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 The cocktail, REGN-COV2, is in separate clinical trials assessing
its effectiveness in preventing and treating COVID-19, the company
said https://reut.rs/2O2ADgu.
Regeneron signed the contract with the U.S. Department of Health and
Human Services' (HHS) Biomedical Advanced Research and Development
Authority (BARDA) and the Department of Defense. The doses
manufactured under the project will be owned by the federal
government.
The contract comes under the government's "Operation Warp Speed"
program, aimed at accelerating access to vaccines and treatments to
fight the coronavirus.
The government will support manufacturing REGN-COV2 for immediate
use in the country, if the clinical trials are successful and the
U.S. Food and Drug Administration grants emergency use authorization
(EUA) or product approval.
The agreement covers a fixed number of bulk lots that are intended
to be completed in the fall of 2020, the company said.
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It expects a range of 70,000 to 300,000 potential treatment doses or 420,000 to
1,300,000 prevention doses to be available from these lots, with initial doses
to be ready as early as end of summer.
If EUA or product approval is granted, the government has committed to making
doses from these lots available to Americans at no cost and would be responsible
for their distribution, Regeneron said.
Separately, the U.S. government on Tuesday awarded a $1.6 billion grant to
Novavax Inc <NVAX.O>, the biggest yet from Operation Warp Speed, to cover
testing, manufacturing and sale of a potential coronavirus vaccine in the
country.
(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)
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