Adverse Events Following Immunization Surveillance Research Articles

Surveillance for adverse events following immunization with DTaP-containing combination vaccines in Linping, China, 2019-2022.

The DTaP-Hib and DTaP-IPV/Hib combination vaccine can be used as a substitute for the diphtheria, tetanus, and acellular pertussis combined vaccine (DTaP). We aimed to evaluate the safety of multi-component vaccines containing DTaP by analyzing the reporting rates and characteristics of adverse events following immunization (AEFIs) in Linping District during the years 2019 to 2022. We obtained data of AEFI and vaccination from the National AEFI Surveillance System of China and Zhejiang Municipal Immunization Information Management System, respectively, during 2019-2022 for a descriptive, epidemiological analysis. The total number of AEFI reported following vaccinations with DTaP-containing combination vaccines was 802 in Linping District from 2019 to 2022. The overall reporting rates of AEFIs following DTaP, DTaP-Hib, and DTaP-IPV/Hib vaccinations were 445.72 (537 cases), 536.29 (45 cases), and 306.13 (220 cases) per 100,000 doses in Linping District from 2019 to 2022, respectively. Only one case of a serious AEFI following DTaP vaccination, with a reporting rate of 0.83 per 100,000 doses. The composition ratio of vaccine product-related reactions for DTaP, DTaP-Hib, and DTaP-IPV/Hib were 99.81, 97.78, and 100.00%, respectively. The composition ratio of coincidental events for DTaP and DTaP-Hib were 0.19 and 2.22%, respectively. The reporting rates of total AEFIs for DTaP-IPV/Hib were lower than for DTaP. The reporting rate of local induration for DTaP-Hib was lower than for DTaP, and the reporting rates of local redness & swelling and local induration for DTaP-IPV/Hib were both lower than for DTaP. DTaP-IPV/Hib had a higher proportion of AEFIs in first quarter compared to DTaP. The reporting rate after the second dose of DTaP-Hib was higher than that of DTaP, and the reporting rates of AEFIs after the first dose and third dose of DTaP-IPV/Hib were lower than DTaP. The reported AEFIs to multi-component vaccines containing DTaP components during 2019-2022 in Linping District were mainly mild vaccine reactions. DTaP-containing combination vaccines demonstrated a good safety profile.

Vaccination coverage and adverse events following a reactive vaccination campaign against hepatitis E in Bentiu displaced persons camp, South Sudan.

Hepatitis E (HEV) genotypes 1 and 2 are the common cause of jaundice and acute viral hepatitis that can cause large-scale outbreaks. HEV infection is associated with adverse fetal outcomes and case fatality risks up to 31% among pregnant women. An efficacious three-dose recombinant vaccine (Hecolin) has been licensed in China since 2011 but until 2022, had not been used for outbreak response despite a 2015 WHO recommendation. The first ever mass vaccination campaign against hepatitis E in response to an outbreak was implemented in 2022 in Bentiu internally displaced persons camp in South Sudan targeting 27,000 residents 16-40 years old, including pregnant women. We conducted a vaccination coverage survey using simple random sampling from a sampling frame of all camp shelters following the third round of vaccination. For survey participants vaccinated in the third round in October, we asked about the onset of symptoms experienced within 72 hours of vaccination. During each of the three vaccination rounds, passive surveillance of adverse events following immunisation (AEFI) was put in place at vaccination sites and health facilities in Bentiu IDP camp. We surveyed 1,599 individuals and found that self-reported coverage with one or more dose was 86% (95% CI 84-88%), 73% (95% CI 70-75%) with two or more doses and 58% (95% CI 55-61%) with three doses. Vaccination coverage did not differ significantly by sex or age group. We found no significant difference in coverage of at least one dose between pregnant and non-pregnant women, although coverage of at least two and three doses was 8 and 14 percentage points lower in pregnant women. The most common reasons for non-vaccination were temporary absence or unavailability, reported by 60% of unvaccinated people. Passive AEFI surveillance captured few mild AEFI, and through the survey we found that 91 (7.6%) of the 1,195 individuals reporting to have been vaccinated in October 2022 reported new symptoms starting within 72 hours after vaccination, most commonly fever, headache or fatigue. We found a high coverage of at least one dose of the Hecolin vaccine following three rounds of vaccination, and no severe AEFI. The vaccine was well accepted and well tolerated in the Bentiu IDP camp community and should be considered for use in future outbreak response.

