Moderna COVID-19 Vaccine: Booster Study Hits Only One Of Two Immunogenicity Endpoints

 
• By Sue Sutter

Immune responses to a single booster dose of mRNA-1273 would be considered successfully bridged to the two-dose primary series if each of two immunobridging criteria were met, but the mRNA vaccine missed the prespecified success criteria for seroresponse rate, the FDA said.

Bullseye hit and miss
Moderna's vaccine booster trial hit the target on one immunogenicity endpoint but missed on the other. • Source: Alamy

The failure of Moderna, Inc.’s COVID-19 vaccine booster study to hit one of two immunogenicity endpoints could give a US Food and Drug Administration advisory committee pause in recommending emergency use authorization for the additional dose in at-risk populations.

In briefing documents released ahead of a 14 October meeting of the Vaccines and Related Biological Products Advisory Committee, the...

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