Explore the vast range of titles available.

•Risk of pertussis increased on average 27% per year after 5th dose of GSK DTaP3.•Regardless of manufacturer, pertussis risk increased 30% per year after 5th DTaP.•Protection wanes substantially as children are more remote from the 5th DTaP3 dose. The effectiveness of diphtheria, tetanus, and acellular pertussis (DTaP) vaccines wanes substantially after the 5th dose given at ages 4–6years, but has not been described following 5 doses of the same type of DTaP vaccine. We investigated waning effectiveness against pertussis in California over nearly 10years, which included large pertussis outbreaks, following 5 doses of GSK DTaP vaccines (DTaP3). We conducted a case-control study (NCT02447978) of children who received 5 doses of DTaP at Kaiser Permanente Northern California from 01/2006 through 03/2015. We compared time since the 5th dose in confirmed pertussis polymerase chain reaction (PCR)-positive cases with pertussis PCR-negative controls. We used logistic regression adjusted for calendar time, age, sex, race, and service area to estimate the effect of time since the 5th DTaP dose on the odds of pertussis. Our primary analysis evaluated waning after 5 doses of DTaP3. We also examined waning after 5 doses of any type of DTaP vaccines. Our primary analysis compared 340 pertussis cases diagnosed at ages 4–12years with 3841 controls. The any DTaP analysis compared 462 pertussis cases with 5649 controls. The majority of all DTaP doses in the study population were DTaP3 (86.8%). Children who were more remote from their 5th dose were less protected than were children whose 5th dose was more recent; the adjusted odds of pertussis increased by 1.27 per year (95% CI 1.10, 1.46) after 5 doses of DTaP3 and by 1.30 per year (95% CI 1.15, 1.46) after any 5 DTaP vaccines doses. Waning protection after DTaP3 was similar to that following 5 doses of any type of DTaP vaccines. This finding is not unexpected as most of the DTaP vaccines administered were DTaP3. Following 5 doses of DTaP3 vaccines, protection from pertussis waned 27% per year on average. NCT number: NCT02447978.

•We estimated IPD relative risk (RR) for non-immunocompromising (IC) conditions.•We also estimated IPD RR for more than one non-IC condition.•RR for a single non-IC medical condition: twofold the general KPNC population RR.•IPD RR for multiple non-IC conditions increased with each additional condition. In the United States, the 13-valent pneumococcal conjugate vaccine is recommended in persons ⩾65years of age, and persons ⩽65years of age with immunocompromising (IC) conditions. For invasive pneumococcal disease (IPD) prevention in those ⩽65 with non-IC medical conditions, the 23-valent polysaccharide vaccine is recommended. This group is at higher risk of IPD than the general population, but the level of risk is not well-quantified. We estimated IPD risk by individual underlying medical conditions, and by total number of conditions, for persons ⩾18years of age. We calculated the relative risks (RR) of various medical conditions, comparing the incident IPD cases to the general study population, and used Poisson regression models to estimate an IPD RR, adjusting for other conditions. We also examined IPD incidence by number of conditions diagnosed in each calendar year, using a risk-stacking model. Underlying medical conditions with the highest adjusted RR for IPD were chronic liver disease (RR 2.1, 95% CI 1.5–2.8) and chronic obstructive pulmonary disease (COPD; RR 2.1, 95% CI 1.8–2.5). IPD risk increased with increasing number of medical conditions: adjusted RR, 2.2 (95% CI 1.9–2.5) 1 condition, 2.9 (2.5–3.5) for 2 conditions, and 5.2 (4.4–6.1) for 3 conditions. For persons with a single, non-IC medical condition, IPD risk was twice that for the general KPNC population. Persons with multiple, non-IC chronic conditions exhibited increased IPD risk with each additional condition. Such information may inform discussions on recommendations for adult pneumococcal immunization and prevention.

