Elaine R. Miller

Adverse event reports following yellow fever vaccination.

Yellow fever (YF) vaccine has been used for prevention of YF since 1937 with over 500 million doses administered. However, rare reports of severe adverse events following vaccination have raised concerns about the vaccines safety. We reviewed reports of adverse events following YF vaccination reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) from 2000 to 2006. We used estimates of age and sex distribution of administered doses obtained from a 2006 survey of authorized vaccine providers to calculate age- and sex-specific reporting rates of all serious adverse events (SAE), anaphylaxis, YF vaccine-associated neurotropic disease, and YF vaccine-associated viscerotropic disease. Reporting rates of SAEs were substantially higher in males and in persons aged > or =60 years. These findings reinforce the generally acceptable safety profile of YF vaccine, but highlight the importance of physician and traveler education regarding the risks and benefits of YF vaccination, particularly for travelers > or =60 years of age. Vaccination should be limited to persons traveling to areas where the risk of YF is expected to exceed the risk of serious adverse events after vaccination, or if not medically contraindicated, where national regulations require proof of vaccination to prevent introduction of YF.

National surveillance of dialysis associated diseases in the United States, 1995.

Chronic hemodialysis centers in the United States were surveyed in 1995 regarding a number of hemodialysis associated diseases and practices. A total of 2,647 centers, representing 224,954 patients and 54,194 staff members, responded. Seventy-seven percent of centers reported that they reused disposable dialyzers. At the end of 1995, 65% of patients were treated with an arteriovenous graft, 22% an arteriovenous fistula, and 13% a temporary or permanent central catheter. By the end of 1995, at least three doses of hepatitis B vaccine had been administered to 35% of patients and to 82% of staff members. Acute infection with the hepatitis B virus (HBV) occurred in 0.06% of patients, and was more likely to be reported by centers with lower proportions of patients vaccinated against HBV. The prevalence of antibody to hepatitis C virus (HCV) was 10.4% among patients and 2.0% among staff. At least one patient with vancomycin resistant enterococci (VRE) was reported by 11.5% of centers, more commonly by hospital (vs freestanding centers not located in hospitals) and government centers, and centers located in certain geographic areas. Vancomycin was received by 7.2% of patients in December 1995. The percentage of centers reporting patients with other pathogens was 7.9% for active tuberculosis, 39% for human immunodeficiency virus (HIV), and 40% for methicillin resistant Staphylococcus aureus (MRSA).

Postlicensure Monitoring of Intussusception After RotaTeq Vaccination in the United States, February 1, 2006, to September 25, 2007

BACKGROUND. In 1999, a previous rotavirus vaccine (RotaShield; Wyeth Laboratories, Marietta, PA) was withdrawn from the US market after postlicensure monitoring identified an association with intussusception. Although the new rotavirus vaccine (RotaTeq; Merck, West Point, PA) introduced in 2006 was not associated with intussusception in prelicensure trials, additional monitoring is important to ensure a complete safety profile. METHODS. We assessed intussusception reports after RotaTeq vaccination by using data from the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink, a cohort of children enrolled in managed care. Observed versus expected rate ratios were determined by using vaccine dose distribution data and Vaccine Safety Datalink background intussusception rates. RESULTS. Between February 1, 2006, and September 25, 2007, the Vaccine Adverse Event Reporting System received 160 intussusception reports after RotaTeq vaccination. With the assumptions that reporting completeness was 75% and that 75% of the distributed doses of RotaTeq were administered, the observed versus expected rate ratios were 0.53 and 0.91 for the 1–21 and 1–7 day interval after vaccination, respectively. In the Vaccine Safety Datalink, 3 intussusception cases occurred within 30 days after 111521 RotaTeq vaccinations, compared with 6 cases after 186722 non–RotaTeq vaccinations during the same period. If, like RotaShield, RotaTeq had a 37-fold increased risk of intussusception within 3 to 7 days after vaccination, then 8 intussusception cases would be expected within 3 to 7 days among the ∼84000 infants vaccinated with the first dose of RotaTeq in the Vaccine Safety Datalink (N = 49902) and the prelicensure trial (N = 34035) combined, whereas no cases have been observed. CONCLUSIONS. Available data do not indicate that RotaTeq is associated with intussusception. Although an intussusception risk similar in magnitude to that of RotaShield can be excluded, continued monitoring is necessary for complete assessment of the safety profile of RotaTeq.

