Novavax, Inc., a biotechnology company developing next-generation vaccines for serious infectious diseases, announced that it has finalized an advance purchase agreement (APA) with Gavi, the Vaccine Alliance (Gavi) for supply of its recombinant protein-based COVID-19 vaccine candidate to the COVAX Facility. Under the APA, Novavax is expected to manufacture and distribute 350 million doses of NVX-CoV2373 to countries participating under the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. Under a separate purchase agreement with Gavi, the Serum Institute of India (Serum Institute) is expected to manufacture and deliver the balance of the 1.1 billion doses of Novavax' vaccine.
"This is a tremendous opportunity to partner with global organizations focused on accelerating equitable access to safe and effective COVID-19 vaccines, particularly in countries where vaccination rates are currently low," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "This arrangement is the culmination of a collaboration among CEPI, Gavi, Serum Institute and Novavax, who are partnering in our urgent mission to deliver significant amounts of vaccines to all countries, regardless of income level. Novavax thanks CEPI for its longstanding support and tireless work with Gavi as the curators of the COVAX Facility."
Under the APA, Novavax expects to deliver doses with antigen and adjuvant manufactured at facilities directly funded by the investments Novavax received from the Coalition for Epidemic Preparedness Innovations (CEPI). CEPI invested nearly $400 million in Novavax in the spring of 2020 to advance preclinical and early clinical development, manufacturing scale-up, technology transfer, and manufacturing capacity reservation for NVX-CoV2373.
"CEPI's investments to accelerate the clinical development and manufacturing of this vaccine candidate have been critical to enabling equitable access to the vaccine through COVAX," said Dr. Richard Hatchett, CEO of CEPI. "With this agreement in place, the Novavax vaccine candidate will play a vital role in our mission to protect those most at risk from COVID-19, wherever they are in the world."
"The agreement with Novavax marks a major step towards COVAX's objective of building the world's largest and most diverse portfolio of COVID-19 vaccines, and a major step towards our goal of delivering 2 billion doses of safe and effective vaccines in 2021," said Dr Seth Berkley, CEO of Gavi. "Novavax' commitment not only to support COVAX directly, but also through technology transfer via other manufacturers, shines a light on the end-to-end nature of COVAX and the kind of collaboration needed to bring this pandemic under control."
Together, Novavax and Serum Institute expect to initiate delivery of the cumulative 1.1 billion doses in the third quarter of 2021, pending receipt of appropriate regulatory authorizations. Under the APA, Novavax will receive an upfront payment from Gavi later this month and an additional payment after it secures Emergency Use Listing for its vaccine by the WHO. In addition, Novavax has agreed to provide additional doses in the event that Serum Institute cannot materially deliver expected vaccine doses to the COVAX Facility.
Vaccine dose allocation will be determined by Gavi across the AMC-eligible and self-financing participants under a tiered pricing schedule.
"CEPI's early support served as a catapult for Novavax to create a global supply network that we expect could provide a significant percent of the world's vaccine supply via COVAX," Erck continued. "We look forward to the ongoing collaboration with Serum Institute to deliver on our manufacturing capacity and to working with WHO to secure authorization as rapid...
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