AbstractObjectivesTo assess the effectiveness of live zoster vaccine during more than 10 years after vaccination; and to describe methods for ascertaining vaccine effectiveness in the context of waning.DesignReal world cohort study using electronic health records.SettingKaiser Permanente Northern California, an integrated healthcare delivery system in the US, 1 January 2007 to 31 December 2018.PopulationMore than 1.5 million people aged 50 years and older followed for almost 9.4 million person years.Main outcome measureVaccine effectiveness in preventing herpes zoster, postherpetic neuralgia, herpes zoster ophthalmicus, and admission to hospital for herpes zoster was assessed. Change in vaccine effectiveness by time since vaccination was examined using Cox regression with a calendar timeline. Time varying indicators were specified for each interval of time since vaccination (30 days to less than one year, one to less than two years, etc) and adjusted for covariates.ResultsOf 1 505 647 people, 507 444 (34%) were vaccinated with live zoster vaccine. Among 75 135 incident herpes zoster cases, 4982 (7%) developed postherpetic neuralgia, 4439 (6%) had herpes zoster ophthalmicus, and 556 (0.7%) were admitted to hospital for herpes zoster. For each outcome, vaccine effectiveness was highest in the first year after vaccination and decreased substantially over time. Against herpes zoster, vaccine effectiveness waned from 67% (95% confidence interval 65% to 69%) in the first year to 15% (5% to 24%) after 10 years. Against postherpetic neuralgia, vaccine effectiveness waned from 83% (78% to 87%) to 41% (17% to 59%) after 10 years. Against herpes zoster ophthalmicus, vaccine effectiveness waned from 71% (63% to 76%) to 29% (18% to 39%) during five to less than eight years. Against admission to hospital for herpes zoster, vaccine effectiveness waned from 90% (67% to 97%) to 53% (25% to 70%) during five to less than eight years. Across all follow-up time, overall vaccine effectiveness was 46% (45% to 47%) against herpes zoster, 62% (59% to 65%) against postherpetic neuralgia, 45% (40% to 49%) against herpes zoster ophthalmicus, and 66% (55% to 74%) against admission to hospital for herpes zoster.ConclusionsLive zoster vaccine was effective initially. Vaccine effectiveness waned substantially yet some protection remained 10 years after vaccination. After 10 years, protection was low against herpes zoster but higher against postherpetic neuralgia.Trial registrationClinicalTrials.gov number NCT01600079; EU PAS register number EUPAS17502

► We reviewed 212 neurological SAEs after H1N1 vaccine reported to VAERS. ► We applied modified WHO causality criteria to case reports. ► The most frequent diagnoses were GBS (37%) and seizure (11%). ► Causal assessment resulted in 72 possible, 108 unlikely, and 20 unrelated to vaccine. Adverse events occurring after vaccination are routinely reported to the Vaccine Adverse Event Reporting System (VAERS). We studied serious adverse events (SAEs) of a neurologic nature reported after receipt of influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 influenza season. Investigators in the Clinical Immunization Safety Assessment (CISA) network sought to characterize these SAEs and to assess their possible causal relationship to vaccination. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) physicians reviewed all SAE reports (as defined by the Code of Federal Regulations, 21CFR§314.80) after receipt of H1N1 vaccine reported to VAERS between October 1, 2009 and March 31, 2010. Non-fatal SAE reports with neurologic presentation were referred to CISA investigators, who requested and reviewed additional medical records and clinical information as available. CISA investigators assessed the causal relationship between vaccination and the event using modified WHO criteria as defined. 212 VAERS reports of non-fatal serious neurological events were referred for CISA review. Case reports were equally distributed by gender (50.9% female) with an age range of 6 months to 83 years (median 38 years). The most frequent diagnoses reviewed were: Guillain–Barré Syndrome (37.3%), seizures (10.8%), cranial neuropathy (5.7%), and acute disseminated encephalomyelitis (3.8%). Causality assessment resulted in classification of 72 events as “possibly” related (33%), 108 as “unlikely” related (51%), and 20 as “unrelated” (9%) to H1N1 vaccination; none were classified as “probable” or “definite” and 12 were unclassifiable (6%). The absence of a specific test to indicate whether a vaccine component contributes to the pathogenesis of an event occurring within a biologically plausible time period makes assessing causality difficult. The development of standardized protocols for providers to use in evaluation of adverse events following immunization, and rapid identification and follow-up of VAERS reports could improve causality assessment.

Postherpetic neuralgia (PHN) occurs in 5–30% of individuals with herpes zoster (HZ) and is characterized by long-lasting pain. Zoster vaccine live (ZVL) is licensed for people 50 years and older to prevent HZ and PHN. This study evaluated vaccine effectiveness (VE) of ZVL against PHN. We conducted an open cohort study within Kaiser Permanente Northern California with continuous accrual of people as they became age-eligible for ZVL. We defined PHN using a PHN diagnosis between 90 and 365 days after an incident episode of HZ. We estimated VE against PHN using Cox regression with a calendar timeline stratified by year of birth and adjusted for sex, race, influenza vaccination, outpatient visit frequency, comorbidities, and immune compromise status. From 2007 to 2016, 1·5 million people entered the study population and 33% received ZVL. During 7·6 million person-years of follow-up, there were 62,205 HZ cases, 4150 (6·7%) of which went on to develop PHN. Overall VE for PHN was 64·8% (95% CI 61·3, 68). VE was 82·8% (95% CI 77·6, 86·7) during the first year after vaccination, 58·3% (95% CI 50.1, 65.2) during the third year, and then waned more gradually to 48·7% (95% CI 30·2, 62·3) during the eighth year. VE in persons vaccinated when aged 80 years or older was similar to VE in younger vaccinees. VE in persons vaccinated when immune compromised was similar to VE in immune competent. Overall, ZVL was 65% effective against PHN. It was effective in all age groups and provided moderate protection through 8 years.

