Risk of immune thrombocytopenic purpura after measles-mumps-rubella immunization in children.

BACKGROUND: The measles-mumps-rubella vaccine has been associated with immune thrombocytopenia purpura in 2 small studies. METHODS: By using the Vaccine Safety Datalink, we identified measles-mumps-rubella-vaccinated children aged 1 to 18. A case of immune thrombocytopenia purpura was defined as a patient with a platelet count of < or = 50,000/microL with clinical bleeding and normal red and white blood cell indices. The immune thrombocytopenia purpura incidence rates during exposed (42 days after vaccination) and unexposed time periods were determined. A retrospective cohort of vaccinated children was used to determine incident rate ratios for children aged 1 to 18 years, 12 to 23 months, and 12 to 15 months. RESULTS: A total of 1,036,689 children received 1,107,814 measles-mumps-rubella vaccinations; there were 259 confirmed patients with immune thrombocytopenia purpura. Because only 5 exposed cases occurred after age 2, analyses were limited to children aged 12 to 23 months. Exposed patients aged 12 to 23 months had lower median platelet counts than those who were unexposed and had similar median duration of illness (11 vs 10 days). The incident rate ratio was highest for children aged 12 to 15 months at 7.10. The incident rate ratio for boys aged 12 to 15 months was 14.59, and the incident rate ratio for girls in the same age group was 3.22. Seventy-six percent of immune thrombocytopenia purpura cases in children aged 12 to 23 months were attributable to measles-mumps-rubella vaccination. This vaccine causes 1 case of immune thrombocytopenia purpura per every 40,000 doses. CONCLUSION: Measles-mumps-rubella vaccine that is given in the second year of life is associated with an increased risk of immune thrombocytopenia purpura.

Impact of maternal influenza vaccination during pregnancy on the incidence of acute respiratory illness visits among infants.

OBJECTIVE: To determine whether influenza vaccination of pregnant women prevents visits for respiratory illness in their infants born during the influenza season. DESIGN: Retrospective matched cohort study. SETTING: Four managed care organizations in the United States. Patients A total of 41 129 infants (3160 and 37 969 born to vaccinated and unvaccinated mothers, respectively) born between 1995 and 2001. Main Exposure Maternal influenza vaccination. Infants were considered exposed if their gestational age at birth was at least 30 weeks, if the time from maternal vaccination to birth was at least 28 days, and if they were exposed to at least 14 days of the influenza season. MAIN OUTCOME MEASURES: Incidence of acute respiratory illnesses (outpatient, emergency department, and inpatient settings combined) and incident rate ratios (IRRs) for infants exposed and unexposed to maternal vaccination during the following 4 periods: peak influenza, respiratory syncytial virus predominant, periseasonal, and summer weeks. The time to the first acute respiratory illness during peak influenza weeks was also assessed. RESULTS: During the peak influenza weeks, infant visit rates were 15.4 and 17.1 per 100 person-months for exposed and unexposed infants, respectively (IRR, 0.90; 95% confidence interval, 0.80-1.02). Adjusted IRRs for the 4 periods found a protective effect of infant female sex, whereas Medicaid status and maternal high-risk status increased infant visit rates. Maternal influenza vaccination did not reduce visit rates during any of the 4 time periods (IRR for peak influenza season, 0.96; 95% confidence interval, 0.86-1.07) and did not delay the onset of first respiratory illness. CONCLUSION: We were unable to demonstrate that maternal influenza vaccination reduces respiratory illness visit rates among their infants.

Compliance with the recommendations for 2 doses of trivalent inactivated influenza vaccine in children less than 9 years of age receiving influenza vaccine for the first time: a Vaccine Safety Datalink study.

OBJECTIVES: Children <9 years of age do not respond optimally to a first dose of trivalent inactivated influenza vaccine, and so 2 doses of trivalent inactivated influenza vaccine are recommended for children <9 years of age who are being vaccinated for the first time. We conducted a population-based retrospective cohort study to evaluate compliance with the 2-dose trivalent inactivated influenza vaccine recommendations. POPULATION AND SETTING: We evaluated 125,928 children 6 months through 8 years of age who were enrolled in health maintenance organizations in the United States participating in the Vaccine Safety Datalink project and who received their first dose of trivalent inactivated influenza vaccine in the 2001-2002, 2002-2003, or 2003-2004 influenza seasons. RESULTS: Compliance with the 2 dose recommendations varied by age group and influenza season. Among children 6 to 23 months of age, the proportion of first-vaccinated children who received a second vaccination was 44% in 2001-2002, 54% in 2002-2003, and 29% in 2003-2004. Among children 2 to 8 years of age, the corresponding proportions were 15%, 24%, and 12%, respectively. In all seasons, compliance with the second vaccination was highest in children first vaccinated by mid-November. CONCLUSIONS: The majority of children who received their first dose of trivalent inactivated influenza vaccine did not complete the 2-dose series. The recently expanded recommendation for universal vaccination of children 6 to 59 months of age and their household contacts will substantially increase the number of children targeted for a first influenza vaccination. Noncompliance with the 2-dose trivalent inactivated influenza vaccine series may be associated with suboptimal protection against infection, which may impact the magnitude of the direct and indirect benefits achieved by the vaccination program.

