Viscerotropic disease: case definition and guidelines for collection, analysis, and presentation of immunization safety data

Viscerotropic disease (VTD) is defined as acute multiple organ system dysfunction that occurs following vaccination. The severity of VTD ranges from relatively mild multisystem disease to severe multiple organ system failure and death. The term VTD was first used shortly after the initial published reports in 2001 of febrile multiple organ system failure following yellow fever (YF) vaccination. To date, VTD has been reported only in association with YF vaccine and has been thus referred to as YF vaccine-associated viscerotropic disease (YEL-AVD)

Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.

Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries

Abstracts from the 8th International Conference on cGMP Generators, Effectors and Therapeutic Implications

This work was supported by a restricted research grant of Bayer AG

Yellow fever vaccine: An updated assessment of advanced age as a risk factor for serious adverse events

Since 1996, the scientific community has become aware of 14 reports of yellow fever vaccine (YEL)-associated viscerotropic disease (YEL-AVD) cases and four reports of YEL-associated neurotropic disease (YEL-AND) worldwide, changing our understanding of the risks of the vaccine. Based on 722 adverse event reports after YEL submitted to the U.S. Vaccine Adverse Event Reporting System in 1990–2002, we updated the estimates of the age-adjusted reporting rates of serious adverse events, YEL-AVD and YEL-AND.We found that the reporting rates of serious adverse events were significantly higher among vaccinees aged ≥60 years than among those 19–29 years of age (reporting rate ratio = 5.9, 95% CI 1.6–22.2). Yellow fever is a serious and potentially fatal disease. For elderly travelers, the risk for severe illness and death due to yellow fever infection should be balanced against the risk of a serious adverse event due to YEL

Notifications of Public Health Events under the International Health Regulations - 5 Year U.S. Experience

The U.S. fully implemented the International Health Regulations and submitted 59 potential Public Health Emergencies of International Concern (PHEIC) to WHO since 2007. The 2009 H1N1influenza pandemic, first notified as required notification of a novel strain of influenza by the U.S., is the only event determined to be a PHEIC by WHO to date. The public health impact of information sharing of PHEICs on a secure IHR website or of direct exchanges between trusted IHR National Focal Points is not known. However, a shared platform and assessment tool has facilitated notifications across national borders

Assessment of Public Health Events through International Health Regulations, United States, 2007–2011

People and goods travel rapidly around the world, and so do infectious organisms. Sometimes a disease has already become widespread before it is detected and reported, which makes control efforts much more difficult. In response to this threat, the World Health Assembly enacted International Health Regulations that require participating countries to report public health events of international concern to the World Health Organization within 72 hours of detection. These health regulations went into effect in 2007 for all WHO Member States including the United States. By December 2011, 24 events reported by the United States were posted on a secure WHO web site, 12 of which were associated with influenza. Others reported were salmonellosis outbreaks, botulism, E. coli infections, Guillain-Barré syndrome, contaminated heparin, Lassa fever, an oil spill, and typhoid fever. International Health Regulations have improved global connectivity through rapid information exchange and increased awareness of threatening situations