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COVID-19 Vaccines: Spikevax Review Reflected Changing Realities Of Omicron In US

 
• By Sue Sutter

Five of the six modeling scenarios in the FDA’s quantitative benefit-risk assessment on myocarditis with Moderna’s vaccine assumed Omicron as the dominant circulating strain, with assumed average vaccine effectiveness of only 30% against COVID-19 cases and 72% against hospitalizations.

Drug Review Profile: Spikevax
Spikevax's BLA approval came in the midst of the Omicron wave in the US. • Source: Alamy

The US Food and Drug Administration’s review and approval of Moderna, Inc.’s COVID-19 vaccine Spikevax reflected the uncertainties of the evidence amid an evolving pandemic, notably the emergence of the Omicron variant.

The biologics license application was submitted to the agency on 24 August, at which time the Delta variant was predominant...

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