Regeneron, J&J Win HHS Funding to Develop Next-Gen COVID Products

2023-08-23

疫苗紧急使用授权

Pictured: Entrance to the Department of Health and Human Services/iStock, hapabapa The Department of Health and Human Services announced on Tuesday more than $1.4 billion in funding to support the development of next-generation COVID-19 vaccines and treatments. The investments are part of the HHS’s Project NextGen, a $5 billion initiative designed to help the U.S. “stay ahead of COVID-19,” according to the agency’s website. By fostering collaborations between the federal government and the private sector, Project NextGen—a successor to Operation Warp Speed—seeks to accelerate the development of new vaccines and therapies, usher them through clinical trials and the regulatory process, and see them through to market. Among the awardees is Regeneron, which secured a $326 million grant as part of its agreement with the Biomedical Advanced Research and Development Authority (BARDA). The New York biotech will use the money to cover up to 70% of costs for certain R&D activities for its preventive monoclonal antibody. In 2020, Regeneron developed an antibody cocktail with casirivimab and imdevimab to treat mild-to-moderate COVID-19. This won the FDA’s emergency use authorization in November of the same year, but in January 2022 the regulator limited its use after finding that it was unlikely to be effective against the dominant Omicron variant. In its press announcement Tuesday, Regeneron noted that the new monoclonal antibody program falls under a 2017 agreement with BARDA to “develop a portfolio of antibodies targeting up to 10 pathogens that pose significant risk to public health.” Regeneron and the HHS expect the new monoclonal antibody to start clinical trials this fall. Tuesday’s funding also includes a $1 billion grant to four clinical trial partners, including the contract research organizations ICON Government and Public Health Solutions, Pharm-Olam, Technical Resources International and Rho Federal Systems, as well as a $10 million award to Johnson & Johnson Innovation to bankroll startups targeting infectious disease treatment and prevention. The HHS will also give $100 million to Global Health Investment Corporation, a non-profit that manages the BARDA Ventures investment portfolio. “Project NextGen is a key part of the Biden-Harris Administration’s commitment to keeping people safe from COVID-19 variants,” HHS Secretary Xavier Becerra said in a statement, adding that Tuesday’s funding awards will spark more efforts across the industry to “quickly develop vaccines and continue to ensure availability of effective treatments.” HHS confirmed to Endpoints News that Pfizer and Moderna will not receive funding through Project NextGen. The agency also plans to announce additional awards under the project by the end of the year. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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