US based biotech firm Novavax, Inc has stated that the company, in collaboration with Serum Institute of India, will provide 1.1 billion cumulative doses of NVX-CoV2373, Novavax's recombinant protein-based COVID-19 vaccine candidate, for the COVAX Facility. The COVAX Facility is a global risk-sharing mechanism for pooled procurement and equitable distribution of eventual COVID-19 vaccines.
Novavax has signed a Memorandum of Understanding (MOU) with Gavi, the Vaccine Alliance, the partnership that is co-leading COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator in this regard on February 18.
Novavax is expected to supply doses primarily to high-income countries (HICs), while SII would provide the majority of supply for low-, middle, and upper-middle-income countries, (LMICs, UMICs), utilising a tiered-pricing schedule.
In addition to Gavi, COVAX is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organisation (WHO), who are working in partnership with developed and developing country vaccine manufacturers, UNICEF, the World Bank, civil society organisations 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.
The COVID-19 vaccine candidate of Novavax is being studied in two ongoing pivotal Phase 3 clinical trials: in the United States and Mexico, as well as in the United Kingdom. Novavax had previously reported positive interim efficacy results from its UK trial.
"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," said Stanley C Erck, President and Chief Executive Officer of Novavax. "We are pleased to deepen our partnership with Novavax and COVAX to increase the doses of vaccine available to benefit humanity," said Adar Poonawalla, Chief Executive Officer, Serum Institute of India.
The company informed that Gavi will work with Novavax to finalise an advance purchase agreement (APA) for vaccine supply and global distribution allocation via the COVAX Facility and its partners. "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 Seth Berkley, CEO of Gavi. "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."
The company said that it has licensed its NVX-CoV2373 technology to SII with no upfront, milestone or technology transfer payments.
"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," said Dr Richard Hatchett, CEO of CEPI. "CEPI's investments in this vaccine have been pivotal to enabling equitable access to a significant volume of this vaccine through COVAX."
In September 2020, Novavax had enhanced the scope of its vaccine manufacturing agreement with Serum Institute by permitting Serum to also manufacture the antigen component of NVX-CoV2373, Novavax's COVID-19 vaccine candidate. With this, the company said that its global supply chain will deliver over 2 billion doses of NVX-CoV2373 in 2021.
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