Europe Approves Novavax's COVID-19 Vaccine Booster For Adults

Europe Approves Novavax's COVID-19 Vaccine Booster For Adults
  • The European Commission has approved the expanded conditional approval of Novavax Inc's NVAX Nuvaxovid COVID-19 vaccine as a homologous and heterologous booster for adults aged 18 and older. 
  • The approval follows the recommendation made by the European Medicines Agency's Committee for Medicinal Products for Human Use earlier this month.
  • The expanded approval was based on data from Novavax's Phase 2 trial conducted in Australia, a separate Phase 2 trial conducted in South Africa, and the UK-sponsored COV-BOOST trial. 
  • The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 trials. In the COV-BOOST trial, Nuvaxovid induced a robust antibody response when used as a heterologous third booster dose.
  • In the Novavax-sponsored trials, local and systemic reactions were generally short-lived following the booster.
  • Nuvaxovid has also been authorized in Japan, Australia, and New Zealand as a booster in adults aged 18 and older and is actively under review in other markets.
  • Price Action: NVAX shares are up 1.73% at $32.27 on the last check Monday.
  • Photo by Jernej Furman via Flickr

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