RALEIGH, N.C. (WNCN) – The FDA was scheduled to vote on COVID-19 vaccines for children ages 5 to 11 on Tuesday. The company’s application for approval said their vaccine was 91 percent effective against symptomatic infection for this age group.
Pfizer’s vaccine for children would be a 10 microgram dose, a third of what adults receive.
Of the 1,518 children in the trials, injection site reactions were the most common side effects.
Seventy-five percent of trial participants reported some kind of injection site reaction. Systemic reactions detected were fatigue and headache but they were reported by less than half of the participants.
Pfizer said side effects were most often seen after the second dose.
An FDA briefing document reported most of those were mild to moderate in severity.
The company no children dropped out of the trial because of side effects and there were no deaths among trial participants.
Below are the side effects for children ages five to 11 after each dose.
|SYMPTOM||DOSE 1||DOSE 2|
|Pain at the injection site||74.1%||71%|
|Redness at the injection site||14.7%||18.5%|
|Swelling at the injection site||10.5%||15.3%|
|New or worsened muscle pain||9.1%||11.7%|
|New or worsened joint pain||3.3%||5.2%|