COVID-19 Vaccine Safety in Adolescents Aged 12–17 Years — United States, December 14, 2020–July 16, 2021

Details

• Personal Author:
  Hause, Anne M. ; Gee, Julianne ; Baggs, James ; Abara, Winston E. ; Marquez, Paige ; Thompson, Deborah ; Su, John R. ; Licata, Charles ; Rosenblum, Hannah G. ; Myers, Tanya R. ; Shimabukuro, Tom T. ; Shay, David K.
• Corporate Authors:
  CDC COVID-19 Response Team. ; United States Food and Drug Administration. ; Centers for Disease Control and Prevention (U.S.)Epidemic Intelligence Service.
• Description:
  What is already known about this topic? In preauthorization trials of the Pfizer-BioNTech COVID-19 Vaccine, adolescents aged 12–17 years reported local and systemic mild and moderate reactions. Myocarditis has been observed after vaccination with mRNA vaccines in postauthorization monitoring.
  
  What is added by this report? Local and systemic reactions after vaccination with Pfizer-BioNTech vaccine were commonly reported by adolescents aged 12–17 years to U.S. vaccine safety monitoring systems, especially after dose 2. A small proportion of these reactions are consistent with myocarditis.
  
  What are the implications for public health practice? Mild local and systemic reactions are common among adolescents following Pfizer-BioNTech vaccine, and serious adverse events are rare. The Advisory Committee on Immunization Practices conducted a risk-benefit assessment and continues to recommend the Pfizer-BioNTech COVID-19 Vaccine for all persons aged ≥12 years.
  
  As of July 30, 2021, among the three COVID-19 vaccines authorized for use in the United States, only the Pfizer-BioNTech BNT162b2 mRNA COVID-19 vaccine is authorized for adolescents aged 12–17 years. The Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech vaccine for use in persons aged ≥16 years on December 11, 2020 (1); the EUA was expanded to include adolescents aged 12–15 years on May 10, 2021 (2), based on results from a Phase 3 clinical trial (3). Beginning in June 2021, cases of myocarditis and myopericarditis (hereafter, myocarditis) after receipt of Pfizer-BioNTech vaccine began to be reported, primarily among young males after receipt of the second dose (4,5). On June 23, 2021, CDC’s Advisory Committee on Immunization Practices (ACIP) reviewed available data and concluded that the benefits of COVID-19 vaccination to individual persons and the population outweigh the risks for myocarditis and recommended continued use of the vaccine in persons aged ≥12 years (6). To further characterize safety of the vaccine, adverse events after receipt of Pfizer-BioNTech vaccine reported to the Vaccine Adverse Event Reporting System (VAERS) and adverse events and health impact assessments reported in v-safe (a smartphone-based safety Surveillance system) were reviewed for U.S. adolescents aged 12–17 years during December 14, 2020–July 16, 2021. As of July 16, 2021, approximately 8.9 million U.S. adolescents aged 12–17 years had received Pfizer-BioNTech vaccine.* VAERS received 9,246 reports after Pfizer-BioNTech vaccination in this age group; 90.7% of these were for nonserious adverse events and 9.3% were for serious adverse events, including myocarditis (4.3%). Approximately 129,000 U.S. adolescents aged 12–17 years enrolled in v-safe after Pfizer-BioNTech vaccination; they reported local (63.4%) and systemic (48.9%) reactions with a frequency similar to that reported in preauthorization clinical trials. Systemic reactions were more common after dose 2. CDC and FDA continue to monitor vaccine safety and provide data to ACIP to guide COVID-19 vaccine recommendations.
  
  Suggested citation for this article: Hause AM, Gee J, Baggs J, et al. COVID-19 Vaccine Safety in Adolescents Aged 12–17 Years — United States, December 14, 2020–July 16, 2021. MMWR Morb Mortal Wkly Rep. ePub: 30 July 2021
  
  mm7031e1.htm?s_cid=mm7031e1_w#contribAff
  
  
• Subjects:
  Adolescent Adverse Drug Reaction Reporting Systems CoronaVirus Infections/Prevention & Control COVID-19 Vaccines COVID-19/Prevention & Control
• Source:
  MMWR: Morbidity and Mortality Weekly Report 2021; v. 70 Early Release
• Series:
  Weekly Report: Morbidity and Mortality Weekly Report (MMWR)
• ISSN:
  0149-2195 (print) ; 1545-861X (digital)
• Document Type:
  Journal Article
• Pages in Document:
  5 pdf pages
• Volume:
  70
• Collection(s):
  Morbidity and Mortality Weekly Report (MMWR)
• Main Document Checksum:
  urn:sha-512:48b7fe6779e5ad84299a634ea243c9311f87ecd221a41718a15663293d1f32fea17cb9b09885d7e0b5c6be120d77e32ca5232a782ac6585de0083698176917bc
• Download URL:
  https://stacks.cdc.gov/view/cdc/108438/cdc_108438_DS1.pdf
• File Type:
  [PDF - 215.36 KB ]