Background: The Longevity Improvement & Fair Evidence (LIFE) Study, which was launched in 2019, is a multi-region community-based database project that aims to generate evidence toward extending ...healthy life expectancy and reducing health disparities in Japan. Herein, we describe the LIFE Study’s design and baseline participant profile.Methods: Municipalities participating in the LIFE Study provide data from government-administered health insurance enrollees and public assistance recipients. These participants cover all disease types and age groups. Centered on healthcare claims data, the project also collects long-term care claims data, health checkup data, vaccination records, residence-related information, and income-related information. The different data types are converted into a common data model containing five modules (health care, long-term care, health checkup, socioeconomic status, and health services). We calculated the descriptive statistics of participants at baseline in 2018.Results: The LIFE Study currently stores data from 1,420,437 residents of 18 municipalities. The health care module contains 1,280,756 participants (mean age: 65.2 years), the long-term care module contains 189,069 participants (mean age: 84.3 years), and the health checkup module contains 274,375 participants (mean age: 69.0 years). Although coverage and follow-up rates were lower among younger persons, the health care module includes 74,151 children (0–19 years), 273,157 working-age adults (20–59 years), and 933,448 older persons (≥60 years).Conclusion: The LIFE Study provides data from over 1 million participants and can facilitate a wide variety of life-course research and cohort studies. This project is expected to be a useful platform for generating real-world evidence from Japan.
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FFLJ, NUK, ODKLJ, UL, UM, UPUK
•This is Japan’s first database that enables comparative assessments of vaccines.•A pilot study assessed influenza vaccine safety in vaccinated and unvaccinated groups.•The VENUS Study can support a ...variety of vaccine studies in the post-authorization phase.
Japan currently lacks a data platform that can support quantitative assessments of the causal relationships between vaccines and adverse events. This study describes the development and application of the Vaccine Effectiveness, Networking, and Universal Safety (VENUS) Study to facilitate such assessments.
A database was created by linking public insurance enrollees’ claims data with vaccination records acquired from participating municipalities. To provide an overview of the study data, we produced descriptive statistics of sex, age, and vaccinations. We also conducted a pilot study using the database to assess influenza vaccine safety during the 2018/2019 season among older persons (≥65 years) residing in a single municipality.
Our database was created using data from approximately 1.12 million individuals in 7 municipalities between 2013 and 2020. The data during fiscal year 2018 included 853,016 individuals (male: 363,079, female: 489,937) with a median age of 70 years (interquartile range: 52–79). We obtained information on 17 vaccine types, including the pneumococcal vaccine and influenza vaccine. In the pilot study, we analyzed 48,723 vaccinated persons matched with 48,723 unvaccinated persons. The only adverse event that occurred in both groups was Bell’s palsy, which had an adjusted incidence rate ratio of 1.21 (95 % confidence interval: 0.48–3.07).
The VENUS Study is Japan’s first healthcare data platform that enables comparative assessments of vaccinated and unvaccinated persons in large samples covering all age groups. Efforts are underway to increase the number of participating municipalities and to generate evidence on vaccine effectiveness and safety.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
•We analyzed influenza vaccine effectiveness during the 2018/2019 season in Japan.•The population-based study cohort comprised older persons aged ≥ 75 years.•Vaccine effectiveness against ...hospitalization was 28.9%.•This is Japan’s largest cohort study on influenza vaccine effectiveness to date.
Older persons are recommended to receive annual influenza vaccinations due to their increased susceptibility to influenza infections and related complications. Routine assessments of influenza vaccine effectiveness (IVE) in older persons may help to improve vaccine development and vaccination strategies, but there is a lack of consistent epidemiological data from Japan. This study aimed to evaluate IVE against hospitalization during the 2018/2019 season among older persons aged ≥ 75 years in Japan.
This cohort study was conducted using insurance claims data and vaccination records provided by the Longevity Improvement & Fair Evidence - Vaccine Effectiveness, Networking, and Universal Safety (LIFE-VENUS) Study. The study cohort comprised older persons aged ≥ 75 years residing in an urban municipality in Japan. Vaccinated participants were identified through vaccination records from October 2018 to January 2019, and were matched with unvaccinated participants using a 1:1 ratio. The IVE against hospitalization was calculated as (1−hazard ratio) × 100% while adjusting for covariates such as age, sex, comorbidities, previous vaccinations, and care needs levels.
We analyzed 30,881 vaccinated participants matched with 30,881 unvaccinated participants. Among these, 587 (1.9%) vaccinated participants and 644 (2.1%) unvaccinated participants were hospitalized during the 2018/2019 season. The adjusted IVE against hospitalization was estimated to be 28.9% (16.6–39.4%).
