Adverse Events Following Immunization Research Articles

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.

Myocarditis and Pericarditis following COVID-19 Vaccination in Thailand.

Myocarditis and pericarditis cases following Coronavirus 2019 (COVID-19) vaccination were reported worldwide. In Thailand, COVID-19 vaccines were approved for emergency use. Adverse event following immunization (AEFI) surveillance has been strengthened to ensure the safety of the vaccines. This study aimed to describe the characteristics of myocarditis and pericarditis, and identify the factors associated with myocarditis and pericarditis following COVID-19 vaccination in Thailand. We carried out a descriptive study of reports of myocarditis and pericarditis to Thailand's National AEFI Program (AEFI-DDC) between 1 March and 31 December 2021. An unpaired case-control study was conducted to determine the factors associated with myocarditis and pericarditis after the CoronaVac, ChAdOx1-nCoV, BBIBP-CorV, BNT162b2, and mRNA-1273 vaccines. The cases consisted of COVID-19 vaccine recipients who met the definition of confirmed, probable, or suspected cases of myocarditis or pericarditis within 30 days of vaccination. The controls were people who underwent COVID-19 vaccination between 1 March and 31 December 2021, with no adverse reactions documented after vaccination. Among the 31,125 events recorded in the AEFI-DDC after 104.63 million vaccinations, 204 cases of myocarditis and pericarditis were identified. The majority of them were male (69%). The median age was 15 years (interquartile range (IQR): 13-17). The incidence was highest following the BNT162b2 vaccination (0.97 cases per 100,000 doses administered). Ten deaths were reported in this study; no deaths were reported among children who received the mRNA vaccine. Compared with the age-specific incidence of myocarditis and pericarditis in Thailand before the introduction of the COVID-19 vaccination, the incidence of myocarditis and pericarditis after the BNT162b2 vaccine was greater in the 12-17 and 18-20 age groups in both males and females. It was higher after the second dose in 12- to 17-year-olds (2.68 cases per 100,000 doses administered) and highest after the second dose in male 12- to 17-year-olds (4.43 cases per 100,000 doses administered). Young age and a mRNA-based vaccination were associated with myocarditis and pericarditis following administration of the COVID-19 vaccine after multivariate analysis. Myocarditis and pericarditis following vaccination against COVID-19 were uncommon and mild, and were most likely to affect male adolescents. The COVID-19 vaccine offers the recipients enormous benefits. The balance between the risks and advantages of the vaccine and consistent monitoring of AEFI are essential for management of the disease and identification of AEFI.

Safety of COVID-19 vaccines in pregnancy: a VAERS based analysis

PurposeSince vaccination against COVID-19 is recommended in pregnant people, we aimed to provide further evidence on the safety profile of COVID-19 vaccines in pregnancy.MethodsData on COVID-19 vaccines adverse events following immunizations (AEFIs) in pregnant people were retrieved from the open-access Vaccine Adverse Event Reporting System (VAERS) from December 2020 to April 2022.ResultsFrom December 2020 to April 1, 2022, a total of 4,869 reports involving pregnant women at COVID-19 vaccination were reported to VAERS. Among vaccines recipients, most belonged to the age group between 30 and 39 years old (3,029; 62.21%) and nearly half experienced an adverse event within 48 h of immunization (2,344; 48.14%). Overall, 21,816 suspected adverse reactions associated with COVID-19 vaccines were reported, and for as many as 80.43% of patients, they were described as non-serious. Most reactions occurred after administration of the mRNA-1273 (53.34%) and the BNT162b2 (40.68%) vaccines, while only a small proportion were related to the Johnson & Johnson’s vaccine (5.69%). The most common non-pregnancy specific adverse events were headache (482; 2.21%), fatigue (472; 2.16%), and pyrexia (436; 2.00%), while adverse pregnancy outcomes with the highest reporting rate were abortions spontaneous (762; 3.49%), and vaginal haemorrhage (229; 1.05%).ConclusionThis post-marketing survey on VAERS data have provided updated evidence on the safety of COVID-19 vaccines during pregnancy, thus supporting clinicians in recommending maternal immunization.

