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Pfizer-BioNTech vaccine seeks FDA approval for use in children, 5 to 11
Data on a vaccine dose of 1/3 the strength of that normally given to adults, made by Pfizer-BioNTech, is being submitted to the U.S. Food and Drug Administration (FDA) from the Phase 2/3 trial of their COVID-19 vaccine in children 5 to <12 years of age. The company said they are ready to ship the vaccine as soon as approval has been received.
The companies announced positive topline results from the pivotal trial on September 20, 2021. In the trial, which included 2,268 participants 5 to <12 years of age, the vaccine demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses. These results – the first from a pivotal trial of any COVID-19 vaccine in this age group – were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 μg doses. The 10 μg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to <12 years of age.
These data have been shared with the FDA for the Agency’s initial review. A formal submission to request Emergency Use Authorization (EUA) of the companies’ COVID-19 vaccine in children 5 to <12 years of age is expected to follow in the coming weeks. Submissions to the European Medicines Agency (EMA) and other regulatory authorities are also planned.
Topline immunogenicity and safety readouts for the other two age cohorts from the trial – children 2 to <5 years of age and children 6 months to <2 years of age – are expected as soon as the fourth quarter of this year.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.
About the Phase 1/2/3 Trial in Children
The Phase 1/2/3 trial initially enrolled up to 4,500 children ages 6 months to <12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. It was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to <12 years; ages 2 to <5 years; and ages 6 months to <2 years. Based on the Phase 1 dose-escalation portion of the trial, children 5 to <12 years of age received a two-dose schedule of 10 μg each while children under age 5 received a lower 3 μg dose for each injection in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.
COMIRNATY® U.S. Indication & Authorized Use
HOW IS THE VACCINE GIVEN?
The vaccine will be given to you as an injection into the muscle.
Primary Series: The vaccine is administered as a 2-dose series, 3 weeks apart. A third dose may be administered at least 4 weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise.
What is the current use?
The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably. Although they may be manufactured in different facilities, the products offer the same safety and effectiveness.
- COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
- It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older.
- It is also authorized under EUA to be administered to provide:
- a two-dose primary series in individuals 12 through 15 years;
- a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise; and
- a single booster dose in individuals:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID‑19
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:
- a two-dose primary series in individuals 12 years of age and older;
- a third primary series dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise; and
- a single booster dose in individuals:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID‑19
The American Association of Pediatrics provides this information for parents on vaccines for COVID: