Data from the study shows a strong immune response in this age group following this dose, with no new safety signals.
Pfizer and BioNTech have applied to the FDA for emergency use authorization (EUA) of a 10-µg booster dose of their COVID-19 vaccine for children aged 5 to 11 years.
The submission included data from the phase 2/3 clinical trial for children in this age range who received a booster dose approximately 6 months after the second dose of the vaccine 10-µg 2-dose primary series, which was authorized under EUA for the same age group in October 2021.
The data from the study showed a strong immune response in this age group following a booster dose of the vaccine, with no new safety signals.
The phase 1/2/3 trial initially enrolled up to 4500 children, ranging from aged 6 months to 11 years in Finland, Poland, Spain, and the United States, in more than 90 clinical trial sites. Additional children were enrolled in all age groups following study amendments, and the trial currently includes more than 10,000 children.
The trial was designed to evaluate the immunogenicity, safety, and tolerability of the Pfizer-BioNTech COVID-19 vaccine on a 2-dose schedule, with the doses being approximately 21 days apart, in 3 age groups: aged 5 to 11 years: aged 2 to under 4 years; and aged 6 months to 1 year.
Based on the phase 1 dose-escalation portion of the trial, children aged 5 to 11 years old received a 2-dose series of 10-µg, while children younger than aged 5 years received a lower 3-µg dose for each injection in the phase 2/3 study.
In December 2021, the companies said that they would test a third 3-µg dose given at least 2 months after the second dose in children younger than aged 5 years and a third dose of 10-µg in children between aged 5 and 11 years.
The companies expect to share data from the ongoing study in children aged 6 months to 4 years later this quarter.
The companies also plan to submit these data to the European Medicine Agency and other regulatory agencies around the world for authorization in the coming weeks.
The vaccines, which is based on BioNTech’s mRNA technology, was developed by both companies.
BioNTech is the marketing authorization holder in Canada, the European Union, the United Kingdom, and the United States, and the holder of EUAs or equivalents in the United States, along with Pfizer.
Submissions to pursue regulatory approvals in those countries where EUAs or equivalent were initially granted are planned.
A booster dose of the vaccine is authorized in individuals aged 12 years or older who had a primary series of the Pfizer-BioNTech vaccine and individuals aged 18 years or older who completed a primary vaccination of a different vaccine.
A second booster does is authorized for individuals aged 50 years and older who have received the first dose of any authorized COVID-19 vaccine and for those age 12 years or older who are immunocompromised and received a first booster dose with any authorized COVID-19 vaccination.
Pfizer and BioNTech submit application for US emergency use authorization for a COVID-19 vaccine booster dose in children 5 Through 11 years of age. Pfizer. News release. April 26, 2022. Accessed April 27, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-application-us-emergency-use