COVAX

COVAX is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator which is co-led by the Coalition for Epidemic Preparedness Innovation (CEPI), Gavi, and the World Health Organization (WHO). They are working in partnership with developed and developing country vaccine manufacturers: UNICEF, the World Bank, civil society organizations, and others, to guarantee fair and equitable access to the vaccine for every country in the world. COVAX currently includes more than 190 participating economies.

From the President & CEO of Novavax

Stanley C. Erck, President and Chief Executive Officer of Novavax, said, “We are proud to partner with all the COVAX collaborators and Serum Institute of India to provide global public health leadership and ensure that all countries have broad access to NVX-CoV2373. “Novavax will play a critical role in the worldwide effort to provide access to safe and effective vaccines to end the pandemic.”

Gavi will work with Novavax to finalize an advance purchase agreement (APA) for vaccine supply and global distribution allocation via the COVAX Facility and its partners.

CEPI has provided critical support to Novavax, including the commitment of approximately $400 million to advance early clinical development and manufacturing scale-up in multiple facilities around the globe. 

Novavax’s global supply network ensures that there can be an adequate and equitable supply of NVX-CoV2373 across the globe. Consistent with its mission to increase global manufacturing capacity and ensure broad, equitable supply distribution, 

Novavax licensed its NVX-CoV2373 technology to SII with no upfront, milestone or technology transfer payments. With this strategic partnership in place, Novavax and SII became jointly committed to delivering 1.1 billion doses to the COVAX Facility. 

Novavax is expected to supply doses primarily to high-income countries (HICs), with SII providing the majority of supply for low-, middle, and upper-middle-income countries, (LMICs, UMICs), utilizing a tiered pricing schedule.

From the CEO of Gavi

Dr. Seth Berkley, CEO of Gavi, said, “This agreement brings the COVAX Facility one step closer to its goal of supplying vaccines globally and ending the acute phase of the pandemic. “It helps us close in on our goal of delivering two billion doses in 2021 and increases the range of vaccines available to us as we build a portfolio suitable for all settings and contexts.”

From the CEO of CEPI

Dr. Richard Hatchett, CEO of CEPI, said, “With this MOU in place, the vaccine candidate developed by our partners at Novavax is poised to play a significant role in combatting COVID-19 around the world. CEPI’s investments in this vaccine have been pivotal to enabling equitable access to a significant volume of this vaccine through COVAX.” 

NVX-CoV2373

• NVX-CoV2373 is 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). It was created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’s patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies.
• 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.  
• NVX-CoV2373 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. 

The vaccine was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing.

Matrix-M™ – The Novavax Patented Saponin-Based Adjuvant

Novavax’s 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 developed innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering. Novavax  is conducting late-stage clinical trials for NVX-CoV2373; its vaccine efficiently produces highly immunogenic nanoparticles designed to address urgent global health needs candidate against SARS-CoV-2.

NanoFlu™ – its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’s Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

Prohost Observations 

All that we intended to add has already been said in the press release posted yesterday on the firm’s website.   

To read more about Novavax please click here.