- The Medicines and Healthcare products Regulatory Agency in the U.K. has granted expanded conditional approval for Novavax Inc's (NASDAQ: NVAX) COVID-19 vaccine, Nuvaxovid (NVX-CoV2373), in adolescents aged 12 through 17.
- The approval follows the FDA nod earlier this week.
- "As we start to prepare for a potential fall surge, we are pleased to offer the first protein-based COVID-19 vaccine to adolescents aged 12 through 17 in the U.K.," said Stanley C. Erck, President, and CEO, of Novavax.
- The expanded approval was based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,247 adolescents.
- Related: Novavax's Covid-19 Vaccine Cleared For Use In New Zealanders Aged 12-17.
- Nuvaxovid achieved its primary endpoint in pediatric expansion and demonstrated 80% overall clinical efficacy when the Delta variant was predominant.
- Also Read: 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.
- The U.K. approved the vaccine for adults as a two-dose regime in February.
- Price Action: NVAX shares are down 4.48% at $35.58 on the last check Friday.
- Photo by hakan german from Pixabay
Read at Benzinga