Novavax Announces Memorandum of Understanding with Gavi for Cumulative Supply to COVAX Facility of 1.1 Billion Doses of COVID-19 Vaccine
- Advances joint commitment from
Novavax, Serum Institute of Indiaand Gavi to ensure equitable access to NVX-CoV2373 worldwide across low-, middle- and high-income countries
- Memorandum of understanding (MOU) between Gavi and
Novavaxto make available a cumulative volume of 1.1 billion doses of the Novavaxvaccine to the COVAX Facility
COVAX is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, which is co-led by the
“We are proud to partner with all the COVAX collaborators and
Gavi leads the design and implementation of the COVAX Facility and will work with
“This agreement brings the COVAX Facility one step closer to its goal of supplying vaccines globally and ending the acute phase of the pandemic,” said Dr.
CEPI has provided critical support to
“With this MOU in place, the vaccine candidate developed by our partners at
“We are pleased to deepen our partnership with
NVX-CoV2373 was the first vaccine to demonstrate clinical efficacy against the original strain of COVID-19 and both of the rapidly emerging variants in the United Kingdom and South Africa. NVX-CoV2373 can neither cause COVID-19 nor can it replicate. It is shipped in a ready-to-use liquid formulation. Because it is stable at 2°C to 8°C (refrigerated), existing vaccine supply chain channels can be used for its distribution.
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that demonstrated 89.3 percent overall efficacy and 95.6 percent against the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated up to 60 percent efficacy against newly emerging escape variants, and a Phase 1/2 continuation in the U.S. and Australia.
Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
Novavax Forward Looking Statements
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements 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 business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
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Source: Novavax, Inc.