President Trump continues to lead the conversation on the issue of the Corona Virus and the development of a vaccine. They would like to have a vaccination available to the public before the end of 2020.
The Department of Defense (DoD) and the U.S. Department of Health and Human Services (HHS) said they have reached an agreement with Moderna to manufacture and deliver 100 million doses of the company’s Corona Virus vaccine candidate, even as clinical trials are still underway.
The government also has the ability to acquire up to an additional 400 million doses of the vaccine. Although it isn’t clear where those vaccines may be used.
Manufacturing in parallel with clinical trials expedites the traditional vaccine development timeline. This builds 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.
If the U.S. Food and Drug Administration (FDA) authorizes use as outlined in agency guidance, the vaccine doses would be distributed and used as part of a vaccination campaign.
Alex Azar, HHS Secretary, said: “In creating a vaccine portfolio for Operation Warp Speed (OWS) the Trump Administration is increasing the likelihood that the United States will have at least one safe, effective vaccine by 2021.”
“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.”
Operation Warp Speed was previously authorized to create 500 million “doses” or syringes of the vaccine for a population of 327 million in the U.S.
It still isn’t known if the vaccine will be mandatory or compelled for other services. Or why 500 million doses need to be created for a population of 327 million.
If these doses are used as part of a vaccination campaign, the vaccine would be available to the American people at no cost. Although healthcare professionals could charge for the cost of administering the vaccine, which is customary with government-purchased vaccines.
The vaccine project includes fill-finish manufacturing in U.S.- based facilities. This step of fill-finish manufacturing ensures the vaccine doses are packaged and ready to ship immediately. It also supports keeping the manufacturing process within the U.S. instead of other countries that do not have our best interests in mind. The vaccine is subject to a successful completion of clinical trials and FDA authorization.
The vaccine which is called mRNA-1273 has been co-developed by Moderna and scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Support for the vaccine’s development has been supported by NIAID, including nonclinical studies and clinical trials.
The Biomedical Advanced Research and Development Authority (BARDA )is a part of the HHS Office of the Assistant Secretary for Preparedness and Response. They collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRN) and the Army Contracting Command providing up to approximately $1.5 billion to manufacture and deliver the vaccine doses to various government-designated locations around the country.
BARDA has supported phase 2/3 clinical trials, vaccine manufacturing scale up and other development activities for this vaccine. On July 27, the phase 3 clinical trial began. It is the first government-funded Phase 3 clinical trial for a COVID-19 vaccine in the United States.
Operation Warp Speed (OWS) is a partnership among components of the Department of Health and Human Services and the Department of Defense. They are also engaging with private firms and other federal agencies coordinating with existing HHS-wide efforts. These efforts include the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
The mission of HHS is to enhance and protect the health and well-being of all Americans, providing for effective health and human services They also foster advances in medicine, public health, and social services.
The mission of Assistant Secretary of Preparedness Response (ASPR) is to save lives and protect Americans from 21st century health security threats.
Within ASPR it is BARDA that invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures. This includes all the vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. So far, BARDA-supported products have achieved 55 FDA approvals, licensures or clearances.
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. The goal of JPEO-CBRND is enabling the Joint Force to fight and win unencumbered by CBRN threats.
JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions. They focus on vaccines, therapeutics, and diagnostics designed to combat CBRN and emerging threats such as COVID-19.