The Pfizer BioNTech CoVID-19 vaccine is often administered to young children. Although mild side effects are common, severe reactions are very rare. AnalysisInformation on vaccine safety for children aged 5-11 years old. The data come from the Vaccine Adverse Event Reporting System (VAERS), a large vaccine safety surveillance system maintained by the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), and v-safe, the CDC’s smartphone-based reporting system specifically for COVID-19 vaccine reactions.
“After over 8 million COVID-19 vaccinations in this age group, we found that side effects reported to v-safe were generally very mild and included things like injection site pain, and fatigue and headache, and were mostly reported the day after vaccination,” says Anne Hause, the lead author of the CDC’s research. This report was published by the CDC. Data gathered between Dec. 3rd and Dec. 19 was included in the Dec. 31st 2021 release.
VAERS reported 97.6% of reactions as non-serious side effect, while 2.4% had serious effects. There were only 11 cases confirmed of myocarditis (inflammation of the heart muscle), and none of these were fatal. All children were either recovering or have recovered. Two deaths were reported to VAERS; both children were in “fragile health” before vaccination and had multiple chronic medical conditions, and the data do not suggest a causal link between death and vaccination, the report says. Data from V-safe showed that while reactions to vaccination were not uncommon, they were very rare. Only 1% of parents sought treatment for their child within the first week following vaccination.
Because the latest report included information from two different surveillance systems—VAERS and v-safe—the results are particularly comprehensive. These systems each collect different data. A patient can, or in the case with a child their parent, report any adverse reaction to vaccinations to VAERS. That ease of reporting means that the system can catch even a very rare adverse event or unusual pattern, but it can be difficult to determine what’s actually causing the adverse event or how often it’s really happening, especially because the system has a negative bias; adverse reactions are more likely to get reported to VAERS if they’re more serious, according to the FDA. The number of people reporting an adverse reaction can be affected by news reports about side effects and controversies surrounding vaccines. “Everyone can dump anything into that database, and people in the past have for non-medical reasons,” says Saad Omer, director of the Yale Institute for Global Health. In one example, Do some researchPublié in Pediatric Infectious Disease JournalHause, Omer, and other researchers discovered that adverse reactions to VAERS increased after California removed non-medical vaccination exemptions in 2015. Researchers suspected the rise in adverse reaction reports to VAERS was due to parents seeking medical exemptions to their children. It’s up to researchers to sort out how many of the reactions reported to VAERS are caused by the vaccine itself and aren’t just symptoms that coincidentally occurred after they’d received the shot; they do this by thoroughly investigating concerning cases, interviewing health care professionals and reviewing electronic health records.
People who join the other database, v-safe, are encouraged to report their child’s reactions as they occur. A few questions about how the child feels and whether they can go back to school are asked via text messages. Other tracking services are available to V-safe users. If they contact a healthcare provider for care, they will be encouraged to inform VAERS.
Pfizer BioNTech COVID-19 has been under close surveillance since its emergency authorization. The vaccine was approved to be used for kids from 5-11 years of age in October 2021. It was approved in May 2021 for children aged 12-15 years old and fully FDA-approved for adults 16 and over. That authorization status means that providers are required to report certain kinds of adverse events, says Dr. Tom Shimabukuro of the CDC’s COVID-19 Vaccine Task Force. “The COVID-19 vaccines have been monitored under the most intense monitoring process in the history of vaccination,” says Shimabukuro.
Scientists cannot find out everything about COVID-19 vaccination safety in children from either database. But they can show how the vaccines are affecting kids in real life—and what we know now is encouraging.