Regeneron seals $450m BARDA contract to scale up production of its COVID-19 vaccine

pharmafile | July 9, 2020 | News story | Manufacturing and Production, Sales and Marketing BARDA, Operation Warp Speed, Regeneron, US, vaccine COVID-19 

Regeneron has revealed that REGN-COV2, its two-antibody vaccine for the treatment and prevention of COVID-19, has been awarded a manufacturing and supply funding contract to the value of $450 million from the Biomedical Advanced Research and Development Authority (BARDA) as part of the US Government’s Operation Warp Speed programme to accelerate development and access to the most promising prophylactics against the novel coronavirus.

The contract concerns Regeneron, BARDA, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.

Regeneron developed the vaccine using mice genetically modified to have a human immune system – known as the company’s proprietary VelocImmune mice. It used these mice to screen thousands of fully-human antibodies, including those isolated from recovered COVID-19 patients.

The two most potent candidates were then combined in a two-antibody cocktail. The vaccine works through the non-competitive binding of both antibodies to the spike protein found on the surface of the SARS-CoV-2 virus. According to Regeneron, this “decreases the ability of mutant viruses to avoid treatment and protects against spike variants that have evolved in the human population.”

The vaccine scored a positive review for a Phase 1 trial of 30 hospitalised and non-hospitalised COVID-19 patients. The company now plans to push forward into a Phase 2/3 extension of this study, as well as a Phase 3 trial to test its prevention capacity in uninfected patients.

The company had already been scaling up its manufacturing capacity for the vaccine back in Spring, but this new contract will take capacity even further, as Leonard S Schleifer, co-Founder, President and CEO of Regeneron, explained: “We made the decision early on to begin large-scale manufacturing at our own risk in order to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted. This manufacturing and supply agreement with BARDA and the Department of Defense could help REGN-COV2 reach many people quickly, hopefully helping to change the course of this deadly and still-raging pandemic.”

Bulk lots with a due manufacture date of Fall 2020, with a total of up to 300,000 treatment doses and up to 1,300,000 preventative doses. Specific dosages of these lots will be determined in future clinical trials.

Matt Fellows

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