Adverse Events Following Immunizations in Infants Under 1 Year of Age in Lorestan Province, Western Iran.

Vaccination is an important intervention for preventing disease and reducing disease severity. Universal vaccination programs have significantly reduced the incidence of many dangerous diseases among children worldwide. This study investigated the side effects after immunization in infants under 1 year of age in Lorestan Province, western Iran. This descriptive analytical study included data from all children <1 year old in Lorestan Province, Iran who were vaccinated according to the national schedule in 2020 and had an adverse event following immunization (AEFI). Data were extracted from 1084 forms on age, sex, birth weight, type of birth, AEFI type, vaccine type, and time of vaccination. Descriptive statistics (frequency, percentage) were calculated, and the chi-square test and Fisher exact test were used to assess differences in AEFIs according to the abovelisted variables. The most frequent AEFIs were high fever (n=386, 35.6%), mild local reaction (n=341, 31.5%), and swelling and pain (n=121, 11.2%). The least common AEFIs were encephalitis (n=1, 0.1%), convulsion (n=2, 0.2%), and nodules (n=3, 0.3%). Girls and boys only showed significant differences in mild local reactions (p=0.044) and skin allergies (p=0.002). The incidence of lymphadenitis (p<0.001), severe local reaction (p<0.001), mild local reaction (p=0.007), fainting (p=0.032), swelling and pain (p=0.006), high fever (p=0.005), and nodules (p<0.001) showed significant differences based on age at vaccination. Immunization is a fundamental public health policy for controlling vaccine-preventable infectious diseases. Although vaccines such as the Bacillus Calmette-Guérin vaccine, oral poliovirus vaccine, and pentavalent vaccine are well-researched and reliable, AEFIs are inevitable.

Adverse Events Following Immunization (AEFI) of COVID-19 Vaccine: A Descriptive Survey in Malang City

Vaccination is used to stop the transmission of COVID-19. However, it can stimulate Adverse Event Following Immunization (AEFI) symptoms, ranging from mild to severe. This study aims to identify the signs and symptoms of AEFI of the COVID-19 vaccine in the Malang City Community. The research design used is a descriptive survey. The sampling technique used was accidental sampling (n=275). The sample criteria were able and willing to fill out the questionnaire by accessing the google form from the researcher. Data were analysed using the Descriptive Statistical Analysis Test. The results of the study indicated that the number of respondents who experienced AEFI after receiving dose 1 vaccine was 97 people (35.2%), with symptoms including fever in 96 people (34.9%), swelling or redness at the injection site in 13 people (4.7%), pain in the injection site in 44 people (16.0%) and 1 person (0.4%) experienced other symptoms that required medical attention. After the second dose of the vaccine, 63 people (22.9%) had a fever, 11 people (4.0%) experienced swelling or redness at the injection site, 18 people (6.5%) experienced pain at the injection site, and 3 people (1.0 %) had other symptoms that required treatment. Signs and symptoms of AEFI of the COVID-19 vaccine most experienced by respondents after vaccine doses 1 and 2 were fever, pain at the injection site, and swelling or redness at the injection site, and there were no severe signs of AEFI were found in this study.&#x0D; Keywords: AEFI, Covid-19 vaccine, signs, symptoms

ASSESSMENT AND ANALYSIS OF ADVERSE EVENTS FOLLOWING COVID-19 VACCINATION AMONG CHILDREN AGED 15-18 Y AT TERTIARY CARE TEACHING HOSPITAL, TELANGANA: A PROSPECTIVE OBSERVATIONAL STUDY

