Search

From the Vanderbilt Vaccine Research Program, Vanderbilt University Medical Center, Nashville, TN; Kaiser Permanente Vaccine Study Center, Oakland, CA; Division of Pediatric Infectious Diseases, Columbia University, New York City, NY; Department of International Health, Disease Prevention and Control Program, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD; Division of Pediatric Infectious Diseases, Stanford University School of Medicine, M any events occurring after vaccination have been attributed to vaccines, when in fact the associationwas often due to chance. However, as with any medical intervention, there are times when adverse events are caused by immunizations. Distinguishing which events are causally related to vaccine, rather than coincidental events, is a challenge for the pediatrician and amajor focus of vaccine safety science. Consider a childwho presents with asepticmeningitis after immunization. Because of the temporal relationship, one may suspect the immunizations as the cause, yet subsequent isolation of enterovirus from cerebrospinal fluid implicates the enteroviral infection instead. The term adverse event following immunization (AEFI) is defined as any untoward event that occurs after immunization, regardless of causal association. AEFI is the preferred notation to describe such clinical events because the term is free from implications regarding causal relationship and favors an openmind about the role of immunizations.AEFIs are a commonpart of routine clinical practice. The Clinical Immunization Safety Assessment (CISA) network has reviewedmany individual cases of AEFIs and found that when a comprehensive investigation for alternative etiologies of the AEFI is completed, other causes for the event can often be identified. Yet, such comprehensive evaluations are rarely performed. We describe a stepwise approach to the comprehensive assessment of serious AEFIs by health care providers. The main objective is to highlight the important role that health care providers play in this effort by actively evaluating for the most likely causes of serious events when they occur after immunization.

The objective of the study was to evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, in pregnant women who received influenza A (H1N1) 2009 monovalent vaccine to assess for potential vaccine safety problems.We reviewed reports of adverse events (AEs) in pregnant women who received 2009-H1N1 vaccines from Oct. 1, 2009, through Feb. 28, 2010.VAERS received 294 reports of AEs in pregnant women who received 2009-H1N1 vaccine: 288 after inactivated and 6 after the live attenuated vaccines. Two maternal deaths were reported. Fifty-nine women (20.1%) were hospitalized. We verified 131 pregnancy-specific outcomes: 95 spontaneous abortions (20 weeks); 18 stillbirths (≥20 weeks); 7 preterm deliveries (37 weeks); 3 threatened abortions; 2 preterm labor; 2 preeclampsia; and 1 each of fetal hydronephrosis, fetal tachycardia, intrauterine growth retardation, and cleft lip.Review of reports to VAERS following H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes.

Risk of Guillain-Barre syndrome, if any, is smaller than for 1976 swine flu vaccines Guillain-Barre syndrome has been a focus of safety monitoring since the report in 1976 of an increased risk of almost one extra case per 100 000 influenza vaccinations of swine origin.1 Subsequent studies have shown either no increased risk or a slightly increased risk (1-2 per million vaccinees) after vaccination for seasonal flu.2 The spread of the 2009 pandemic influenza A (H1N1) virus, which contained genes of swine origin, resulted in the development and widespread use of influenza A (H1N1) monovalent vaccines (2009 H1N1 vaccines).3 These included formulations containing oil in water adjuvants that had not previously been widely used in flu vaccines in Europe. Although available evidence suggested that the adjuvanted vaccines had acceptable safety profiles,3 data on the risk of rare adverse events, such as Guillain-Barre syndrome, were limited. In the linked study (doi:10.1136/bmj.d3908), Dieleman and colleagues report the first data on adjuvanted 2009 H1N1 vaccines and the risk of Guillain-Barre syndrome from a …

Objective The objective of the study was to characterize reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received seasonal influenza vaccines to assess for potential vaccine safety concerns. Study Design We searched VAERS for reports of adverse events (AEs) in pregnant women who received trivalent inactivated influenza vaccine (TIV) from July 1, 1990 through June 30, 2009, or live attenuated influenza vaccine (LAIV) from July 1, 2003, through June 30, 2009. Results A total of 148 reports after TIV and 27 reports after LAIV were identified. Twenty TIV (13.5%) and 1 LAIV (4%) reports were classified as serious. No specific AEs were reported in 30 TIV (20.3%) and 16 LAIV (59%) reports. The most common pregnancy-specific AE was spontaneous abortion: 17 after TIV (11.5%) and 3 after LAIV (11%). The reporting rate of spontaneous abortion was 1.9 per million pregnant women vaccinated. Conclusion No unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of TIV or LAIV.

This report examines alternative methods of paying for clinical preventive care services. First, the extent of coverage of preventive health care services in public and private health insurance plans is reviewed. Included in this review are Medicare, Medicaid, health maintenance organizations, and private health insurance plans. Second, four alternative methods for paying for preventive care are discussed. These options are: 1) fee-for-service; 2) a periodic preventive health visit fee; 3) capitation; and 4) a preventive services account. The report concludes with recommendations for constructing an equitable system for increasing access to preventive services. A multi-pronged approach is recommended involving improvements in public and private coverage of these services; development of a periodic preventive health visit fee payment mechanism; initiation of additional research and demonstration efforts designed to determine cost-effectiveness of services and payment approaches; and modifications to the current coding system that would lead to a more appropriate method for reimbursement of preventive care services.