Novavax Submits Regulatory Filing for COVID Vax in United Arab Emirates

Novavax, Inc., a biotechnology company dedicated to next-generation vaccines for serious infectious diseases, has submitted a regulatory filing to the Ministry of Health and Prevention (MoHaP) for emergency use of its COVID-19 vaccine in the United Arab Emirates (UAE).
 
NVX-CoV2373 is the company’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. The filing includes clinical data from two pivotal Phase 3 trials: PREVENT-19, which included 30,000 participants in the U.S. and Mexico and demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulating variants of concern and variants of interest, and 90.4% efficacy overall; and a trial of 15,000 participants in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall. In both trials, NVX-CoV2373 demonstrated a reassuring safety and tolerability profile.
 
Novavax and Serum Institute of India Pvt. Ltd. (SII) recently received Emergency Use Authorization (EUA) for the vaccine in Indonesia and the Philippines, and the companies have filed for EUA in India and for Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the UK, Australia, New Zealand, Canada, the EU, Singapore and with the WHO. Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) submission to MFDS in South Korea. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.
 
The chemistry, manufacturing and controls (CMC) data package submitted to MoHaP and other global regulatory agencies leverages Novavax’ manufacturing partnership with SII, the world’s largest vaccine manufacturer by volume. It will later be supplemented with data from additional manufacturing sites in Novavax’ global supply chain.