, rather than the other way around, members of the

Committee members also said new systems should be put in place across the government to better coordinate such research ahead of any decision on a composition change for COVID-19 vaccines

More from US FDA Performance Tracker

More from Regulatory Trackers