Moderna’s COVID Vaccine Had Longer FDA Review Than Pfizer’s; Similar Post-Market Requirements

 
• By Brenda Sandburg
  
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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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US FDA grants full approval to Moderna's COVID-19 vaccine • Source: Alamy

Moderna, Inc. received US Food and Drug Administration’s full approval of its biologics license application for its COVID-19 vaccine Spikevax five months after Pfizer Inc./BioNTech SE’s vaccine cleared the agency. Despite a longer review time by the agency, Moderna is on a similar trajectory going forward. Like Pfizer, it is required to conduct post-marketing studies to further assess the risks of myocarditis and pericarditis.

In a 31 January release, FDA said the approval is based on the agency’s evaluation and analysis of follow-up safety...

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