Trust in pharmaceuticals and vaccine hesitancy: exploring factors influencing COVID-19 immunization among Lebanese children aged 1 to 11 years.

INTRODUCTION: The COVID-19 pandemic is a serious threat to everyone's health. Numerous studies have demonstrated that vaccines are very effective in preventing COVID-19-related severe illness, hospitalization, and death. Children's vaccination exerts its protecting effect by preventing the spread of the virus. The purpose of this study was to analyze the rate of COVID-19 immunization among Lebanese children aged 1 to 11 years and assess parental factors that affect immunization rates. METHODS: An online cross-sectional study was conducted between January and March 2023. The online survey was distributed across all social media channels, including the Ministry of Public Health website. RESULTS: A total of 390 parents filled the survey (mean age = 37.48 ± 8.39 years; 50.5% mothers; 70% with a university level of education). Mothers compared to fathers, having a history of bad reaction to a vaccine vs. not, and higher vaccine hesitancy were significantly associated with less willingness to administer the vaccine to the child. Trusting pharmaceutical companies was significantly associated with more willingness to administer the vaccine to the child. CONCLUSION: The results of this study show that the factors associated with parents' decisions to vaccinate their children may vary. Our findings conclude that vaccine acceptance is being highly associated with parental concerns, trust, and information regarding the vaccine safety and efficacy.

Active surveillance of adverse events following COVID-19 vaccines in a tertiary care hospital.

Background: Vaccination is a safe and effective way to prevent disease and save lives, but it may also produce some undesirable adverse events (AEs)which may affect healthy individuals. Therefore, the monitoring of AE following immunization (AEFIs) is necessary. The objective of this study was to assess the AEs following COVID-19 vaccinations in a tertiary care hospital. Methodology: The study was conducted as active vaccine safety surveillance for a period of 6 months among the COVID-19 vaccine beneficiaries of the study site. Active surveillance was conducted via initiating two telephone contacts. The first surveillance was conducted in 8 days and the second surveillance after 28 days of post-vaccination. All identified AEs following immunizations (AEFIs) were reported and analysed by the AEFI investigation team at the study site. The causality assessment of each identified AEFI was performed using the World Health Organization's causality assessment algorithm. Results: A total of 2927 enrolled study population completed the study with a response rate of 80.85%. The study identified 902 AEFIs from 614 study populations with an incidence rate of 20.97%. Of which 794 and 79 AEFIs were associated with COVISHIELD™ and COVAXIN®, respectively. The majority of the events were reported among the age group of 18-29 years. Overall, only three events were serious and no deaths were reported among the study population. A total of 75.59% of events had a consistent causal association with vaccination and were categorized as vaccine product-related reactions. The study identified various factors such as gender (p = 0.019), age (p < 0.05), co-morbid status (p = 0.032) and dose number (p = 0.001) as potential predictors for development of AEFI. Conclusion: The study identified only 0.33% of events as serious, and 99.67% of the study population recovered from the AEFIs, which reveals that COVISHIELD™ and COVAXIN® have a generally favourable safety profile. However, close monitoring is required to identify the potential signals, as the safety data from the clinical trials are limited.

Clinico-epidemiological profile and outcome of infected health care workers during the three consecutive waves of COVID-19 pandemic: a longitudinal cohort study.

Background: Health care workers are considered as high-risk population, who deal with many unknown, undiagnosed, and subclinical infectious diseases in their daily life. Currently, the COVID-19 pandemic posed as an add-on burden for these frontline workers in all aspects. Although, many adverse physical and mental effects of pandemic among health care workers (HCWs) were discussed worldwide, a long-term study for delayed complications needed to be explored. Aim: The study evaluates and compares three waves of the pandemic in various aspects such as the incidence, prevalence, severity, risk factors, and variations in the pattern of COVID-19 infection, impact of vaccination, and post-infection complications among the HCWs. Methodology: A longitudinal observational study was carried out over a period of 2 years and another 6 months for follow-up. The study included all HCWs who tested positive in any one wave of COVID-19 pandemic with any one of the confirmed COVID-19 test. Each COVID-19-affected HCW was followed up through telephone calls and direct interviews conducted at the study site. Admission details and other background details of the study population were collected from the hospital records. Results: A total of 968 HCWs were COVID-19 positive in any of the three waves, and highest incidence (53.00%) was caused by the Omicron variant. High severity and hospitalization was observed in the first wave (no vaccination) and fully immunized personnel were found to be out of danger of being hospitalized during all succeeding waves (chi-square value: 87.04, p < 0.05). Predictors such as female gender, occupational exposure, and comorbid status were identified as possible risk factors for infection. A total of 70 HCWs reported with 104 complications, of which chronic diseases such as new onset of diabetes (n = 3), cardiovascular events (n = 8), worsening of preexisting comorbidities (n = 8), etc. were found out. Conclusions: This study proves the benefit of being immunized rather than the risk of being infected. This study documents that immunization impacted complication and hospitalization rates of COVID-19 infection. This evidence may help in tackling vaccine hesitancy across the nations.

