October 7, 2021 – Pfizer Inc. and BioNTech have submitted a request to the FDA for approval of their Covid-19 vaccine for children ages 5 to 11 years old.
The FDA has scheduled for a panel of outside experts to review the data Oct. 26. While the agency doesn’t have to follow the panel’s recommendation, it normally does. A positive review would likely mean that the FDA could clear the shot for use in that age group before November.
If authorized, young children would get two injections of the Pfizer-BioNTech, three weeks apart, just like adolescents and adults do, but at a lower age-appropriate dosage. Antibody levels in the child volunteers who received the vaccine were similar to those observed in younger adults, the companies said.
School districts and public-health officials have begun preparations for vaccinations, though the work remains in early stages, the Wall Street Journal reports. Health and vaccine experts expect the vaccines to be administered at certain schools, pediatrician offices and pharmacies.
Schools and public-health departments are experienced with childhood vaccines unrelated to Covid-19 because they routinely administer them, although the cold-storage requirements of the Pfizer-BioNTech vaccine may pose some challenges, according to the experts.