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Safety of measles-containing vaccines in 1-year-old children
Nicola P Klein1, Edwin Lewis2, Bruce Fireman2
1Kaiser Permanente Vaccine Study Center, Oakland, California; nicola.klein@kp.org.
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.
Insights
The measles-mumps-rubella-varicella (MMRV) vaccine showed a slightly increased risk of seizure and fever compared to separate MMR and varicella vaccines. However, no new safety concerns were identified for either vaccine.
Area of Science:
- Vaccinology
- Pediatric Safety
- Immunization
Background:
- Measles-containing vaccines are linked to adverse events like seizures and immune thrombocytopenia purpura (ITP).
- The measles-mumps-rubella-varicella (MMRV) vaccine may increase toddlers' risk for febrile seizures compared to separate MMR and varicella (MMR + V) vaccines.
Purpose of the Study:
- To compare the safety profiles of the MMRV vaccine versus the combined MMR + V vaccine.
- To investigate if either vaccine increases the risk for specific adverse safety outcomes.
Main Methods:
- A large cohort study using the Vaccine Safety Datalink (2000-2012) included children aged 12-23 months.
- Investigated nine outcomes: anaphylaxis, ITP, ataxia, arthritis, meningitis/encephalitis, acute disseminated encephalomyelitis, Kawasaki disease, seizure, and fever.
- Relative risks were estimated comparing MMRV to MMR + V, with secondary analyses examining risks versus non-vaccine periods.
Main Results:
- No significant differences in risks for seven main outcomes were found when comparing MMRV to MMR + V.
- ITP risk was elevated after both MMRV and MMR + V vaccination compared to baseline.
- MMRV vaccination was associated with an increased risk of seizure and fever 7-10 days post-vaccination compared to MMR + V.
Conclusions:
- The study found no new safety concerns when comparing the MMRV vaccine to the MMR + V vaccine.
- The findings provide reassurance regarding the safety of both MMRV and MMR + V vaccines for the studied outcomes.
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