In an interview with Bloomberg News this summer, top FDA vaccine official Peter Marks said he asked drugmakers to expand their pediatric trials three or four times in size “to try to have a larger safety dataset” to increase confidence in the shots.
Safety is a crucial metric for young kids, as they get infected frequently and help spread the virus, but are at lower risk of developing severe complications than older adults. In rare cases, the messenger RNA vaccines have been linked to heart inflammation and heart-lining inflammation, and the risk appears to be highest in younger males.
The companies didn’t give specific side effect numbers in the release. Pfizer and BioNTech also didn’t say whether kids who got the vaccine had lower rates of Covid illness compared with those who got a placebo, data that the trial planned to collect as a secondary goal.
A spokesman for Pfizer said the trial is still ongoing and some data is still blinded. In the statement, the companies said they planned to submit the full data from the trial for publication in a scientific journal.