Pfizer and BioNTech announced Tuesday they have submitted data to the U.S. Food and Drug Administration (FDA) from the Phase 2/3 trial of their COVID-19 vaccine in children 5 to 11 years of age.
The vaccine makers plan to request Emergency Use Authorization from the FDA for this age group to receive the vaccine in the coming weeks. The FDA is expected to take several weeks to review the data from the trial that included more than 2,000 children. Submissions to the European Medicines Agency (EMA) and other regulatory authorities are also planned, Pfizer said.
“The FDA takes very seriously the importance of getting vaccines, shown to be safe and effective in children,” Dr. Anthony Fauci, the nation’s leading infectious disease expert, told MSNBC’s “Morning Joe” show. “I would imagine in the next few weeks they will examine that data and hopefully give the O.K. so we can start vaccinating children hopefully by the end of October.”
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Pfizer announced back on Sept. 20 that its COVID-19 vaccine works for children ages 5 to 11. For elementary school-aged kids, Pfizer tested a much lower dose that was a third of the amount that’s in each shot given to older age groups now. After their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press.
The vaccine made by Pfizer and its German partner BioNTech already is available for anyone 12 and older. Pfizer and BioNTech said they plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.
Meanwhile, Pfizer said topline immunogenicity and safety readouts for the other two age groups from the trial -- children 2 to 4 years of age and children 6 months to 1 years of age -- are expected as soon as the fourth quarter of this year.
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About Pfizer’s Phase 1/2/3 trial in children
Here’s how Pfizer and BioNTech describe the Phase 1/2/3 trial:
The Phase 1/2/3 trial initially enrolled up to 4,500 children ages 6 months to 11 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 11 years; ages 2 to 4 years; and ages 6 months to 1 years. Based on the Phase 1 dose-escalation portion of the trial, children 5 to 11 years of age received a two-dose schedule of 10 micrograms each while children under age 5 received a lower 3 micrograms 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.
Common side effects
The Mayo Clinic reports children ages 12 through 15 given the Pfizer-BioNTech COVID-19 vaccine had side effects similar to those experienced by people age 16 and older.
The most commonly reported side effects, according to the Mayo Clinic, include:
- Pain where the shot was given
- Fatigue
- Headache
- Chills
- Muscle pain
- Fever
- Joint pain
Similar to adults, children have side effects that typically last 1 to 3 days. Many people don’t report any side effects.
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