05.08.2021 – 14:20
Gaithersburg, Md. (ots/PRNewswire)
– Agreeing to 100 million cans with an option of an additional 100 million cans by 2023
– Possibly the first COVID-19 sub-protein vaccine to be available in the European Union
Novavax, Inc. has announced. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, has announced that it has reached an agreement with the European Commission (EC) to purchase up to 200 million doses of NVX-CoV2373 nanoparticles. Recombinant COVID-19 vaccine-based vaccine with Matrix-M(TM) adjuvant. The agreement includes the purchase of up to 100 million doses of the vaccine with an option to purchase an additional 100 million doses by 2023.
Novavax is working to complete the ongoing review process for NVX-CoV2373 with the European Medicines Agency (EMA) in the third quarter of 2021, with delivery of the first doses expected to begin after approval.
Stanley C. said: Erk, President and CEO of Novavax. “It is clear that our vaccine candidate will have a vital role in the fight against the epidemic in the European Union and other regions of the world, where clinical data from our studies show strong efficacy against variables of concern and variables of interest.”
In a Phase III clinical trial in nearly 30,000 adults in the United States and Mexico, NVX-CoV2373 demonstrated 100% protection against moderate to severe disease and an overall efficacy of 90.4%. In a Phase III clinical study conducted in the United Kingdom in nearly 15,000 adults, NVX-CoV2373 demonstrated an overall efficacy of 89.7% and an efficacy of greater than 96% against the original strain of the virus.
“Given the prevalence of novel coronavirus variants in Europe and around the world, this new contract with a company that has already successfully tested its vaccine against these variants provides additional security to protect our population. It enhances our broad range of vaccines benefits for Europeans and our partners around the world,” said Ursula von der der Laine, President of the European Commission.
Novavax’s global supply chain extends to more than 10 countries, including facilities across the European Union from which Novavax plans to deliver vaccine doses.
Information on NVX-CoV2373
NVX-CoV2373 is a protein-based candidate vaccine developed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. Developed using Novavax’s recombinant nanoparticle technology to generate an antigen derived from the coronavirus (S) protein, NVX-CoV2373 has been formulated with Novavax’s patented M(TM) Matrix to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains a purified protein antigen and cannot replicate and cannot cause COVID-19. In preclinical studies, NVX-CoV2373 triggered antibodies that blocked spike protein binding to cellular receptors and provided protection against infection and disease. It was generally well tolerated and elicited a robust antibody response in phase I/II clinical trials.
NVX-CoV2373 is being investigated in two pivotal Phase III studies: a study in Great Britain found efficacy of 96.4% against the original virus strain, and 86.3% against the B.1.1.7 (alpha) variant and showed 89.7% overall; And in the PREVENT-19 study in the United States and Mexico, which showed 100% protection against moderate to severe disease and an overall efficacy of 90.4%. It is also being tested in two ongoing Phase II studies beginning in August 2020: A Phase 2B study in South Africa showed an overall efficacy of 55% in HIV-negative participants and an efficacy of 48.6% versus one of a newly emerging variant from the outbreak first described in South Africa. In addition to the continuation of the first / second phase in the USA and Australia.
NVX-CoV2373 can be stored stably at temperatures between 2 and 8 °C, so that existing channels of the vaccine supply chain can be used for distribution. It is packaged in a ready-to-use liquid formulation in vials of 10 doses.
Matrix M(TM) Helpful Information
The patented Matrix-M (TM) adjuvant from Novavax demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells at the puncture site and by increasing the presentation of antigen in local lymph nodes, thereby increasing the immune response.
Information about Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes better 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 manufacture highly immunogenic nanoparticles that meet urgent global health needs. Novavax is currently conducting late-stage clinical trials with NVX-CoV2373, its candidate vaccine for SARS-CoV-2, the virus that causes COVID-19. NanoFlu(TM), a quadrivalent nanoparticle-based influenza vaccine, has achieved all primary goals in a pivotal phase III clinical trial in the elderly and is being prepared for regulatory deposit. Both vaccine candidates contain Novavax’s proprietary Matrix-M (TM) saponin-based adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
Statements in this document regarding the future of Novavax and the continued development of a vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to many risks and uncertainties that could cause actual results to differ materially from those expressed or implied in these statements. These risks and uncertainties include those outlined under “Risk Factors” in Novavax’s Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission (SEC). Investors are cautioned not to place undue reliance on the forward-looking statements contained in this press release. We encourage you to read our filings with the Securities and Exchange Commission, available at sec.gov, to learn about these and other risks and uncertainties. The forward-looking statements contained in this press release speak only as of the date of this document, and we assume no obligation to update or revise such 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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