Objective: Government of India (GOI) has allowed vaccination for age group of 15-18 y. It is a positive step toward boosting immunization rates across the nation. As per guidelines, BBV152 vaccine, Bharat Biotech's “Covaxin” is approved for adolescents. The study was designed to evaluate adverse events following immunization (AEFI) among adolescents. Methods: A prospective, observational survey was carried out among the first 315 beneficiaries (adolescents of age 15-18 y) for a period of 5 mo at Osmania medical college and hospitals. Within 24 h, 48-72 h, and two weeks following the first and second doses of Covaxin, active and passive surveillance using telephonic inquiry and documentation relating to adverse events was conducted. The prevalence of AEFI and its association with demographic factors have been identified. Collected data were analyzed using SPSS 25. Results: The first 315 beneficiaries (Adolescents between the ages of 15 and 18) who received Covaxin were identified. All AEFIs reported were within the first 24-72 h of vaccination. AEFI incidence was higher in 1st dose (16.6%) when compared to 2nd dose (3.5%). No AEFIs were noted after 2 w. We found no association of AEFI with sex, age group, and past history of Covid as this finding is not significant (p&gt;0.05). Conclusion: Overall, Covaxin has a good safety profile in adolescents. Symptoms were transient and of low intensity. There were no documented severe and serious AEFI. It is obligatory for documentation as the AEFI profile will encourage vaccine adoption and lessen reluctance.

Evaluation of short-term COVID-19 vaccines adverse events following immunization severity as reported by Iraqi consumers

Introduction: Consumer-generated Adverse Events Following Immunization (AEFI) reports are a major source of vaccine safety information in pharmacovigilance, which was unprecedented within the Iraqi settings.&#x0D; Methods: A self-assessment form was developed to be accessed by the consumers country-wide via the Iraqi pharmacovigilance center’s (IPvC) WhatsApp number. A retrospective analysis was then performed on the responses submitted from April 2021 until April 2022. Different independent variables were analyzed for their influence on subjective AEFI severity.&#x0D; Results: 2843 responses were finally included. The average number of reported AEFI was 4.03 (S.D. ± 2.58) per response and significantly different among vaccine types. Both Comirnaty and Vaxzevria-associated AEFIs were reported to affect daily life similarly (~59 %), while Sinopharm was 42.4 %. Treatment-seeking was highest in Vaxzervria reports (22.8 %). Factors associated with higher reported severity include; younger people, females, and previous COVID-19 infection. Also, for the Comirnaty vaccine, the second dose. Fever, body rash, and difficulty breathing were the most significantly associated with treatment-seeking. A very small number of serious AEFIs were also detected.&#x0D; Conclusion: Consumer reporting is valuable for generating data regarding COVID-19 vaccines’ AEFIs within the Iraqi spontaneous surveillance system and their engagement is recommended in the future for other medicinal products as well.

Adverse events following immunization (AEFI): COVID-19 vaccine dose and characteristics in Central Java, Indonesia.

Vaccination is an effort to control the COVID-19 pandemic. Although vaccines can be effective prevention, they can have potential side effects, or adverse events following immunization (AEFI). CoronaVac, BBIBP-CorV, BNTb262-BioNTech, mRNA-1273, and ChAdOx1NCoV-19 were vaccines used in Indonesia when this study was conducted. This study aimed to analyze the factors associated with AEFI for the COVID-19 vaccines for each dose in the community. This study used a cross-sectional design. The study was conducted in Central Java Province, Indonesia from August to October 2021. The variables included respondent characteristics, COVID-19 infection history, COVID-19 vaccine AEFI, dose, and type. Data collection was performed through questionnaires and data was analyzed by a logistic regression test. The percentage of AEFI was 21.1% after the first dose, 14.1% after the second dose, and 83.9% after the third dose of the vaccine. The factors associated with higher odds of COVID-19 vaccine AEFI were different for each dose, as follows: for the first dose: age group >45 years (p=0.009; OR=2.837; 95%CI: 1.301-6.187) and overweight (p=0.007; OR=3.323; 95%CI: 1.242-8.689); for the second dose: overweight (p=0.007; OR=9.118; 95%CI: 1.827-45.5), female sex (p=0.011; OR=2.885; 95%CI: 1.274-6.531), age group >45 years (p=0.017; OR=3.257; 95%CI: 1.24-8.555) and prior episode of COVID-19 (p=0.044; OR=2.459; 95%CI: 1.026-5.893); and for the third dose: female sex (p=0.040; OR=3.650; 95%CI: 1.062-12.550). The factors that were associated with AEFI of COVID-19 vaccine were sex, age, nutritional status and prior history of COVID-19.

