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Electronic Medical Records Strengthen Vaccine Safety Monitoring In Seizure Study

 |  By cclark@healthleadersmedia.com  
   June 28, 2010

Intelligent use of electronic health records—even those collected from multiple health systems—can alert providers to harmful medical practices.

That's how Kaiser Permanente's analysis of 459,000 pediatric health records revealed that young children who received the combo MMRV (measles, mumps, rubella, varicella) vaccine experienced twice the rate of febrile seizures as did children who received two separate shots—one for measles, mumps, rubella and the other just for varicella.

"This study shows the tremendous power of electronic medical records to improve vaccine safety monitoring," says Nicola P. Klein, MD, co-director of the Kaiser Permanente Vaccine Study Center.

She adds that with either type of vaccine, the risk of a child having a seizure and a high fever as a result is very low, but it's important that parents know that risk so they can have informed discussions with their doctors about whether the combination vaccine is worth the risk.

For every 10,000 children given MMRV instead of MMR +V, there was an additional 4.3 seizures during the seven to 10 days following vaccination.

The finding, published in today's edition of the journal Pediatrics, prompted the Centers for Disease Control and Prevention last month to change its vaccine guidance to one that favored the MMRV over MMR plus V.

"Unless the parent or the caregiver expresses a preference for MMRV vaccine, CDC recommends that MMR vaccine and varicella vaccine should be administered for the first dose in this age group (between 12 and 47 months of age)," the CDC said in a May 7 issue of the Morbidity and Mortality Weekly Report .

What was important about this report is that it drew conclusions from an enormous sample size of children between 12 and 23 months of age collected from seven health organizations across the United States. That large of a sample size gives researchers greater confidence in its reliability.

The data were collected between January 2000 and October 2008 from Group Health Cooperative in Washington State, Kaiser Permanente systems in Colorado, Northern California and Oregon, Harvard Pilgrim Health Care in Massachusetts, HealthPartners in Minnesota and Marshfield Clinic in Wisconsin.

The project discovered that seizure incidence peaked during days seven through 10 after vaccination, "with the most prominent peak following MMRV." However, there was no peak in seizures for children vaccinated against just varicella. Other complications, such as the severity of the seizures or death rates, were not evaluated in this portion of the project although that may be included in a later analysis.

The MMRV vaccine was licensed in the U.S. in September 2005. It is made by ProQuad, Merck & Co. Inc. "At the time of its licensure, use of MMRV vaccine was preferred for both the first and second doses over separate injections of equivalent component vaccines (MMR vaccine and varicella vaccine), which was consistent with the CDC's Advisory Committee on Immunization Practices' 2006 general recommendations on use of combination vaccines," the MMWR said on May 7.

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