scholarly journals Assessing safety of Ontario’s publicly funded MMR and MMRV immunization programs, 2012 to 2016

2019 ◽  
Vol 25 (6) ◽  
pp. 358-364
Author(s):  
Chi Yon Seo ◽  
Mohammed Rashid ◽  
Tara Harris ◽  
Jody Stapleton ◽  
Shelley L Deeks
Keyword(s):  
Adverse Events ◽  
Vaccine Safety ◽  
Reporting Rate ◽  
Public Confidence ◽  
Publicly Funded ◽  
Systemic Reactions ◽  
Event Category ◽  
Reporting Rates ◽  
Surveillance Database ◽  
Routine Immunization Schedule

Abstract Background The combined measles, mumps, rubella (MMR) and measles, mumps, rubella, and varicella (MMRV) vaccines are part of Ontario’s routine immunization schedule. Objective To assess adverse events following immunization (AEFIs) reported in Ontario following administration of MMR and MMRV vaccines between 2012 and 2016. Methods Reports of AEFIs were extracted from the provincial surveillance database on May 9, 2017. Events were grouped by provincial surveillance definitions. Reporting rates were calculated using provincial population estimates or net doses distributed as the denominator. A serious AEFI is defined as an AEFI that resulted in an in-patient hospitalization or death. Results Overall, 289 AEFIs were reported following administration of MMR (n=246) or MMRV (n=43) vaccines, for annualized reporting rates of 16.6 and 8.8 reports per 100,000 distributed doses, respectively. The highest age-specific reporting rate was in children aged 1 to 3 years for MMR (7.7 per 100,000 population) and children aged 4 to 9 years for MMRV (0.8 per 100,000 population). Systemic reactions were the most frequently reported event category, while rash was the most frequently reported event for both vaccines. There were 22 serious AEFIs, 19 following MMR and 3 following MMRV (1.3 and 0.6 per 100,000 doses distributed, respectively). Conclusions Our assessment found a low reporting rate of adverse events following MMR and MMRV vaccines in Ontario. No safety concerns were identified. Our findings are consistent with the safety profiles of these vaccines. Continued monitoring of vaccine safety is necessary to maintain timely detection of unusual postvaccine events and public confidence in vaccine safety.

Surveillance of adverse events following immunisation in Australia annual report, 2017

2019 ◽  
Vol 43 ◽  
Author(s):  
Aditi Dey ◽  
Han Wang ◽  
Helen Quinn ◽  
Rona Hiam ◽  
Nicholas Wood ◽  
...  
Keyword(s):  
Adverse Events ◽  
Annual Report ◽  
Injection Site Reaction ◽  
Reporting Rate ◽  
Vaccination Programs ◽  
National Immunisation ◽  
National Immunisation Program ◽  
Conjugate Vaccination ◽  
Reporting Rates ◽  
To Receive

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2017 reported to the Therapeutic Goods Administration and describes reporting trends over the 18-year period 1 January 2000 to 31 December 2017. There were 3,878 AEFI records for vaccines administered in 2017; an annual AEFI reporting rate of 15.8 per 100,000 population. There was a 12% increase in the overall AEFI reporting rate in 2017 compared with 2016. This increase in reported adverse events in 2017 compared to the previous year was likely due to the introduction of the zoster vaccine (Zostavax®) provided free for people aged 70–79 years under the National Immunisation Program (NIP) and also the state- and territory-based meningococcal ACWY conjugate vaccination programs. AEFI reporting rates for most other individual vaccines in 2017 were similar to 2016. The most commonly reported reactions were injection site reaction (34%), pyrexia (17%), rash (15%), vomiting (8%) and pain (7%). The majority of AEFI reports (88%) described non-serious events. Two deaths were reported that were determined to have a causal relationship with vaccination; they occurred in immunocompromised people contraindicated to receive the vaccines.

scholarly journals Surveillance of adverse events following immunisation in Australia: annual report, 2018