Safety of mRNA vaccination for COVID‐19 in children with polyethylene glycol (PEG)‐asparaginase allergy

Safety of <scp>mRNA</scp> vaccination for <scp>COVID</scp>‐19 in children with polyethylene glycol (<scp>PEG</scp>)‐asparaginase allergy

Safety of concomitant administration of inactivated hepatitis A vaccine with other vaccines in children under 16years old in post-marketing surveillance.

Concomitant administration refers to the receipt of two or more vaccines during a single healthcare encounter, which is an efficient way to increase vaccination coverage in children. However, the post-marketing safety studies of concomitant administration are scarce. Inactivated hepatitis A vaccine (Healive®) has been used widely in China and other countries for more than a decade. We aimed to explore the safety of Healive® co-administered with other vaccines compared to Healive® alone in children under 16years old. We retrieved Adverse Events Following Immunization (AEFI) cases and vaccination doses of Healive® during 2020-2021 in Shanghai, China. The AEFI cases were divided into concomitant administration group and Healive® alone group. We used administrative data on vaccine doses as denominators to calculate and compare crude reporting rates between groups. We also compared baseline gender and age distribution, clinical diagnoses, and time interval from vaccination to onset of symptoms between groups. A total 319,247 doses of inactivated hepatitis A vaccine (Healive®) were used and 1,020 AEFI cases (319.50 per million doses) associated with Healive® were reported during 2020-2021 in Shanghai. There were 259,346 doses concomitantly administered with other vaccines and 830 AEFI cases (320.04 per million doses) were reported. There were 59,901 doses of Healive® that vaccinated alone, with 190 AEFI cases (317.19 per million doses). There was only one case with serious AEFI in concomitant administration group, with a rate of 0.39 per million doses. Reported rates of AEFI cases were similar between groups in general (p>0.05). Concomitant administration of inactivated hepatitis A vaccine (Healive®) with other vaccines has a similar safe profile as Healive® alone.

Serious adverse event following immunization and thromboembolic events associated with COVID19 vaccination: An analysis of nationwide causality assessment from India

BackgroundVaccines against the COVID-19 pandemic were introduced in late 2020. The present study has been conducted to study the serious Adverse Events Following Immunization (AEFIs) reported for COVID-19 vaccines from India. MethodsSecondary data analysis of the causality assessment reports for the 1112 serious AEFIs published by the Ministry of Health & Family Welfare, Government of India, was conducted. For the current analysis, all the reports published till 29.03.2022 were included. The primary outcome variables analyzed were the consistent causal association and the thromboembolic events. ResultsThe majority of the serious AEFIs assessed were either coincidental (578, 52%) or vaccine product related (218, 19.6%). All the serious AEFIs were reported among the Covishield (992, 89.2%) and COVAXIN (120, 10.8%) vaccines. Among these, 401 (36.1%) were deaths, and 711 (63.9%) were hospitalized and recovered. On adjusted analysis, females, the younger age group and non-fatal AEFIs showed a statistically significant consistent causal association with COVID-19 vaccination. Thromboembolic events were reported among 209 (18.8%) of the analyzed participants, with a significant association with higher age and case fatality rate. ConclusionDeaths reported under serious AEFIs were found to have a relatively lower consistent causal relationship with the COVID-19 vaccines than the recovered hospitalizations in India. No consistent causal association was found between the thromboembolic events and the type of COVID-19 vaccine administered in India.

Adverse Events Following Immunization (AEFI) in Nursing Science Program Sam Ratulangi University Students Based on the Type of COVID-19 Vaccine

Aims: The purpose of this study is to describe Adverse Events Following Immunization (AEFI) among Nursing Science Program Sam Ratulangi University students based on the type of Covid-19 vaccination that they received. Methods: This investigation was conducted using a descriptive retrospective study approach. Purposive sampling was utilized to choose the sample for this study, which included 183 undergraduate students in the Nursing Science Program Sam Ratulangi University. Results: After receiving the first dosage of the vaccination, Nursing Science Program Sam Ratulangi University students most frequently reported headache and muscle pain (30.4%), followed by pain and weakness in the injected arm (20.8%), and swelling at the injection site (26%). Additionally, there were students who received doses 1, 2, and 3 of the vaccination who did not exhibit any side effects. These students were 45 at dosage I, 73 at dose II, and 45 at dose III. At dose 1, the majority of Nursing Science Program Sam Ratulangi University students (73.2%) exhibited AEFI symptoms for less than a day, at doses II and III, 43.7% and 31.1%, respectively, reported experiencing symptoms for one to three days. Conclusion: Based on the research that has been done, it can be said that Nursing Science Program Sam Ratulangi University students only encounter mild AEFI symptoms. So it is hoped that the general public or students won't have to worry about the COVID 19 vaccine causing AEFI symptoms and can get vaccinated right away to strengthen their immunity against the virus.

