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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A timeline of the development and approval of Moderna's mRNA vaccine, and a listing of FDA reviewers on the biologics license application.
Application could be first major test of FDA’s comfort in authorizing a product with vaccine efficacy estimated to be at or below 50%. ‘Final components’ of the request to be submitted in the coming week. In interview, Moderna CMO Burton says results are ‘really strong.’
Lilly appeared to benefit from agency’s increased familiarity in treating COVID-19 with these types of biologics. Changing nature of the pandemic and the loss of utility of older antibodies due to the Omicron variant may have also played a role in the data required for latest EUA.