Details:

Personal Author:
Hause, Anne M. ; Baggs, James ; Marquez, Paige ; Abara, Winston E. ; Olubajo, Babatunde ; ... More +
Hause, Anne M. ; Baggs, James ; Marquez, Paige ; Abara, Winston E. ; Olubajo, Babatunde ; Myers, Tanya R. ; Su, John R. ; Thompson, Deborah ; Gee, Julianne ; Shimabukuro, Tom T. ; Shay, David K. Less -
Corporate Authors:
CDC COVID-19 Emergency Response Team ; U.S. Food and Drug Administration
CDC COVID-19 Emergency Response Team ; U.S. Food and Drug Administration Less -
Description:
What is already known about this topic? Adults aged ≥18 years reported adverse reactions less frequently after receipt of a homologous Pfizer-BioNTech COVID-19 booster dose than after the second primary dose.

What is added by this report? Among persons aged 12–17 years, reactions after Pfizer-BioNTech booster vaccination were generally mild to moderate and transient; the frequency of local and systemic reactions reported to v-safe after a booster dose were equal to or slightly higher than after the second primary dose. Myocarditis was less frequently reported after a booster dose than a second primary dose.

What are the implications for public health practice? Health care providers, parents, and adolescents should be advised that local and systemic reactions are expected among adolescents after a homologous Pfizer-BioNTech booster vaccination and that serious adverse events are rare.

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 U.S. (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.

V-safe is a voluntary, smartphone–based U.S. active safety Surveillance system established to monitor adverse events after COVID-19 vaccination (https://vsafe.cdc.gov/en/). The v-safe platform allows current registrants to report receipt of a booster dose of COVID-19 vaccine and new registrants to enter information about all doses received. Registrants aged ≤15 years must be enrolled by a parent or guardian. Health surveys are sent daily during the first week after administration of each dose and include questions about local injection site and systemic reactions and health impacts.§ CDC’s v-safe call center contacts registrants who indicate that medical care was sought after vaccination and encourages completion of a VAERS report, if indicated.

Suggested citation for this article: Hause AM, Baggs J, Marquez P, et al. Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12–17 Years — U.S. December 9, 2021–February 20, 2022. MMWR Morb Mortal Wkly Rep. ePub: 1 March 2022.

mm7109e2.htm?s_cid=mm7109e2_x

mm7109e2-H.pdf


Subjects:
[+]
BNT162 Vaccine COVID-19 COVID-19 Vaccines COVID-19 Vaccines/ Immunization, Secondary Patient Safety Vaccines
Series:
MMWR; v. 71, ER, 3/1/22
Document Type:
Journal Article
Name as Subject:
v-safe ; v-safe
v-safe ; v-safe Less -
Place as Subject:
U.S.
Collection(s):
Morbidity and Mortality Weekly Report (MMWR)
Main Document Checksum:
[+]
urn:sha256:e54e43f7a3fca9fd6da45c7d10731d948610a8d85db0159c2ceace2c7c191c07
Download URL:
https://stacks.cdc.gov/view/cdc/114958/cdc_114958_DS1.pdf
File Type:

Supporting Files

• mm7109e2.htm

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