29.10.2021 – 17:32
Gaithersburg, Maryland (ots/PRNewswire)
- Application for approval of the first protein-based COVID-19 vaccine at the MHRA
- All modules required for regulatory review, including CMC data, are now complete
- The application is based on phase III data from around 45,000 patients, which show a high level of efficacy and well-tolerated safety, also against the variants
- Applications to other regulatory authorities such as the EU, Canada and Australia are expected shortly
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company specializing in the development and commercialization of next-generation vaccines for serious infectious diseases, today closed its ongoing MHRA regulatory filing for announced the approval of its COVID-19 vaccine candidate. The company’s Conditional Marketing Authorization (CMA) application is the first application in the UK for a protein-based COVID-19 vaccine.
“The application brings Novavax much closer to delivering millions of doses of the first protein-based COVID-19 vaccine. It is based on a proven, well-studied vaccine platform that is highly effective against multiple strains of the coronavirus,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We look forward to the MHRA review and are ready to deliver our vaccine doses following the positive decision we believe. We thank the UK clinical trial participants and the UK Vaccines Task Force for their support and their important contribution to this program. “
Novavax has now submitted all modules required by MHRA for regulatory review of NVX-CoV2373, the company’s recombinant COVID-19 vaccine based on nanoparticle protein with Matrix-M (TM) adjuvant. This includes preclinical and clinical data, as well as chemistry, manufacture and control (CMC) data. Clinical data from a pivotal phase III study with 15,000 volunteers in Great Britain were submitted to the MHRA at the beginning of this year, in which NVX-CoV2373 an efficacy of 96.4% against the original virus strain, 86.3% against the alpha variant ( B.1.1.7) and showed a total of 89.7% effectiveness, as well as a favorable safety and tolerability profile. The application also includes data from PREVENT-19, a study of 30,000 participants in the United States and Mexico that showed 100 percent protection against moderate and severe illness and an overall effectiveness of 90.4%. NVX-CoV2373 was generally well tolerated and elicited a robust antibody response.
Novavax expects to receive further regulatory filings in key markets shortly after filing in the UK, including Europe, Canada, Australia, New Zealand, the World Health Organization and other markets around the world. In the USA, Novavax expects to be able to submit the entire package to the FDA by the end of the year. The company continues to work closely with governments, regulators and non-governmental organizations (NGOs) to ensure equal access to its COVID-19 vaccine worldwide.
“The application to MHRA leverages our manufacturing partnership with the Serum Institute of India, the world’s largest supplier of COVID-19 vaccines,” said Rick Crowley, executive vice president and chief operations officer of Novavax. “We expect to add deliveries from our global supply chain to this application in the near future.”
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Information on NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate developed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes Covid-19. NVX-CoV2373 was developed using Novavax’s recombinant nanoparticle technology to generate an antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’s patented saponin-based Matrix-M (TM) adjuvant to Boost the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate or cause Covid-19.
Novavax’s COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a ten-dose vial. The vaccination schedule is two 0.5 ml doses (5 micrograms of antigen and 50 micrograms of Matrix-M (TM) adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2 ° to 8 ° Celsius so that the existing vaccine supply and cold chains can be used.
Matrix M (TM) Adjuvant Information
Novavax’s patented saponin-based Matrix-M (TM) adjuvant has shown a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the puncture site and increasing antigen presentation in the local lymph nodes, thereby increasing the immune response .
Information on Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes better health worldwide through the discovery, development, and commercialization of innovative vaccines for the prevention of serious infectious diseases. The company’s own recombinant technology platform combines the power and speed of genetic engineering to efficiently manufacture highly immunogenic nanoparticles that address urgent global health needs. Novavax is currently conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate for SARS-CoV-2, the virus that causes COVID-19. NanoFlu (TM), the quadrivalent flu vaccine based on nanoparticles, has achieved all primary goals in the pivotal Phase III clinical trial in older adults and is being prepared for regulatory filing. Both vaccine candidates contain Novavax’s proprietary Matrix-M (TM) saponin-based adjuvant to boost the immune response and stimulate high levels of neutralizing antibodies.
Statements in this press release regarding the future of Novavax, its operating plans and prospects, its partnerships, the ongoing development of NVX-CoV2373 and other Novavax vaccine candidates, the scope, timing and outcome of future regulatory filings and actions, and Novavax’s readiness to inject vaccine doses are forward-looking statements. Novavax advises that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied in these statements. These risks and uncertainties include the difficulty of meeting, alone or with partners, the various safety, efficacy and product characterization requirements, including the process qualification and test validation requirements necessary to meet the requirements of the relevant regulatory authorities; Difficulties in obtaining scarce raw materials and materials; Resource constraints, including human capital and production capacity, in relation to Novavax’s ability to pursue the envisaged regulatory pathways; Challenges in meeting contractual requirements under agreements with multiple commercial, government, and other entities; and the other risk factors set out in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’s Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission (SEC). We caution investors not to place undue reliance on the forward-looking statements contained in this press release. For a discussion of these and other risks and uncertainties, you should read our filings with the SEC, located at www.sec.gov and www.novavax.com Are available. The forward-looking statements in this press release speak only as of the date of this document, and we assume no obligation to update or revise these statements. Our business is subject to significant risks and uncertainties, including the above. Investors, potential investors and others should carefully consider these risks and uncertainties.
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Original content by: Novavax, Inc., transmitted by news aktuell