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Biotechnology company Novavax, Inc. (NVAX) announced Monday that it 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).


RTTNews | Dec 13, 2021 06:45AM EST

06:45 Monday, December 13, 2021 (RTTNews.com) - Biotechnology company Novavax, Inc. (NVAX) announced Monday that it 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).

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.

The second trial was 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.

Read the original article on RTTNews ( https://www.rttnews.com/3248769/novavax-files-for-emergency-use-of-covid-19-vaccine-nvx-cov2373-in-uae-quick-facts.aspx)

For comments and feedback: contact editorial@rttnews.com

Copyright(c) 2021 RTTNews.com All Rights Reserved






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