The US FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 0 (with 1 abstention) to recommend the emergency use of the Pfizer/BioNTech COVID-19 vaccine (brand name Comirnaty) in children 5 to <12 years of age.

According to Pfizer, the FDA is expected to make a decision on emergency use of the vaccine in this age group “in the coming days.” If authorized and subsequently recommended by the US CDC Advisory Committee on Immunization Practices (ACIP), the Pfizer-BioNTech COVID-19 Vaccine will be the first COVID-19 vaccine available for use in children 5 to <12 years of age in the US.

VRBPAC reviewed the totality of scientific evidence shared by the companies, including results from a Phase 2/3 randomized, controlled trial that included ~4,500 children 5 to <12 years of age (2,268 from the original group and 2,379 from the supplemental safety group). Participants in this age group received a two-dose regimen of 10-µg doses administered 21 days apart, one-third of the 30-µg dose used for people 12 years and older. This dose level was carefully selected for use in the trial based on safety, tolerability and immunogenicity data evaluated as part of a dose-ranging study. The Phase 2/3 trial showed a favorable safety profile, robust immune responses and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose. The Data Monitoring Committee for the study has reviewed the data and has not identified any serious safety concerns related to the vaccine.

If authorized, the companies expect to begin shipping pediatric vaccine doses immediately. Eligible US residents will continue to receive the vaccine for free, consistent with the US government’s commitment to free access to COVID-19 vaccines, according to Pfizer.

The companies also announced the federal government has purchased an additional 50 million doses of Comirnaty to support preparedness for pediatric vaccinations, “including securing vaccines for children under 5 years of age, should they receive regulatory authorization,” according to Pfizer. The companies expect to deliver all these doses by April 30, 2022.

With this order, the U.S. government has exercised its final purchase option under its existing US 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 US 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 US 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 US 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.”