2020 ◽  
Vol 44 ◽  
Author(s):  
Aditi Dey ◽  
Han Wang ◽  
Helen Quinn ◽  
Alexis Pillsbury ◽  
Catherine Glover ◽  
...  
Keyword(s):  
Adverse Events ◽  
Seasonal Influenza ◽  
Annual Report ◽  
Injection Site Reaction ◽  
Reporting Rate ◽  
Vaccination Programs ◽  
National Immunisation ◽  
Program Schedule ◽  
National Immunisation Program ◽  
Reporting Rates

This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2018 reported to the Therapeutic Goods Administration and describes reporting trends over the 19-year period 1 January 2000 to 31 December 2018. There were 4221 AEFI records for vaccines administered in 2018, an annual AEFI reporting rate of 16.9 per 100,000 population. There was a 2.9% increase in the overall AEFI reporting rate in 2018 compared to 2017. This slight increase in reported adverse events in 2018 was likely due to new additions to the National Immunisation Program schedule, namely meningococcal ACWY vaccination for children aged 12 months, enhanced immunogenicity trivalent influenza vaccines for adults aged ≥65 years, and state- and territory-funded seasonal influenza vaccination programs for children aged 6 months to <5 years. AEFI reporting rates for most individual vaccines in 2018 were similar to 2017. The most commonly reported adverse events were injection site reaction (34%), pyrexia (15%), rash (15%), vomiting (8%), headache (6%) and pain (6%). Two deaths were reported to the TGA but no clear causal relationship with vaccination was found.

scholarly journals Surveillance of adverse events following immunisation in Australia annual report, 2019

2021 ◽  
Vol 45 ◽  
Author(s):  
Aditi Dey ◽  
Han Wang ◽  
Helen Quinn ◽  
Alexis Pillsbury ◽  
Catherine Glover ◽  
...  
Keyword(s):  
Adverse Events ◽  
Seasonal Influenza ◽  
Annual Report ◽  
Injection Site Reaction ◽  
Clinical Findings ◽  
Reporting Rate ◽  
Influenza Vaccines ◽  
Causal Association ◽  
Site Reaction ◽  
Reporting Rates

This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2019 reported to the Therapeutic Goods Administration (TGA) and describes reporting trends over the 20-year period from 1 January 2000 to 31 December 2019. There were 3,782 AEFI records for vaccines administered in 2019, an annual AEFI reporting rate of 14.9 per 100,000 population. There was an 11.8% decrease in the overall AEFI reporting rate in 2019 compared to 2018 (16.9 per 100,000 population). This decrease in the AEFI reporting rate in 2019 was mainly attributable to a decline in reported adverse events related to the human papillomavirus (HPV), dTpa, meningococcal ACWY and seasonal influenza vaccines. AEFI reporting rates for most individual vaccines in 2019 were similar to 2018. The most commonly-reported adverse events were injection site reaction (35.8%), rash (16.6%), pyrexia (15.3%), vomiting (8.1%), urticaria (5.8%), pain (5.8%) and headache (5.7%). There were five deaths reported to the TGA. In one report, the timing and clinical findings were consistent with a causal association with vaccination. In the remaining four reports, no clear causal relationship with vaccination was found.

scholarly journals AEFI Reporting Rates in Albania During 2008-2015: A Retrospective Analysis of AEFI Reporting Forms

2016 ◽  
Vol 6 (1) ◽  
pp. 62
Author(s):  
Irsida Mehmeti ◽  
Silva Bino ◽  
Erida Nelaj ◽  
Eugena Tomini
Keyword(s):  
Public Health ◽  
Health Care Workers ◽  
Vaccine Safety ◽  
Reporting Rate ◽  
Safety Reporting ◽  
Infectious Disease Department ◽  
Care Workers ◽  
High Adherence ◽  
Central Database ◽  
Reporting Rates