Adverse Events to SARS-CoV-2 (COVID-19) Vaccines and Policy Considerations that Inform the Funding of Safety Surveillance in Low- and Middle-Income Countries: A Mixed Methods Study.

Rapid global approval of coronavirus disease 2019 (COVID-19) vaccines and concurrent introduction in high-income countries and low- and middle-income countries (LMIC) highlights the importance of equitable safety surveillance of adverse events following immunization (AEFIs). We profiled AEFIs to COVID-19 vaccines, explored reporting differences between Africa and the rest of the world (RoW), and analyzed policy considerations that inform strengthening of safety surveillance in LMICs. Using a convergent mixed-methods design we compared the rate and profile of COVID-19 vaccines' AEFIs reported to VigiBase by Africa versus the RoW, and interviewed policymakers to elicit considerations that inform the funding of safety surveillance in LMICs. With 87,351 out of 14,671,586 AEFIs, Africa had the second-lowest crude number and a reporting rate of 180 adverse events (AEs) per million administered doses. Serious AEs (SAEs) were 27.0%. Death accounted for about 10.0% of SAEs. Significant differences were found in reporting by gender, age group, and SAEs between Africa and the RoW. AstraZeneca and Pfizer BioNTech vaccines were associated with a high absolute number of AEFIs for Africa and RoW; Sputnik V contributed a considerably high rate of AEs per 1 million administered doses. Funding decisions for safety surveillance in LMICs were not based on explicit policies but on country priorities, perceived utility of data, and practical implementation issues. African countries reported fewer AEFIs relative to the RoW. To enhance Africa's contribution to the global knowledge on COVID-19 vaccine safety, governments must explicitly consider safety monitoring as a priority, and funding organizations need to systematically and continuously support these programs.

A 1-year analysis of adverse events following COVID-19 vaccination in Lebanon: a retrospective study

BackgroundSince the deployment of Coronavirus Disease 2019 (COVID-19) vaccines, skepticism about the safety, incidence, and severity of Adverse Events Following Immunization (AEFI) was a concern. The study has two main objectives. First, to analyze AEFIs following COVID-19 vaccines (Pfizer-BioNTech, AstraZeneca, Sputnik, and Sinopharm) during the vaccination campaign in Lebanon and correlate them with age and gender. Second, to correlate Pfizer-BioNTech and AstraZeneca vaccines’ AEFI with the dose administered.MethodsA retrospective study was carried out between February 14th, 2021, and February 14th, 2022. AEFI case reports received to the Lebanese Pharmacovigilance (PV) Program were cleaned, validated, and analyzed using SPSS software.ResultsA total of 6808 AEFI case reports were received to the Lebanese PV Program during the period of this study. Case reports were mostly received from females (60.7%) and from vaccine recipients aged 18–44 years. As for the vaccine type, AEFIs occurred more frequently with the AstraZeneca vaccine compared to the Pfizer-BioNTech vaccine. The latter had AEFIs mainly following dose 2, whereas AEFIs with the AstraZeneca vaccine were more frequently reported after dose 1, with general body pain being the most reported systemic AEFI with PZ (34.6%), while fatigue was the most reported AEFI with AZ vaccine (56.5%).ConclusionsThe AEFI reported with COVID-19 vaccines in Lebanon were aligned with those reported worldwide. The incidence of rare serious AEFIs should not discourage the public from getting vaccinated. Further studies are needed to evaluate their long-term potential risk.

Incidence and Associated Factors of SARS-CoV-2 Infection Post-mRNA-1273 Booster Vaccination in Health-Care Workers.

