The Trump Administration, through the U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD), will purchase an additional 100 million doses of COVID-19 vaccine candidate, called mRNA-1273, from Moderna.
If authorized by the U.S. Food and Drug Administration for emergency use as outlined in agency guidance, doses of the vaccine will begin shipping immediately. The vaccine would be provided at no cost to Americans. Vaccine administration costs for private-sector administration partners will be covered by healthcare payers: private insurance, Medicare or Medicaid, and an HHS program to cover COVID-19 costs for the uninsured which is reimbursing the provider at Medicare rates from the provider relief fund.
Under the agreement, Moderna will leverage its U.S.-based manufacturing capacity to fill, finish and ship vials of mRNA-1273 as the bulk material is produced. The additional doses ordered today provide for continuous delivery through the end of June 2021. This strategy will help meet the anticipated demand for mRNA-1273 and safely accelerate the delivery schedule for all 200 million doses the U.S. government is purchasing.
“Securing another 100 million doses from Moderna by June 2021 further expands our supply of doses across the Operation Warp Speed portfolio of vaccines,” said HHS Secretary Alex Azar. “This new federal purchase can give Americans even greater confidence we will have enough supply to vaccinate all Americans who want it by the second quarter of 2021.”
The purchase announced today brings the total doses of mRNA-1273 owned by the federal government to 200 million. Moderna began manufacturing the first 100 million doses while clinical trials were getting underway. Manufacturing in parallel with clinical trials expedited the traditional vaccine development timeline and built toward the U.S. government’s Operation Warp Speed goal to begin delivering safe and effective vaccines to the American people by the end of the year.
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, has now collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command to provide up to approximately $3.2 billion to expand the manufacturing capacity reserved for mRNA-1273 and to deliver the vaccine doses to government-designated locations across the country. This federal funding brings the total provided to Moderna for this vaccine, including vaccine development, clinical trials and manufacturing, to $4.1 billion. The government also has the option to acquire up to an additional 300 million doses of the Moderna vaccine.
The vaccine candidate was co-developed by Moderna and scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, with NIAID also supporting the vaccine’s nonclinical studies and clinical trials. BARDA supported phase 2/3 clinical trials, vaccine manufacturing scale up and other development activities for this vaccine.
The Phase 3 clinical trial, which began July 27, was the first government-funded Phase 3 clinical trial for a COVID-19 vaccine in the U.S. and enrolled approximately 30,000 adult volunteers who did not have COVID-19. An independent data safety monitoring board overseeing the Phase 3 clinical trial reviewed the trial data and concluded that the vaccine was safe, prevented disease in 94 percent of the volunteers who received the vaccine and was generally well tolerated. The clinical studies are ongoing.
Moderna is the second company to apply for FDA emergency use authorization of a coronavirus vaccine that uses messenger RNA (mRNA), and FDA has scheduled a Vaccines and Related Biological Products Advisory Committee meeting Dec. 17 to review the company’s request. Messenger RNA vaccines take advantage of the process that cells use to make proteins in order to trigger an immune response and build immunity to a virus. In contrast, most vaccines use weakened or inactivated versions or components of a disease-causing virus to stimulate the body’s immune response to create antibodies.
Under Operation Warp Speed, federal partners are working with multiple companies – Moderna, Pfizer, Janssen (Johnson&Johnson), AstraZeneca, Novavax, and Sanofi in collaboration with GSK – to develop vaccines that use a variety of vaccine platform technologies and manufacture the COVID-19 vaccine doses while clinical trials are underway. If any of these vaccine candidates are authorized by the U.S. Food and Drug Administration for emergency use, as outlined in agency guidance, HHS and DOD can negotiate agreements with the respective companies to purchase enough vaccine to meet demand in the United States.
About Operation Warp Speed
OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
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, BARDA-supported products have achieved 56 FDA approvals, licensures or clearances. 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 (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.