COVID-19 vaccination recommended for US children 5 to 11 years, despite adverse events

In a recent study, investigators examined data from 3 United States safety monitoring systems to monitor adverse events in children aged 5 to 11. The data studied the test group for 6 weeks after they received the BNT-162b2 vaccination. Of the 8.7 million vaccines administered during this time, 42,504 children were involved in a safety findings test from v-safe, a smartphone system which, with permission, surveys for safety signals. An additional 4249 Vaccine Adverse Events Reporting System (VAERS) reports were included in this data.

Centers for Disease Control (CDC) created a survey system to monitor vaccine reactions in children. Parents voluntarily enrolled their children in these programs after the vaccination was injected. They then filled out health surveys throughout the testing period. The first of these, which were sent out during the first week, asked about system reactions and health impacts. Parents could describe the severity as mild, moderate, or severe. Throughout the testing period, more surveys were sent out with further questioning.

The American Academy of Pediatrics (AAP) found that adverse events from the COVID-19 vaccine in children ages 5 to 11 were mild to moderate. These events appeared most often the day after the vaccine was injected, and were most common with the second dose. No safety signals were found, and the VAERS found that myocarditis rates after the second dose were less frequent in this age group than with adolescents aged 12 to 15 years.

For the week following vaccination, hospitalization was reported in in 0.02% of children after both the first and second doses. Visits to outpatient clinics were more common at 0.7% and 0.6% after the first and second doses respectively. However, not all of these cases were related to the vaccination, as was found in a follow-up call.

Of the 4 deaths reported after BNT-162b2 vaccination, none were found to be caused by the vaccine. Myocarditis was found to be a rare adverse event, lower among boys ages 5 to 11 than those ages 12 to 15.

These results match with preauthorization studies of the Pfizer-BioNTech coronavirus vaccine from 2019, which also surveyed children ages 5 to 11 for 6 weeks after receiving a vaccination. The AAP recommends that children ages 5 to 11 receive the BNT-162b2 vaccination.

Reference

Hause AH, Shay DK, Klein NP. et al. Safety of COVID-19 vaccination in United States children ages 5 to 11 years. Pediatrics. 2022; 150 (2). doi:https://doi.org/10.1542/peds.2022-057313