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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

New variant-directed, COVID-19 vaccines should demonstrate superior, rather than merely noninferior, antibody response against the targeted variant relative to the original prototype vaccine, the US Food and Drug Administration said in a revised guidance released on 31 March.

With these new, more stringent recommendations for demonstrating immunogenicity of modified vaccines, both for the primary series and booster doses, the agency is setting a higher bar that must be met before making the switch from the

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