The U.S. Food and Drug Administration has now authorized the first covid-19 vaccine for children between the ages of 5 and 11. The authorization will cover the Pfizer/BioNTech mRNA vaccine, though the Centers for Disease Control and Prevention will have to give their blessing next week before the vaccine can be widely available.
The authorization comes after a nearly unanimous endorsement from an FDA advisory committee that met earlier this week to discuss the vaccine. During that meeting, data was presented from a trial of 3,100 children given the vaccine, who were compared to children given placebo. The trial showed that children’s immune responses were similar to the immune responses seen in young people between the ages of 16 and 25, and the vaccine was estimated to be 90.7% effective at preventing covid-19. Furthermore, no serious adverse events connected to the vaccine were reported, though one child was noted to have eaten a penny in an unrelated incident.
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said acting FDA commissioner Janet Woodcock in a statement from the FDA. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”
The child version of the vaccine will come in a smaller dose than the version for adults. But it will similarly be offered as a two-dose shot given over a three-week period.
Though there were no serious adverse events detected during the trial, common side effects did include injection site pain, redness and swelling, fatigue, and headache. Health officials also noted that rare side effects previously documented in younger recipients, particularly myocarditis (heart inflammation), may appear once the vaccine is administered widely. But in modeling various scenarios of the pandemic’s near future, FDA researchers concluded that the benefits of vaccination in preventing covid-19 would still outweigh its risks. Notably, several studies have estimated covid-19 to have a higher risk of causing myocarditis than the vaccine. And while younger children have rarely died from covid-19, it has still been a leading cause of death in that age group.
The FDA’s authorization is only the first step needed for children to receive the vaccine. Early next week, the CDC’s advisory committee will meet to discuss the exact guidelines for administration, after which the CDC is expected to give their green light. Earlier this week, Moderna released promising results from its own trial of young children and is expected to file for authorization soon.