The influenza vaccine for the 2018/2019 season showed moderate effectiveness among older persons in Japan. The LIFE-VENUS Study represents a potential platform for the continued monitoring of IVE among the older Japanese population.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
•This report contains the first results of the Vaccine Effectiveness, Networking, and Universal Safety (VENUS) study conducted in Japan.•This cohort study assessed COVID-19 messenger RNA vaccine ...effectiveness (VE).•VE of two doses against symptomatic infection was 89.8% during the Delta wave.•VE of two doses against symptomatic infection was 21.2% during the Omicron wave.•VE of three doses against symptomatic infection was 71.8% during the Omicron wave.
We aimed to evaluate COVID-19 messenger RNA vaccine effectiveness during the Delta- and Omicron-predominant periods in Japan.
We conducted a population-based cohort study among individuals aged 16–64 years during two periods: the Delta-predominant period (July 1–December 31, 2021) and the Omicron-predominant period (January 1–March 29, 2022).
When comparing individuals who were vaccinated with those who were unvaccinated, the effectiveness of a second dose against symptomatic infection was 89.8% (95% confidence interval CI: 80.5–94.7%) during the Delta-predominant period and 21.2% (95% CI: 11.0–30.3%) during the Omicron-predominant period. The effectiveness of a third dose against symptomatic infection was 71.8% (95% CI: 60.1–80.1%) during the Omicron-predominant period.
Vaccine effectiveness against symptomatic infection decreased during the Omicron-predominant period but was maintained by a third dose.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background: We evaluated the effectiveness of the BNT162b2 vaccine against infection, symptomatic infection, and hospitalization in older people during the Delta-predominant period (July 1 to ...September 30, 2021).Methods: We performed a population-based cohort study in an older adult population aged ≥65 years using data from the Vaccine Effectiveness, Networking, and Universal Safety Study conducted from January 1, 2019, to September 30, 2021, in Japan. We matched BNT162b2-vaccinated and -unvaccinated individuals in a 1:1 ratio on the date of vaccination of the vaccinated individual. We evaluated the effectiveness of the vaccine against infection, symptomatic infection, and coronavirus disease (COVID-19)-related hospitalization by comparing the vaccinated and unvaccinated groups. We estimated the risk ratio and risk difference using the Kaplan–Meier method with inverse probability weighting. The vaccine effectiveness was calculated as (1 − risk ratio) × 100%.Results: The study included 203,574 matched pairs aged ≥65 years. At 7 days after the second dose, the vaccine effectiveness of BNT162b2 against infection, symptomatic infection, and hospitalization was 78.1% (95% confidence interval CI, 65.2–87.8%), 79.1% (95% CI, 64.6–88.9%), and 93.5% (95% CI, 83.7–100%), respectively.Conclusion: BNT162b2 was highly effective against infection, symptomatic infection, and hospitalization in Japan’s older adult population aged ≥65 years during the Delta-predominant period.
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FFLJ, NUK, ODKLJ, UL, UM, UPUK
Although previous studies have shown no increased mortality risk after the primary series of COVID-19 mRNA vaccines, reports on booster doses are lacking. This study aimed to evaluate mortality risk ...after the mRNA vaccine boosters in addition to the primary series. This nested case-control study included two age-specific cohorts (18-64 and ≥65 years as of February 1, 2021) in two municipalities. All deaths were identified and matched five controls for each case at each date of death (index date) with risk set sampling according to municipality, age, and sex. The adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for mRNA vaccines (first to fifth doses) were estimated by comparing with no vaccination within 21 and 42 days before the index date using a conditional logistic regression model. The 18-64-years cohort comprised 431 cases (mean age, 57.0 years; men, 58.2%) and 2,155 controls (mean age, 56.0; men, 58.2%), whereas the ≥65-years cohort comprised 12,166 cases (84.0; 50.2%) and 60,830 controls (84.0, 50.2%). The aORs (95% CI) in 0-21 days after the third and fourth doses in the 18-64-years cohort were 0.62 (0.24, 1.62) and 0.38 (0.08, 1.84), respectively. The aORs (95% CI) after the third to fifth doses in the ≥65 years cohort were 0.36 (0.31, 0.43), 0.30 (0.25, 0.37), and 0.26 (0.20, 0.33), respectively. In conclusion, booster doses of mRNA vaccines do not increase mortality risk. These findings could help subsequent vaccine campaigns and alleviate vaccine hesitancy.
Purpose
To evaluate the safety‐related regulatory actions implemented by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in 2012.
Methods
We analyzed serious safety issues appended to drug ...package inserts (PIs) in Japan in 2012. The issues were characterized according to drug class, adverse event, years since drug approval, initiator of regulatory actions, revised section of PI, and evidence source. We also quantified the durations from signal detection to tentative decision and from tentative decision to regulatory action.
