Novavax applies to license COVID-19 vaccine in the UK (1)

  • The submission marks the first protein-based COVID-19 vaccine submitted to the MHRA for clearance
  • Completed all modules required for regulatory review, including CMC بيانات data
  • Presentation is based on Phase 3 data from approximately 45,000 patients showing high efficacy and well-tolerated safety, even against variants
  • Applications are expected soon to other global regulatory bodies, such as those in the European Union, Canada and Australia

Gaithersburg, Maryland28, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and marketing next-generation vaccines against serious infectious diseases, today announced the completion of its application for authorization of the COVID-19 vaccine with the United Kingdom’s Medicines and Health Products Regulatory Agency (MHRA). The company’s application for a Conditional Marketing Authorization (CMA) represents the first application for a license for a protein-based COVID-19 vaccine in the UK.

“This presentation brings Novavax significantly closer to delivering millions of doses of the first protein-based COVID-19 vaccine, built on a well-understood and proven vaccine platform that has demonstrated high efficacy against multiple coronavirus strains,” he said. Stanley C. ErkPresident and CEO of Novavax Corporation. “We are awaiting the review of the MHRA and will be ready to provide vaccine doses after what we expect to be a positive decision. We thank the participants in clinical trials and trial sites in the UK as well as vaccines in the UK. The staff, your support and your vital contributions to this program.”

Novavax has completed submission of all units required by the MHRA for regulatory review of NVX-CoV2373, the company’s nanoparticle-based COVID-19 vaccine with Matrix-M™ adjuvant. This includes preclinical, clinical, chemistry, and manufacturing and controls (CMC) data. Earlier this year, clinical data from a baseline Phase III trial with 15,000 UK volunteers was submitted to the MHRA, with NVX-CoV2373 showing 96.4% efficacy against the parent virus strain, and 86.3% compared to the alpha variant (B.1.1. 7) and 89.7% overall, as well as a favorable appearance for safety and endurance. The presentation also includes data from PREVENT-19, a trial of 30,000 people in the United States and Mexico, which showed 100% protection against moderate to severe disease and an overall efficacy of 90.4%. NVX-CoV2373 was generally well tolerated and elicited a strong antibody response.

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Novavax expects to complete other regulatory filings in key markets such as Europe and Canada, AustraliaNew Zealand, the World Health Organization and other markets around the world, shortly after its launch in the United Kingdom. In the United States, Novavax expects to submit the full package to the FDA by the end of the year. The company continues to work closely with governments, regulatory authorities, and NGOs in their commitment to ensuring equitable global access to its COVID-19 vaccine.

“Introducing the MHRA benefits from our manufacturing partnership with the Serum Institute of IndiaThe world’s largest supplier of COVID-19 vaccines. Rick Crowley, executive vice president and chief operating officer of Novavax. “In the near future, we look forward to supplementing this presentation with sourcing from our global supply chain.”

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Acerca De NVX-CoV2373NVX-CoV2373 is a candidate protein-based vaccine designed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. Created using Novavax’s recombinant nanoparticle technology to generate antigens derived from the spike(S) protein of the coronavirus, NVX-CoV2373 has been formulated with Matrix-M™, Novavax’s proprietary saponins, to enhance the immune response and stimulate high levels of neutralization. . Antibodies. NVX-CoV2373 contains pure protein antigens and cannot replicate or cause COVID-19.

Novavax COVID-19 vaccine comes as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen requires two 0.5 mL doses (5 mcg of antigen and 50 mcg of Matrix-M adjuvant) administered intramuscularly for 21 days apart. The vaccine is stored at 2°-8°C, which allows the use of existing vaccine supply channels and the cold chain.

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About Matrix-M™ Adjuvant Novavax’s proprietary Matrix-M™ has demonstrated a potent and well-tolerated effect in stimulating entry of antigen-presenting cells at the injection site and enhancing antigen presentation in local lymph nodes, thereby enhancing the immune response.

About NovavaxNovavax, Inc. (NASDAQ: NVAX) is a biotechnology company that promotes improved health worldwide through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to meet the urgent needs of global health. Novavax is conducting advanced clinical trials of NVX-CoV2373, its candidate vaccine for SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent nanoparticle influenza vaccine, has achieved all primary goals in its phase 3 primary clinical trial in the elderly. Both vaccine candidates incorporate the saponin-based Matrix-M™ adjuvant from Novavax to boost the immune response and stimulate high levels of neutralizing antibodies.

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forward-looking statementsStatements here regarding the future of Novavax, its operating plans and prospects, its partnerships, the continued development of NVX-CoV2373 and other Novavax vaccine candidates, the scope, timing, and results of filings, future regulatory actions, and Novavax’s preparation for delivery of vaccine doses are forward-looking statements. Novavax cautions that such forward-looking statements are subject to many risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. These risks and uncertainties include challenges to be met, alone or in combination with partners, and various requirements for safety, efficacy and product characterization, including those related to process qualification and validation of tests needed to satisfy regulatory authorities. Difficulty obtaining raw materials and scarcity of supplies; Resource constraints, including human capital and manufacturing capacity, on Novavax’s ability to follow planned regulatory paths; Difficulties in fulfilling contractual requirements under agreements with various commercial, government and other entities; and other risk factors identified in the “Risk Factors” and “Analysis of Financial Position and Results of Operations by Management” sections of Novavax’s annual report on Form 10-K for the year ended. on December 31, 2020 and subsequent quarterly reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). Investors are cautioned not to place heavy emphasis on the forward-looking statements contained in this press release. We recommend reading our SEC filings, available at And www.novavax.comTo analyze these and other risks and uncertainties, among others. The forward-looking statements contained in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our Company is subject to significant risks and uncertainties, including those listed above. Investors, potential investors, and others should be fully aware of these risks and uncertainties.

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InvestorsNovavax, Erica Schultz Company | 240-268-2022[email protected]

Solibury Trout Alexandra Roy | 617-221-9197[email protected]

modesAlison Chartan | 240-720-7804 Laura Keenan Lindsey | 202-709-7521[email protected]

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