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.
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