National Surveillance of Dialysis-Associated Diseases in the United States, 1997

The Centers for Disease Control and Prevention (CDC) has been conducting surveillance of hemodialysis-associated hepatitis since the early 1970s (1), when the CDC reported that the incidence of hepatitis B virus (HBV) infection among patients and staff during 1972– 1974 had increased by more than 100% to 6.2% and 5.2%, respectively. These early surveys had only a 50– 65% response rate of centers listed by the National Dialysis Registry. In an effort to obtain a higher response rate, and thus more complete information, the CDC initiated a cooperative program with the Health Care Financing Administration (HCFA) in 1976 that provided for a questionnaire from the CDC to be included in HCFA’s annual facility survey. As a result of this collaboration, the response rate to the CDC questionnaire now exceeds 90%. Since collaboration with the HCFA was begun, the CDC survey has been performed for calendar years 1976, 1980, and 1982 to 1997 (2–12). Questions about other hemodialysis-associated diseases and practices not related to hepatitis have been included over the years, and the questionnaire is continually updated to collect data about hemodialysis practices and hemodialysisassociated diseases of current interest and importance. The objectives of this yearly survey are to determine the frequency with which certain hemodialysis practices, including measures designed to prevent disease, are used; determine the frequency of hemodialysis-associated complications and diseases; and to use this information to suggest further measures to prevent complications and disease in hemodialysis patients and staff.

Protective effect of hepatitis B vaccine in chronic hemodialysis patients

Hepatitis B virus (HBV) infection is a well-recognized risk in chronic hemodialysis patients. Although the risk has declined dramatically since the 1970s, outbreaks of HBV infection among these patients continue to occur. The Centers for Disease Control and Prevention (CDC) has recommended hepatitis B vaccination of hemodialysis patients since 1982; however, by 1996, only 36% of the approximately 200,000 US chronic hemodialysis patients had received the vaccine, perhaps in part because of doubts among dialysis personnel of its efficacy. We performed a case-control study to determine whether receipt of hepatitis B vaccine was associated with a decreased risk of acquiring HBV infection. We determined the vaccination status of all chronic hemodialysis patients at 98 US hemodialysis centers that reported patients with acute HBV infection on a nationwide mailed survey in 1995. A total of 111 hepatitis B surface antigen (HBsAg) positive case patients were compared with 12,500 control patients. Case patients were significantly less likely than control patients to have received hepatitis B vaccine (10.8% v 23.6%; odds ratio, 0.39; 95% confidence interval, 0.22-0.72). After stratifying by dialysis center to control for differing community and dialysis center risks of HBV infection, we found that the risk for HBV infection was 70% lower in vaccinated patients (adjusted odds ratio, 0.30; 95% confidence interval, 0.18-0.50). These results suggest that hepatitis B vaccine has a significant protective effect against acquiring HBV infection in chronic hemodialysis patients, and efforts should be expanded to increase the use of hepatitis B vaccine in this patient population.

National surveillance of dialysis associated diseases in the United States, 1992

To determine trends in a number of hemodialysis associated diseases and practices, the Centers for Disease Control and Prevention, in collaboration with the Health Care Financing Administration, completed a mail survey of chronic hemodialysis centers in the United States in 1992. Of 2,321 centers surveyed, 2,170 (93%) representing 170,028 patients and 43,535 staff members responded. In 1992, 2,049 (94%) centers used bicarbonate dialysate as the primary method of dialysis, 765 (35)% used high flux dialysis, and 1,569 (72%) reused dialyzers, continuing the trends toward increased use of these methods. Central (subclavian or jugular) venous catheters were used in > or = 1 patient as permanent vascular access for hemodialysis at 69% of dialysis centers. Hepatitis B surface antigen was present at low frequency in patients (incidence = 0.1%, prevalence = 1.2%) and staff members (incidence - 0.03%, prevalence = 0.3%). Among centers that had > or = 1 hepatitis B surface antigen positive patient, the incidence of hepatitis B virus infection was lower in those centers that used a separate room for dialysis of patients positive for hepatitis B surface antigen. From 1991 to 1992, reported hepatitis B vaccine coverage increased from 17% to 24% among patients and from 56% to 69% among staff members; in absolute terms, these were the largest single year increases since introduction of hepatitis B vaccine. The prevalence of antibody to hepatitis C virus was 8.1% among patients and 1.6% among staff members. Pyrogenic reactions in the absence of septicemia were reported by 19% of centers and associated with use of high flux dialysis. New dialyzer syndrome was reported by 24% of centers, most frequently by centers using regenerated cellulose or cuprophan membranes. Human immunodeficiency virus was known to be present in 1.5% of patients; 34% of centers reported providing hemodialysis to one or more patients infected with HIV.