In Albania, passive AEFI surveillance is conducted by Institute of Public Health, which is under the supervision of Ministry of Health. Reports of suspected adverse events following immunisation (AEFI) are reviewed by the Control of infectious disease department in the Institute of Public Health and recorded in a central database. In this study AEFI database is analysed for individual AEFI reporting forms during 2008-2015. AEFI reporting rates and their patterns were assessed. At 2003 a national standardized AEFI reporting form was introduced to the health-care workers who were obligated to report any observed AEFI. This form was changed and added more requisites in 2008 and nowadays this is the formal AEFI reporting form in Albania. Safe vaccines are essential to preserve high adherence to immunization programs¬ [1]. During the last years the reporting rate increased significantly due to implementation of enhanced vaccine safety reporting strategies but it is still low and underreporting remains one of the limits of passive surveillance. Reporting rates were calculated using as a denominator the administered doses of vaccines.

scholarly journals Timeliness of signal detection for adverse events following influenza vaccination in young children: a simulation case study

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e031851 ◽  
Author(s):  
Peter Jacoby ◽  
Catherine Glover ◽  
Chloe Damon ◽  
Parveen Fathima ◽  
Alexis Pillsbury ◽  
...  
Keyword(s):  
Young Children ◽  
Adverse Events ◽  
Influenza Vaccination ◽  
Vaccination Programme ◽  
Seasonal Influenza ◽  
Vaccine Safety ◽  
Public Confidence ◽  
Safety Signal ◽  
Seasonal Influenza Vaccination ◽  
Safety Surveillance

ObjectivesTo determine how soon after commencement of the seasonal influenza vaccination programme, the AusVaxSafety active vaccine safety surveillance system, currently in use across Australia, would have detected a safety signal had it been operating in 2010 when there was an unprecedented number of febrile seizures in young children associated with one specific influenza vaccine brand, Fluvax (CSL Biotherapies).DesignSimulation study.SettingWestern Australian vaccine influenza coverage and adverse event surveillance data.Outcome measuresSimulated solicited responses from caregivers who would have received an SMS survey about adverse events experienced following seasonal influenza vaccination of their children aged 6 months to <5 years.ParticipantsNone.ResultsWe estimated a >90% probability of a safety signal being detected by AusVaxSafety based on solicited reports for either fever or medical attendance at or before the week ending 28 March 2010, 3 weeks after the start of vaccine distribution. Suspension of the national paediatric influenza vaccination programme as a result of the passive adverse events surveillance operating at the time did not occur until 23 April 2010.ConclusionsActive vaccine safety surveillance leading to rapid detection of a safety signal would likely have resulted in earlier suspension of Fluvax from the vaccination programme, prevention of many febrile convulsions and maintenance of public confidence in influenza vaccination for young children.

scholarly journals Surveillance for Adverse Events following Immunization from 2008 to 2011 in Zhejiang Province, China

2012 ◽  
Vol 20 (2) ◽  
pp. 211-217 ◽  
Author(s):  
Yu Hu ◽  
Qian Li ◽  
Luoya Lin ◽  
Enfu Chen ◽  
Yaping Chen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Injection Site Reaction ◽  
Influenza Virus Vaccine ◽  
H1n1 Influenza ◽  
Reporting Rate ◽  
Zhejiang Province ◽  
The Individual ◽  
Zhejiang Provincial ◽  
Two Peaks ◽  
Reporting Rates

ABSTRACTThis study summarizes passive surveillance data for adverse events following immunization (AEFI) reported to the National AEFI Surveillance System (NASS) in Zhejiang province and describes reporting trends from 2008 to 2011. AEFI reporting rates were calculated using denominator data from the Individual Immunization Information System and the Zhejiang provincial Bureau of Statistics. A total of 6,265 AEFI records were reported; the overall reporting rate was 9.2 per 100,000 doses. There were two peaks of reporting rates, which were associated mainly with the introduction of the pandemic H1N1 influenza virus vaccine (pH1N1) in 2009 and the measles-mumps vaccine (MM) campaign in 2010. The majority of the AEFI described nonserious events. Fifteen deaths were recorded, but only one was possibly related to immunization. The most frequently reported reactions were fever and injection site reaction. Vaccines distributed in Zhejiang province have proven to be generally safe. The data on AEFI surveillance provide a reference point for ongoing reporting of trends and illustrate the value of the NASS database as a surveillance tool for monitoring of AEFI.

