FLC | HHS, DOD partner with Novavax to demo investigational COVID-19 vaccine

HHS, DOD partner with Novavax to demo investigational COVID-19 vaccine

July 8, 2020

The U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) on July 7 jointly announced a $1.6 billion agreement with Novavax, Inc. of Gaithersburg, Maryland, to demonstrate commercial-scale manufacturing of the company’s COVID-19 investigational vaccine. By funding this manufacturing effort, the federal government will own the 100 million doses of investigational vaccine expected to result from the demonstration projects.

The doses would become available for use in clinical trials or, if the U.S. Food and Drug Administration (FDA) grants Emergency Use Authorization (EUA) or licenses (approves) the investigational vaccine, the federal government could distribute the doses as part of a COVID-19 vaccination campaign.

FDA can issue EUAs to facilitate the availability of an unapproved product only after several statutory requirements are met. For investigational vaccines being developed to prevent COVID-19, an assessment will be made on a case-by-case basis depending on the clinical trial data and the total scientific evidence available about the vaccine candidate. Additional analysis is required for FDA to license a vaccine.

“Operation Warp Speed is creating a portfolio of vaccines to increase the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” said HHS Secretary Alex Azar. “Depending on success in clinical trials, today’s $1.6 billion investment supports our latest vaccine candidate, being developed by Novavax, all the way through clinical trials and manufacturing 100 million doses for the American people.”

This manufacturing demonstration project will take place while clinical trials are underway. Working in parallel this way shaves months off the traditional vaccine development timeline. This step builds toward the Operation Warp Speed goal to begin delivering 300 million of doses of safe and effective vaccine to the American people in 2021.

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command, to support advanced development, including clinical trials, and the manufacturing demonstration project.