Novavax's Covid-19 Vaccine Cleared For Use In New Zealanders Aged 12-17

  • New Zealand's Medsafe has granted expanded provisional approval for Novavax Inc's NVAX Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in adolescents aged 12 through 17.
  • The provisional approval was based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through 17. 
  • In the pediatric expansion, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% overall clinical efficacy when the Delta variant was predominant.
  • Related Content: Novavax Seeks FDA Emergency Use Nod For Its COVID-19 Vaccine Booster.
  • Preliminary safety data from the pediatric expansion showed the vaccine to be generally well-tolerated.
  • There was no increase in reactogenicity in younger (12 to <15 years old) adolescents compared to older (15 to <18 years old) adolescents. No new safety signal was observed through the placebo-controlled portion of the pediatric expansion.
  • Yesterday, New Zealand granted expanded use approval for the shot as a heterologous and homologous booster dose in adults.
  • Price Action: NVAX shares are down 4.11% at $37.75 on the last check Thursday.
  • Image by torstensimon from Pixabay
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