scholarly journals Evaluation of the safety profile of COVID-19 vaccines: a rapid review

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Qianhui Wu ◽  
Matthew Z. Dudley ◽  
Xinghui Chen ◽  
Xufang Bai ◽  
Kaige Dong ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Safety Profile ◽  
Meta Analysis ◽  
Safety Data ◽  
Rapid Review ◽  
Protein Subunit ◽  
Serious Adverse Events ◽  
Systemic Reactions ◽  
Reporting Rates

Abstract Background The rapid process of research and development and lack of follow-up time post-vaccination aroused great public concern about the safety profile of COVID-19 vaccine candidates. To provide comprehensive overview of the safety profile of COVID-19 vaccines by using meta-analysis technique. Methods English-language articles and results posted on PubMed, Embase, Web of Science, PMC, official regulatory websites, and post-authorization safety surveillance data were searched through June 12, 2021. Publications disclosing safety data of COVID-19 candidate vaccines in humans were included. A meta-analysis of proportions was performed to estimate the pooled incidence and the pooled rate ratio (RR) of safety outcomes of COVID-19 vaccines using different platforms. Results A total of 87 publications with safety data from clinical trials and post-authorization studies of 19 COVID-19 vaccines on 6 different platforms were included. The pooled rates of local and systemic reactions were significantly lower among inactivated vaccines (23.7%, 21.0%), protein subunit vaccines (33.0%, 22.3%), and DNA vaccines (39.5%, 29.3%), compared to RNA vaccines (89.4%, 83.3%), non-replicating vector vaccines (55.9%, 66.3%), and virus-like particle vaccines (100.0%, 78.9%). Solicited injection-site pain was the most common local reactions, and fatigue and headache were the most common systemic reactions. The frequency of vaccine-related serious adverse events was low (< 0.1%) and balanced between treatment groups. Vaccine platforms and age groups of vaccine recipients accounted for much of the heterogeneity in safety profiles between COVID-19 vaccines. Reporting rates of adverse events from post-authorization observational studies were similar to results from clinical trials. Crude reporting rates of adverse events from post-authorization safety monitoring (passive surveillance) were lower than in clinical trials and varied between countries. Conclusions Available evidence indicates that eligible COVID-19 vaccines have an acceptable short-term safety profile. Additional studies and long-term population-level surveillance are strongly encouraged to further define the safety profile of COVID-19 vaccines.

scholarly journals Use of routinely collected electronic healthcare data for postlicensure vaccine safety signal detection: a systematic review

2019 ◽  
Vol 4 (4) ◽  
pp. e001065 ◽  
Author(s):  
Yonatan Moges Mesfin ◽  
Allen Cheng ◽  
Jock Lawrie ◽  
Jim Buttery
Keyword(s):  
Systematic Review ◽  
Statistical Analysis ◽  
Adverse Events ◽  
Signal Detection ◽  
Real Time ◽  
Sequential Analysis ◽  
Vaccine Safety ◽  
Cochrane Library ◽  
Public Confidence ◽  
Healthcare Data

BackgroundConcerns regarding adverse events following vaccination (AEFIs) are a key challenge for public confidence in vaccination. Robust postlicensure vaccine safety monitoring remains critical to detect adverse events, including those not identified in prelicensure studies, and to ensure public safety and public confidence in vaccination. We summarise the literature examined AEFI signal detection using electronic healthcare data, regarding data sources, methodological approach and statistical analysis techniques used.MethodsWe performed a systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Five databases (PubMed/Medline, EMBASE, CINAHL, the Cochrane Library and Web of Science) were searched for studies on AEFIs monitoring published up to 25 September 2017. Studies were appraised for methodological quality, and results were synthesised narratively.ResultWe included 47 articles describing AEFI signal detection using electronic healthcare data. All studies involved linked diagnostic healthcare data, from the emergency department, inpatient and outpatient setting and immunisation records. Statistical analysis methodologies used included non-sequential analysis in 33 studies, group sequential analysis in two studies and 12 studies used continuous sequential analysis. Partially elapsed risk window and data accrual lags were the most cited barriers to monitor AEFIs in near real-time.ConclusionRoutinely collected electronic healthcare data are increasingly used to detect AEFI signals in near real-time. Further research is required to check the utility of non-coded complaints and encounters, such as telephone medical helpline calls, to enhance AEFI signal detection.Trial registration numberCRD42017072741

scholarly journals AEFI Reporting Rates in Albania During 2008-2015: A Retrospective Analysis of AEFI Reporting Forms

