Initial Safety Findings of COVID-19 Vaccination in Children Aged 6 Months to 5 Years

Recent data from the Centers for Disease Control and Prevention (CDC) indicates that COVID-19 vaccines have been widely administered to children aged 6 months to 5 years since June 2022, with approximately one million doses administered during June to August 2022. The CDC has reviewed adverse events and health impacts after receipt of Pfizer-BioNTech and Moderna vaccines that were reported to v-safe and the Vaccine Adverse Event Reporting System (VAERS). The findings suggest that local and systemic reactions are expected after vaccination, and serious adverse events are rare.

Key Takeaways:

• Local and systemic reactions such as irritability or crying, injection site pain, and mild to moderate systemic reactions were the most frequently reported reactions among children aged 6 months to 5 years.
• Serious adverse events were rarely reported, with 19 serious events (1.9%) out of 1,017 reports to VAERS.
• The majority of adverse events (998, or 98.1%) reported to VAERS were classified as nonserious.
• No reports of myocarditis were reported after vaccination with either Pfizer-BioNTech or Moderna vaccine.
• Health surveys sent through v-safe included questions about local injection site and systemic reactions, health impacts, and severe events.
• CDC's v-safe call center encourages completion of a VAERS report for children who have received medical care after vaccination.
• Analyses were conducted using SAS software (version 9.4) to identify possible cases of myocarditis and other rare adverse events.

Statistics:

• Approximately 599,457 children aged 6 months to 4 years received the Pfizer-BioNTech vaccine, and 440,773 children aged 6 months to 5 years received the Moderna vaccine during June 18 to August 21, 2022.
• Approximately 23,266 children were enrolled in v-safe after mRNA COVID-19 vaccination.
• 1,017 reports of adverse events were received by VAERS, with 998 (98.1%) classified as nonserious and 19 (1.9%) classified as serious.

Sources:

• Centers for Disease Control and Prevention (CDC). Initial Safety Findings of COVID-19 Vaccination in Children Aged 6 Months to 5 Years. Atlanta, GA: CDC; 2022.
• Food and Drug Administration (FDA). Emergency Use Authorization (EUA) for mRNA COVID-19 Vaccines. Washington, D.C.: FDA; 2022.
• CDC. v-safe. Centers for Disease Control and Prevention; 2022.
• Vaccine Adverse Event Reporting System (VAERS). Centers for Disease Control and Prevention; 2022.