Progress in Immunization Safety Monitoring - Worldwide, 2020-2022.

Effective surveillance of adverse events following immunization (AEFIs) primarily relies on the collaboration of two partners: national regulatory authorities (NRAs) and national expanded programs on immunization (EPIs). In December 2020, the World Health Organization (WHO) Global Advisory Committee for Vaccine Safety recommended a new case-based indicator of national capacity to monitor immunization safety: at least one serious AEFI reported per 1 million total population per year. To achieve this indicator, WHO-affiliated countries and territories (WHO countries) rely upon data generated from functional AEFI surveillance systems. This report describes 2020-2022 global, regional, and national progress in use of the newly introduced immunization safety monitoring indicator and progress on joint AEFI reporting from national EPIs and NRAs. Among WHO countries, 51 (24%) of 214 implemented the new indicator in 2020, 111 (52%) of 214 implemented it in 2021, and 92 (43%) of 215 in 2022. In 2020, 41 (19%) WHO countries reported AEFI data jointly from EPIs and NRAs; this increased to 55 (26%) in 2021 and 57 (27%) in 2022. These findings, resulting in part from the intensified support for COVID-19 vaccination, demonstrate that national AEFI surveillance systems increasingly support the timely use and sharing of case-based immunization safety data, but work is still needed to strengthen global vaccine safety monitoring.

Efficacy and feasibility of SMS m-Health for the detection of adverse events following immunisation (AEFIs) in resource-limited setting-The Zimbabwe stimulated telephone assisted rapid safety surveillance (Zm-STARSS) randomised control trial

IntroductionThe mHealth active participant centred (MAPC) adverse events following immunisation (AEFI) surveillance is a promising area for early AEFI detection resulting in risk minimisation. Passive (spontaneous) AEFI surveillance is the backbone for vaccine pharmacovigilance, but has inherent drawbacks of under reporting, and requires strengthening with active surveillance methods. AimThe Zimbabwe stimulated telephone assisted rapid safety surveillance (Zm-STARSS) randomised controlled trial (RCT) sought to evaluate the efficacy and feasibility of AEFI detection using a short message service (SMS) and computer assisted telephone interview (CATI) approach. MethodA multicentre Zm-STARSS RCT enrolled consented adult vaccinees or parents or guardians of children receiving vaccines, including COVID-19 vaccines, at study vaccination clinics. At enrolment study participants were randomised to either SMS-CATI group or control group. SMS prompts were sent on days 0–2 and 14 post-vaccination to SMS-CATI group to ascertain if a medically attendance or attention due to an Adverse event following immunisation (AEFI) had occurred. However, no SMSs were sent to the control group. SMS-CATI group who responded “Yes” to SMS prompts were interviewed by research healthcare workers (RHCWs) who completed a CATI to determine if an AEFI had occurred whilst an AEFI in control group was determined from passive AEFI reporting channels. The primary study outcome was the AEFI detection rate in the SMS-CATI group compared to the control group. ResultsA total of 4560 participants were enrolled after signed informed consent, all were encouraged to report AEFIs and randomised automatically on 1:1 basis into two arms SMS CATI intervention group (n = 2280) and a control passive AEFI surveillance group (n = 2280) on day 0. A total of 704 (31 %) participants responded to the SMS prompts, with 75 % (528/704) indicating “No” and 25 % (176/704) reporting “Yes” to seeking medical attention or attendance post-immunisation. 69 % (121/176) completed a CATI survey but in only 36 % (44/121) was the AEFI confirmed. There were no AEFIs reported in control group participants. The detection rate of a AEFI associated with medically attendance or attention using the SMS-CATI methodology was 2 % (44/2280) on an intention to treat cohort. ConclusionDespite the low SMS response and CATI completion rate, we demonstrated that Zm-STARSS SMS system improves AEFI detection compared to passive AEFI surveillance. We recommend that this and similar approaches are explored further using cost-effective multi-channel digital approaches for holistic pharmacovigilance to improve AEFI detection in Low Middle-Income Countries (LMICs) for all vaccines.

Analysis of deaths following yeast-derived hepatitis B vaccination of infants, China, January 2013 to December 2020.

