The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted 17 to 0, with 1 abstention, in favor for the FDA to grant Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine in children 5 to <12 years of age.
VRBPAC is a group of independent scientists who advise the FDA on scientific and regulatory issues, such as vaccine safety and efficacy evaluations. The committee has examined all of the scientific information presented by the companies, including the outcomes of a Phase 2/3 randomized, controlled study involving 4,500 children aged 5 to 12. (2,268 from the original group and 2,379 from the supplemental safety group). Participants in this age cohort were given a two-dose regimen of 10-g doses administered 21 days apart, which was one-third of the 30-g dosage assigned to those aged 12 and above.
Clinical data shows a high vaccine efficacy of 90.7% in children 5 to <12 years of age
Based on findings from a dose-ranging research, the dosage level was carefully chosen for use in the study. In individuals without past SARS-CoV-2 infection, the Phase 2/3 study revealed a satisfactory safety profile, significant immune responses, and a vaccination effectiveness rate of 90.7%, evaluated 7 days after the second dose. The data has been examined by the study’s Data Monitoring Committee, and no serious safety concerns about the vaccination have been detected.
Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer stated:
“We appreciated the opportunity to present our clinical data demonstrating the safety and high efficacy of our COVID-19 vaccine in children 5 to under 12 years of age. COVID-19 is an ongoing threat for the more than 28 million young children in this age group in the U.S., as they remain at risk for this infection. About 10% of all weekly U.S. cases occur in children 5 to under 12 years of age with a potential risk of complications. In addition, immunizing children will help to get us closer to herd immunity, with the potential to stem the pandemic sooner. We thank the FDA advisory committee for their review and positive recommendation in support of Emergency Use Authorization to help protect this young population.”
Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech said:
“We are committed to support the ongoing efforts to reduce infections and COVID-19 cases around the world by expanding the population of people protected against COVID-19. The clinical data reviewed underline that our vaccine induces a strong immune response in children when Delta was the prevalent strain and thus may contribute to help address this public health crisis.”
In the coming days, the FDA is expected to reach a decision. The Pfizer-BioNTech COVID-19 Vaccine will be the first COVID-19 vaccine accessible in the United States if approved and advised by the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC). Following that, the plan is to distribute vaccine doses as soon as possible, as required by the US government and in accordance with the US government’s commitment to continue the free access to COVID-19 vaccine to eligible US residents.