Top 5 Takeaways

1. Common Reactions: Local and systemic reactions were frequently reported in children aged 5–11 years after Pfizer-BioNTech COVID-19 vaccination, especially after the second dose.
2. Nonserious Events: Approximately 97.6% of adverse events reported to VAERS were nonserious.
3. Serious Events: Serious adverse events were rare, with the most common being fever, vomiting, and increased troponin levels.
4. Myocarditis Cases: Eleven cases of myocarditis were verified, with most children recovering or in recovery.
5. Hospitalizations: Fourteen children were reported to have been hospitalized, but no causal association with vaccination was determined.

Original Article Author and Citation

Corresponding Author

Anne M. Hause, eocevent416@cdc.gov

Suggested Citation

Hause AM, Baggs J, Marquez P, et al. COVID-19 Vaccine Safety in Children Aged 5–11 Years — United States, November 3–December 19, 2021. MMWR Morb Mortal Wkly Rep 2021;70:1755–1760. DOI: http://dx.doi.org/10.15585/mmwr.mm705152a1

Summary

This article reviews the safety of the Pfizer-BioNTech COVID-19 vaccine in children aged 5–11 years based on data from the Vaccine Adverse Event Reporting System (VAERS) and v-safe, collected between November 3 and December 19, 2021. Approximately 8.7 million doses were administered during this period, with most adverse events being nonserious. Commonly reported reactions included injection-site pain, fatigue, and headache. Serious adverse events were rare, with myocarditis being one of the more notable conditions observed.

Methods

Data were collected from VAERS and v-safe, focusing on adverse events reported for children aged 5–11 years who received the Pfizer-BioNTech COVID-19 vaccine. VAERS is a passive surveillance system, while v-safe is a voluntary smartphone-based active surveillance system. Reports were analyzed using SAS software, and the data were reviewed in accordance with applicable federal law and CDC policy.

Discussion

The findings from this report are consistent with preauthorization clinical trials, which showed that most adverse events were mild to moderate. The majority of VAERS reports were nonserious, with administration errors being the most common issue. Myocarditis cases were rare and generally mild. The report highlights the importance of continued monitoring and the need for parents and guardians to be informed about the expected reactions post-vaccination.

Conclusion

Vaccination remains the most effective way to prevent COVID-19. The safety data for the Pfizer-BioNTech COVID-19 vaccine in children aged 5–11 years are reassuring, with most adverse events being nonserious. Continued surveillance and reporting will help guide future vaccination recommendations.

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