2016 ◽  
Vol 2 (4) ◽  
pp. 62
Author(s):  
Irsida Mehmeti ◽  
Silva Bino ◽  
Erida Nelaj ◽  
Eugena Tomini
Keyword(s):  
Public Health ◽  
Health Care Workers ◽  
Vaccine Safety ◽  
Reporting Rate ◽  
Safety Reporting ◽  
Infectious Disease Department ◽  
Care Workers ◽  
High Adherence ◽  
Central Database ◽  
Reporting Rates

In Albania, passive AEFI surveillance is conducted by Institute of Public Health, which is under the supervision of Ministry of Health. Reports of suspected adverse events following immunisation (AEFI) are reviewed by the Control of infectious disease department in the Institute of Public Health and recorded in a central database. In this study AEFI database is analysed for individual AEFI reporting forms during 2008-2015. AEFI reporting rates and their patterns were assessed. At 2003 a national standardized AEFI reporting form was introduced to the health-care workers who were obligated to report any observed AEFI. This form was changed and added more requisites in 2008 and nowadays this is the formal AEFI reporting form in Albania. Safe vaccines are essential to preserve high adherence to immunization programs¬ [1]. During the last years the reporting rate increased significantly due to implementation of enhanced vaccine safety reporting strategies but it is still low and underreporting remains one of the limits of passive surveillance. Reporting rates were calculated using as a denominator the administered doses of vaccines.

scholarly journals Vaccine Safety International Monitoring

2019 ◽  
Vol 7 (1) ◽  
pp. 6-14 ◽  
Author(s):  
M. A. Darmostukova ◽  
I. I. Snegireva ◽  
N. Yu. Velts ◽  
A. S. Kazakov ◽  
R. N. Alyautdin
Keyword(s):  
European Union ◽  
Adverse Events ◽  
South Korea ◽  
Febrile Seizures ◽  
Vaccine Safety ◽  
The United States ◽  
Asia Pacific ◽  
Public Confidence ◽  
The European Union ◽  
The Usa

Vaccine safety is an important aspect of mass immunization of the population. Adverse reactions that occur following vaccination result in a decrease in public confidence. The aim of this research was to identify information on the development of adverse events after immunization with vaccines included into the national vaccination calendars of the USA, European Union (EU), Japan, China, South Korea and India. Particular attention was paid to vaccines that are not included in the vaccination calendar, but are presented in the Russian Federation. During monitoring of vaccination against human papillomavirus information in the European Union, Japan and the United States, according the possible connection with development of autoimmune diseases was refuted. Monitoring of adverse events after vaccination with rotavirus vaccine I generation in the USA, EU and India, allowed to establish a link with the development of intestine invagination and limit the use of this medicinal product in favor of vaccine II generation. After starting vaccination against influenza was detected narcolepsy as a complication of this procedure; and when analyzing the complications of meningococcal vaccination Guillain — Barre syndrome was detected. We also analyzed information on various complications associated with vaccination against Japanese viral encephalitis, which was included into the national vaccination calendar of countries in Asia and the Pacifi c region — China, India, Japan, and South Korea. The main complications registered in the PRC after the introduction of Japanese encephalitis vaccine into the national vaccination calendar included: febrile seizures, thrombocytopenic purpura, encephalitis and meningitis. The main safety concerns about vaccines included into the national vaccination calendars of EU countries, the USA and the Asia-Pacific region concern vaccines that have recently appeared on the pharmaceutical market.

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