Modified COVID Vaccines: FDA Shifts To Superiority Standard For Immune Response To Variants

 
• By Sue Sutter

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.

Pulling the trigger
The immunogenicity comparisons FDA wants to see are "really important data to decide if and when to pull the trigger on a variant vaccine," Georgetown's Jesse Goodman says. • Source: Alamy

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