Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have entered an agreement with the US Department of Health and Human Services and the Department of Defense, in a deal worth up to $1.95 billion, to provide up to 600 million doses of their COVID-19 vaccine candidate as part of the US government’s Operation Warp Speed program, which seeks to deliver COVID-19 vaccines and treatments.

Under the agreement, the US government will receive 100 million doses of BNT162, the COVID-19 vaccine candidate being jointly being developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from the US Food and Drug Administration (FDA). The US government will pay the companies $1.95 billion upon receiving the first 100 million doses following FDA authorization or approval. The US government also can acquire up to an additional 500 million doses.

The Pfizer/BioNTech vaccine development program is evaluating at least four experimental COVID-19 vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen Earlier this month (July 2020), two of the companies’ four investigational vaccine candidates (BNT162b1 and BNT162b2) received fast-track designation from the FDA. Additionally, this week (July 20, 2020) Pfizer and BioNTech reported positive preliminary data from a Phase I/II COVID-19 study being conducted in Germany of BNT162b1, the most advanced of the company’s COVID-19 vaccines. Overall, the new preliminary data from the German study supports and expands upon recently disclosed promising early results from a corresponding US trial with BNT162b1.

Preliminary data from both the German and US Phase I/II studies, together with additional preclinical and clinical data being generated, will be used by the two companies to determine a dose level and select among multiple vaccine candidates to seek to progress to an anticipated large, global Phase IIb/III safety and efficacy trial. That trial may involve up to 30,000 healthy participants and is anticipated to begin in late July 2020, if regulatory approval is received.

If the ongoing studies are successful, Pfizer and BioNTech say they expect to be ready to seek emergency use authorization or some form of regulatory approval as early as October 2020. The companies currently expect to 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, subject to final dose selection from their clinical trial.

In addition to its supply pact with the US government, Pfizer and BioNTech announced an agreement with the UK to supply 30 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and regulatory approval. Financial details were not disclosed, but the terms were based on the timing of delivery and the volume of doses.

In addition to engagements with governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVID-19 Vaccine Global Access (COVAX) Facility, a mechanism established by Gavi, a global public health partnership, the Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases, and World Health Organization, which aims to provide governments with early access to a large portfolio of COVID-19 candidate vaccines using a range of technology platforms and produced by multiple manufacturers globally.

Source: Pfizer (US government), Pfizer (COVID-19 vaccine update), Pfizer (UK government) and BioNTech (US government), BioNTech (COVID-19 vaccine update) and BioNTech (UK government)