National surveillance of dialysis associated diseases in the United states-1994

Dialysis centers in the United States were surveyed in 1994 regarding a number of hemodialysis associated diseases and practices. A total of 2,449 centers, representing 206,884 patients and 50,314 staff members, responded. In 1994, 99% of centers used bicarbonate dialysate as the primary method of dialysis, 45% used high flux dialysis, and 75% reused dialyzers. Hepatitis B vaccine had been administered to 31% of patients and to 80% of staff members. Acute infection with hepatitis B virus occurred in 0.1% of patients and was more likely to be reported by centers with lower proportions of patients vaccinated against hepatitis B virus and those not using a separate room and dialysis machine to treat hepatitis B surface antigen positive patients. The prevalence of antibody to hepatitis C virus was 10.5% among patients and 1.9% among staff members and varied according to geographic region. Pyrogenic reactions in the absence of septicemia were reported by 22% of centers and were most highly associated with dialyzer reuse. Human immunodeficiency virus infection was reported to be present in 1.5% of patients; 37% of centers provided hemodialysis to one or more patients infected with human immunodeficiency virus.

Early estimate of the effectiveness of quadrivalent meningococcal conjugate vaccine.

Background: In January 2005, a quadrivalent meningococcal conjugate vaccine (MenACWYD) was licensed for use in the United States. The Advisory Committee on Immunization Practices recommends MenACWYD for all adolescents 11 to 18 years of age and others at increased risk for meningococcal disease. Methods: Reports of breakthrough meningococcal disease after vaccination with MenACWYD were collected. A simulation approach was used to estimate the expected number of cases in vaccinated persons. Results: Between 2005 and 2008, 14 breakthrough cases, including 3 deaths occurred. At a vaccine effectiveness (VE) of 90%, 7 breakthrough cases would be expected (range, 1–17); at VE of 85%, 11 cases (range, 2–30); at VE of 80%, 15 cases (range, 5–28); and at VE of 75%, 18 cases (range, 7–32) would be expected. The probability of the ≥14 observed cases occurring was 2.9% at VE of 90%, 29.3% at VE of 85%, 66.1% at VE of 80%, and 83.0% at VE of 75%. Conclusions: This report provides an early estimate of MenACWYD effectiveness within 3 to 4 years after vaccination, and suggests that MenACWYD effectiveness is 80% to 85%, similar to the VE reported for meningococcal polysaccharide vaccine.

Feasibility of national surveillance of health-care-associated infections in home-care settings.

This article examines the rationale and strategies for surveillance of health-care-associated infections in home-care settings, the challenges of nonhospital-based surveillance, and the feasibility of developing a national surveillance system.

National surveillance of dialysis associated diseases in the United States, 1993

To determine trends in a number of hemodialysis associated diseases and practices, the Centers for Disease Control and Prevention, in collaboration with the Health Care Financing Administration, performed a mail survey of 2,304 chronic hemodialysis centers in the United States in 1993. By the end of 1993, at least three doses of hepatitis B vaccine were administered to 29% of patients and 76% of staff at responding centers. Hepatitis B surface antigen was present at low frequency in patients (incidence = 0.1%, prevalence = 1.2%) and staff members (incidence = 0.2%, prevalence = 0.3%). The 1993 incidence of hepatitis B virus infection among patients was higher at centers that accepted hepatitis B surface antigen positive patients but did not use a separate room and dialysis machine for treatment of these patients, government and profit (versus nonprofit) centers, and centers in four End Stage Renal Disease Networks. The prevalence of antibody to hepatitis C virus was 9.7% among patients and 1.6% among staff members. Pyrogenic reactions in the absence of septicemia were reported by 21% of centers and associated with use of high flux dialysis. Human immunodeficiency virus infection was known to be present in 1.5% of patients; 34% of centers reported providing hemodialysis to one or more human immunodeficiency virus infected patients.