Results
We identified 144 serious safety issues during the study period, and the majority of evidence originated from spontaneous reports (83.5%). The PMDA initiated regulatory actions for half of all safety issues, and the median duration from drug approval to regulatory action was 8 years (interquartile range IQR, 3–26.5 years). The median duration was 49 days (IQR, 0–362 days) from signal detection to tentative decision and 84 days (IQR, 63–136 days) from tentative decision to regulatory action. Several safety issues involving older drugs and multiple products had protracted decision‐making durations.
Conclusions
Most safety issues led to prompt regulatory actions predominantly based on spontaneous reports. Some safety issues that were not easily detected by the spontaneous reporting system were identified years after approval. In addition, several safety issues required assessments of multiple drug products, which prolonged the decision‐making process.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
BackgroundCharacterising the psychiatric sequelae of coronavirus disease 2019 (COVID-19) can inform the development of long-term treatment strategies. However, few studies have examined these ...sequelae at different time points after COVID-19 infection.AimsThe study aimed to investigate the incidences and risks of acute and delayed psychiatric sequelae in patients hospitalised with COVID-19 in Japan.MethodsThis retrospective cohort study was conducted using a database comprising healthcare claims data from public health insurance enrollees residing in a Japanese city. We analysed a primary cohort comprising patients hospitalised with COVID-19 between March 2020 and July 2021 and two control cohorts comprising patients hospitalised with influenza or other respiratory tract infections (RTI) during the same period. We calculated the incidences of acute (1–3 months after infection) and delayed (4–6 months after infection) psychiatric sequelae. These sequelae were identified using diagnosis codes and categorised as mood/anxiety/psychotic disorder, mood disorder, anxiety disorder, psychotic disorder or insomnia. Multivariable logistic regression models were used to estimate the odds ratios (ORs) of psychiatric sequelae occurrence after COVID-19 infection compared with influenza and other RTI.ResultsThe study population with acute psychiatric sequela consisted of 662 patients with COVID-19, 644 patients with influenza, and 7369 patients with RTI who could be followed for 3 months; the study population with delayed psychiatric sequelae consisted of 371 patients with COVID-19, 546 patients with influenza, and 5397 patients with RTI who could be followed for 6 months. In the analysis of acute psychiatric sequelae, COVID-19 had significantly higher odds of mood/anxiety/psychotic disorder (OR: 1.39, p=0.026), psychotic disorder (OR: 2.13, p<0.001), and insomnia (OR: 2.59, p<0.001) than influenza, and significantly higher odds of insomnia (OR: 1.44, p=0.002) and significantly lower odds of anxiety disorder (OR: 0.56, p<0.001) than other RTI. In the analysis of delayed psychiatric sequelae, COVID-19 had significantly higher odds of psychotic disorder (OR: 2.25, p=0.007) than influenza, but significantly lower odds of anxiety disorder (OR: 0.55, p=0.011) than other RTI.ConclusionsCOVID-19 was generally associated with an increased risk of psychiatric sequelae occurring within 3 months after infection, but had a lower risk of new psychiatric sequelae developing 4–6 months after infection.
Although hyperlipidemia is a well known adverse event of atypical antipsychotic (AAP) medication, there are few studies that have quantitatively compared the risks of various AAPs.
Our aim was to ...comparatively evaluate the risk of hyperlipidemia associated with the use of AAPs approved in Japan through a consecutive epidemiological study.
We conducted a sequence symmetry analysis (SSA) using health insurance claims data to analyze the following nine AAPs approved for use in Japan: risperidone, paliperidone, perospirone hydrochloride hydrate, blonanserin, clozapine, olanzapine, quetiapine fumarate, aripiprazole, and zotepine. Exposed cases were identified from drug dispensing records as those who had been administered both AAPs and antihyperlipidemic drugs. The adjusted sequence ratio (ASR) and 95 % confidence interval (CI) for each individual AAP and for all AAPs were calculated while controlling for time trends in dispensing patterns.
Olanzapine was significantly associated with increased hyperlipidemia occurrence (ASR 1.56; 95 % CI 1.25-1.95). The ASRs obtained for risperidone (1.01; 95 % CI 0.80-1.27), perospirone hydrochloride hydrate (0.93; 95 % CI 0.63-1.39), blonanserin (0.83; 95 % CI 0.52-1.33), quetiapine fumarate (0.93; 95 % CI 0.73-1.18), and aripiprazole (1.02; 95 % CI 0.82-1.26) were approximately 1.0. Unstable estimates (wide CIs) were obtained for paliperidone and zotepine due to the small sample sizes.
Among the AAPs used in Japan, only olanzapine was found to have an elevated risk of hyperlipidemia. In contrast, risperidone, perospirone hydrochloride hydrate, blonanserin, quetiapine fumarate, and aripiprazole had relatively low risks.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
