HHS, DOD collaborate with Novavax to produce millions of COVID-19 investigational vaccine doses in commercial-scale manufacturing demonstration project
The U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) today 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 project.
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 Trump Administration’s 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.
The project also includes fill-finish manufacturing in the United States so that vaccine doses are packaged and ready to ship immediately if clinical trials are successful and FDA grants an EUA or licenses the investigational vaccine. If these doses are used in a COVID-19 vaccination campaign, the vaccine would be available to the American people at no cost. As is customary with government-purchased vaccines, healthcare professionals could charge insurers for the cost of administering the vaccine.
Today’s effort with Novavax builds on an agreement between DoD and Novavax announced in June. Under that approximately $70 million agreement, the company is manufacturing components of the vaccine in the U.S. and delivering 10 million doses of NVX‑CoV2373 that could be used in Phase 2/3 clinical trials or under EUA.
NVX‑CoV2373 relies on a stable, prefusion protein antigen made using the company’s proprietary nanoparticle technology and includes Novavax’s proprietary Matrix‑M adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Antigen stimulates the body’s immune response against the virus, and adjuvant enhances the immune response, reduces the amount of antigen required per dose, and improves the chances of delivering an effective vaccine that can be manufactured at scale.
About HHS, ASPR, and BARDA:
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 55 BARDA-supported products have achieved FDA approval, licensure or clearance. To learn more about federal support for the nationwide COVID-19 response, visit coronavirus.gov.
About the JPEO-CBRND:
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear threats. As an effective DoD acquisition program, the JPEO-CBRND’s vision is a resilient Joint Force enabled to fight and win unencumbered by a CBRN environment; championed by innovative, agile, results-oriented acquisition professionals. The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) facilitates the advanced development and acquisition of medical solutions to combat CBRN and emerging threats. JPM CBRN Medical works with JPEO-CBRND’s Joint Project Lead for Chemical, Biological, Radiological and Nuclear Defense - Enabling Biotechnologies to provide new and improved medical countermeasures to enable a single treatment for many threats, rapid medical countermeasure responses, genomic sequencing and the capability to diagnose CBRN threats before the onset of symptoms. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus.