Safety of COVID-19 Vaccination in United States Children Ages 5 to 11 Years

Details

• Alternative Title:
  Pediatrics
• Personal Author:
  Hause, Anne M. ; Shay, David K. ; Klein, Nicola P. ; Abara, Winston E. ; Baggs, James ; Cortese, Margaret M. ; Fireman, Bruce ; Gee, Julianne ; Glanz, Jason M. ; Goddard, Kristin ; Hanson, Kayla E. ; Hugueley, Brandon ; Kenigsberg, Tat’Yana ; Kharbanda, Elyse O. ; Lewin, Bruno ; Lewis, Ned ; Marquez, Paige ; Myers, Tanya ; Naleway, Allison ; Nelson, Jennifer C. ; Su, John R. ; Thompson, Deborah ; Olubajo, Babatunde ; Oster, Matthew E. ; Weintraub, Eric S. ; Williams, Joshua T.B. ; Yousaf, Anna R. ; Zerbo, Ousseny ; Zhang, Bicheng ; Shimabukuro, Tom T.
• Description:
  BACKGROUND AND OBJECTIVES:
  
  Limited postauthorization safety data for the Pfizer-BioNTech coronavirus disease 2019 vaccination among children ages 5 to 11 years are available, particularly for the adverse event myocarditis, which has been detected in adolescents and young adults. We describe adverse events observed during the first 4 months of the United States coronavirus disease 2019 vaccination program in this age group.
  
  METHODS:
  
  We analyzed data from 3 United States safety monitoring systems: v-safe, a voluntary smartphone-based system that monitors reactions and health effects; the Vaccine Adverse Events Reporting System (VAERS), the national spontaneous reporting system comanaged by the Centers for Disease Control and Prevention and Food and Drug Administration; and the Vaccine Safety Datalink, an active surveillance system that monitors electronic health records for prespecified events, including myocarditis.
  
  RESULTS:
  
  Among 48 795 children ages 5 to 11 years enrolled in v-safe, most reported reactions were mild-to-moderate, most frequently reported the day after vaccination, and were more common after dose 2. VAERS received 7578 adverse event reports; 97% were nonserious. On review of 194 serious VAERS reports, 15 myocarditis cases were verified; 8 occurred in boys after dose 2 (reporting rate 2.2 per million doses). In the Vaccine Safety Datalink, no safety signals were detected in weekly sequential monitoring after administration of 726 820 doses.
  
  CONCLUSIONS:
  
  Safety findings for Pfizer-BioNTech vaccine from 3 United States monitoring systems in children ages 5 to 11 years show that most reported adverse events were mild and no safety signals were observed in active surveillance. VAERS reporting rates of myocarditis after dose 2 in this age group were substantially lower than those observed among adolescents ages 12 to 15 years.
  
  
• Subjects:
  Adolescent Adverse Drug Reaction Reporting Systems Article Child Child, Preschool COVID-19 COVID-19 Vaccines Humans Male Myocarditis United States Young Adult

  More +
• Source:
  Pediatrics. 150(2)
• Pubmed ID:
  35581698
• Pubmed Central ID:
  PMC9706403
• Document Type:
  Journal Article
• Funding:
  CC999999/Intramural CDC HHSUnited States/
• Volume:
  150
• Issue:
  2
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:c9b957a7b23854217d9631bafd5c129715e742d302b2f1d053aa4766eb333f8f
• Download URL:
  https://stacks.cdc.gov/view/cdc/122654/cdc_122654_DS1.pdf
• File Type:
  [PDF - 245.91 KB ]