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

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

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