August 18, 2022MMWR Morbidity and Mortality Weekly ReportOpen Access

Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine Booster Doses Among Children Aged 5–11 Years — United States, May 17–July 31, 2022

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Why the study?

Following FDA authorization of a homologous Pfizer-BioNTech booster dose for children aged 5-11 years, further characterization of booster vaccination safety in this age group was needed.

Is the Pfizer-BioNTech COVID-19 vaccine third dose safe in children aged 5-11 years?

Population

Approximately 657,302 U.S. children aged 5-11 years who received a third Pfizer-BioNTech dose

Comparison

Third dose vs second dose reported reactions

Design

Surveillance study using v-safe and VAERS reporting systems

Authors

AHAnne M. HauseCenters for Disease Control and Prevention JBJames BaggsCenters for Disease Control and Prevention PMPaige MarquezCenters for Disease Control and Prevention

Discussion

Member takes

Implication

Supports third-dose tolerability in children 5–11 years; extends surveillance data but leaves open confirmation in larger prospective studies.

Structured PICO

Is the Pfizer-BioNTech COVID-19 vaccine third dose safe in children aged 5-11 years?

Population

U.S. children aged 5-11 years who received a third Pfizer-BioNTech COVID-19 vaccine dose (n=657,302 total; n=3,249 in v-safe; n=581 in VAERS)

Intervention

Pfizer-BioNTech COVID-19 vaccine third dose (homologous booster or third primary dose)

Comparator

Second dose of the same vaccine (for v-safe analysis)

Outcome

Adverse events and health impacts reported to v-safe and VAERSsafety

A third dose of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years is well tolerated, with mostly mild-to-moderate local and systemic reactions and rare serious adverse events.

Limitations

v-safe participation is voluntary and might not be representative
recipients who experience an adverse event might be more likely to respond to v-safe surveys
v-safe does not include information about immune status
VAERS is subject to reporting biases and underreporting
limited 10-week surveillance period

Cite This Study

Hause et al. (2022) studied this question.

synapsesocial.com/papers/6a824801cbd7585844ac8fa8 https://doi.org/10.15585/mmwr.mm7133a3

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Implication

Supports third-dose tolerability in children 5–11 years; extends surveillance data but leaves open confirmation in larger prospective studies.