Pfizer and BioNTech have officially submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization of their COVID-19 vaccine for children aged 5 to 11.
Thursday’s announcement from Pfizer comes a week after the drugmaker submitted data to the FDA from the Phase 2/3 trial of its COVID-19 vaccine in children 5 to 11 years of age. U.S. regulators and public health officials are now expected to review the evidence and consult with their advisory committees in public meetings to determine if the shots are safe and effective enough to recommend use.
That process may mean the shots for this younger age group may not be available until closer to Thanksgiving. Depending on how quickly the FDA acts, the shots could become available earlier in November, the AP reported last week.
The two-dose Pfizer vaccine, now called Comirnaty, is currently available for those 12 and older. About 100 million people in the U.S. have been fully vaccinated with it, according to the Centers for Disease Control and Prevention (CDC).
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.
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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