Safety of trivalent inactivated influenza vaccine in children 6 to 23 months old.

CONTEXT: Beginning with the winter season of 2004-2005, influenza vaccination has been recommended for all children 6 to 23 months old in the United States. However, its safety in young children has not been adequately studied in large populations. OBJECTIVE: To screen for medically attended events in the clinic, emergency department, or hospital after administration of trivalent inactivated influenza vaccine in children 6 to 23 months old. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort using self-control analysis, with chart review of significant medically attended events at 8 managed care organizations in the United States that comprise the Vaccine Safety Datalink. Participants were all children in the Vaccine Safety Datalink cohort 6 to 23 months old who received trivalent inactivated influenza vaccine between January 1, 1991, and May 31, 2003 (45,356 children with 69,359 vaccinations). MAIN OUTCOME MEASURE: Any medically attended event significantly associated with trivalent inactivated influenza vaccine in risk windows 0 to 3 days, 1 to 14 days (primary analysis), 1 to 42 days, or 15 to 42 days after vaccination, compared with 2 control periods, one before vaccination and the second after the risk window. All individual ICD-9 codes as well as predefined aggregate codes were examined. RESULTS: Before chart review, only 1 diagnosis, gastritis/duodenitis, was more likely to occur in the 14 days after trivalent inactivated influenza vaccine (matched odds ratio [OR], 5.50; 95% confidence interval [CI], 1.22-24.81 for control period 1, and matched OR, 4.33; 95% CI, 1.23-15.21 for control period 2). Thirteen medically attended events were less likely to occur after trivalent inactivated influenza vaccine, including acute upper respiratory tract infection, asthma, bronchiolitis, and otitis media. After chart review, gastritis/duodenitis was not significantly associated with trivalent inactivated influenza vaccine (matched OR, 4.00; 95% CI, 0.85-18.84 for control period 1; matched OR, 3.34; 95% CI, 0.92-12.11 for control period 2). CONCLUSIONS: In the largest population-based study to date of the safety of trivalent inactivated influenza vaccine in young children, there were very few medically attended events, none of which were serious, significantly associated with the vaccine. This study provides additional evidence supporting the safety of universally immunizing all children 6 to 23 months old with influenza vaccine.

Effectiveness of the 2003-2004 influenza vaccine among children 6 months to 8 years of age, with 1 vs 2 doses.

OBJECTIVE: To evaluate the effectiveness of 1 and 2 doses of the 2003-2004 influenza vaccine in preventing medically attended influenza-like illness (ILI) among children 6 to 23 months and 6 months to 8 years of age. DESIGN AND METHODS: Outpatient and emergency department visits and immunization records were used to conduct a retrospective cohort study among children 6 months to 8 years of age. ILI and pneumonia and influenza (P&I) outcomes were defined on the basis of International Classification of Diseases, Ninth Revision, codes. Influenza vaccine effectiveness (VE) was calculated as (1 - hazard rate ratio) x 100. RESULTS: A total of 29726 children were included in the analyses; 17.3% were 6 to 23 months of age. By November 19, 2003, the start of peak influenza activity, 7.5% and 9.9% of children 6 months to 8 years were fully or partially vaccinated against influenza, respectively. For fully vaccinated children 6 to 23 months of age, VE against ILI and P&I was 25% and 49%, respectively. No statistically significant reduction in ILI or P&I rates was observed for partially vaccinated children 6 to 23 months of age (-3% and 22%, respectively). For fully vaccinated children 6 months to 8 years of age, VE against ILI and P&I was 23% and 51%, respectively. For partial vaccination, VE was significant only for P&I (23%). CONCLUSIONS: Despite a suboptimal match between the influenza vaccine and predominant circulating strains, influenza vaccination provided substantial protection for fully vaccinated children and possibly some protection for partially vaccinated children <9 years of age. These findings support vaccinating targeted children even when the vaccine match is suboptimal, and they highlight the need to vaccinate previously unvaccinated children with 2 doses for optimal protection.