The Wall Street Journal reported that the U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) reached a $1.95 billion deal with Pfizer and BioNTech SE to purchase 100 million doses of their experimental coronavirus vaccine, also known as BNT162, if it receives Emergency Use Authorization (EUA) or it meets U.S. Food and Drug Administration (FDA) standards and receives its approval. The agreement also allows the government to obtain an additional 500 million doses.
The American pharmaceutical giant and German biotechnology company have been working together to develop the vaccine using BioNTech’s proprietary mRNA technology and Pfizer’s global vaccine development and manufacturing capabilities. In a press release, Pfizer said that the companies "remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021."
The vaccine would be free to Americans but health care providers could charge to administer it.
Dr. Albert Bourla, Pfizer's Chairman and CEO said, "We’ve been committed to making the impossible possible by working tirelessly to develop and produce in record time a safe and effective vaccine to help bring an end to this global health crisis. We made the early decision to begin clinical work and large-scale manufacturing at our own risk to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted. We are honored to be a part of this effort to provide Americans access to protection from this deadly virus.”
The deal falls in line with the government's Operation Warp Speed (OWS), which was announced by President Trump on May 15, 2020, and is led by HHS Secretary Alex Azar and Defense Secretary Mark Esper. OWS is a private-public partnership among HHS, DoD, FDA, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA), private firms, and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. According to HHS's website, its mission is "to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures)." Congress approved $10 billion to fund OWS as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
In addition to striking an agreement with Pfizer, the Trump Administration selected and provided funding four other candidates--Moderna Inc, AstraZeneca Plc, Johnson & Johnson, and Merck & Co Inc-- to develop COVID-19 vaccines.
HHS Secretary Alex Azar said regarding the Pfizer-BioNTech agreement, “Through Operation Warp Speed, we are assembling a portfolio of vaccines to increase the odds that the American people will have at least one safe, effective vaccine as soon as the end of this year. Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of a vaccine being developed by Pfizer and BioNTech.”
DoD reported that senior administration officials said that while the timeline to find a COVID-19 vaccine has shortened due to advances in vaccine research and development, the science will not be compromised. "The return on this investment to our country in terms of lives saved and economic confidence is far greater than that of any single vaccine developer. So while we'll be lowering the financial risk for these companies, we will not be lowering any standards of development, safety, and efficacy."
Looking ahead, senior administration officials also noted a tiered approach to the vaccine's distribution, which would be similar to the way the influenza vaccine is deployed, beginning with the elderly, those with preexisting health conditions, and essential workers.
In an interview reported by WSJ, Pfizer Chief Business Officer John Young said, “We’re bringing all the resources to bear that we possibly can to try and be a part of a solution to what is a global pandemic.”