FDA Panel Votes to Recommend Pfizer-BioNTech COVID-19 Vaccine in Children 5 to 11 Years of Age

No timetable was set for the FDA to decide on an official EUA designation for the Pfizer-BioNTech vaccine in children 5 to 11 years of age, however a decision is expected within the next few days.

The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted to recommend the Pfizer-BioNTech vaccine for children 5 to 11 years of age.

The panel voted on whether the totality of scientific evidence available shows the benefits of the Pfizer-BioNTech COVID-19 vaccine outweighing its risk for use in children 5-11 years of age when administered as a 2-dose series—10 µg each dose, 3 weeks apart. The vote was 17-0 in favor with 1 member voting to abstain. The VRBPAC recommendation is expected to facilitate younger children being able to obtain the first series of COVID-19 vaccines for the first time.

“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,” said Kathrin U. Jansen, PhD, senior vice president and head of Pfizer Vaccine Research & Development, in a press release. “COVID-19 is an ongoing threat for the more than 28 million young children in this age group in the US, as they remain at risk for this infection. About 10% of all weekly US 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 (EUA) to help protect this young population.”

No timetable was set for the FDA to decide on an official EUA designation, however a decision is expected within the next few days, according to Pfizer.

The committee evaluated results from a phase 2/3 randomized, controlled trial that included ~4500 children 5 to <12 years of age (2268 from the original group and 2379 from the supplemental safety group). Children in the trial received a 2-dose regimen of 10-µg doses administered 21 days apart, one-third of the 30-µg dose currently used for individuals 12 years of age and older.

According to Pfizer, the dose level was selected for use in the trial based on safety, tolerability, and immunogenicity data reviewed as part of a dose-ranging study. The phase 2/3 trial illustrated a favorable safety profile and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose, according to Pfizer. A Data Monitoring Committee evaluated the data and did not identify any serious safety concerns related to the vaccine, according to Pfizer.

“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,” Özlem Türeci, MD, co-founder and chief medical officer of BioNTech, said in a press release. “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.”

There were no cases of severe COVID-19 and no cases of MIS-C reported as of the 3-month follow-up period after the second vaccine dose. The reactogenicity profile of this patient population was mild to moderate, with most events reported 1-2 days after vaccination before disappearing soon thereafter. The most common adverse events (AEs) were injection site pain, fatigue, headache, muscle pain, and chills. No serious AEs related to the vaccine were reported.

If an EUA is granted and the CDC Advisory Committee on Immunization Practices issues a recommendation, the Pfizer-BioNTech vaccine will become the first COVID-19 vaccine available for use in this age group in the United States. The companies expect to begin shipping pediatric vaccine doses immediately, as directed by the US government, according to Pfizer.

Initial data from a clinical trial of the vaccine in children 2 to <5 years of age and in those 6 months to <2 years of age are expected as soon as late 2021 or early 2022, according to Pfizer.

Reference

Fda Advisory Committee Votes in Favor of Granting Emergency Use Authorization For The Pfizer-Biontech Covid-19 Vaccine In Children 5 To <12 Years. Pfizer; October 26, 2021. Accessed October 26, 2021. https://www.pfizer.com/news/press-release/press-release-detail/fda-advisory-committee-votes-favor-granting-emergency-use