Efficacy and Tolerability of Twice-Daily Dosing Schedule of Deferasirox in Transfusion-Dependent Paediatric Beta-Thalassaemia Patients: A Randomized Controlled Study.

Background: Deferasirox has proved good efficacy and acceptable safety for the management of thalassaemia patients. However, some patients are unresponsive or intolerant to once-daily administration of deferasirox even at a high dose. The current study evaluated the effectiveness and tolerability of twice-daily dosing of deferasirox among transfusion-dependent paediatric beta-thalassaemia patients. Methods: This prospective randomized single-blinded parallel study included all transfusion-dependent paediatric beta-thalassaemia patients prescribed with deferasirox, who visit the study site for their regular blood transfusions and follow-up. The enrolled patients were randomized into intervention and control groups by using a simple block randomization method. In the intervention group, the once-daily dosing of deferasirox was changed to twice-daily dosing with the same total daily dose. Whereas, in the control group, the patients continued with the once-daily deferasirox dosing. The serum ferritin levels of both groups were determined on the enrolment day and after 6 months of follow-up. Results: Forty-one patients were included for analysis. A statistically significant mean decrease in serum ferritin levels was detected in the intervention group, while the serum ferritin levels of the control group significantly increased from baseline. The twice-daily dosing of deferasirox was better tolerated by the thalassaemia patients when compared to once-daily dosing. Conclusion: This study concludes that twice-daily dosing of deferasirox with the same total daily dose significantly enhances the iron chelation efficacy and tolerability among transfusion-dependent paediatric beta-thalassaemia patients when compared to once-daily regimen.

COVID-19 vaccine triggered autoimmune hepatitis: case report.

Autoimmune hepatitis (AIH) is a non-contagious, chronic, inflammatory autoimmune disease in which one's own immune system attacks healthy, normal hepatic cells. The exact cause of AIH is unknown; however, the combination of genetic, environmental (eg, drugs and natural infection) and immunological factors may lead to AIH. AIH may also be potentiated with the use of vaccines: this case reports one such event following immunisation, along with 1 year of follow-up. A female patient in her late 20s presented to the hospital with yellowish discolouration of eyes, urine and stools. Her medical history revealed that she had been vaccinated with the first dose of a COVID-19 vaccine 10 days earlier. She had a history of asymptomatic COVID-19 infection 3 months ago and a history of chronic analgesic consumption for migraine. She was diagnosed as having AIH through extensive clinical and laboratory workup. This case may be an immediate enhancement of a hidden autoimmune disorder triggered by the vaccination. This adverse event following immunisation has an adequate temporal relationship with her COVID-19 vaccine. The causality can be categorised as 'indeterminate' and may be considered as a potential signal following COVID-19 vaccination.

Leukocytoclastic Vasculitis Following COVID-19 Vaccination: A Case Report.

Background: Hypersensitivity or Leukocytoclastic vasculitis (LCV) following the COVID-19 vaccination has been reported rarely all over the world. LCV can be induced by certain factors such as infections, autoimmune disorders, malignancy, or some classes of drugs. Case presentation: A 32-year-old man, who was a known case of seizure disorder from his childhood presented to the department of dermatology with itchy red lesions on extremities and abdomen for the past 1 month. He explains a history of COVID-19 vaccination 1-month back and experienced itching on his lower limbs on the same day at night. A gradual worsening of the condition was observed day by day. He was hospitalized and diagnosed as LCV through clinical and laboratory findings. Conclusion: This case highlights a temporal association with the event of vaccination. The causality assessment showed an indeterminate causal association to LCV with COVID-19 Vaccination.

Adverse events following COVID-19 vaccination: first 90 days of experience from a tertiary care teaching hospital in South India.