The COVID-19 pandemic has caused significant morbidity and mortality worldwide, especially among health-care workers. One of the most important preventive measures is vaccination. This study examined factors associated with the incidence rate of SARS-CoV-2 infection after mRNA-1273 booster vaccination (preceded by the CoronaVac primary vaccination) and the antibody profile of health-care workers at one of the tertiary hospitals in Indonesia. This was a combined retrospective cohort and cross-sectional study. Three hundred health-care workers who were given the mRNA-1273 booster vaccine a minimum of 5 months prior to this study were randomly selected. Participants were then interviewed about their history of COVID-19 vaccination, history of SARS-CoV-2 infection, and comorbidities. Blood samples were taken to assess IgG sRBD antibody levels. The median antibody level was found to be 659 BAU/mL (min 37 BAU/mL, max 5680 BAU/mL, QIR 822 BAU/mL) after the booster, and this was not related to age, sex, comorbidities, or adverse events following immunization (AEFI) after the booster. SARS-CoV-2 infection after the booster was correlated with higher antibody levels. In sum, 56 participants (18.6%) experienced SARS-CoV-2 infection after the mRNA-1273 booster vaccination within 5 months. Incidence per person per month was 3.2%. Age, sex, diabetes mellitus type 2, hypertension, obesity, and post-booster AEFI were not related to COVID-19 incidence after the booster. History of SARS-CoV-2 infection before the booster vaccination was significantly associated with a reduced risk of SARS-CoV-2 infection after booster vaccination, with a relative risk (RR) of 0.21 (95% CI 0.09-0.45, p < 0.001).

Knowledge, Perception, and Reporting Practices of Healthcare Providers about Adverse Events Following the COVID-19 Vaccination in Iraq(Conference Paper )#

Routine vaccination activities, such as detection, reporting, and management of adverse events following immunization (AEFIs), are generally handled by healthcare providers (HCPs). Safe vaccines against severe acute respiratory syndrome coronavirus (SARS-CoV-2) were introduced to control the Coronavirus Disease-19 (COVID-19) pandemic. The study aimed to assess the knowledge, perceptions, and practice of HCPs in Iraq about reporting adverse events following COVID-19 vaccination, and their association with sociodemographic variables. The study was a cross-sectional study that was carried out between August and September 2021 at the COVID-19 vaccination centers in Iraq. This study used an online and paper-based questionnaire, which was distributed among HCPs (physicians and pharmacists) in COVID-19 vaccination centers. A total of 117 pharmacists and physicians responded to the survey. Two-thirds of respondents were pharmacists. The majority of the respondents (49.6%) had fair knowledge levels on AEFIs. The perception of 43% of the participants was very good, whereas the perception of 28%, 23%, and 6% of the participants was fair, good, and poor, respectively. The reporting practice of HCPs was inadequate in 53% of respondents. The number of pharmacists who had good knowledge of AEFIs was significantly higher than that of the physicians. The age group (30-39) years of HCPs was significantly associated with more positive perception towards AEFIs. The number of pharmacists that had good perception was significantly higher than that of the physicians. Furthermore, HCPs aged 30 to 39 years had significantly higher reporting practices than other age groups. The study highlighted that the HCPs working at the COVID-19 vaccination centers have low knowledge of AEFIs. On the other hand, HCPs had more positive perception towards reporting AEFIs. Education programs and reference materials are needed to increase their awareness about AEFIs.

Safety Monitoring of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years by Using EudraVigilance Pharmacovigilance Database: The CoVaxChild Study.

Although the safety profiles of mRNA COVID-19 vaccines (mRNA-1273 and BNT162b2) were evaluated in pre-authorization clinical trials, real-world data allow us to better define their benefit/risk ratio in the paediatric population. The current study aimed to evaluate the safety profiles of mRNA COVID-19 vaccines in children by analysing the pharmacovigilance data of the European spontaneous reporting system database EudraVigilance (EV) in the period from 1 January 2021, to 1 October 2022. During our study period, overall 4838 ICSRs related to mRNA COVID-19 vaccines referring to 5-11-year-old subjects were retrieved from EV, of which 96.9% were related to BNT162b2 and 49.3% were related to males. A total of 12,751 Adverse Events Following Immunization (AEFIs) were identified, of which 38.7% were serious. The most frequently reported AEFIs were pyrexia, headache, and vomiting. Only 20 Individual Case Safety Reports (ICSRs) reported Multisystem Inflammatory Syndrome (MIS) as an AEFI, all related to BNT162b2. The majority of MIS cases were females, and six cases were completely resolved at the time of reporting. Our results show a favourable risk-benefit profile for all mRNA COVID-19 vaccines in this paediatric sub-population, supporting their use in children. Considering the peculiarity and fragility of children, continuous safety monitoring of COVID-19 vaccines is required.