In China, adverse events following immunization (AEFI) are reported by the China AEFI Surveillance System (CNAEFIS). Serious AEFI, including deaths, are mandatorily reported and are evaluated for causality by province-or prefecture-level panels of experts. Yeast-derived HepB is the most widely used HepB in China for infants. However, the information about the death of infants caused by HepB is unclear. The CNAEFIS data on deaths following HepB from 2013 to 2020 were used for analyses. Descriptive analysis of epidemiologic characteristics was used to report death cases following HepB. We used administered doses to calculate denominators to estimate the risk of death after vaccination. During 2013-2020, there were 161 deaths following the administration of 173 million doses of HepB, for an overall incidence of 0.9 deaths per million doses. One hundred fifty-seven deaths were categorized as coincidental, and four deaths were accompanied by an abnormal reaction determined to be unrelated to the cause of death. The most common causes of death were neonatal pneumonia and foreign body asphyxia. These data provide reliable evidence on the safety of HepB among infants in China and can enhance public confidence in HepB immunization. To ensure public confidence in infants' HepB vaccination, monitoring and scientifically evaluating AEFI-related deaths of HepB is necessary.

EPH47 Active Surveillance for Safety Monitoring of COVID-19 Vaccines in Saudi Arabia

It is generally accepted that the world will not return to the pre-pandemic normally situation until safe and effective vaccines become available. However, the rare and unknown adverse events following immunization (AEFIs) are not usually detected in the clinical trials. Thus, monitoring the safety of coronavirus disease of 2019 (COVID-19) vaccines in real-world population is essential. Therefore, the Saudi Food and Drug Authority (SFDA) performed a post-marketing safety surveillance of AEFIs following administration of COVID-19 vaccines. A prospective cohort study conducted and followed subjects who received COVID-19 vaccines from the first day of vaccination for seven days after the first and second doses, then biweekly for three months. All information from the vaccinee (demographic information, vaccine type and AEFIs) were collected by phone through a standardized online questionnaire. Baseline characteristics and AEFIs were analyzed descriptively by SPSS software. AEFIs classified according to medical Dictionary for Regulatory Activities (MedDRA). 544 subjects of 8867 agreed to be part of the study. Among them, 218 subjects completed the study. Out of 218, 87 (39.91%) individual received Pfizer-BioNTech vaccine, 45(20.64%) received Oxford/AstraZeneca vaccine, 5(2.3%) individual received Moderna vaccine, and 81 (37.2%) received two different COVID-19 vaccines. The reported events were categorized to system organ class (SOC) according to MedDRA. The most reported SOCs were skin and subcutaneous tissue disorders (n=66 with Pfizer-BioNTech vaccine, n=34 with Oxford/AstraZeneca vaccine, n=5 with Moderna vaccine), nervous system disorder(n=20with Pfizer-BioNTech vaccine, n=18with Oxford/AstraZeneca vaccine, n=3with Moderna vaccine) infections and infestations (n=23 with Pfizer-BioNTech vaccine, n=33 with Oxford/AstraZeneca vaccine, n=4 with Moderna vaccine), musculoskeletal and connective tissue disorders (n=53with Pfizer-BioNTech vaccine, n=46 with Oxford/AstraZeneca vaccine, n=7 with Moderna vaccine). Only 10 (4.6%) cases were serious and required medical intervention. The preliminary results shows the short-term safety profiles of included COVID-19 vaccines are acceptable in Saudi Arabia.

Knowledge of Adverse Events Following Immunization and Awareness of its Reporting System among Primary Healthcare Workers in Jigawa State

Background: Healthcare workers (HCWs) have an essential and pivotal role to play in gaining and maintaining public confidence in the safety of vaccines through operational Adverse Events Following Immunization (AEFI) surveillance. For primary healthcare workers to be able to do this work effectively they should have the knowledge to detect an AEFI and at the same time be conversant with the reporting system. Objective: This study determined the knowledge of Adverse Events Following Immunization and the awareness of its reporting system among HCWs in primary health care centers of Jigawa State. Methodology: A cross-sectional study was conducted among 290 HCWs working in immunization units, selected through a multistage sampling technique. Data were collected using a pre-tested self-administered structured questionnaire. The data collected was sorted, checked for completeness, and entered into computer analysis software (IBM SPSS version 20) for analysis. The results obtained were presented in tables and charts. All statistical tests were two-tailed with a p-value of < 0.05 used as the statistical significance level. Results: About 167 (57.6%) of the respondents were aged between 21-30 years with a mean age of 31.3±7.4 years. The majority 278 (95.9%) of the primary HCWs were aware of AEFI, and seminars/workshops or training were the common sources of information on AEFI (216 (77.7%). Of the 278 primary HCWs that are aware of AEFI, only 120 (43.2%) could define AEFI correctly, and 142 (51.1%) and 87 (31.3%) could identify serious AEFI and non-serious (minor) as a type of AEFI respectively. Up to 213 (76.6%) of healthcare workers know the correct AEFI reporting flow, and only 44 (15.8%) know that only serious AEFI are reported. Conclusion: The majority of the primary healthcare workers were aware of AEFI and how to report it, but few had good knowledge of reporting it. The Jigawa State Primary Healthcare Development Agency in collaboration with Local government authorities should provide on the-job training on AEFI surveillance for the primary healthcare workers especially those that provide immunization services.

