DETROIT – Pfizer officially requested emergency use authorization for its COVID vaccine in children ages 5 to 11.
It’s a move that has been highly anticipated by pediatricians and many parents as coronavirus cases have risen in that age group.
The most important element that will be under scrutiny is safety. Vaccines in general need to be safe, but the safety bar is raised even higher for children. Although the Pfizer data hasn’t been made public yet, they would not have submitted to the Food and Drug Administration if they didn’t think it could easily clear that hurdle.
Pfizer tested the vaccine in 2,268 children, giving two shots 21 days apart. The dose was 1/3rd the dose given to those 12 and older.
Prior research suggested that a lower dose would be just as effective at generating a protective antibody response in younger children, while potentially reducing the chance of any adverse events -- especially the rare heart inflammatory conditions called myocarditis and pericarditis.
Since there were only a couple thousand children in Pfizer’s study, if the vaccine is authorized for younger children, close monitoring for rare adverse reactions will be essential.
By design, the study measured the levels of protective antibodies after vaccination. It remains to be seen how that correlates to protection against infection or severe illness, like MIS-C.
If the FDA issues an emergency use authorization for children aged 5-11, it would then be additionally reviewed by the Centers for Disease Control and Prevention before being released for use and become a decision left to parents.
“I would anticipate that as parents and children have questions with their pediatricians and other local health officials and they get those questions answered, that more and more parents and kids will want to get their kids vaccinated,” said White House COVID-19 Response Coordinator Jeff Zients.
The FDA’s vaccine advisory panel is set to meet Oct. 26. The FDA and Pfizer will release more detailed data on the trials to the public a couple of days in advance of that meeting.
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