Capture-recapture analysis of all-cause mortality data in Bohol, Philippines

Background: Despite the importance of mortality data for effective planning and monitoring of health services, official reporting systems rarely capture every death. The completeness of death reporting and the subsequent effect on mortality estimates were examined in six municipalities of Bohol province in the Philippines using a system review and capture-recapture analysis.Methods: Reports of deaths were collected from records at local civil registration offices, health centers and hospitals, and parish churches. Records were reconciled using a specific set of matching criteria, and both a two-source and a three-source capture-recapture analysis was conducted. For the two-source analysis, civil registry and health data were combined due to dependence between these sources and analyzed against the church data.Results: Significant dependence between civil registration and health reporting systems was identified. There were 8,075 unique deaths recorded in the study area between 2002 and 2007. We found 5% to 10% of all deaths were not reported to any source, while government records captured only 77% of all deaths. Life expectancy at birth (averaged for 2002-2007) was estimated at 65.7 years and 73.0 years for males and females, respectively. This was one to two years lower than life expectancy estimated from reconciled reported deaths from all sources, and four to five years lower than life expectancy estimated from civil registration data alone. Reporting patterns varied by age and municipality, with childhood deaths more underreported than adult deaths. Infant mortality was underreported in civil registration data by 62%.Conclusions: Deaths are underreported in Bohol, with inconsistent reporting procedures contributing to this situation. Uncorrected mortality measures would subsequently be misleading if used for health planning and evaluation purposes. These findings highlight the importance of ensuring that official mortality estimates from the Philippines are derived from data that have been assessed for underreporting and corrected as necessary

Allergic adverse events following 2015 seasonal influenza vaccine, Victoria, Australia

Australia was alerted to a possible increase in allergy-related adverse events following immunisation (AEFI) with 2015 seasonal trivalent influenza vaccines (TIV) by the Victorian state vaccine safety service, SAEFVIC. We describe SAEFVIC's initial investigation and upon conclusion of the 2015 influenza vaccination programme, to define the signal event and implications for vaccine programmes. Allergy-related AEFI were defined as anaphylaxis, angioedema, urticaria or generalised allergic reaction. Investigations compared 2015 TIV AEFI reports to previous years as proportions and reporting risk (RR) per 100,000, stratified by influenza vaccine brand. The initial investigation showed an increased proportion of allergy-related AEFI compared with 2014 (25% vs 12%), predominantly in adults, with insufficient clinical severity to alter the programme risk-benefit. While overall TIV AEFI RR in 2015 was similar to previous years (RR: 1.07, 95% confidence interval (CI): 0.88-1.29), we identified a near-doubling RR for allergy-related AEFI in 2015 (RR: 1.78, 95% CI: 1.14-- 2.80) from 2011 to 2014 with no difference by vaccine brand or severity increase identified. This increase in generalised allergy-related AEFI, across all used vaccine brands, supports evidence of variable reactogenicity arising from influenza vaccine strain variations. This investigation underlines the importance of effective seasonal influenza vaccine pharmacovigilance

Early signal detection of adverse events following influenza vaccination using proportional reporting ratio, Victoria, Australia

INTRODUCTION:Timely adverse event following immunisation (AEFI) signal event detection is essential to minimise further vaccinees receiving unsafe vaccines. We explored the proportional reporting ratio (PRR) ability to detect two known signal events with influenza vaccines with the aim of providing a model for prospective routine signal detection and improving vaccine safety surveillance in Australia. METHODS:Passive AEFI surveillance reports from 2008-2017 relating to influenza vaccines were accessed from the Australian SAEFVIC (Victoria) database. Proportional reporting ratios were calculated for two vaccine-event categories; fever and allergic AEFI. Signal detection sensitivity for two known signal events were determined using weekly data; cumulative data by individual year and; cumulative for all previous years. Signal event thresholds of PRR ≥2 and Chi-square ≥4 were applied. RESULTS:PRR provided sensitive signal detection when calculated cumulatively by individual year or by all previous years. Known signal events were detected 15 and 11 days earlier than traditional methods used at the time of the actual events. CONCLUSION:Utilising a single jurisdiction's data, PRR improved vaccine pharmacovigilance and showed the potential to detect important safety signals much earlier than previously. It has potential to maximise immunisation safety in Australia. This study progresses the necessary work to establish national cohesion for passive surveillance signal detection and strengthen routine Australian vaccine pharmacovigilance

SAEFVIC:Surveillance of adverse events following immunisation (AEFI) in Victoria, Australia, 2018

Background: SAEFVIC is the Victorian surveillance system for adverse events following immunisation (AEFI). It enhances passive surveillance by also providing clinical support and education to vaccinees and immunisation providers. This report summarises surveillance, clinical and vaccine pharmacovigilance activities of SAEFVIC in 2018. Methods: A retrospective observational cohort study of AEFI reports received by SAEFVIC in 2018, compared with previous years since 2008. Data were categorised by vaccinee demographics of age, sex, pregnancy and Indigenous status, vaccines administered and AEFI reactions reported. Age cohorts were defined as infant (0-12 months); young child (1-4 years); school-aged (5-17 years); adult (18-64 years); and older person (65+ years). Proportional reporting ratios were calculated for signal investigation of serious adverse neurological events with all vaccines and with influenza vaccines. Clinical support services and educational activities are described. Results: SAEFVIC received 1730 AEFI reports (26.8 per 100,000 population), with 9.3% considered serious. Nineteen percent (n = 329) attended clinical review. Annual AEFI reporting trends increased for infants, children and older persons, but were stable for school-aged and adult cohorts. Females comprised 55% of all reports and over 80% of reports among adults. There were 17 reports of AEFI in pregnant women and 12 (0.7%) in persons identifying as Indigenous Australians. A possible signal regarding serious adverse neurological events (SANE) was detected, but was not supported by signal validation testing. A clinical investigation is ongoing. Two deaths were reported coincident to immunisation with no evidence of causal association. Conclusion: SAEFVIC continues to provide robust AEFI surveillance supporting vaccine safety monitoring in Victoria and Australia, with new signal detection and validation methodologies strengthening capabilities

