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Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12-17 Years - United States, December 9, 2021-February 20, 2022.
MMWR Morb Mortal Wkly Rep. 2022 Mar 04; 71(9):347-351.MM

Abstract

As of February 20, 2022, only BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine has been authorized for use in persons aged 12-17 years in the United States (1). The Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for Pfizer-BioNTech vaccine on December 9, 2021, to authorize a homologous* booster dose for persons aged 16-17 years ≥6 months after receipt of dose 2 (1). On January 3, 2022, authorization was expanded to include persons aged 12-15 years, and for all persons aged ≥12 years, the interval between dose 2 and booster dose was shortened to ≥5 months (1). To characterize the safety of Pfizer-BioNTech booster doses among persons aged 12-17 years (adolescents), CDC reviewed adverse events and health impact assessments during the week after receipt of a homologous Pfizer-BioNTech booster dose reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system managed by CDC and FDA. During December 9, 2021-February 20, 2022, approximately 2.8 million U.S. adolescents received a Pfizer-BioNTech booster dose.† During this period, receipt of 3,418 Pfizer-BioNTech booster doses were reported to v-safe for adolescents. Reactions were reported to v-safe with equal or slightly higher frequency after receipt of a booster dose than after dose 2, were primarily mild to moderate in severity, and were most frequently reported the day after vaccination. VAERS received 914 reports of adverse events after Pfizer-BioNTech booster dose vaccination of adolescents; 837 (91.6%) were nonserious and 77 (8.4%) were serious. Health care providers, parents, and adolescents should be advised that local and systemic reactions are expected among adolescents after homologous Pfizer-BioNTech booster vaccination, and that serious adverse events are rare.

Authors

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Pub Type(s)

Technical Report

Language

eng

PubMed ID

35239637

Citation

Hause, Anne M., et al. "Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12-17 Years - United States, December 9, 2021-February 20, 2022." MMWR. Morbidity and Mortality Weekly Report, vol. 71, no. 9, 2022, pp. 347-351.
Hause AM, Baggs J, Marquez P, et al. Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12-17 Years - United States, December 9, 2021-February 20, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(9):347-351.
Hause, A. M., Baggs, J., Marquez, P., Abara, W. E., Olubajo, B., Myers, T. R., Su, J. R., Thompson, D., Gee, J., Shimabukuro, T. T., & Shay, D. K. (2022). Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12-17 Years - United States, December 9, 2021-February 20, 2022. MMWR. Morbidity and Mortality Weekly Report, 71(9), 347-351. https://doi.org/10.15585/mmwr.mm7109e2
Hause AM, et al. Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12-17 Years - United States, December 9, 2021-February 20, 2022. MMWR Morb Mortal Wkly Rep. 2022 Mar 4;71(9):347-351. PubMed PMID: 35239637.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12-17 Years - United States, December 9, 2021-February 20, 2022. AU - Hause,Anne M, AU - Baggs,James, AU - Marquez,Paige, AU - Abara,Winston E, AU - Olubajo,Babatunde, AU - Myers,Tanya R, AU - Su,John R, AU - Thompson,Deborah, AU - Gee,Julianne, AU - Shimabukuro,Tom T, AU - Shay,David K, Y1 - 2022/03/04/ PY - 2022/3/3/entrez PY - 2022/3/4/pubmed PY - 2022/3/15/medline SP - 347 EP - 351 JF - MMWR. Morbidity and mortality weekly report JO - MMWR Morb Mortal Wkly Rep VL - 71 IS - 9 N2 - As of February 20, 2022, only BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine has been authorized for use in persons aged 12-17 years in the United States (1). The Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for Pfizer-BioNTech vaccine on December 9, 2021, to authorize a homologous* booster dose for persons aged 16-17 years ≥6 months after receipt of dose 2 (1). On January 3, 2022, authorization was expanded to include persons aged 12-15 years, and for all persons aged ≥12 years, the interval between dose 2 and booster dose was shortened to ≥5 months (1). To characterize the safety of Pfizer-BioNTech booster doses among persons aged 12-17 years (adolescents), CDC reviewed adverse events and health impact assessments during the week after receipt of a homologous Pfizer-BioNTech booster dose reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system managed by CDC and FDA. During December 9, 2021-February 20, 2022, approximately 2.8 million U.S. adolescents received a Pfizer-BioNTech booster dose.† During this period, receipt of 3,418 Pfizer-BioNTech booster doses were reported to v-safe for adolescents. Reactions were reported to v-safe with equal or slightly higher frequency after receipt of a booster dose than after dose 2, were primarily mild to moderate in severity, and were most frequently reported the day after vaccination. VAERS received 914 reports of adverse events after Pfizer-BioNTech booster dose vaccination of adolescents; 837 (91.6%) were nonserious and 77 (8.4%) were serious. Health care providers, parents, and adolescents should be advised that local and systemic reactions are expected among adolescents after homologous Pfizer-BioNTech booster vaccination, and that serious adverse events are rare. SN - 1545-861X UR - https://www.unboundmedicine.com/medline/citation/35239637/Safety_Monitoring_of_COVID_19_Vaccine_Booster_Doses_Among_Persons_Aged_12_17_Years___United_States_December_9_2021_February_20_2022_ L2 - https://doi.org/10.15585/mmwr.mm7109e2 DB - PRIME DP - Unbound Medicine ER -