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.

A Retrospective Evaluation of Self-Reported Adverse Events Following Immunization with Different COVID-19 Vaccines in Türkiye.

The Sinovac and BioNTech vaccines were the first to be introduced in Türkiye to fight the ongoing global COVID-19 pandemic. As these vaccines had shown some side-effects in its clinical trial, we aimed to conduct a survey study to assess the short-term adverse events following immunization (AEFIs) in Türkiye. A cross-sectional study was conducted using social and electronic media platforms by delivering a pre-formed and validated online questionnaire among people who had received at least one dose of the COVID-19 vaccine. This survey study focused on mass populations from different regions in Türkiye. A total of 603 responses were collected. Among these, 602 were selected based on complete answers and used for the assessment. The collected data were then analyzed to evaluate the various parameters related to the AEFIs of the respondents. Among the total 602 participants, 20.8% were male, and 78.7% were female, actively answering all of the constructive questions. Most of the respondents were between 18-30 years of age. We found that a total of 23.3% of the total respondents had been infected with the SARS-CoV-2 virus. Our survey revealed that out of 602 volunteers, the rate of experiencing physical discomfort was higher in participants who had received the Pfizer-BioNTech vaccine at all three doses than in those who had received the Sinovac vaccine. When all vaccine types were examined, the most common side effect was pain at the injection site, reported by 75.19% participants. When the side effects were compared according to vaccine types, there was a significant difference only in terms of fever. Fever rates in those who had received the Pfizer-BioNTech vaccine (20.96%) were found to be significantly higher than those who had received the Sinovac vaccine (8%). The studied vaccines showed minor side effects and there was no significant difference between the vaccines in terms of other side effects. Moreover, further research is needed to determine the efficacy of the existing vaccines in preventing SARS-CoV-2 infections or after-infection hospitalization.

BARRIER PERCEPTION FACTORS AFFECTING THE ACCEPTANCE OF THE COVID-19 VACCINE IN SALATIGA CITY

Background: In Salatiga City, COVID-19 immunization still needs to meet the 70% vaccination target needed to generate herd immunity. Vaccine skepticism and injection phobia can be barriers. A study of community barriers to COVID-19 vaccination and vaccine uptake is needed. Purpose: This study aimed to analyze barriers affecting the acceptance of the COVID-19 vaccine in Salatiga City. Methods: The study collected data from 323 Salatiga City people. Fear of pain, doubts about the COVID-19 vaccine, perception of fear of AEFI (Adverse Events Following Immunization), perception of accessibility of the COVID-19 vaccine, and the perception of information about the COVID-19 vaccine were independent variables in this study. Acceptance of COVID-19 vaccination is dependent. Data analysis using Chi-Square with 0.05 significance. Results: The results of this study found a relationship between fear of pain (p-value = 0.00), doubt about the COVID-19 vaccine (p-value = 0.00), perception of fear of AEFI (p-value = 0.00), perception of accessibility of COVID-19 vaccine (p-value = 0.00), and perception of information about COVID-19 vaccine (p-value = 0.00) and acceptance of the COVID-19 vaccine by Salatiga City residents. Conclusion: Perceived COVID-19 vaccination barriers affected vaccine acceptance. Acceptance of COVID-19 vaccination in Salatiga City is related to fear of pain, doubt about the COVID-19 vaccine, perception of fear of AEFI, perception of accessibility of the COVID-19 vaccine, and perception of information about the COVID-19 vaccine. Salatiga City's COVID-19 education efforts should focus on vaccine safety and side effects in collaboration with health cadres and cross-sector collaboration.