WASHINGTON — Pfizer-BioNTech said Tuesday that the company has submitted initial data to the Food and Drug Administration to support using its COVID-19 vaccine in children ages 5 to 11 but the shots may not be available until November.
Pfizer said last week that a trial with 2,268 participants between the ages of 5 and 11 showed a lower dose of its two-dose vaccine led to coronavirus-fighting antibody levels for kids that was just as strong as teenagers and young adults
Pfizer said that a formal submission to request Emergency Use Authorization (EUA) for their COVID-19 vaccine for kindergartners and elementary school-aged kids is expected to happen "in the coming weeks."
Once the company files its application, U.S. regulators and public health officials will 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 may not be available until closer to Thanksgiving, according to a person familiar with the process but not authorized to discuss it publicly. But it is possible that, depending on how quickly the FDA acts, the shots could become available earlier in November, the person said.
Pfizer tested a lower dose of the shots in children. The drugmaker said last week that researchers found the vaccine developed coronavirus-fighting antibody levels in children that were just as strong as those found in teenagers and young adults getting regular-strength doses.
As of Tuesday, the Pfizer COVID-19 vaccine is only approved for people 12 and older. The American Academy of Pediatrics reports that children make up more than a quarter of all COVID-19 cases reported across the country.
A vaccine for children ages 5-11 would cover most elementary school students. Vaccinated students relieve some of the hassle and burden of contact tracing for schools. It is expected that students who are vaccinated and show no symptoms can avoid the quarantines that have disrupted so many classrooms in the past couple months.
On Monday, Pfizer said it had reached the mid-to-late stage portion of a large study to find an oral antiviral drug against COVID-19. Its purpose would be to prevent infection among people who have been exposed to the virus.
The study is seeking up to 2,660 healthy adults ages 18 and older who live in the same household as someone who is confirmed symptomatic with COVID-19, the pharmaceutical maker said in a statement.