Impact of the introduction of pneumococcal conjugate vaccine on rates of community acquired pneumonia in children and adults.

Pneumococcal conjugate vaccine use among young children has led to significant declines in invasive pneumococcal disease in the United States, but the impact on community-acquired pneumonia is unknown. We conducted population-based pneumonia surveillance among 794,282 Group Health members before and after infant vaccine introduction in 2000. We presumptively identified pneumonia episodes using diagnosis codes assigned to medical encounters and confirmed 17,513 outpatient and 6318 hospitalized events by reviewing chest radiograph reports or hospitalization records. There was evidence for a decline in rates of both outpatient and hospitalized pneumonia in children less than 1 year of age following vaccine introduction but there were no consistent reductions in pneumonia rates among older children and adults.

Prospective assessment of the effect of needle length and injection site on the risk of local reactions to the fifth diphtheria-tetanus-acellular pertussis vaccination.

OBJECTIVE: Local reactions are relatively common after the fifth diphtheria-tetanus-acellular pertussis vaccination, but factors associated with an increased risk of those reactions are not well defined. The objective of this study was to assess the relationship between needle length and injection site on the risk of local reactions to the fifth diphtheria-tetanus-acellular pertussis vaccination administered in the context of usual clinical care. METHODS: In this prospective assessment, parents reported signs and symptoms of adverse events for 7 days after vaccination. The relative risk of adverse events in relation to needle length (16 or 25 mm) and injection site (arm or thigh) was estimated in multivariate analyses that adjusted for age, gender, and BMI. RESULTS; Of the 1315 study participants, 89% were vaccinated in the arm, and 67% were vaccinated with a 25-mm needle. Among children vaccinated in the arm, use of the shorter 16-mm needle was associated with a significantly higher risk of any redness, > or = 5 cm of redness, persistent redness on day 2, and pain compared with vaccination with a 25-mm needle. Similar trends among the smaller group of children vaccinated in the thigh were also suggested but were not statistically significant. In analyses that were restricted to children vaccinated with a 25-mm needle, vaccination in the thigh versus arm was associated with a substantially lower risk of > or = 5 cm of redness and a significantly lower risk of swelling and any itching but not with any difference in the risk of pain, irritability, or change in activity. CONCLUSIONS: These findings suggest that a 25-mm needle should be used for the fifth diphtheria-tetanus-acellular pertussis vaccination regardless of injection site and that vaccination in the thigh is an option that may be considered by parents and providers who would like to decrease the risk of local reactions characterized by redness and swelling.

Hepatitis B vaccine and risk of autoimmune thyroid disease: a Vaccine Safety Datalink study.

PURPOSE: Hepatitis B vaccine has been postulated as a possible cause of autoimmune disorders, including autoimmune thyroid diseases (ATD). Cases of Graves' disease and Hashimoto's thyroiditis, following hepatitis B vaccine have been reported to the Vaccine Adverse Events Reporting System (VAERS). To test the hypothesis that hepatitis B vaccine increases the risk of ATD, we conducted a case-control study, within the Vaccine Safety Datalink project. METHODS: We identified potential cases of Graves' disease and Hashimoto's thyroiditis, among persons aged 18-69 years from administrative data recorded by three health maintenance organizations (HMOs) and verified cases by medical record review. Controls were frequency-matched to cases by birth year, sex, and study site. Vaccine information was collected from administrative records, chart review, and telephone interviews with study subjects. We enrolled 355 Graves' disease cases, 418 Hashimoto's thyroiditis cases, and 1102 controls. We assessed the association between ever-receipt of hepatitis B vaccine, as well as receipt of hepatitis B vaccine less than 1 year, 1-5 years and at least 5 years prior to the index date, and the risk of ATD. RESULTS: Ever-receipt of hepatitis B vaccine was not associated with risk of Graves' disease (odds ratio (OR), 0.90; 95% confidence interval (CI), 0.62-1.32) or Hashimoto's thyroiditis (OR, 1.23; 95%CI, 0.87-1.73). There was also no association between the time interval since receipt of hepatitis B vaccination and either outcome. CONCLUSIONS: We did not observe an increased risk of Graves' disease or Hashimoto's thyroiditis, following receipt of hepatitis B vaccine.

Prophylaxis with acetaminophen or ibuprofen for prevention of local reactions to the fifth diphtheria-tetanus toxoids-acellular pertussis vaccination: a randomized, controlled trial.

