COVID Vaccines: US FDA Should Play More Activist Role In Development Of Modified Formulations
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.
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FDA advisors will vote 28 June on whether an Omicron component should be included in new COVID-19 booster vaccines. Following WHO recommendations, the FDA may no longer also be looking to update the primary vaccine series at this time.
US FDA Leaves Pfizer’s Efficacy Data Out Of Under 5 EUA Due To ‘Data Maturity,’ Lack of ‘Confidence’
Moderna’s ‘more mature’ vaccine efficacy data in children under 6 get agency highlight due to what Peter Marks called a ‘confidence’ difference in the numbers, the but CBER chief also said differences between Moderna’s and Pfizer’s vaccines are ‘subtle’ in this age group.
The FDA commissioner said several aspects of the advisory committee system should be considered for updates or adjustment. A revamp effort has predated his return trip to the agency.