Highlights • Q/LAIV is similar to T/LAIV, with an additional influenza B vaccine strain. • 62,040 Q/LAIV recipients were enrolled in this prospective observational study. • Rates of events after vaccination were compared versus later in the follow-up. • Rates were also compared versus IIV recipients and unvaccinated controls. • No safety signal associated with administration of Q/LAIV was observed.

•Initiation rate rose after implementation of 1st-dose reminder at intervention site.•Completion rate rose after introduction of all-dose alert at intervention site.•During the same period, the corresponding rates at control site remained stable. The Advisory Committee on Immunization Practices recommends Hepatitis B (HepB) vaccine for previously unvaccinated adults <60 years with diabetes mellitus. This observational retrospective cohort study assessed the impact of implementing electronic provider reminders on HepB vaccine initiation and 3-dose series completion rates among insured adults with diabetes aged 19–59 years old. Difference-in-difference (DID) analyses compared changes in vaccine initiation and completion rates (ratio of the rate ratio [RRR] and 95% confidence interval [CI]) during 12 months pre- and post-implementation between intervention and control sites. We examined trends in vaccine initiation and completion rates by plotting monthly rates during the study period. We also calculated the overall HepB vaccine coverage rates with 95% CI among all adults with diabetes aged 19–59 years old at the start and end date of the study period. Baseline HepB vaccine initiation and completion rates were similar at both the intervention and control sites. Gender, age, and race/ethnicity distributions within both sites were similar during the 12 months pre- and post-implementation. DID analyses demonstrated statistically significant differences in the changes of the annual vaccine initiation rates (RRR: 70.7, 95% CI: 62.8–79.6) and the third dose completion rates (RRR = 18.7, 95% CI: 14.2–24.8) between the two sites. The coverage increased significantly at the intervention site while it remained low at the control site. Use of provider reminders is highly effective in increasing both HepB vaccine initiation and series completion rates among adults with diabetes.

•Q/LAIV is similar to T/LAIV, with an additional influenza B vaccine strain.•62,040 Q/LAIV recipients were enrolled in this prospective observational study.•Rates of events after vaccination were compared versus later in the follow-up.•Rates were also compared versus IIV recipients and unvaccinated controls.•No safety signal associated with administration of Q/LAIV was observed. Quadrivalent live attenuated influenza vaccine (Q/LAIV) was licensed in 2012 and replaced trivalent live attenuated influenza vaccine in the United States during the 2013–2014 influenza season. This study assessed the safety of Q/LAIV in children and adults aged 2–49years. This was a prospective observational cohort study using data collected from Kaiser Permanente Northern California. Post-vaccination events of interest were any hospitalization, hospitalization for lower respiratory tract infection, and the following medically attended events: hypersensitivity, seizures/convulsions, lower respiratory tract infection, wheezing, Guillain-Barré syndrome, Bell’s palsy, encephalitis, neuritis, vasculitis, and narcolepsy/cataplexy. The rates of these events during the risk interval post-vaccination were compared with rates observed during reference periods later in the follow-up (within-cohort analysis) and with rates observed in frequency-matched unvaccinated controls and inactivated influenza vaccine (IIV) recipients. A total of 62,040 eligible Q/LAIV recipients were identified during the 2013–2014 influenza season. Within-cohort comparisons of all Q/LAIV recipients as well as comparisons between Q/LAIV recipients and unvaccinated controls or IIV recipients did not show any significantly higher risk of hospitalizations or medically attended events following administration of Q/LAIV. Additional analyses by setting (clinic visits, emergency department visits, and hospital admissions) and age group (2–4, 5–8, 9–17, and 18–49years) also did not reveal clinically consistent findings that suggested any increased risk after administration of Q/LAIV. In this large population study of individuals aged 2–49years, no safety signals associated with the administration of Q/LAIV were observed. A much larger study population would be needed to confidently reject any association between Q/LAIV and very rare events, specifically those with an incidence of <1 event/10,000 person-years. Trial registration: ClinicalTrials.gov NCT01985997