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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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Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
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Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
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Global Pharma Guidance Tracker - June 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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