BACKGROUND: The COVID-19 vaccination program was introduced in India on 16 January 2021. The Government-issued fact sheet was the only source of information regarding Adverse Events Following Immunizations (AEFIs) for these vaccines. The objective of this study was to assess the AEFIs reported following COVID-19 vaccination in a tertiary care teaching hospital. MATERIALS AND METHODS: The spontaneous reporting method was used for data collection for a period of 3 months. A data collection form was designed to collect the data from the study population who reported adverse events. Collected data were analyzed and categorized by severity and seriousness. The causality assessment team performed causality assessment of the AEFIs using the World Health Organization's causality assessment algorithm. RESULTS: A total of 11,656 doses of COVID-19 vaccine were administered at the study site during the study period, of which 9292 doses were COVISHIELD™ and 2364 doses were COVAXIN™. In all, 445 AEFIs were reported from 269 subjects with an incidence rate of 3.48%. The majority of the subjects with AEFIs belonged to the age group of 18-45 years. Out of the total 445 AEFIs, 418 AEFIs were expected as per the fact sheets, 409 with COVISHIELD™ and 9 with COVAXIN™. Most of the AEFIs [62.02% (n = 276)] were observed at the system organ class of 'General disorders and administration site conditions'. After the causality assessment, out of 433 AEFIs to COVISHIELDTM vaccine, 94.22% (n = 408) of events were categorized to have 'consistent causal association with immunization'. Out of 12 adverse events following COVAXIN™, 8 (66.66%) events were categorized as 'consistent causal association with immunization'. All of them recovered from their adverse events without any sequelae. CONCLUSION: Spontaneous reporting is one of the cheapest methods that can be used for the reporting of AEFI. This method helps health care professionals to identify rare events and potential signals.

Impact of educational intervention on the best immunization practices among practicing health care professionals in a south Indian city.

BACKGROUND AND AIMS: Maintaining the quality and safety of immunization is as important as the efficacy of vaccines in vaccine-preventable diseases (VPD) programs. The aim of this study was to determine the problems associated with different stages of vaccine use and to assess the outcome of an educational intervention on safety and quality use of vaccines among health care providers. METHODS: A pilot prospective interventional study was conducted over a period of 2 years at 271 sites in Mysuru, India. The study population was health care professionals (HCPs) involved in immunization and a sample of parents (one per site). A validated questionnaire was used as a study tool. An educational intervention on best immunization practice was conducted for the enrolled HCPs and the impact of the educational intervention was assessed using the study tool after 3 weeks. RESULTS: The total number of the study population was 594 (323 HCPs and 271 parents). Of these, 41.49% were working at community health care facility and 33.13% were enrolled from primary care centers. There were statistically significant improvements in post interventional assessment of all stages of the immunization process including storage (p -0.001), transportation (p -0.001), administration (p 0.001), monitoring and reporting of adverse events following immunization (AEFIs) (p -0.001), knowledge of AEFIs (p 0.001), and HCP-parent communication (p 0.001). AEFI reporting improved by 30% in the post education phase. CONCLUSION: Continuous education and motivation can result in positive behavioral changes on best immunization practices amongst HCPs involved in immunization, which may help to improve and maintain the safety and quality use of vaccines in immunization centers irrespective of the type of facility.

Prescribing patterns and drug-related problems (DRPs) in transfusion-dependent paediatric thalassemia patients: A prospective interventional study from a tertiary care hospital in India.

BACKGROUND: Each year nearly 10,000 children with thalassaemia major are born in India, but among them, very few are optimally managed mainly in urban regions even though the Government of India has incorporated their care and treatment in the 12th Five-Year Plan. Data on prescribing patterns and drug-related problems (DRPs) in paediatric thalassaemia patients in India are limited. METHODS: In this prospective interventional study, the medications prescribed were recorded after reviewing the treatment charts, thalassaemia register, thalassaemia card, nurses' notes, as well as discharge summaries. When DRPs and/or medication errors were identified, the same was discussed with the concerned health care professionals and suitable suggestions were made at the earliest. RESULTS: Out of the enrolled 54 patients, only 94% (n = 51) of the patients received iron chelation therapy with deferasirox and/or deferiprone, Folic acid tablet was prescribed for 100% of the patients (n = 54). Five percent of patients (n = 3) had undergone splenectomy and was prescribed with amoxicillin prophylactically. There were a total of 16 DRPs and 15 medication errors were identified and suitable measurements were taken to solve these problems. CONCLUSIONS: The prescribing patterns, DRPs and medication errors in transfusion-dependent paediatric thalassaemia patients were discussed in this study. Our study was effective in identifying and solving the DRPs and medication problems that occurred in thalassaemia patients.

Impact of indirect education on knowledge and perception on cervical cancer and its prevention among the parents of adolescent girls: an interventional school-based study.