Predictors of Adverse Events Following Immunization Reporting amongst Healthcare Workers in Jigawa State, Northern Nigeria, 2022

An adverse event following immunization (AEFI) is any untoward medical occurrence that follows immunization and does not necessarily have a causal relationship with the usage of the vaccine. Reporting of AEFI is suboptimal amongst healthcare workers (HWs). This study aimed to determine predictors of HW’s reporting of AEFI. A descriptive cross-sectional study was conducted among HWs in selected health facilities (HFs) in Jigawa State using an open data kit self-administered questionnaire to collect data on socio-demographic characteristics, training, knowledge, and their practices on AEFI reporting. Analysis was conducted using Statistical Package for Social Sciences (SPSS) for frequencies, proportions, and associations using bivariate analysis and multivariate analysis using logistic regression to determine predictors of AEFI reporting with statistical significance set at p<0.05 and 95% confidence interval. Of the 400 respondents, 280 (70%) respondents had good knowledge of AEFI, 328(82%) sends routine AEFI reports and of 212 (53%) who recently encountered an AEFI, 174 (82.1%) exhibited some good reporting practices. Female gender (AOR 0.46, p=0.035), full-time employees (AOR 0.227, p=0.019), a recent encounter with an AEFI (AOR 3.087, p=0.007) and being trained on AEFI (AOR 5.54, p=0.011), reporting to elicit training (AOR 2.70, p=0.031) were predictors of routine reporting from health facility and reporting an encountered AEFI respectively. Overall, gender, employment status, being trained, and recent AEFI encounter to elicit training were predictors of AEFI reporting. To improve reporting of AEFI, there is a need to engage and train health workers on AEFI surveillance. Keywords: Adverse events following immunization, Knowledge, Practice, Predictors, Reporting.

Descriptive Research Study of the Adverse Events Following Immunization (AEFIs) Surveillance System in Zimbabwe

Aim: Functional national systems that monitor Adverse Events Following Immunization (AEFIs) are vital for implementing evidence-based vaccination policy while ensuring the safe access to these life-saving technologies. These systems can counteract vaccine hesitancy by increasing public trust and uptake in vaccination minimizing the burden of vaccine-preventable diseases (VPDs). Ensuring that these systems function optimally is a critical public health imperative. This is a novel study evaluating AEFI surveillance system including causality assessment, in Zimbabwe. This study provides a review of Zimbabwe’s national AEFI surveillance system since its launch in 1998, highlighting strengths, weaknesses, and opportunities for improvement. Materials and Methods: We conducted an in-depth analysis of all AEFI reports received until 2021, assessing reporting trends and overall performance of the AEFI system in terms of investigation, causality assessment. The WHO Global Benchmarking Tool (GBT) was used to assess regulatory performance in terms of AEFI surveillance. Duplications were excluded and reports with evidence of AEFI(s) after vaccination were included by examining the WHO 25 AEFI form core variables. Results: There was a steady increase of AEFI reports per annum particularly from 2006 to 2021 with a more dramatic increase during the COVID-19 epidemic with an AEFI reporting ratio of 43.46/million adults for COVID-19 vaccinations in 2021. The reporting ratio exceeded the WHO recommended minimum AEFI reporting ratio of 10 per 100000 surviving infants during eleven years (47.84%) out of the twenty-three years since inception of the surveillance. The GBT assessment demonstrated that the AEFI surveillance system evolved for all manufacturers or license holders. Conclusion: Close partnership between the immunization program and regulatory authority has enhanced AEFI surveillance in Zimbabwe. Incomplete AEFI case investigations for and timely AEFI detection are challenges that need to be addressed. System strengthening should include consideration of digital innovations to improve detection, optimizing case investigation of serious AEFI including post-mortems and utilizing VigiPoint disproportionate analysis for signal detection.