Shoulder injury following COVID-19 vaccine administration: a case series and proposed diagnostic algorithm

Background Shoulder Injury Related to Vaccine Administration (SIRVA) is a preventable adverse event following incorrect vaccine administration, which can result in significant long-term morbidity. There has been a notable surge in reported cases of SIRVA as a rapid national population-based COVID-19 immunization program has been rolled out across Australia. Methods Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC) in Victoria identified 221 suspected cases of SIRVA following the commencement of the COVID-19 vaccination program, reported between February 2021 and February 2022. This review describes the clinical features and outcomes of SIRVA in this population. Additionally, a suggested diagnostic algorithm is proposed, in order to facilitate early recognition and management of SIRVA. Results 151 cases were confirmed as SIRVA, with 49.0% having received vaccines at state vaccination centers. 75.5% were suspected incorrect administration site, with most patients experiencing shoulder pain and restricted movement within 24 hours of vaccination, lasting on average 3 months. Conclusion Improved awareness and education regarding SIRVA is imperative in a pandemic vaccine roll-out. The development of a structured framework for evaluating and managing suspected SIRVA will aid in timely diagnosis and treatment, essential to mitigate potential long-term complications

Victorian Specialist Immunisation Services (VicSIS) – bolstering adult clinics for COVID-19 vaccines

The Victorian Specialist Immunization Services (VicSIS) was established in Victoria, Australia, in February 2021, aiming to enhance vaccine safety services for Coronavirus disease (COVID-19) vaccines. VicSIS supports practitioners and patients with complex vaccine safety questions, including those who experience adverse events following immunization (AEFI) after COVID-19 vaccines. VicSIS provides individual vaccination recommendations, allergy testing, vaccine challenges, and vaccination under supervision. VicSIS initially comprised of eight adult COVID-19 specialist vaccination clinics, subsequently, expanding to better support pediatric patients as the Australian vaccine roll-out extended to adolescents and children. Since their establishment to September 2021, the inaugural VicSIS clinics received a total of 26,401 referrals and reviewed 6,079 patients. Consults were initially predominantly for pre-vaccination reviews, later predominantly becoming post-vaccination AEFI reviews as the program progressed. Regardless of the type of consult, the most common consult outcome was a recommendation for routine vaccination (73% and 55% of consult outcomes respectively). VicSIS is an integral component of the COVID-19 vaccination program and supports confidence in COVID-19 vaccine safety by providing consistent advice across the state. VicSIS aims to strengthen the health system through the pandemic, bolstering specialist immunization services beyond COVID-19 vaccines, including training the next generation of vaccinology experts

Background rates of adverse events of special interest for COVID-19 vaccines: A multinational Global Vaccine Data Network (GVDN) analysis

International audienceBackground: The Global COVID Vaccine Safety (GCoVS) project was established in 2021 under the multinational Global Vaccine Data Network (GVDN) consortium to facilitate the rapid assessment of the safety of newly introduced vaccines. This study analyzed data from GVDN member sites on the background incidence rates of conditions designated as adverse events of special interest (AESI) for COVID-19 vaccine safety monitoring. Methods: Eleven GVDN global sites obtained data from national or regional healthcare databases using standardized methods. Incident events of 13 pre-defined AESI were included for a pre-pandemic period (2015–19) and the first pandemic year (2020). Background incidence rates (IR) and 95% confidence intervals (CI) were calculated for inpatient and emergency department encounters, stratified by age and sex, and compared between pre-pandemic and pandemic periods using incidence rate ratios. Results: An estimated 197 million people contributed 1,189,652,926 person-years of follow-up time. Among inpatients in the pre-pandemic period (2015–19), generalized seizures were the most common neurological AESI (IR ranged from 22.15 [95% CI 19.01–25.65] to 278.82 [278.20–279.44] per 100,000 person-years); acute disseminated encephalomyelitis was the least common (<0.5 per 100,000 person-years at most sites). Pulmonary embolism was the most common thrombotic event (IR 45.34 [95% CI 44.85–45.84] to 93.77 [95% CI 93.46–94.08] per 100,000 person-years). The IR of myocarditis ranged from 1.60 [(95% CI 1.45–1.76) to 7.76 (95% CI 7.46–8.08) per 100,000 person-years. The IR of several AESI varied by site, healthcare setting, age and sex. The IR of some AESI were notably different in 2020 compared to 2015–19. Conclusion: Background incidence of AESIs exhibited some variability across study sites and between pre-pandemic and pandemic periods. These findings will contribute to global vaccine safety surveillance and research