FEBRARUY 12, 2021 – The U.S. Department of Health and Human Services (HHS) and Department of Defense (DOD) have purchased an additional 100 million doses of COVID-19 vaccines from both Pfizer Inc. and Moderna Inc. to help meet demand for COVID-19 vaccines in the United States.
The orders placed today bring the vaccine purchased by the U.S. government from these two companies to a total of 600 million doses, enough to vaccinate 300 million people. Each company is delivering 300 million doses in regular increments through the end of July 2021. Each company will leverage U.S.-based manufacturing capacity to fill, finish and ship vials as the bulk material is produced.
“As the President directed, we are expanding our supply of COVID vaccines to protect people as quickly as possible,” said Acting HHS Secretary Norris Cochran. “These purchases will allow us to accelerate our vaccination efforts to get shots into the arms of the American people. While we rapidly ramp up the pace of vaccinations, I encourage everyone to take actions now to protect themselves and their families: wear a mask, wash your hands often, and practice physical distancing.”
The companies began manufacturing doses of their vaccines at the same time that clinical trials were getting underway last year. Beginning the complex process of scaling up to large-scale manufacturing in parallel with clinical trials expedited the traditional vaccine development timeline so that initial doses could begin shipping when the U.S. Food and Drug Administration (FDA) granted emergency use authorization.
The vaccine is available at no cost. Vaccine administration costs for private-sector administration partners are being covered by healthcare payers: private insurance, Medicare or Medicaid, and an HHS program to cover COVID-19 costs for the uninsured which is reimbursing providers at Medicare rates from the Provider Relief Fund.
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 (JPEO-CBRND) and Army Contracting Command to provide approximately $2 billion for the additional doses of the Pfizer-BioNTech vaccine, bringing the total purchase from Pfizer to approximately $6 billion.
BARDA, JPEO-CBRND and Army Contracting Command also collaborated to provide up to approximately $1.65 billion to Moderna, bringing the total federal investment in Moderna’s vaccine development, clinical trials, manufacturing and purchase to approximately $5.75 billion. Moderna’s vaccine was co-developed with 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.
Moderna’s Phase 3 clinical trial began July 27 as 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, reduced the severity of illness in the small percentage of volunteers who contracted COVID-19, and was generally well tolerated.
The Phase 3 clinical trial for the Pfizer-BioNTech vaccine enrolled approximately 43,000 adult volunteers in the U.S. who did not have COVID-19. The clinical trial showed that the vaccine was safe, prevented disease in approximately 95 percent of the volunteers who received the vaccine, reduced the severity of illness in the five percent of volunteers who contracted COVID-19 and was generally well-tolerated.
The clinical studies of both vaccines are ongoing to gather additional data such as the vaccines’ efficacy in younger populations, the duration of immunity after vaccination, and the impact of vaccination on transmissibility of the virus.
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.
HHS and DOD have contracted with four other companies to expedite development and production of vaccines that use a variety of vaccine platform technologies and are manufacturing COVID-19 vaccine doses while clinical trials are underway. If any of these other vaccine candidates are authorized by the FDA for emergency use, HHS and DOD can negotiate agreements with the respective companies to purchase additional vaccine doses to meet the demand in the United States.