- Novavax Inc NVAX has completed its rolling submission to Health Canada for the authorization of its protein-based COVID-19 vaccine candidate.
- In addition, the Company has completed the submission of all data and modules to the European Medicines Agency (EMA) to support the final regulatory review of its dossier.
- The chemistry, manufacturing, and controls (CMC) data packages submitted leverage Novavax's manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the largest supplier of COVID-19 vaccines.
- It will later include data from additional manufacturing sites in Novavax's global supply chain.
- Related Link: Novavax Rips Higher After Completing Regulatory Filing For Authorization Of COVID-19 Vaccine In UK.
- Separately, the regulatory authority of Indonesia has granted emergency use authorization (EUA) for Novavax's COVID-19 vaccine, manufactured by Serum Institute under the brand name COVOVAX.
- Novavax and SII have already filed for Novavax's COVID-19 vaccine authorization in India and the Philippines and Emergency Use Listing (EUL) with the World Health Organization (WHO).
- The Company will submit its complete package to the FDA by the end of 2021.
- Price Action: NVAX shares are up 10.2% at $163.97 during the premarket session on Monday's last check.
- Photo by hakan german from Pixabay
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