The U.S. Department of Health and Human Services and Department of Defense, 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.
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Under the agreement, Moderna will leverage its U.S.-based manufacturing capacity to fill, finish and ship vials of the vaccine as the bulk material is produced. The additional doses ordered are projected to provide for continuous delivery through the end of June 2021, and are intended to help meet the anticipated demand and safely accelerate the delivery schedule for the 200 million doses the U.S. government is purchasing.
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 vaccines to people by the end of the year.
WHAT'S THE IMPACT?
The Biomedical Advanced Research and Development Authority, part of the HHS Office of the Assistant Secretary for Preparedness and Response, now has collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command to provide up to $3.2 billion to expand the manufacturing capacity reserved for mRNA-1273 and deliver the vaccine doses to government-designated locations across the country.
This federal funding brings the total provided to Moderna for this vaccine, including 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 codeveloped 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 and 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 about 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% 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 the 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, 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 of the vaccine to meet demand.
THE LARGER TREND
Distribution of the Pfizer/BioNTech vaccine began in the United States this morning and has already begun in the United Kingdom, with a focus on inoculating healthcare workers. While those with a significant history of allergic reactions have had adverse reactions to the vaccine, the effect is mild on most people and is compared to the feeling one gets after receiving a flu shot.
As a vaccine becomes available, more than a third of adults say they are unwilling to take it, according to the private nonprofit Employee Benefit Research Institute and independent research firm Greenwald Research, which released their annual Consumer Engagement in Health Care Survey.
The CEHCS found that only 55% of the adult population was willing to receive a COVID-19 vaccine, and 24% said they would not get the vaccine. Nine percent said that it depends, and 12% were unsure.
ON THE RECORD
"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."