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4mo ago

FDA Grants Limited Approval to Novavax’s COVID-19 Vaccine

The approval restricts use to seniors and high-risk individuals, with mandated safety studies and significant financial implications for Novavax.

People pose with syringe with needle in front of displayed Novavax logo in this illustration taken, December 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo
FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed, Oct. 14, 2015. (AP Photo/Andrew Harnik, File)
Four vials with the "Nuvaxovid" COVID-19 vaccine from Novavax are pictured in Saabruecken, Germany, February 26, 2022. REUTERS/Frank Simon/File Photo

Overview

  • The FDA approved Novavax’s protein-based COVID-19 vaccine for adults 65 and older and individuals aged 12–64 with underlying health conditions.
  • The approval follows a six-week delay as the FDA sought additional data and imposed heightened safety requirements.
  • Novavax is required to conduct postmarketing studies on myocarditis and pericarditis risks as part of the approval conditions.
  • The decision triggered a $175 million milestone payment to Novavax from Sanofi and caused Novavax shares to surge by 17%.
  • This vaccine provides a non-mRNA alternative, but its restricted use contrasts with broader approvals for Pfizer and Moderna vaccines.