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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.

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.