Therapy Areas: Respiratory
Novavax receives Taiwan regulatory expanded emergency use authorisation for Nuvaxovid COVID-19 vaccine in adolescents aged 12 to 17
19 September 2022 -

Novavax, Inc. (Nasdaq: NVAX), a US-based biotechnology company, announced on Friday that it has received expanded emergency use authorisation (EUA) from the Taiwan Food and Drug Administration (TFDA) for its Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 to 17.

The approval is based on data from the ongoing paediatric expansion of the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 to 17 years across 75 sites in the United States to assess the safety and effectiveness of the product.

Preliminary safety data from the paediatric expansion indicated the vaccine to be generally well-tolerated.

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