Dec. 23, 2020
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 from Pfizer.
On Dec. 11, the U.S. Food and Drug Administration (FDA) authorized the vaccine for emergency use and doses began shipping immediately. The vaccine is being provided at no cost to Americans. Vaccine administration costs for private-sector administration partners are covered by healthcare payers: private insurance, Medicare or Medicaid, and HHS’s 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, Pfizer will manufacture and deliver up to 100 million doses of its SARS-CoV-2 vaccine, BNT162b2, to Government designated locations. Under the terms of the agreement, Pfizer will deliver at least 70 million doses by June 30, 2021, with the balance of the 100 million doses to be delivered no later than July 31, 2021.
The additional doses ordered today provide for a seamless transition from the first 100 million doses contracted earlier this year. This represents successful implementation of the U.S. government’s overall strategy to ensure continued availability of safe and effective SARS-CoV-2 vaccines to Americans. This strategy began in spring 2020 with Operation Warp Speed (OWS) planning and has been consistent in all initial OWS contracts and agreements with industry partners supporting large scale manufacturing of SARS-CoV-2 vaccines.
Today’s agreement also includes options for an additional 400 Million doses of the Pfizer vaccine. As part of ongoing coordination, the government and Pfizer are also continuing to discuss potential approaches to further strengthen our partnership and safely expand output and accelerate production.
“Securing more doses from Pfizer and BioNTech for delivery in the second quarter of 2021 further expands our supply of doses across the Operation Warp Speed portfolio,” said HHS Secretary Alex Azar. “This new federal purchase can give Americans even more confidence that we will have enough supply to vaccinate every American who wants it by June 2021.”
The agreement announced today brings the total doses of Pfizer’s vaccine purchased by the federal government to 200 million. Pfizer began manufacturing the first 100 million doses while clinical trials were 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. This goal has been achieved with the initial distribution of the Pfizer vaccine beginning immediately after the Food and Drug Administration granted Emergency Use Authorization (EUA).
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 (JPEO-CBRND) and Army Contracting Command - New Jersey to provide Pfizer approximately $4B total for the delivery of 200 million doses of the vaccine to Government-designated locations across the country.
The Pfizer vaccine was developed using messenger RNA, also called mRNA; mRNA 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.
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.
Posts
No comments:
Post a Comment