COVID-19 vaccine-related adverse events following immunization in the WHO Western Pacific Region, 2021-2022.

The speed at which new vaccines against coronavirus disease (COVID-19) were developed and rolled out as part of the global response to the pandemic was unprecedented. This report summarizes COVID-19 vaccine-related safety data in the World Health Organization Western Pacific Region. Data for 1 March 2021 to 31 March 2022 from 36 out of 37 countries and areas in the Western Pacific Region are presented. More than 732 million doses of eight COVID-19 vaccines were administered; reporting rates of adverse events following immunization (AEFIs) and serious AEFIs were 130.1 and 5.6 per 100 000 doses administered, respectively. Anaphylaxis, thrombosis with thrombocytopenia syndrome, and myocarditis/pericarditis were the most frequent COVID-19 adverse events of special interest (AESIs) reported. The reported rates of AESIs in the Western Pacific Region were within the range of expected or background rates. Vaccine benefits far outweigh the risk of reported serious adverse reactions and serious outcomes of COVID-19. Continued AEFI surveillance is recommended to better understand and ensure the safety profiles of novel COVID-19 vaccines.

System and facility readiness assessment for conducting active surveillance of adverse events following immunization in Addis Ababa, Ethiopia.

To help distinguish vaccine-related adverse events following immunization (AEFI) from coincidental occurrences, active vaccine pharmacovigilance (VP) prospective surveillance programs are needed. From February to May 2021, we assessed the system and facility readiness for implementing active AEFI VP surveillance in Addis Ababa, Ethiopia. Selected hospitals were assessed using a readiness assessment tool with scoring measures. The site assessment was conducted via in-person interviews within the specific departments in each hospital. We evaluated the system readiness with a desk review of AEFI guidelines, Expanded Program for Immunization Guidelines and Ethiopian Food and Drug Administration and Ethiopian Public Health Institute websites. Of the hospitals in Addis Ababa, 23.1% met the criteria for our site assessment. During the system readiness assessment, we found that essential components were in place. However, rules, regulations and proclamations pertaining to AEFI surveillance were absent. Based on the tool, the three hospitals (A, B and C) scored 60.6% (94/155), 48.3% (75/155) and 40% (62/155), respectively. Only one of three hospitals assessed in our evaluation scored >50% for readiness to implement active AEFI surveillance. We also identified the following areas for improvement to ensure successful implementation: training, making guidelines and reporting forms available and ensuring a system that accommodates paper-based and electronic-based recording systems.

Surveillance of Vaccination Coverage of Inactivated Influenza Vaccines and Allergic Rash Adverse Events Following Immunization for Children From 6 Manufacturers.

The composition of influenza vaccines is updated annually. To ensure vaccine safety, the coverage and adverse events following immunization (AEFI) of 6 manufacturers of trivalent inactivated influenza vaccine (TIV3) need to be evaluated. In January 2022, we analyzed data from more than 1.59 million children in the Childhood Vaccination Information Management System and the AEFI Surveillance Information Management System and evaluated influenza vaccines for children aged 6 to 35 months in Guangzhou from 2016/17 to 2019/20 Vaccination rates and AEFI reporting rates. From 2016/17 to 2019/20, the 1-dose influenza vaccination rate was 25.0% (range: 20.7%-30.2%), and the 2-dose (full course) influenza vaccination rate was 21.6% (range: 17.7%-26.4%). The full vaccination coverage rate has trended down since 2017/2018 (2017/18: 26.0%; 2018/19: 8.3; 2019/20: 17.7%). Fifty-two cases (13.1/100 000) and 24 cases (6.9/100 000) received AEFI reports for 1 dose and 2 doses, respectively, mainly due to fever ≥38.6°C (39 cases for 1 dose, 9.8/100 000; 15 cases for 2 dose, 4.3/100 000) and allergic rash (9 cases with 1 dose, 2.3/100 000; 5 cases with 2 doses, 1.4/100 000). Patients who received A and F manufacturers were more likely to report side effects. The safety of influenza vaccines from 6 manufacturers is good, and it is necessary to improve the recommended information on influenza vaccines to dispel people's concerns and increase the vaccination rate.

