Top 5 Takeaways

1. Full FDA Approval: The Pfizer-BioNTech COVID-19 vaccine, Comirnaty, received full FDA approval for use in persons aged ≥16 years on August 23, 2021.
2. High Efficacy: Clinical trials showed 91.1% efficacy in preventing symptomatic COVID-19, 100% efficacy against COVID-19 hospitalization, and 83.3% efficacy against death attributed to COVID-19.
3. Safety Monitoring: Postauthorization safety monitoring identified rare adverse events such as anaphylaxis and myocarditis, with higher rates of myocarditis observed in younger males after the second dose.
4. Real-World Effectiveness: Observational studies reported pooled vaccine effectiveness of 92.4% for symptomatic COVID-19, 94.3% against hospitalization, and 96.1% against death.
5. ACIP Recommendation: The Advisory Committee on Immunization Practices (ACIP) recommended the Pfizer-BioNTech vaccine for persons aged ≥16 years, concluding that the benefits outweigh the risks.

Original Article Author and Citation

Corresponding Author

Sara E. Oliver, yxo4@cdc.gov

Suggested Citation

Dooling K, Gargano JW, Moulia D, et al. Use of Pfizer-BioNTech COVID-19 Vaccine in Persons Aged ≥16 Years: Recommendations of the Advisory Committee on Immunization Practices — United States, September 2021. MMWR Morb Mortal Wkly Rep 2021;70:1344–1348. DOI: http://dx.doi.org/10.15585/mmwr.mm7038e2

Summary

The Pfizer-BioNTech COVID-19 vaccine, Comirnaty, has been granted full FDA approval for use in individuals aged ≥16 years. The Advisory Committee on Immunization Practices (ACIP) reviewed extensive data, including clinical trials and real-world studies, and concluded that the vaccine’s benefits in preventing COVID-19 and its severe outcomes outweigh the associated risks. The vaccine demonstrated high efficacy in preventing symptomatic COVID-19, hospitalizations, and deaths. Postauthorization safety monitoring identified rare adverse events, such as anaphylaxis and myocarditis, particularly in younger males after the second dose.

Methods

The ACIP used the Evidence to Recommendation (EtR) Framework and the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach to assess the Pfizer-BioNTech COVID-19 vaccine. Data sources included a large phase II/III clinical trial, observational vaccine effectiveness studies, and postauthorization safety monitoring systems like VAERS and VSD. The evidence was rated on a certainty scale from 1 (high certainty) to 4 (very low certainty).

Discussion

The ACIP concluded that COVID-19 remains a significant public health problem and that the benefits of the Pfizer-BioNTech vaccine in preventing disease outweigh the potential harms. The vaccine is acceptable to providers and feasible to implement. Full FDA approval may increase vaccine acceptability among unvaccinated individuals. The Work Group noted variability in vaccine acceptance among different subpopulations and discussed the potential impact on health equity.

Conclusion

After 8 months of use under an EUA, the Pfizer-BioNTech COVID-19 vaccine has now received full FDA approval and is recommended for individuals aged ≥16 years. The vaccine continues to be authorized for emergency use in adolescents aged 12–15 years and for an additional dose in immunocompromised individuals aged ≥12 years. Providers should inform recipients about potential adverse events and ensure proper reporting of any significant adverse events to VAERS.

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