FDAnews
www.fdanews.com/articles/198442-novavax-taps-indias-serum-institute-to-commercialize-covid-19-vaccine-for-low-income-countries

Novavax Taps India’s Serum Institute to Commercialize COVID-19 Vaccine for Low-Income Countries

August 7, 2020

Novavax signed a licensing agreement with the Serum Institute of India yesterday to commercialize the drugmaker’s COVID-19 vaccine candidate in low- and middle-income countries, as well as in India.

The agreement is expected to support a minimum of 1 billion doses of NVX-CoV2373 for these countries and builds on an existing agreement with the Coalition for Epidemic Preparedness Innovations to develop and distribute the vaccine for these regions.

Under the agreement, the Serum Institute, which is the world’s largest manufacturer of vaccines, will have non-exclusive commercialization rights to NVX‑CoV2373 in low- and middle-income countries and exclusive rights to the vaccine in India. The Serum Institute will be responsible for regulatory submissions and marketing authorizations of the vaccine in these countries. — Jordan Williams