Perception of Health Workers on Reporting of Adverse Events Following Immunization in Jigawa State, Nigeria, 2022

An adverse event following immunization (AEFI) is any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the usage of the vaccine. Reporting of AEFI is suboptimal amongst healthcare workers (HCWs). This study aimed to determine health workers’ perception on AEFI reporting. A descriptive cross-sectional study was conducted among health workers in selected health facilities in Jigawa State. We used an Open data kit (ODK) based self-administered questionnaire to collect data on socio demographic characteristics, knowledge, and perception of respondents on AEFI. Data was analyzed using Statistical Package for Social Sciences (SPSS), for frequencies, associations and factors affecting HCWs perception of AEFI reporting at 5% significance (p-value<0.05) and 95% confidence interval. Perception was graded as: poor<50%, fair 50–70% and good ≥70%. Of the 400 respondents, 227(56.8%) had good perception. Building public trust in immunization (94.8%), to enable proper diagnosis and management (94.0%), elicit training needs (94.0%) and reduce consequences of AEFI on health workers (86.0%) were the main reasons for reporting AEFI. The barriers to reporting AEFI were time constraints (51.6%), poor feedback (48.8%) and fear of consequences (41.0%). AEFI knowledge (AOR 2.312, p=0.018) and receipt of feedback on reported AEFIs (AOR 0.45, p=0.026) were independent predictors of good perception of AEFI. Only 57% of health workers had a good perception of AEFI. To improve reporting of AEFI, there is need to train heath workers and strengthen feedback mechanism of AEFI surveillance system. Keywords: Adverse events following immunization, Health providers, Perception, Surveillance.

Author Response: Stroke Among SARS-CoV-2 Vaccine Recipients in Mexico: A Nationwide Descriptive Study.

We greatly appreciate the insightful comments by Dr. Taccetta on our article.1 We agree that passive epidemiologic surveillance is less likely to detect incidence, which is why we only reported the observed incidence and not a rate or ratio. This is a limitation we acknowledged in our article.1 In addition, concerning the 30-day timeframe from immunization to event detection in our study, we recognize that some neurologic events such as cerebral venous thrombosis (CVT) and Guillain-Barré syndrome (GBS) may occur up to 42 days after immunization. However, as stated in the Methods section, the World Health Organization's noted operational definition for surveillance of adverse events following immunization (AEFI) in our country only includes events occurring within the first 30 days after immunization.2,3 Hence, we were unable to detect or collect data on those cases occurring beyond the time frame specified by our legislature—a limitation that we also acknowledged as a potential selection bias. Recently, the increasing number of vaccine-induced thrombotic thrombocytopenia with CVT and GBS reports worldwide, especially with adenovirus-based vaccines,4,5 has compelled the expansion of our country's AEFI surveillance time frame to consider cases occurring within the first 42 days. We plan to consider this information in future reports.

Barriers to healthcare workers reporting adverse events following immunization in Zhejiang province, China

ABSTRACT Objectives A cross-sectional survey was conducted among healthcare workers (HCWs) to assess their knowledge, attitude, and reporting behavior in adverse event following immunization (AEFI) surveillance as well as to identify barriers. Methods A simple random sample of 170 vaccination clinics was selected and one HCW was informed to participate in this survey in each selected vaccination clinic. The survey was developed using a secure online platform and consisted of a structured online questionnaire. The distributions of the respondents’ characteristics were presented. Training status, knowledge, attitude, and reporting behavior were compared between sub-groups of HCWs. Barriers and suggestions on AEFI reporting were also summarized. Results Of the 170 surveyed HCWs, 61.76% received the training on AEFI surveillance while 15.88% had no AEFI training at all. The higher level of knowledge and the more positive attitude and reporting behavior on AEFI surveillance were observed among HCWs with the longer working duration on AEFI surveillance, or among HCWs who received the training. The most critical barrier to reporting an AEFI was ‘not being sure if the AEFI is related to the vaccine’ (122, 71.76%). Other barriers were: ‘I do not want to raise unnecessary public alarm about a vaccine’ (105, 61.76%); ‘reporting form or other method being too complicated’ (65, 38.23%). Conclusion The study findings highlighted the need to prioritize training on AEFI surveillance for HCWs. It is recommended that the development of the targeted interventions to strengthen AEFI surveillance system be required based on the barriers found in this study.

