âToday’s announcement from the EMA brings Novavax closer to our goal of ensuring broad global access to our protein-based COVID-19 vaccine across Europe,â said Stanley C. Erck, President and CEO of Novavax. âNovavax looks forward to providing an additional vaccine option in Europe, based on a proven and well-understood technology platform, and thanks the European Commission for its continued partnership and confidence in our COVID-19 program. “
The company previously announced that it has completed the submission of all data and modules required by the EMA for the regulatory assessment of NVX-CoV2373, Novavax’s recombinant protein nanoparticle-based COVID-19 vaccine with Matrix adjuvant. -Mr. The EMA has indicated that its assessment will proceed on an accelerated schedule, with an advisory potentially issued in a few weeks.
The chemistry, manufacturing and controls (CMC) dataset submitted to the EMA and other global regulatory agencies is based on Novavax’s manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer by volume. It will then be supplemented with data from additional manufacturing sites in Novavax’s global supply chain.
The Novavax / IBS vaccine recently received Emergency Use Authorization (EUA) in Indonesia and the Philippines, and the companies have also filed for Emergency Authorization in India and an Emergency Use List. (EUL) to the World Health Organization (WHO). Novavax has also announced regulatory filings for its vaccine in the UK, Australia, New Zealand, Canada and with the WHO.
Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) submission to MFDS in South Korea. Novavax plans to submit the complete package to the US FDA by the end of the year.
About the Phase 3 trials of NVX-CoV2373
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a UK trial that demonstrated 96.4% efficacy against the original viral strain, 86.3% against the Alpha variant (B.1.1 .7) and an overall efficiency of 89.7%; and the PREVENT-19 trial in the United States and Mexico which demonstrated 100% protection against moderate and severe disease and an overall efficacy of 90.4%. It was generally well tolerated and elicited a strong antibody response.