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In observational vaccine safety studies, diagnosis codes assigned prior to or on the day of vaccination (Day 0) are often excluded from analysis of safety signals since they usually represent pre-existing conditions. The limitations of this approach have been described for autoimmune conditions but not for other chronic conditions. We draw on our experience in a post-licensure quadrivalent human papillomavirus...
In an effort to maximize vaccine acceptance by minimizing adverse events following immunization associated with fever, including seizures, the Advisory Committee on Immunization Practices (ACIP) recommended in 2009 the use of measles, mumps and rubella vaccine (MMR) and varicella vaccines (V) given separately (MMR+V) rather than combination MMRV as the first dose of MMR-containing vaccine to infants...
The monitoring of vaccine safety is critical to maintaining the public acceptance of vaccines required to ensure their continued success. Methods used to assess adverse events following immunization (AEFI) must accurately reflect their occurrence. Assessment of AEFI is often done via medical record review (MR) or via patient report (PR). However, these sources of data have not previously been compared...
Our recent experience in a post-licensure safety study of autoimmune conditions following the quadrivalent human papillomavirus vaccine in 189,629 girls and young women ages 9–26 years led us to question the adequacy of the exclusion of Day 0 events to prevent the erroneous association of prevalent conditions with vaccination. Of the 18 confirmed cases of Graves’ disease diagnosed in days 1–60 following...
A combined measles, mumps, rubella, varicella live vaccine (MMRV, Merck and Co., Inc., US) was recently licensed in the US. Pre-licensure clinical trial data showed a significant increase in fever in days 5–12 following MMRV vaccination as compared to the vaccines given separately (MMR+V). This post-licensure retrospective cohort study was undertaken to assess the incidence of febrile convulsion following...
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