Adverse Events Following Immunization (AEFI) Reporting in A Rural District in Ghana

Background: Even though vaccines used in routine childhood immunization programmes are safe, adverse events following immunization (AEFI) may occur. These events must be recognized for prompt and effective response. This can contribute to success of the immunization programme and sustain interest of the public in vaccination.Methods: A descriptive cross-sectional study comprising primary and secondary data collection methods were used for the study at Jaman North District in Ghana. The secondary data was extracted from immunization reports using a Microsoft excel spread sheet. The primary data was obtained from respondents using structured interview questionnaire. Simple random sampling was used to select caregivers and health workers were purposively selected. The data was analyzed using Statistical Package for Social Sciences (SPSS) windows (version 21.0).Results: A total of 140 mothers or caregivers and 47 health workers were studied, with mean age of 27.8 years in each group. The rates of AEFI ranged from 0.02% for pneumococcal vaccine to 0.14% for pentavalent vaccine. In all, 63.8% of the health workers could not define AEFI, and 91.5% of the health workers do not use anaphylactic pack at immunization sessions. Majority (95.7%) of the participants agreed that poor AEFIs monitoring can lead to reduction in immunization coverage. AEFI training for health workers had a strong association (p<0.001) on their ability to identify AEFIs. The study indicated that mothers or caregivers were knowledgeable in many of the indicators of AEFI. In all, 93.7% of mothers or caregivers indicated that attitude of health workers was very good.Conclusion: The study revealed low (<1%) AEFI reporting rate by mothers or caregivers. Only 36.2% health workers had knowledge with respect to definition of AFEI. The study indicated that more than a third of mothers (36%) were of the view that reporting of AEFIscan lead to personal consequences. Increased national efforts at surveillance for AEFI is imperative.

Knowledge and Perceptions of Nurse Practitioners on Adverse Events Following Immunization and Barriers to Reporting in the Central Region, Eritrea: A Cross-Sectional Study.

BackgroundThough vaccines are generally considered extremely safe and effective, they have been associated with some serious adverse events following immunization (AEFIs). AEFIs might be related to either the vaccine, immunization error, anxiety related to immunization, and/or coincidental events. If they are not reported and investigated in timely fashion, they can create rumors and confidence gaps. In the last few years, reporting AEFIs in the Central Region of Eritrea, compared to other regions, has been found to be very low, with the root cause for this variation unknown, making intervention strategies challenging. This study was conducted to assess nurse practitioners’ knowledge and perceptions on AEFI surveillance and barriers to reporting in the region.MethodsAn analytical cross-sectional study was conducted among all nurse practitioners who were directly or indirectly involved in immunization services working in all health facilities of the region. Data were collected between October 2019 and February 2020 using an interview-based questionnaire. Percentages and medians (IQR) were used as descriptive statistics, and Mann–Whitney and Kruskal–Wallis tests were used as inferential tools.ResultsA total of 130 respondents with a median age of 40 (IQR 23) years were included in the study. The overall median (IQR) knowledge score of the respondents on AEFI surveillance was 87.50 (19) out of 100. Furthermore, median (IQR) comprehensive perception score was 70 (20) out of 100 (range 40–95). Shortage of motivation and not knowing how to report were identified as the main barriers to reporting AEFIs.ConclusionKnowledge and perceptions of nurse practitioners in the Central Region on AEFI surveillance were generally encouraging. They should however need to be further trained on the basics of AEFI surveillance to bridge the identified barriers to reporting.

An evaluation of adverse events following an immunization campaign with the live, attenuated SA14-14-2 Japanese encephalitis vaccine in Cambodia.

