Novavax announces start of rolling review by multiple regulatory authorities for NVX CoV2373, its COVID-19 vaccine .

Novavax, Inc. has announced the start of the rolling review process for authorization of NVX CoV2373, its COVID-19 vaccine, by multiple regulatory agencies. The reviews will continue while the company completes its pivotal Phase III trials in the United Kingdom (U.K.) and United States (U.S.) and through initial authorization for emergency use granted under country-specific regulations. To date, Novavax has begun the rolling review process with several regulatory agencies worldwide, including the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), U.K. Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada. As part of the rolling review, the company will continue to submit additional information, including clinical and manufacturing data. Novavax’ recombinant protein-based vaccine candidate is currently in Phase III clinical development in both the U.K. and U.S. for the prevention of COVID-19. It was the first vaccine to demonstrate clinical efficacy against the original strain of COVID-19 and both of the rapidly emerging variants in the United Kingdom and South Africa.