Moderna’s COVID Vaccine Had Longer FDA Review Than Pfizer’s; Similar Post-Market Requirements
Moderna fell behind Pfizer after receiving EUA for Spikevax, as it took three months longer to file its BLA and had an extra two months of FDA review for full approval. Novavax files request for FDA emergency use authorization of its vaccine.
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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.
Phase II/III data for mRNA-1273.211 showed superiority against variants of concern to the original Spikevax, but Moderna’s top competitor has questioned the need for multivalent approaches.
While data suggests higher risk of myocarditis in young males receiving Moderna’s vaccine, US CDC advisory committee did not consider preferential recommendation. ACIP voted to recommend Spikevax for those 18 years and older following full FDA approval.