Modified COVID Vaccines: FDA Shifts To Superiority Standard For Immune Response To Variants
Updated guidance says variant-directed vaccines should demonstrate statistically superiority to the prototype vaccine in a comparison of geometric mean titers against the particular variant of concern; seroresponse rates can be assessed on the basis of either noninferiority or superiority.
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US FDA’s advisory committee members question when it will be clear current vaccines are not providing sufficient protection and express concern about the time it will take to change their composition given the need for clinical data to gain authorization.
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.
Influenza vaccine strain change process could provide framework to update composition of COVID-19 vaccines, agency says. Advisory committee to discuss when changes could be supported by manufacturing information alone, and timing and populations for use of additional boosters.