Pfizer and BioNTech announced Wednesday that the US government agreed to pay $1.95 billion for an initial order of 100 million doses of BNT162, an mRNA-based COVID-19 vaccine candidate being jointly developed by the companies. Under the deal, the government can also acquire up to 500 million more doses.
The agreement with the Department of Health and Human Services (HHS) and the Department of Defense is part of efforts to meet the government's Operation Warp Speed programme, under which multiple COVID-19 vaccines are being developed simultaneously, with the goal of beginning to deliver 300 million doses of a vaccine to Americans in 2021. HHS Secretary Alex Azar remarked that "adding a vaccine from Pfizer and BioNTech increases the odds that we will have a safe, effective vaccine as soon as the end of this year."
Depending on if the vaccine succeeds in clinical testing, and then secures eventual approval, it would be available to Americans for free. Pfizer would begin nationwide delivery of the vaccine doses to locations "at the US government's direction," beginning in the fourth quarter of 2020, according to HHS. Speaking before a US Congressional panel earlier this week, an executive at Pfizer said individuals would not have to pay anything toward the cost of the company's COVID-19 vaccine, but he did not give details on how much governments or insurers would be charged, indicating that the price would reflect the "extraordinary times" of the pandemic.
"We are also in advanced discussions with multiple other government bodies and we hope to announce additional supply agreements soon," noted Ugur Sahin, CEO at BioNTech. The companies say they are on track to launch a Phase IIb/III trial later this month and to seek regulatory review as early as October. They currently expect to manufacture "globally up to 100 million doses by the end of 2020," and potentially ramping that up to more than 1.3 billion doses by the end of next year.
Pfizer and BioNTech recently reported data from both the US and German cohorts of an ongoing Phase I/II study showing that BNT162b1, the most advanced of four COVID-19 vaccine candidates being developed as part of their BNT162 mRNA-based vaccine programme, was able to stimulate immune responses in healthy volunteers. BNT162b1, as well as BNT162b2, another vaccine candidate in the programme, recently received fast-track designations from the FDA.
Meanwhile, in May, the Biomedical Advanced Research and Development Authority, an office within HHS, also agreed to supply $1.2 billion in funding to secure at least 300 million doses of AstraZeneca and the University of Oxford's COVID-19 candidate vaccine AZD1222, starting as early as October.
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