Novavax seeks expanded authorization for COVID vaccine in Europe for adolescents aged 12 to 17

Novavax Inc. said Thursday it has submitted a request for an expanded authorization for its COVID-19 vaccine in the European Union for adolescents aged 12 to 17. "We are continuing to see spikes in COVID-19 across Europe and recognize the need to improve vaccination rates, particularly in the pediatric population," Chief Executive Stanley C. Erck said in a statement. The submission includes data from a Phase 3 trial involving 2,247 adolescents across 73 sites in the U.S. that found the vaccine showed 80% efficacy overall while the delta variant was still dominant. The Indian regulator recently approved the use of the Novavax vaccine for restricted use in adolescents in that age group, said the statement. The European Medicines Agency has granted it authorization for people 18 years and older. The vaccine has not yet been authorized for use in the U.S. Novavax's vaccine is protein-based and similar to ones used for years to inoculate against flu and other illnesses. Shares jumped 2.1% premarket, but are down 58% in the last 12 months, while the S&P 500 has gained 15.9%.

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