AstraZeneca and the Department of Health and Human Services have signed a potential $1.2B public-private partnership agreement to further develop a recombinant adenovirus vaccine as potential treatment for the novel coronavirus.
HHS said Thursday its Biomedical Advanced Research and Development Authority will support the development and production of the company’s AZD1222, an investigational vaccine against SARS-CoV-2 virus, through the public-private collaboration as part of the Trump administration's Operation Warp Speed.
The department expects late-stage clinical trials to begin this summer and estimates 30K volunteers nationwide will participate in the studies.
University of Oxford in England developed and licensed the vaccine candidate to AstraZeneca.
The company seeks to advance the injectable experimental drug into Phase 3 trials in parallel with production efforts by BARDA’s Centers for Innovation and Advanced Development in Manufacturing.
According to HHS, the Food and Drug Administration requires that the investigational medicine undergo the agency's emergency use authorization or licensure process before making it available for coronavirus response efforts.
AZD1222 Phase 1 and 2 trials have been underway in the U.S. since late April.
The AstraZeneca-BARDA partnership seeks to produce at least 300M doses of the vaccine and deliver the initial doses by October.
“Getting a vaccine to the American public as soon as possible is one part of President Trump’s multi-faceted strategy for safely reopening our country and bringing life back to normal, which is essential to Americans’ physical and mental well-being in so many ways," HHS Secretary Alex Azar said.
Last month, an interagency group that includes the National Institutes of Health selected AstraZeneca and 15 other companies to drive vaccine development under the Accelerating COVID-19 Therapeutic Interventions and Vaccines program.