Novavax, Inc. 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).
"The rapid emergence and continued spread of variants is a stark reminder that no one is safe until everyone is safe in the fight against COVID-19," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We remain committed to delivering our vaccine, which is based on a proven, well understood platform, to countries around the world as we anticipate that ongoing vaccination will be necessary over the long term to end the pandemic."
Novavax made the submission for the regulatory evaluation by MoHaP of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. The filing includes clinical data from two pivotal Phase 3 clinical 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 United Kingdom, Australia, New Zealand, Canada, the European Union, 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.
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