Pfizer, BioNTech to provide additional 50 Million Pediatric doses of COVID-19 Vaccine to US

With this order, the U.S. government has exercised its final purchase option under its existing U.S. supply agreement with the companies, bringing the total number of Pfizer-BioNTech COVID-19 Vaccine doses secured under the agreement since the start of the pandemic to 600 million – spanning doses for adults and adolescents, and children. Separately, Pfizer and BioNTech have agreed to provide a total of 1 billion doses to the U.S. government at a not-for-profit price for donation to low- and lower-middle-income countries.

"We are extremely proud to provide enough doses of our vaccine to help protect every U.S. child under 12 from COVID-19, if authorized by the FDA," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "As we await the agency's review of our application for emergency use of the vaccine in children 5 to under 12 years of age, and clinical trial results in children under 5, we are working with the U.S. government to help ensure communities across the country have access to pediatric doses as soon as possible. The introduction of doses for young children will be another critical milestone in addressing this public health crisis."

"From the very beginning, it has been our goal to provide access to a highly effective vaccine to as many people as possible. This supply agreement will help to offer a vaccine to all children younger than 12 years of age in the United States," said Ugur Sahin, CEO and Co-founder of BioNTech. "We would like to thank the U.S. government for its trust in us and our vaccine."

Pfizer and BioNTech submitted a request earlier this month to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization of their COVID-19 vaccine in children 5 to <12 years of age. The dosage strength for this age group (10 µg) was carefully selected as the preferred dose for safety, tolerability and immunogenicity, and differs from the dosage strength for individuals 12 years and older (30 µg). If authorized and subsequently recommended by the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), the companies expect to then begin shipping 10-µg pediatric doses immediately, as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government's commitment to free access to COVID-19 vaccines.

In addition to the U.S. FDA, the companies have submitted data to the European Medicines Agency to support the vaccination of children 5 to <12 years of age. Further submissions for this age group are planned or underway with other regulatory agencies around the world. Initial data from the other two age cohorts in the ongoing Pfizer-BioNTech clinical trial in children – those 2 to <5 years of age and those 6 months to <2 years of age – are expected as soon as fourth quarter 2021 or early first quarter 2022.