The U.S. purchased the additional doses of the vaccine in its effort to support preparedness for pediatric vaccinations as it seeks authorization for use in younger adolescents and children.
Earlier this month, Pfizer submitted a request to the FDA to expand the authorization of their COVID-19 vaccine, which has full FDA approval for people 16 years of age and older, in children aged 5 to 11. It received emergency use authorization (EUA) for adolescents aged 12 to 15 in May.
Last week, the company announced that the vaccine was 90.7% effective at protecting against symptomatic COVID-19 in children ages 5 to 11 and, earlier this week, FDA’s Vaccines and Related Biological Products Advisory Committee endorsed the vaccine for that age group.
According to a news release, the U.S. bought the doses to not only support the pediatric vaccinations but to secure vaccines for children under five years of age, should that age group receive regulatory authorization. Pfizer and BioNTech expect to deliver all of the 50 million doses by April 30, 2022.
The order is an exercise of the U.S. government’s final purchase option under its existing supply agreement with Pfizer and BioNTech, meaning the total amount of COVID-19 vaccine doses secured under the agreement is now at 600 million. Separately, the companies 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,” Pfizer Chairman & CEO Albert Bourla said in the release. “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,” added BioNTech CEO & Co-Founder Ugur Sahin. “We would like to thank the U.S. government for its trust in us and our vaccine.”
Filed Under: Drug Discovery, Drug Discovery and Development, Infectious Disease