The companies plan to submit these data to the FDA in the coming days for an Emergency Use Authorization of a booster dose for children ages 5 through 11 in the United States.
New data from a subanalysis of 30 sera from a phase 2/3 clinical trial of children aged 5 through 11 years show a 36-fold increase in SARS-CoV-2 Omicron neutralizing titers following a booster dose of the Pfizer-BioNTech COVID-19 vaccine.1
According to the study, the phase 2/3 trial included 140 children who received a booster dose, which increased neutralizing antibodies by 6-fold against the SARS-CoV-2 wild-type strain in this age group. These data reinforce the potential function of a third dose of the vaccine in maintaining high levels of protection against the virus in this age group. Furthermore, a robust response was observed regardless of prior SARS-CoV-2 infection.1
The phase 1/2/3 trial initially enrolled up to 4500 children aged 6 months to under 12 years in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. Additional children have been enrolled in all age groups following study amendments and the trial currently includes more than 10,000 children.1
The trial was originally designed to evaluate the safety, tolerability, and immunogenicity of the vaccine on a 2-dose schedule approximately 21 days apart and in 3 age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years. Children ages 5 to under 12 years received 2 doses of 10 µg each whereas children under age 5 received a lower 3 µg dose for each injection.1
A primary series of 2 10-µg doses was previously authorized under Emergency Use Authorization (EUA) for children ages 5 to less than 12 in October 2021. A third primary dose is authorized by the FDA for individuals 5 years of age and older with certain kinds of immunocompromise.
In these new data, the vaccine was well tolerated with no new safety signals. Adverse effects can include injection site pain, tiredness, headache, muscle pain, joint pain, fever, and nausea. The companies plan to submit these data to the FDA in the coming days for an EUA of a booster dose for children ages 5 through 11 in the United States.1
Pfizer and BioNTech Announce Data Demonstrating High Immune Response Following a Booster Dose of their COVID-19 Vaccine in Children 5 Through 11 Years of Age. News release. Pfizer; April 14, 2022. Accessed April 14, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-data-demonstrating-high-immune