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.
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US FDA estimated the three-dose primary series of Pfizer/BioNTech’s vaccine would prevent 364 hospitalizations, while Moderna estimated that a two-dose primary series of mRNA-1273 would prevent 248 hospitalizations and 60 ICU stays.
US FDA also says there appears to be 'causal association' of myocarditis with the vaccine, which Novavax denies.
A timeline of the development and approval of Moderna's mRNA vaccine, and a listing of FDA reviewers on the biologics license application.