Biotechnology company Novavax Inc. (NVAX:NASDAQ), which is engaged in developing next-generation vaccines to address serious infectious diseases, today announced that "it has reached an agreement with the European Commission (EC) for the purchase of up to 200 million doses of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant."
Novavax explained that, under the terms of the agreement, the EC plans to purchase up to 100 million doses of its NVX-CoV2373 vaccine and has the option to buy another 100 million doses through 2023. The company noted that it anticipates that the vaccine will become the first protein subunit COVID-19 vaccine available in the EU.
The firm mentioned that it is now actively working on the completion of its rolling application submission to the European Medicines Agency (EMA) for NVX-CoV2373. Novavax advised that it expects the process to be completed during Q3/21 and, if granted approval, will act quickly to commence with the delivery of initial vaccine doses. The company pointed out that its global supply chain spans over 10 countries including facilities throughout the EU and that it will be readily able to fully meet the contracted supply needs. The NVX-CoV2373 vaccine will be packaged as a ready-to-use liquid formulation in 10-dose vials that can be stored and remain stable at 2-8°C (35.6-46.4°F), which will permit Novavax to use its existing vaccine supply chain channels for distribution.
The company's President and CEO Stanley C. Erck stated, "We thank the European Commission for their partnership in this important step to expand vaccine options for the citizens of Europe and globally as we work to bring the first COVID-19 protein subunit vaccine to the market. . .With clinical data from our trials showing strong efficacy against Variants of Concern and Variants of Interest, we believe that our vaccine candidate will play a critical role in the effort to help control the pandemic in the EU and other regions in the world."
European Commission President Ursula von der Leyen remarked, "As new coronavirus variants are spreading in Europe and around the world, this new contract with a company that is already testing its vaccine successfully against these variants is an additional safeguard for the protection of our population. It further strengthens our broad vaccine portfolio, to the benefit of Europeans and our partners worldwide."
The company described NVX-CoV2373 as "a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease." The firm indicated that during Phase 1/2 clinical testing, NVX-CoV2373 was shown to be well-tolerated and elicited a robust antibody response.
Novavax advised that in a Phase 3 trial of 15,000 adults conducted in the U.K., "NVX-CoV2373 demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7 (Alpha) variant and 89.7% overall." In addition, the firm stated that in its Phase 3 PREVENT-19 study that enrolled nearly 30,000 adult subjects in the U.S. and Mexico, "NVX-CoV2373 demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall."
Novavax is a biotechnology company based in Gaithersburg, Md., that utilizes its proprietary recombinant nanoparticle vaccine technology platform to discover, develop and commercialize new and innovative vaccines designed to prevent serious infectious diseases.
Novavax Inc. started the day with a market cap of around $14.0 billion with approximately 74.1 million shares outstanding and a short interest of about 8.2%. NVAX shares opened more than 9% higher today at $206.17 (+$17.60, +9.33%) over yesterday's $188.57 closing price. The stock has traded today between $202.57 to $231.25 per share and closed at $223.81 (+$35.24, +18.69%).
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