Gaithersburg, Md. (ots/PRNewswire) –
- Novavax and Serum Institute in India submits application to WHO for emergency approval of Novavax’s recombinant nanoparticle-based COVID-19 vaccine
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company specializing in developing and marketing next-generation vaccines for serious infectious diseases, and its partner Serum Institute of India Pvt. Ltd. (SII), today announced the submission of an application for approval to the World Health Organization (WHO) for Emergency Approval (EUL) for a candidate COVID-19 recombinant vaccine based on nanoparticles with adjuvant matrix (TM). Submission to WHO is based on the company’s previous application of the Controller General of Medicines of India (DCGI).
“Today’s application to WHO for a protein-based COVID-19 vaccine to the WHO is an important step toward faster access and more equitable distribution to countries in need around the world,” said Stanley C. Erk, President and CEO of Novavax. “It represents another important milestone in Novavax’s development into a global commercial vaccine company and underscores the value of global collaboration and the need for different approaches to fighting the pandemic.”
WHO emergency authorization is a prerequisite for export to many of the participating countries in the COVAX facility, which is set up to distribute vaccines and distribute them equitably among participating countries and economies. In addition to the application submitted to the World Health Organization, SII and Novavax have now provided all modules required by regulatory authorities in India, Indonesia and the Philippines to begin testing the vaccine, including preclinical and clinical data as well as data on chemistry, manufacturing and controls.
Information on NVX-CoV2373
NVX-CoV2373 is being investigated in two pivotal Phase III studies: a study in Great Britain with 96.4% efficiency against the original virus strain, 86.3% against an alpha variant (B.1.1.7) and one that showed an overall efficacy of 89.7%, and the PREVENT-19 study in the United States and Mexico, which found 100% protection against moderate to severe disease and an overall efficacy of 90.4%. It was generally well tolerated and elicited a strong antibody response.
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. NVX-CoV2373 was developed using Novavax’s recombinant nanoparticle technology to generate an antigen derived from the coronavirus (S) protein and is 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 reproduce and cannot 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 mcg of antigen and 50 mcg of Matrix-M adjuvant) given by intramuscular injection for 21 days. The vaccine is stored at 2 to 8°C so that existing vaccine supplies and cold chains can be used.
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 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 of NVX-CoV2373, its candidate vaccine for SARS-CoV-2, the virus that causes Covid-19. NanoFlu(TM), a tetravalent 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) saponins to enhance the immune response and stimulate high levels of neutralizing antibodies.
Statements in this document regarding the future of Novavax, its operating plans and prospects, the continued development of NVX-CoV2373 and other Novavax candidate vaccines, the timing of filings and future regulatory actions, and the role that Novavax will play in combating the COVID-19 pandemic are forward-looking statements. Novavax advises 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 the difficulty of fulfilling, alone or with partners, various requirements for safety, efficacy and product description, including process qualification and test validation requirements necessary to meet the requirements of relevant regulatory authorities; difficulties in obtaining rare raw materials; Resource constraints, including human capital and production capacity, with respect to Novavax’s ability to pursue envisaged regulatory paths; Challenges in meeting contractual requirements under agreements with many commercial, government and other entities; and other risk factors described in the “Risk Factors” and “Management 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). Investors are cautioned not to place undue reliance on the forward-looking statements contained in this press release. To discuss these and other risks and uncertainties, you should read our filings with the SEC, located at www.sec.gov And www.novavax.com Available. 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.
Inquiries and contact:
Erica Schultz | 240-268-2022
Alexandra Roy | 617-221-9197
Alison Chartan | 240-720-7804
Laura Keenan Lindsey | 202-709-7521
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