Novavax Concludes Filing For WHO's Emergency Use Listing For COVID-19 Vaccine

  • Novavax Inc NVAX has completed its rolling submission to the World Health Organization (WHO) for emergency use listing (EUL) of NVX-CoV2373, its COVID-19 vaccine candidate.
  • Today's filing by Novavax is in addition to a previous filing to WHO by Novavax and Serum Institute of India Pvt Ltd (SII).
  • The submission includes data from PREVENT-19 Phase 3 trial of 30,000 participants in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. 
  • Related Link: Why Are Novavax Shares Trading Higher Today?
  • Novavax executed an advance purchase agreement with the European Commission to supply a minimum of 20 million doses and up to 100 million initial doses, with an option to purchase an additional 100 million doses through 2023.
  • The Company achieved a capacity of 100 million doses per month for its COVID-19 vaccine as of the end of Q3.
  • It is on track to achieve a capacity of 150 million doses per month by the end of Q4 and expect to have the capacity of over 2 billion annual doses in 2022
  • Novavax ended Q3 with $1.9 billion in cash, cash equivalents, and restricted cash.
  • Price Action: NVAX shares dropped 8.97% at $163.32 during the premarket session on the last check Friday.
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Posted In: BiotechEarningsNewsGuidanceHealth CareFDAMoversTrading IdeasGeneralBriefsCOVID-19 CoronavirusCOVID-19 Vaccine
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