Novavax announces collaboration with SK bioscience for COVID-19 vaccine

Novavax and SK bioscience have announced a development and supply agreement for the antigen component of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate, for supply to global markets including the COVAX Facility. In addition, the companies have signed a letter of intent with the Republic of Korea’s Ministry of Health and Welfare to work toward broad and equitable access to NVX-CoV2373 for the global market as well as to make the vaccine available in South Korea.

Under the terms of the agreement, SK bioscience will manufacture the vaccine antigen component for use in the final drug product globally during the pandemic period.

NVX-CoV2373 was developed using Novavax’ recombinant nanoparticle technology to generate a stable, prefusion antigen derived from the coronavirus spike (S) protein. It contains Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralising antibodies. Phase 1 data from the Company’s Phase 1/2 randomised, observer-blinded, placebo-controlled trial shows that NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.

SK bioscience, using its cell culture and recombinant protein capability, will initiate the production of the NVX-CoV2373 antigen at its vaccine facility in Andong L-house, South Korea beginning in August 2020.

This contract development and manufacturing organisation agreement leverages the capacity reservation agreement between SK bioscience and the Coalition for Epidemic Preparedness Innovations (CEPI). Novavax’ NVX-CoV2373 will be manufactured using a part of the reserved capacity at SK Bioscience’s “L-House” facility.

Through a partnership with CEPI, Novavax has committed to develop and manufacture significant amounts of NVX-CoV2373, including vaccine derived from antigen coming from SK bioscience, if proved safe and effective, to be procured and distributed by the COVAX Facility through a globally fair allocation framework.