• Expected to support minimum of 1 billion doses of NVX-CoV2373 for India and low- and middle-income countries
• Leverages Serum Institute’s existing reach and infrastructure
• Builds on and complement Novavax-CEPI collaboration to develop and distribute NVX-CoV2373 for low- and middle-income countries through the COVAX Facility
• Serum Institute gains exclusive rights to commercialize in India and non-exclusive rights to commercialize in other LMIC countries

Important first step in ensuring global supply during worldwide pandemic  
In another development, Novavax Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced a license agreement with Serum Institute of India Private Limited (SIIPL) for the development and commercialization of NVXCoV2373, Novavax’ COVID19 vaccine candidate, in low- and middle-income countries (LMIC) and India. This agreement excludes major upper-middle and high-income countries, for which Novavax continues to retain rights. NVXCoV2373 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology and includes Novavax’ proprietary MatrixM™ adjuvant.
“Novavax is strongly committed to ensuring a global supply of NVXCoV2373, including for low- and middle-income countries that are also significantly impacted by coronavirus,” said Mr Stanley C. Erck, President and Chief Executive Officer of Novavax. “As the world’s largest vaccine manufacturer in terms of doses delivered, Serum Institute is the ideal partner to advance NVXCoV2373 throughout India and the LMIC countries. This partnership continues to build on our companies’ collaborative history.”
For LMICs and India, Novavax and SIIPL are partnering on clinical development, co-formulation, filling and finishing and commercialization of NVX-CoV2373. SIIPL will be responsible for regulatory submissions and marketing authorizations. Novavax will provide to SIIPL both vaccine antigen and MatrixM adjuvant, and Novavax and SIIPL are in discussions to have SIIPL manufacture vaccine antigen in India. Novavax and SIIPL will split the revenue from the sale of product, net of agreed costs.
“We believe that Novavax’ NVX-CoV2373 has significant potential to successfully prevent COVID-19. Given our experience with Novavax on the development of a malaria vaccine, we know the power of their vaccine technologies,” said Mr Adar Poonawalla, Chief Executive Officer of Serum Institute of India. “We will work urgently together to bring this vaccine to patients in these geographies.”
This agreement further boosts the global supply of the NVX-CoV2373 vaccine and builds on and complements Novavax’ collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI). Through that partnership with CEPI, Novavax has committed to develop and manufacture significant amounts of NVX-CoV2373, if proved safe and effective, to be procured and distributed equitably by the COVAX Facility through a globally fair allocation framework.
NVXCoV2373 is a vaccine candidate engineered from the genetic sequence of SARSCoV2, the virus that causes COVID-19 disease. NVXCoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVXCoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 portion of the Phase 1/2 clinical trial, NVXCoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Novavax was awarded $1.6 billion by the federal government as part of Operation Warp Speed (OWS), a U.S. government program to deliver millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVXCoV2373 beginning as early as late 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is also investing up to $388 million, and Department of Defense (DoD) is investing up to $60 million of funding to advance clinical development of NVXCoV2373.

In another development, Novavax Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced a license agreement with Serum Institute of India Private Limited (SIIPL) for the development and commercialization of NVXCoV2373, Novavax’ COVID19 vaccine candidate, in low- and middle-income countries (LMIC) and India.