IntroductionJapanese encephalitis (JE) virus is the most common cause of vaccine-preventable encephalitis in Asia. The SA14-14-2 JE vaccine manufactured by Chengdu Institute of Biological Products has been shown to be safe and effective in clinical trials and childhood routine immunization programs. However, there are few published reports describing results of surveillance for adverse events following immunization (AEFI) when the vaccine is used in mass campaigns. We describe the results of AEFI surveillance following a 2013 vaccination campaign among almost 310,000 children aged 9 months–12 years in Battambang Province, Cambodia.MethodsRoutine AEFI surveillance was strengthened by staff training and supplemented by active hospital surveillance. An AEFI was defined as any sign, symptom, or disease temporally associated (i.e., within 4 weeks) with receipt of the vaccine, irrespective of whether it was considered related to immunization. Data were collected on standardized forms and causality assessments were conducted for serious AEFI.ResultsPassive and active surveillance detected 28 AEFI for an overall incidence of 9.0 AEFI per 100,000 doses administered. The most frequent events were vasovagal episodes (n = 7, 25%) and rash (n = 6, 21%), and most other events were common childhood conditions such as fever and vomiting. Three AEFI were classified as serious, including one hypersensitivity reaction and two meningoencephalitis cases. Of these, the hypersensitivity event was the only serious AEFI classified as being consistent with a causal association to immunization.ConclusionsMost reported adverse events were conditions that commonly occur after other childhood vaccinations or independently of vaccination, and in the context of careful monitoring for serious AEFI only one serious event consistent with a causal association with immunization was identified. These results support the good safety profile of the SA14-14-2 JE vaccine, and provide reassuring data as the vaccine’s use expands.

Awareness of Immunisation Health Care Providers on Adverse Events Following Immunisation: A Multicentre Study

Introduction:Adverse events following immunisation (AEFI) are often under-reported in India due to limited awareness among immunisation health care providers negatively affecting the immunisation programme of the country. This study assesses the knowledge, attitude and reporting practices (KAP) of AEFI among immunisation healthcare providers (IHPs) of private hospitals and clinics in South India.Methods: Using a semi-structured questionnaire, 58 IHPs were interviewed. The mean age was found to be 14.5 ± 7.2 years. Few IHPs had good knowledge (34.5%) while 91.4% had a good attitude, but it didn’t influence their good reporting practices (25.9%). The overall KAP score was the highest for physicians (50%), followed by pharmacists (43.8%) and nurses (37.8%).Results: Barriers to effective reporting were lack of knowledge about AEFI surveillance, filling an AEFI reporting form, time constraints and unfamiliarity with electronic reporting.Conclusion: KAP of immunisation health care providers isn’t satisfactory. In recent years, the rate of serious AEFIs has decreased to a greater extent. This also decreased the IHPs’ awareness of AEFI reporting as they don’t need to frequently report. Improving the perception of AEFI and active participation in reporting by IHPs can strengthen the nation’s AEFI surveillance system.

A Comparison with Adverse Events Following Immunization Associated with Sabin-Strains and Salk-Strains Inactivated Polio Vaccines in Zhejiang Province, China.

Objectives: One dose of Sabin-strains inactivated polio vaccine (IPV) was introduced into the Chinese immunization program on 1 May 2016. This study aimed to evaluate the safety of Sabin-strains IPV and provide a comparison with conventional Salk-strains IPV. Methods: Adverse events following immunization (AEFI) records associated with Sabin-strains IPV and Salk-strains IPV were extracted from the national AEFI surveillance system (NAEFISS) from 1 May 2016 to 31 December 2020. The vaccination information on Sabin-strains IPV and Salk-strains IPV during the same period was obtained from the Zhejiang provincial immunization information system. Reporting rates of AEFI were calculated by age, city, severity of AEFI, categories of AEFI, and reaction categories and were compared between Sabin-strains IPV and Salk-strains IPV. Results: In total, 3,861,758 doses of Sabin-strains IPV and 1,018,604 doses of Salk-strains IPV were administered during the study period. The overall AEFI reporting rate for Sabin-strains IPV (3.96/10,000 doses) was significantly lower than that for Salk-strains IPV (5.03/10,000 doses) due to the reporting rate of the minor vaccine product-related reaction following Sabin-strains IPV was significantly lower than that for Salk-strains IPV (2.76/10,000 doses vs. 3.83/10,000 doses). The most frequently reported symptoms/signs were fever, induration/swelling, and rash/urticaria. The most frequently reported serious AEFI with a causal relationship was febrile convulsion, with the reporting rates of 0.10/10,000 doses for Sabin-strains IPV and 0.08/10,000 doses for Salk-strains IPV. No significant difference was found in the reporting rates of the other serious AEFI between the two types of IPV. Conclusion: Most of the AEFI following Sabin-strains IPV and Salk-strains IPV were mild and common adverse reactions. The reporting rate of serious AEFI was not significantly different between Sabin-strains IPV and Salk-strains IPV. Sabin-strains IPV had a favorable safety profile and could be widely used.