Top 5 Takeaways

1. FDA Authorization: On October 29, 2021, the FDA granted Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine for children aged 5–11 years.
2. ACIP Recommendation: On November 2, 2021, the Advisory Committee on Immunization Practices (ACIP) recommended the Pfizer-BioNTech COVID-19 vaccine for children aged 5–11 years after a systematic review of available data.
3. Vaccine Efficacy: The Pfizer-BioNTech COVID-19 vaccine has shown high efficacy (>90%) in preventing COVID-19 in children aged 5–11 years.
4. Safety Profile: Clinical trials indicated that the vaccine is safe for children aged 5–11 years, with most adverse reactions being mild to moderate and no serious safety concerns identified.
5. Public Health Impact: Vaccinating children aged 5–11 years is crucial for protecting them against COVID-19 and reducing community transmission of SARS-CoV-2.

Original Article Author and Citation

Corresponding Author

Sara E. Oliver, yxo4@cdc.gov

Suggested Citation

Woodworth KR, Moulia D, Collins JP, et al. The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5–11 Years — United States, November 2021. MMWR Morb Mortal Wkly Rep 2021;70:1579–1583. DOI: http://dx.doi.org/10.15585/mmwr.mm7045e1

Summary

On November 2, 2021, the Advisory Committee on Immunization Practices (ACIP) made an interim recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5–11 years. This decision followed the FDA’s Emergency Use Authorization issued on October 29, 2021. The vaccine has shown high efficacy (>90%) in preventing COVID-19 in this age group, with a favorable safety profile. The recommendation aims to protect children from COVID-19 and reduce community transmission of the virus.

Methods

ACIP used the Evidence to Recommendation (EtR) Framework and the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach to review the available data. This included a systematic review of published and unpublished evidence on the vaccine’s benefits and harms. The primary data came from a randomized, double-blind, placebo-controlled phase II/III clinical trial involving 2,268 participants aged 5–11 years.

Discussion

The ACIP’s recommendation was based on the high efficacy of the Pfizer-BioNTech COVID-19 vaccine in preventing symptomatic COVID-19 in children aged 5–11 years. The safety profile was also favorable, with most adverse reactions being mild to moderate. The committee considered the significant public health impact of COVID-19 on children, including hospitalizations and multisystem inflammatory syndrome in children (MIS-C), and the role of children in community transmission of SARS-CoV-2.

Conclusion

The interim recommendation by ACIP supports the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5–11 years to protect them from COVID-19 and reduce community transmission. The recommendation will be updated as more data become available. Educating providers on the specific formulation and dosage for this age group is essential for successful implementation.

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