When Should COVID Vaccines Get Full Approval? US FDA Squeezed By ‘Too Fast’ And ‘Too Slow’ Camps
Some experts argue full FDA approval will help boost vaccination rates that are waning, but others want the agency to mandate studies in special populations and gather other data before making a final decision.
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US FDA veterans offered varying opinions as to the benefits and risks of the CBER director taking on a more hands-on role in reviewing Pfizer’s COVID-19 vaccine. The move was called unusual, but not inappropriate; some said it should be monitored closely to ensure review staff’s judgements are not pushed aside.
Agency is pledging to act well ahead of the six-month review deadline in reviewing full applications for COVID 19 vaccines that are already authorized for emergency use. Going too fast may be counterproductive, in more ways than one.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker