Top 5 Takeaways

1. Similar Adverse Reaction Frequencies: Children aged 5–11 years reported local and systemic reactions to the Pfizer-BioNTech COVID-19 vaccine booster dose with similar frequency as after the second dose, but with variations in severity.
2. Vaccine Administration Errors Most Common: The most frequently reported adverse events were related to vaccine administration errors, highlighting the need for additional provider education.
3. Rare Serious Adverse Events: Serious adverse events were rare, with no reports of myocarditis or death following the third dose among this age group.
4. Impact on Daily Activities: A small percentage of children experienced reactions severe enough to prevent attendance at school or disrupt daily activities, though these instances were less common than after the second dose.
5. Continued Safety Monitoring: Initial safety findings are consistent with clinical trial results, reinforcing the vaccine’s safety. The CDC and FDA will continue to monitor for adverse events to update recommendations as needed.

Original Article Author and Citation

Corresponding Author

Anne M. Hause, voe5@cdc.gov.

Suggested Citation

Hause AM, Baggs J, Marquez P, et al. Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine Booster Doses Among Children Aged 5–11 Years — United States, May 17–July 31, 2022. MMWR Morb Mortal Wkly Rep 2022;71:1047–1051. DOI: http://dx.doi.org/10.15585/mmwr.mm7133a3.

Summary

This MMWR article discusses the safety monitoring of Pfizer-BioNTech COVID-19 vaccine booster doses among children aged 5–11 years in the United States from May 17 to July 31, 2022. Approximately 657,302 third doses were administered, with adverse events reported through the v-safe and Vaccine Adverse Event Reporting System (VAERS). The findings underscore similar frequencies of local and systemic reactions between second and third doses, with specific reactions varying in severity. The prevalence of serious adverse events was low, with no cases of myocarditis or death reported following the third dose.

Methods

The CDC reviewed adverse events reported to v-safe, a voluntary smartphone-based safety surveillance system, and VAERS, a passive vaccine safety surveillance system co-managed by the CDC and FDA. The review included reports of local and systemic reactions, vaccine administration errors, and serious adverse events among children aged 5–11 years who received a third Pfizer-BioNTech dose.

Discussion

The discussion highlights the importance of continuous monitoring for vaccine safety and the rarity of serious adverse events following the third dose in children aged 5–11 years. The similarity in adverse reaction frequencies after the second and third doses aligns with clinical trial findings, reinforcing the vaccine’s safety profile. The most common adverse events reported were vaccine administration errors, suggesting the need for further provider education to prevent such errors.

Conclusion

The preliminary safety findings from the administration of Pfizer-BioNTech COVID-19 booster doses to children aged 5–11 years are generally consistent with clinical trial results, supporting the vaccine’s safety in this population. Serious adverse events after the third dose are rare, and local and systemic reactions are similar to those observed after the second dose. Ongoing safety monitoring will help guide future vaccination recommendations.

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