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Comparative Study
. 2015 Feb;135(2):e321-9.
doi: 10.1542/peds.2014-1822. Epub 2015 Jan 5.

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

Nicola P Klein  1 , Edwin Lewis  2 , Bruce Fireman  2 , Simon J Hambidge  3 , Allison Naleway  4 , Jennifer C Nelson  5 , Edward A Belongia  6 , W Katherine Yih  7 , James D Nordin  8 , Rulin C Hechter  9 , Eric Weintraub  10 , Roger Baxter  2
Affiliations
Comparative Study

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

Nicola P Klein et al. Pediatrics. 2015 Feb.

Abstract

Background 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.

Keywords: measles; safety; vaccine; varicella.

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