Pfizer, BioNTech Agree to Supply an Additional 100M doses of COVID-19 Vaccine to US

Pfizer and BioNTech have announced a second agreement with the US government to supply 100 million doses of BNT162b2 (Comirnaty), the companies’ vaccine against the coronavirus disease 2019 (COVID-19), from domestic production facilities. This agreement brings the total number of doses to be delivered to the United States to 200 million.¹

“With these 100 million additional doses, the United States will be able to protect more individuals and hopefully end this devastating pandemic more quickly,” Albert Bourla, CEO and chairman of Pfizer, said in a statement. “We look forward to continuing our work with the U.S. government and health care providers around the country.”¹

The companies expect to deliver the full 200 million doses to Operation Warp Speed by July 31, 2021. Consistent with the original agreement announced July 22, 2020, the US government will pay $1.95 billion for the additional 100 million doses.¹

“Securing more doses from Pfizer and BioNTech for delivery in the second quarter of 2021 further expands our supply of doses across the Operation Warp Speed portfolio,” said the US Department of Health & Human Services Secretary Alex Azar. “This new federal purchase can give Americans even more confidence that we will have enough supply to vaccinate every American who wants it by June 2021.”

Under the terms of the second agreement, the companies will deliver at least 70 million of the additional doses by June 30, 2021, with the remaining 30 million doses to be delivered no later than July 31, 2021. The government also has the option to acquire up to an additional 400 million doses of the Pfizer-BioNTech Vaccine.¹

In a statement, BioNTech CEO and co-founder Ugur Sahin, MD, said that the latest agreement with the US government sends a clear message of confidence and trust in the Pfizer-BioNTech COVID-19 vaccine, as well as the companies’ ability to deliver it.¹

“Our goal remains to bring a safe and effective COVID-19 vaccine to as many people as we can all around the world,” he said.¹

The FDA has not approved or licensed the Pfizer-BioNTech COVID-19 vaccine, but it is authorized to be administered under an emergency use authorization (EUA) for active immunization to prevent COVID-19, which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vaccine is indicated for use in individuals age 16 years and older.¹

The COVID-19 vaccine by Pfizer and BioNTech became the first to be granted EUA status by the FDA on December 12, 2020. A second vaccine against COVID-19 was granted EUA designation on December 19, 2020, for Moderna’s mRNA-1273.²

The availability of 2 COVID-19 vaccines is a crucial step in combating the global pandemic, which has caused a vast number of deaths and hospitalizations in the United States, according to FDA Commissioner Stephen M. Hahn, MD.²

“Through the FDA’s open and transparent scientific review process, 2 COVID-19 vaccines have been authorized in an expedited timeframe, while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA," he said in a December 18, 2020, statement. "These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts, as well as a thorough analysis of the data by the agency’s career staff.”²

Eligible US residents will continue to receive the companies’ vaccine for free, according to Pfizer and BioNTech.

The assertion is consistent with the US government’s commitment to providing free access for COVID-19 vaccines and, according to the CDC Advisory Committee on Immunization Practices (ACIP) recommendations, for the vaccine’s phased rollout.¹

References

• Pfizer and BioNTech to supply the U.S. with 100 million additional doses of COVID-19 vaccine. [news release]. New York, NY, and Mainz, Germany; December 23, 2020: Pfizer. Accessed December 23, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-supply-us-100-million-additional-doses
• Coppock K. FDA grants emergency use authorization to Moderna COVID-19 vaccine. Pharmacy Times^®. December 19, 2020. Accessed December 23, 2020. https://www.pharmacytimes.com/news/fda-grants-emergency-use-to-moderna-covid-19-vaccine