1. Clinical trials show similar safety outcomes including febrile convulsion rates for GSK's and Merck's measles-mumps-rubella (MMR) vaccines.
- Author
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Habib MA, Povey M, Casabona G, Singh T, and Abu-Elyazeed R
- Subjects
- Child, Humans, Infant, Child, Preschool, Measles-Mumps-Rubella Vaccine, Vaccines, Combined, Antibodies, Viral, Rubella prevention & control, Mumps prevention & control, Seizures, Febrile chemically induced, Seizures, Febrile epidemiology, Measles prevention & control
- Abstract
Combined measles-mumps-rubella (MMR) vaccines produced by GSK (GSK-MMR) and Merck (Merck-MMR) have demonstrated effectiveness and an acceptable safety profile, as documented over decades of post-licensure use in various regions worldwide. In the United States, 2 doses of the MMR vaccine are recommended at the ages of 12-15 months and 4-6 years. All-cause febrile convulsions have the highest incidence at 12-18 months of age, when the first MMR vaccine dose is administered. Because febrile convulsions can also occur rarely after MMR vaccine administration, we reviewed safety data of the GSK-MMR compared to the Merck-MMR vaccine from 4 clinical trials that evaluated a first dose in 12-15-month-olds and 2 clinical trials that evaluated a second dose in ≥4-year-olds. Overall frequencies of febrile convulsions were ≤0.4% across studies and vaccine groups. The frequency of febrile convulsions occurring 7-10 days post-vaccination with the GSK-MMR vaccine (5.7/10,000) was generally consistent with previously published data. The other safety outcomes were similar between the GSK-MMR and Merck-MMR vaccines in both age groups. Hence, as recommended by the Advisory Committee on Immunization Practices, the GSK-MMR vaccine can also be used for routine immunization of children according to the current immunization schedule in the United States to prevent MMR.
- Published
- 2023
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