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Safety of measles-containing vaccines in 1-year-old children.

AbstractBACKGROUND AND OBJECTIVES:
All measles-containing vaccines are associated with several types of adverse events, including seizure, fever, and immune thrombocytopenia purpura (ITP). Because the measles-mumps-rubella-varicella (MMRV) vaccine compared with the separate measles-mumps-rubella (MMR) and varicella (MMR + V) vaccine increases a toddler's risk for febrile seizures, we investigated whether MMRV is riskier than MMR + V and whether either vaccine elevates the risk for additional safety outcomes.
METHODS:
Study children were aged 12 to 23 months in the Vaccine Safety Datalink from 2000 to 2012. Nine study outcomes were investigated: 7 main outcomes (anaphylaxis, ITP, ataxia, arthritis, meningitis/encephalitis, acute disseminated encephalomyelitis, and Kawasaki disease), seizure, and fever. Comparing MMRV with MMR + V, relative risk was estimated by using stratified exact binomial tests. Secondary analyses examined post-MMRV or MMR + V risk versus comparison intervals; risk and comparison intervals were then contrasted for MMRV versus MMR+V.
RESULTS:
We evaluated 123,200 MMRV and 584,987 MMR + V doses. Comparing MMRV with MMR + V, risks for the 7 main outcomes were not significantly different. Several outcomes had few or zero postvaccination events. Comparing risk versus comparison intervals, ITP risk was higher after MMRV (odds ratio [OR]: 11.3 [95% confidence interval (CI): 1.9 to 68.2]) and MMR + V (OR: 10 [95% CI: 4.5 to 22.5]) and ataxia risk was lower after both vaccines (MMRV OR: 0.8 [95% CI: 0.5 to 1]; MMR + V OR: 0.8 [95% CI: 0.7 to 0.9]). Compared with MMR + V, MMRV increased risk of seizure and fever 7 to 10 days after vaccination.
CONCLUSIONS:
This study did not identify any new safety concerns comparing MMRV with MMR + V or after either the MMRV or the MMR + V vaccine. This study provides reassurance that these outcomes are unlikely after either vaccine.
AuthorsNicola P Klein, Edwin Lewis, Bruce Fireman, Simon J Hambidge, Allison Naleway, Jennifer C Nelson, Edward A Belongia, W Katherine Yih, James D Nordin, Rulin C Hechter, Eric Weintraub, Roger Baxter
JournalPediatrics (Pediatrics) Vol. 135 Issue 2 Pg. e321-9 (Feb 2015) ISSN: 1098-4275 [Electronic] United States
PMID25560438 (Publication Type: Comparative Study, Journal Article, Research Support, U.S. Gov't, P.H.S.)
CopyrightCopyright © 2015 by the American Academy of Pediatrics.
Chemical References
  • Biomarkers, Pharmacological
  • Chickenpox Vaccine
  • Measles-Mumps-Rubella Vaccine
  • Vaccines, Combined
  • measles, mumps, rubella, varicella vaccine
Topics
  • Biomarkers, Pharmacological
  • Chickenpox Vaccine (administration & dosage, adverse effects)
  • Cohort Studies
  • Female
  • Humans
  • Infant
  • Male
  • Measles-Mumps-Rubella Vaccine (administration & dosage, adverse effects)
  • Risk Assessment
  • Seizures, Febrile (chemically induced)
  • United States
  • Vaccines, Combined (administration & dosage, adverse effects)

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