In a recently published study in the American Academy of Pediatrics Journal, researchers examined the safety of vaccines for coronavirus disease 2019 (COVID-19) in children in the United States.

Study: Safety of COVID-19 Vaccine in US Children Ages 5-11.  Credit: Halfpoint/Shutterstock
Study: Safety of COVID-19 Vaccine in US Children Ages 5-11. Credit: Halfpoint/Shutterstock

Vaccines against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have played a crucial role in containing the COVID-19 pandemic. However, limited data are available on the safety of the BNT162b2 COVID-19 vaccine in younger children.

About the study

In the present study, researchers evaluated post-authorisation safety surveillance data related to the BNT162b2 messenger ribonucleic acid (mRNA) COVID-19 vaccine administered to children between the ages of five and eleven years.

The v-safe database established by the Centers for Disease Control and Prevention (CDC) monitored health effects after COVID-19 vaccination. Health-based surveys were sent via SMS to guardians or parents from day 0 to day 7 after receiving the vaccine. The surveys were also answered at six weeks and three, six and 12 months after vaccination. Health questionnaires in the first week included questions about the injection site and the presence of systemic reactions. VAERS was established by the CDC and the Food and Drug Administration (FDA) and accepted reports of vaccine-related adverse events.

The team collected information from v-safe and VAERS from November 3, 2021 to February 27, 2022 and from the Vaccine Safety Data Link (VSD) from October 31, 2021 to February 26, 2022. The data included information on children between the ages of five and eleven who were vaccinated with the COVID-19 vaccine BNT162b2.

The study described reactions and health effects reported in the health surveys recorded in v-safe and serious and non-serious reports in VAERS. The number of myocarditis cases was evaluated for VAERS and classified by gender and the number of vaccine doses received. Outcome rates of VSD data recorded 1 to 21 days post-vaccination were compared to those recorded 22 to 42 days post-vaccination.


In the v-safe data set, a total of 48,795 children between the ages of five and eleven received the BNT162b2 vaccine with a mean age of eight years, including 49.7% of women. Almost 96% of v-safe participants had received one dose of vaccine, while 99.3% had received two doses. The study results showed that 54.9% of participants reported injection site reactions after the first dose of vaccine and 56.8% after the second dose of vaccine. On the other hand, systemic reactions were reported by 35.3% of the single-dose subjects and 41.0% of the double-dose subjects. The team found that symptoms such as injection site pain, fever, myalgia and fatigue were reported most commonly and were mild to moderate in severity.

The team also observed that 7.6% of parents reported that their child was unable to perform normal daily tasks the day after the second vaccination, 9.0% reported that the child was unable to attend school visit, while 0.3% said their child required medical attention. After administration of the first and second doses, 0.7% and 0.6% of vaccinees required an outpatient visit, while 0.02% and 0.02% of vaccinees required hospitalization.

A total of 7,578 reports of adverse reactions in children aged five to eleven years who received the BNT162b2 vaccine were collected in the VAERS dataset. The average age of the participants was eight years, including 47.0% women. Almost 97.7% of the participants had only received the COVID-19 vaccine, while 2.0% also received the seasonal influenza vaccine. Study results showed that 97.4% of VAER reports recorded non-serious events, with 5.0% syncope, 5.2% dizziness, 7.3% fever, 7.3% vomiting, 6.3% headache, 4 .5% reported nausea, 4.2% urticaria and 4.2%. rash Serious adverse reactions were reported by 13.4% for Pediatric Multisystem Inflammatory Syndrome (MIS-C), 10.8% for seizures, 9.7% for myocarditis, 6.7% for appendicitis, and 4.1% for an allergic reaction .

In addition, the team identified 45 reports of myocarditis with symptoms occurring from zero to 21 days after vaccination. The reporting rate for vaccine-associated myocarditis was higher in men than in women and significantly higher after the second dose than after the first vaccine dose. The team found that the reporting rate of myocarditis in men detected zero to seven days after the second dose was 2.2 per million vaccine doses administered.

Overall, the study results showed that most adverse events reported following vaccination of the BNT162b2-COVID-19 vaccine in children between the ages of five and eleven years were mild and showed no safety signals.

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