Despite periodic case reports, no cases found after more than 49,000 vaccinations
WEDNESDAY, July 14 (HealthDay News) -- Meningococcal polysaccharide vaccine (MPV4) does not appear to be associated with post-vaccination Henoch-Schönlein purpura (HSP) in 16- to 20-year-olds, according to research published online July 12 in Pediatrics.
Michael J. Goodman, Ph.D., of the University of Utah College of Pharmacy in Salt Lake City, and colleagues used data from the Vaccine Safety Datalink (VSD) to determine the 42-day post-vaccination incidence rate of HSP in the VSD population 16 to 20 years of age. The study was undertaken to determine whether periodic case reports of HSP after MPV4 vaccination were indications of an increased risk associated with the vaccine.
The researchers found the background incidence rate of HSP in the non-immunized population to be 4.2 per 100,000 person-years. After 49,027 doses of vaccine were administered, there were zero cases of HSP identified within 42 days. The authors concluded that these data provided strong evidence that HSP was not associated with receipt of MPV4 in the 16- to 20-year age group.
"These data strongly suggest that the MPV4 vaccine should be used, because no cases of HSP were found in the 42-day window after MPV4. For evaluating the risk of rare serious adverse events that may occur associated with a vaccine, large post-marketing studies are needed, which are especially important when the disease being prevented is rare. These data provide the strongest evidence so far that HSP is likely not associated with MPV4 in the 16- to 20-year age group," the authors write.
The VSD Study was funded through a subcontract with America's Health Insurance Plans.
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