Incident autoimmune conditions among males receiving quadrivalent human papillomavirus vaccine in the United States.

BACKGROUND: The potential for vaccines to induce autoimmunity has been the subject of considerable investigation and autoimmune induction remains a common focus for vaccine safety research. This study assessed the risk of new onset autoimmune conditions among males receiving the 4-valent human papillomavirus (HPV) vaccine (4vHPV). METHODS: Within a US health insurance claims database, we formed a cohort of male 4vHPV vaccine recipients between 2009 and 2016, along with a propensity score matched cohort of males who did not receive the 4vHPV vaccine. The study outcome was new onset autoimmune conditions (20 separate conditions) within four categories (rheumatologic/hematologic, gastroenterologic, endocrinologic and neurologic/ophthalmalogic). Outcomes identified using diagnosis codes were adjudicated through medical record review. Incidence rates (per 1,000 person-years) were estimated for the vaccinated and unvaccinated groups along with rate ratios (RRs). RESULTS: There were 65,606 males receiving at least one dose of 4vHPV vaccine, and 55,670 were matched to a comparator. The matched 4vHPV vaccine cohort provided 35 confirmed cases among 39,735 person-years, for an incidence rate of 0.88 (95% CI: 0.61-1.23), while the comparator cohort provided 47 confirmed cases among 58,215 person-years, an incidence rate of 0.81 (0.59-1.07), a RR of 1.09 (0.70-1.69). The RR within categories was 0.49 (0.10-2.42) for rheumatologic/hematologic, 1.26 (0.58-2.71) for gastroenterologic, 1.11 (0.61-2.02) for endocrinologic and 1.46 (0.21-10.40) for neurologic. CONCLUSIONS: The incidence of autoimmune conditions among males receiving the 4vHPV vaccine was similar to that among unvaccinated males. These results are consistent with other studies that have assessed autoimmunity with the 4vHPV vaccine.

Vaccine discontinuation and switching following regulatory interventions in response to rotavirus vaccine contamination with porcine circovirus DNA fragments.

PURPOSE: The Food and Drug Administration temporarily suspended monovalent rotavirus vaccine (RV1) use following discovery of contamination with porcine circovirus fragments and subsequently announced similar contamination of the pentavalent rotavirus vaccine (RV5) but recommended continued use of the product. We assessed the utilization of these vaccines in relation to the announcements. METHODS: Using claims submitted to a commercial health insurer for administration of RV1 and RV5, we estimated the number of administrations of the vaccines and the extent of switching between RV1 and RV5. Procedure codes on submitted claims identified vaccine administrations among infants ≤ 1 year old through 16 June 2010. Among infants who received a first dose of vaccine before the corresponding announcement, and whose second dose was anticipated following the announcement, we estimated the number who received no second dose of rotavirus vaccine. RESULTS: There were 31 178 RV1 initiators and 514 357 RV5 initiators. We observed a 93% reduction in RV1 doses in the month following the recommended suspension of use, coupled with extensive switching to RV5 (90% of subsequent doses) and a reduction in second RV1 doses (from 35.5% incomplete to 40.9%). There was a 15% increase in number of RV5 administrations following announcement of its contamination, with little switching to RV1 but with a possible decrease in completion. CONCLUSIONS: Recommended suspension of RV1 use led to a substantial decrease in use and extensive switching to RV5. The announcement that RV5 was similarly contaminated, but without a corresponding recommendation to suspend use, had little effect on use.

Atomoxetine and cerebrovascular outcomes in adults.

OBJECTIVE: The aim of this study was to estimate the association between atomoxetine and cerebrovascular accident (CVA) and transient ischemic attack (TIA) in adults. METHODS: This cohort study conducted within a health insurance database included 21,606 atomoxetine initiators matched to 21,606 stimulant attention-deficit/hyperactivity disorder (ADHD) medication initiators on the basis of propensity scores and a sample from the source population (N = 42,993). Outcomes were confirmed through a medical record review or a National Death Index search. Poisson regression was used to estimate the rate ratio and 95% confidence interval (CI) of CVA or TIA according to the treatment. Cox regression was used to estimate the hazards ratio (HR) and 95% CI for comparisons across cohorts. RESULTS: Forty-four CVAs and 21 TIAs occurred during a mean follow-up of 1.5 years. The rate ratio of the current atomoxetine compared with the current stimulant ADHD medication was 1.38 for CVA (95% CI, 0.42-4.54) and 0.31 for TIA (95% CI, 0.04-2.63). Results for atomoxetine compared with the stimulant ADHD medication according to initial cohort assignment were consistent, with no increased risk for CVA or TIA. An increased risk of TIA was observed between initiation of an ADHD medication compared with the general population (HR, 3.44; 95% CI, 1.13-10.60); however, a similar pattern was not observed for CVA (HR, 0.71; 95% CI, 0.34-1.47). CONCLUSIONS: These results do not support an increased risk of CV events with atomoxetine compared with the stimulant ADHD medication. Users of ADHD medications may be at an increased risk of TIA compared with the general population.

Evaluation of hospital and patient factors that influence the effective administration of surgical antimicrobial prophylaxis.

OBJECTIVE: To analyze and model the patient and healthcare system factors that may interfere with the appropriate administration of surgical antimicrobial prophylaxis. DESIGN: Between 1994 and 1998, surgical-site surveillance data were collected prospectively for a cohort of eligible surgical patients. For all cases, and each individual procedure (cardiothoracic, colonic, gynecologic, orthopedic, or vascular), forward stepwise multiple logistic regression was applied to relate key hospital and patient factors to an effective first prophylactic dose (ie, appropriate administration time, dose, route, and drug). SETTING: A 450-bed, tertiary-care teaching hospital in Canada. PATIENTS: A total of 4,835 patients admitted for surgical procedures who required antimicrobial prophylaxis. RESULTS: Factors positive for an effective first prophylactic dose for all cases were when an order was written (OR, 19.7; CI95, 9.1-42.7; P < .001) and given in the operating room (OR, 13.9; CI95, 7.5-25.6; P < .001). Factors negative for an effective first prophylactic dose were beta-lactam allergy (OR, 0.49; CI95, 0.4-0.61; P < .001) and same-day surgery (OR, 0.57; CI95, 0.4-0.82; P < .001). CONCLUSIONS: With few exceptions, the four factors included in the procedure models showed that when a preoperative order was written or the antibiotic was given in the operating room, a patient was more likely to receive an effective first prophylactic dose. Conversely, when a patient had a beta-lactam allergy or the surgery was performed on the day the patient was admitted, the administration of an effective first prophylactic dose was less likely.