US Secures Deal with Pfizer, BioNTech for 100 Million Doses of COVID-19 Vaccine Candidate

As part of a national effort to ramp up the development of a coronavirus disease 2019 (COVID-19) vaccine, the US government agreed to pay $1.95 billion for the first 100 million doses of Pfizer and BioNTech’s investigational candidate following FDA approval, according to a press release.¹

The candidate, named BNT162, is the latest in a portfolio of vaccines receiving investments from the Biomedical Advanced Research and Development Authority (BARDA) through Operation Warp Speed. The goal of the program is to begin delivering 300 million doses of a COVID-19 vaccine to Americans by the end of 2020.²

Under the agreement, the United States can also acquire up to an additional 500 million doses of the BNT162, Pfizer announced.¹

“Expanding Operation Warp Speed’s diverse portfolio by 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,” Department of Health and Human Services (HHS) Secretary Alex Azar said in a statement.¹ “Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of this vaccine to the American people.”

Related: HHS Invites NACDS to Join Federal Vaccine Consultation Panel

If approved, Americans will be able to receive the vaccine for free, according to HHS.²

The United States has already ordered other COVID-19 vaccine candidates, including AZD1222, which is being co-developed by the University of Oxford and AstraZeneca. The first doses are expected to be delivered as early as October 2020, according to HHS. Other investments include vaccine candidates being developed by Johnson & Johnson, Novavax, and Moderna.

Pfizer and BioNTech’s vaccine development program includes at least 4 experimental vaccines in total, which represents a unique combination of messenger RNA (mRNA) format and target antigen.¹ Two of these candidates, BNT162b1 and BNT162b2, received Fast Track designation from the FDA based on preliminary data from phase 1/2 studies that are currently ongoing.

BNT162 must first prove safe and effective in a large phase 3 trial and receive regulatory approval. Pfizer and BioNTech hope to start phase 2b/3 trials in late July with an anticipated enrollment of 30,000 participants. If the ongoing studies are successful, Pfizer and BioNTech anticipate to seek Emergency Use Authorization or some form of regulatory approval as early as October 2020. The companies 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, according to Pfizer.¹

References

1. Pfizer and BioNTech Announce An Agreement With US Government for Up to 600 Million doses of MRNA-Based Vaccine Candidate Against SARS-CoV-2. News Release. Pfizer; Accessed July 22, 2020. Published July 22, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-agreement-us-government-600

2. US Government Engages Pfizer to Produce Millions of Doses of COVID-19 Vaccine. News Release. HHS; Accessed July 22, 2020. Published July 22, 2020. https://www.hhs.gov/about/news/2020/07/22/us-government-engages-pfizer-produce-millions-doses-covid-19-vaccine.html