Novavax announces start of rolling review by multiple regulatory authorities for COVID-19 vaccine authorisation


4 February 2021 - Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada.

Novavax today 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 3 trials in the United Kingdom and United States and through initial authorization for emergency use granted under country-specific regulations.

Read Novavax press release

Michael Wonder

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Michael Wonder

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Vaccine , Dossier , COVID-19