HHS, DoD to Manufacture 100M Doses of Moderna’s COVID-19 Vaccine

HHS and the Department of Defense (DoD) recently announced an agreement with Moderna to manufacture and deliver 100 million doses of the company’s COVID-19 vaccine candidate.

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The vaccine, mRNA-1273, was co-developed by Moderna and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. 

Under the agreement, Moderna will manufacture the vaccine doses while clinical trials are underway.

Additionally, the federal government will own the doses and will be able to acquire up to an additional 400 million doses of mRNA-1273.

Manufacturing in parallel with clinical trials increases the speed of vaccine development and furthers the US government’s Operation Warp Speed goal to deliver safe and effective vaccines to Americans by the end of 2020, the government said.

Operation Warp Speed is a partnership among HHS, DoD, and other private firms and federal agencies to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

“In creating a vaccine portfolio for Operation Warp Speed, the Trump Administration is increasing the likelihood that the United States will have at least one safe, effective vaccine by 2021,” HHS Secretary Alex Azar said in the announcement.

“Today’s investment represents the next step in supporting this vaccine candidate all the way from early development by Moderna and the National Institutes of Health, through clinical trials, and now large-scale manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.

The agreement also includes fill-finish manufacturing in US-based facilities, HHS said. 

This type of manufacturing step ensures vaccine doses are packaged and ready to ship immediately once a vaccine shows success in clinical trials.

The vaccine doses will be distributed as part of a COVID-19 vaccination campaign once FDA authorizes use, which is outlined in its guidance.

Under the COVID-19 vaccination campaign, mRNA-1273 would be available to the American people at no cost. But generally, government-purchased vaccines allow healthcare professionals to charge for the cost of administering the vaccine.

At the beginning of July, FDA issued guidance to assist sponsors with COVID-19 vaccine development and licensure of their products. The guidance will be effective for the remainder of the pandemic.

FDA’s first general consideration is that the COVID-19 vaccines licensed in the US must meet the statutory and regulatory requirements for vaccine development and approval, including for quality, development, manufacture, and control.

Additionally, COVID-19 vaccine development may be accelerated based on knowledge gained from similar products manufactured with the same well-characterized platform technology.

FDA also noted that facilities must be of suitable construction to facilitate operations and should be able to handle cross-contamination and mix-ups. Clinical development programs for COVID-19 vaccines might be expedited by seamless clinical trial design, the agency stated.

The Biomedical Advanced Research and Development Authority also collaborated with the DoD Joint program executive office for chemical, biological, radiological, and nuclear defense and army contracting command.

Together, the organizations will provide up to $1.5 billion to manufacture and deliver vaccine doses to government-designated locations across the country.

BARDA has supported phase 2/3 clinical trials, vaccine manufacturing scale up and other development activities for mRNA-1273. The Phase 3 clinical trial, which began July 27, is the first government-funded Phase 3 trial for a COVID-19 vaccine in the United States.

“The launch of this Phase 3 trial in record time while maintaining the most stringent safety measures demonstrates American ingenuity at its best and what can be done when stakeholders come together with unassailable objectivity toward a common goal,” Francis S. Collins, MD, PhD, director of NIH, said in a press release.