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www.fdanews.com/articles/197982-government-issues-2-billion-in-operation-warp-speed-contracts-for-covid-19-vaccine-therapeutic

Government Issues $2 Billion in Operation Warp Speed Contracts for COVID-19 Vaccine, Therapeutic

July 8, 2020

The federal government has granted two contracts worth more than $2 billion as part of Operation Warp Speed — $1.6 billion to Novavax to manufacture and develop its COVID-19 vaccine candidate, and $450 million to Regeneron Pharmaceuticals to manufacture and supply its antibody cocktail to treat COVID-19.

The Novavax contract with HHS’ Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense is the largest to date under Operation Warp Speed and puts the vaccine in the running as a top U.S.-based candidate, although it still lags behind Warp Speed vaccine candidates from Moderna and AstraZeneca, which are expected to begin phase 3 clinical testing in the U.S this summer.

The Novavax contract will fund a phase 3 clinical trial of the vaccine in 30,000 participants and is expected to begin in the fall, following positive results from a phase 1 /2 clinical trial in Australia. Preliminary results of that trial are expected later this month.

The Regeneron contract is for its antibody cocktail REGN-COV2 and is the first granted under Operation Warp Speed to support the development and manufacturing of a COVID-19 therapeutic.

The dual antibody cocktail entered a phase 3 trial this week and is being conducted with the National Institute of Allergy and Infectious Diseases (NIAID). — Jordan Williams and James Miessler