Moderna will manufacture doses of its experimental coronavirus disease 2019 vaccine candidate as clinical trials are ongoing to expedite the production process.
Today, the Department of Health and Human Services (HHS) and Department of Defense (DoD) announced a deal with Moderna, Inc, to manufacture and deliver 100 million doses of the manufacturer’s novel COVID-19 vaccine candidate.
Moderna will manufacture these vaccine doses, which will be owned by the US government, as clinical trials are conducted simultaneously. In a press release, the DoD and HHS said that manufacturing the vaccine while clinical trials are ongoing will expedite the traditional development timeline.
If the vaccine doses are used as part of a COVID-19 vaccination campaign, it would be available to Americans at no cost; however, health care providers may charge for the cost of administering the vaccine, according to the HHS.
This initiative will also bolster the US government’s Operation Warp Speed, which aims to begin delivering safe and effective COVID-19 vaccines to the US population by the end of 2020.
“In creating a vaccine portfolio for Operation Warp Speed, the Trump Administration is increasing the likelihood that the United States will have at least 1 safe, effective vaccine by 2021,” said HHS Secretary Alex Azar, in a press release. “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.”
Should the vaccine be approved by the FDA, doses of the vaccine will be distributed and administered as part of a COVID-19 vaccination campaign, according to the press release.
The Biomedical Advanced Research and Development Authority worked in conjunction with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command to provide up to approximately $1.5 billion in funding to produce and deliver the vaccine to government-designated locations across the country, the agencies stated in a press release. Additionally, the US government can acquire up to 400 million additional doses of the vaccine.
The agencies also announced that fill-finish manufacturing will be conducted in US-based facilities, which will ensure the vaccine doses are packaged and ready to ship immediately, subject to successful clinical trials and FDA authorization.
In May, Moderna, Inc, announced a collaboration with Lonza Ltd, to manufacture the mRNA vaccine (mRNA-1273) candidate, for immunization against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), on a larger scale.
Over time, the companies plan to maintain additional production sites at Lonza’s facilities internationally, which should allow for the companies to develop to up to 1 billion doses of mRNA-1273 per year, they announced in a press release.
The mRNA-1273 vaccine was selected by Moderna in collaboration with investigators from Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health (NIH). The first clinical batch was finished on February 7, 2020, and underwent analytical testing at that time. That first batch was then shipped to NIH on February 24, which was 42 days following the sequence selection.
Moderna submitted an Investigational New Drug application to the FDA for phase 2 and late stage studies of mRNA-1273 on April 27, 2020.
A phase 3 clinical trial that began on July 27 is the first government-funded phase 3 clinical trial for a COVID-19 vaccine in the United States.