BACKGROUND: The frequency of local vaccination reactions increases with successive doses of diphtheria-tetanus toxoids-acellular pertussis (DTaP) vaccine, and local reactions occur for the majority of children receiving the fifth DTaP vaccination. It is not known whether these reactions can be prevented with prophylactic use of acetaminophen or ibuprofen. METHODS: In this 3-group, randomized, blinded, controlled trial, 372 children were assigned randomly, in a 2:2:1 ratio, to receive 3 doses of acetaminophen, ibuprofen, or placebo. The first dose of study medication was administered within 2 hours before the fifth DTaP vaccination, and the remaining 2 doses were given at 6-hour intervals. The primary outcome measures included a local reaction with an area of redness or discoloration > or =5 cm in diameter on the evening of or during the 2 days after vaccination, an increase in mid-limb circumference of > or =2 cm on the evening of or during the 2 days after vaccination, and a persistent local reaction, defined as an area of redness or discoloration present on the third day after vaccination. RESULTS: Local reactions with a > or =5-cm area of redness or discoloration were reported for 35% of children in the placebo group, compared with 33% of children in the acetaminophen group and 37% of children in the ibuprofen group. There was also no significant difference between the placebo and treatment groups in the proportions of children with a > or =2-cm increase in mid-limb circumference or with a persistent local reaction. CONCLUSIONS: We did not find evidence that prophylaxis with acetaminophen or ibuprofen offers a clinically significant benefit in prevention of local reactions to the fifth DTaP vaccination.

Post-marketing evaluation of the short term safety of COMVAX.

We report an evaluation of the short-term safety of a pediatric bivalent combination vaccine containing RECOMBIVAXHB and Liquid PedvaxHIB, COMVAX. Safety was assessed through identification of medical utilization; potential adverse events were identified through computerized clinical databases for deaths, hospitalizations, emergency room visits, and outpatient clinic visits. We calculated relative risks whenever there was at least one diagnosis-specific event in the risk period following vaccination and compared the rates in specific time windows following vaccination with rates at 31-60 days following vaccination and also with rates in a historical cohort of children. A total of 27,802 doses of COMVAX were administered, with 127 separate adverse event codes with statistically significant elevated risks, and 66 codes with significantly decreased risks. Most potentially serious diagnoses appeared in four major categories: "Respiratory Events"; "Gastroenteritis"; "Adverse Effect of Medicinal and Biological Substance, NOS"; and "Fever". There was no consistent pattern to indicate increased risks for serious respiratory or gastrointestinal illness. For fever, most of the findings appeared to be explained by changes in data collection or by concomitant vaccination with M-M-R(-)II. There was an increased risk for fever hospitalizations following shot 1. The total number of children hospitalized with fever was seven out of 12,468 children; all recovered fully. In this study population of 27,802 vaccine recipients, COMVAX appeared to have a favorable safety profile.

Barriers to implementing the group B streptococcal prevention guidelines.

BACKGROUND: Group B streptococcal disease is the leading cause of neonatal sepsis in the United States. We assessed predictors of compliance with the consensus guidelines for perinatal group B streptococcus disease prevention at two Group Health Cooperative hospitals. METHODS: A descriptive and cohort analysis was conducted of failure to comply with the screening-based approach to group B streptococcus prevention among singleton birth pregnancies in two Group Health Cooperative hospitals, September 1, 1996 to December 31, 1997. We studied determinants of failure to screen pregnant women for group B streptococcus at 35 to 37 weeks' gestation and failure to deliver intrapartum antibiotic prophylaxis to Group B streptococcus-positive women. RESULTS: Nearly 28 percent of 1969 women delivering at two Group Health Cooperative hospitals were not screened appropriately for group B streptococcus. Women who were not screened properly were more likely to be in their teens. A short length of hospital stay before delivery was the strongest predictor of the lack of administration of intrapartum antibiotic prophylaxis to infected multiparas at delivery. Group B streptococcus-positive women without pregnancy complications were less likely to receive intrapartum antibiotic prophylaxis than infected women with complications. CONCLUSIONS: The findings of this study suggest that to improve group B streptococcus disease prevention, screening efforts should focus on teenage women, and intrapartum antibiotic prophylaxis delivery efforts should be aimed at low-risk women with precipitous labor.