HHS, DOD, Novavax Partner to Scale-Up COVID-19 Vaccine Doses

HHS and the Department of Defense (DoD) recently announced a $1.6 billion agreement with Novavax Inc. to demonstrate commercial-sale manufacturing of the company’s COVID-19 investigational vaccine.

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As part of the funding, 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 FDA grants Emergency Use Authorization (EUA) or licenses the investigational vaccine, the federal government could distribute the doses as part of a COVID-19 vaccine campaign.

By working  in parallel, HHS officials hope to shave months off the traditional vaccine development timeline.

Today’s effort with Novavax also builds on a $70 million agreement between DoD and Novavax, which was announced in June.

Under the agreement, the company is manufacturing components of the vaccine in the US and delivering 10 million doses of NVX-CoV2373 that could be used in Phase 2/3 clinical trials or under EUA.

The Biomedical Advanced Research and Development Authority (BARDA) collaborated with the DoD joint program executive officer for chemical, biological, radiological, and nuclear defense and army contracting command.

The collaboration will help support advanced development, including clinical trials and the manufacturing demonstration project.

Additionally, the collaboration also builds toward the Trump Administration’s Operation Warp Speed goal to begin delivering 300 million doses of safe and effective vaccine to individuals in 2021.

In mid-May, The Trump Administration released a framework and leadership for Operation Warp Speed (OWS), a public-private partnership designed to accelerate the development, manufacturing, and distribution of COVID-19 vaccines.

Operation Warp Speed is tasked with  facilitating the development, manufacturing, and distribution of COVID-19 countermeasures, including vaccines, therapeutics, and diagnostics, between components of HHS.

Congress directed almost $10 billion to Operation Warp Speed through supplemental funding, including the CARES act. Lawmakers have also appropriated other flexible funding.

Over $6.5 billion has been designated by Congress for countermeasure development through BARDA, along with $3 billion for NIH research.

“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,” HHS Secretary Alex Azar said in the recent announcement.

“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.”

HHS stated that FDA can only issue EUA’s to facilitate the availability of an unapproved product after statutory requirements are met.

For example, for nvestigational 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.

Additionally, HHS stated that the project also includes fill-finish manufacturing in the US 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,” HHS said.