BACKGROUND: India has almost 225 million adolescent girls and they seem to be at a disadvantage, both economically and by their lack of knowledge on human papilloma virus (HPV) vaccine, when compared to adolescent girls of other Asian countries. AIM: To assess the prevalence of HPV vaccination and to identify the impact of education in improving the knowledge and perception about the HPV infection and vaccination among the parents of adolescent girls. METHODOLOGY: The prospective interventional study was conducted in four schools within a South Indian City, Mysuru. The informed consent form and the questionnaire were sent home with the identified adolescent girls during the pre-interventional phase. Educational sessions were conducted for the students in their school and an education leaflet was distributed to their parents. Three weeks later, questionnaires were re-administered to the parents via the enrolled girls and their responses were collected. RESULTS: The prevalence of HPV vaccination in the study population was 4.4%. There was a statistically significant improvement in knowledge in the post-interventional phase of the study (p = 0.001), but could not identify a significant change in their perception (p = 0.479). Parents belonging to the socioeconomic class of upper middle and upper lower showed better improvement at the end of the study, with a percentage improvement of 58.93% and 48.44%, respectively. CONCLUSION: The study proved that the healt care professional can target school children to communicate effectively to their parents on the importance of HPV vaccine as the study clearly observed a positive behavioral change among the study population.

Drug Rash With Eosinophilia and Systemic Symptoms (DRESS) Syndrome Probably Related to Cefpodoxime: A Case Report.

Cefpodoxime is a common antibiotic with a favorable side effect profile. Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome has been described with several cephalosporins but not cefpodoxime. We report the probable first case of cefpodoxime-induced DRESS syndrome in a 52-year-old female patient. In our case, the patient presented with symptoms of DRESS syndrome 16 days after initiation of cefpodoxime. This case highlights the necessity of consideration of an iatrogenic reason for presenting signs and symptoms at all times. Reinforcing the importance of taking a thorough drug history and considering drug reactions even if onset of symptoms are delayed.

Cosmetovigilance in a tertiary care hospital: A prospective observational study.

BACKGROUND: Cosmetovigilance is a term used for the activities related to the collection, evaluation, and monitoring of reporting of undesirable events observed during or after normal or reasonably foreseeable use of a cosmetic product. AIM: The study was conducted to assess the adverse cosmetic events from a tertiary care hospital. PATIENTS/METHODS: The patients visiting the study site was reviewed and those who met the study criteria are enrolled in the study after administration of the informed consent. Study participants were followed on regular intervals either telephonically or hospital visits in order to determine the outcome. The causality assessment of the reported event was performed using Colipa and PLM method. RESULTS: During the study period 22,893 patients visited the dermatology department, in which 87 subjects were enrolled in the study. The incidence of adverse cosmetic event was 0.38%. Hair care products caused more events than body care products. In 73.56% of cases, the suspected cosmetic was withdrawn and all the study population received symptomatic treatment for the adverse events. Causality assessment of Using Colipa method, categorized 49.43% events as likely and using PLM method, 64.37% events were probable. Study couldn't identify any predictors of adverse cosmetic events. Median cost associated with the management of ACRs for hair care products and body care products were 716.62 (IQR: 1011.36-470) and 557.4 (IQR: 711.63-373.8). CONCLUSION: The study suggest need for approaches such as awareness programs among the cosmetic sellers, consumers and other stakeholders on cosmetovigilance needs to be developed and implemented.

Effectiveness and tolerability of twice daily dosing of deferasirox in unresponsive and intolerant transfusion-dependent beta-thalassemia patients: A narrative review.

Chronic iron overload in beta-thalassemia patients after continuous blood transfusions has caused notable morbidity and mortality in these patients. The once-a-day oral iron chelator, deferasirox has established efficacy and bearable safety in adults and pediatric thalassemia patients. It is now extensively used for the management of transfusional hemosiderosis. However, a number of studies have revealed a few patients continued to be none respondent or intolerant toward the once-a-day regimen of deferasirox even after the administration of maximum dose recommended by the World Health Organization. In the literature, there were three studies showing the boon of twice in a day dosing of deferasirox among transfusional-dependent beta thalassemia patients. Therefore, a nonsystematic review was conducted on above three studies to ascertain the enhanced effectiveness and tolerability of twice per day regimen of deferasirox with the same total dose as that of once daily regimen of deferasirox in unresponsive or intolerant transfusion-dependent beta-thalassemia (TDT) patients. All the above studies concluded that the twice per day regimen of deferasirox was more efficacious and tolerable among TDT patients when compared to the once-a-day regimen with the same total daily dose. Although there was a significant good results from these studies, there is a need to conduct either muticenter study or randomized control study in a larger number of patients for the better confirmation of the results as all the above studies were conducted in the small number of TDT patients.

Active surveillance of adverse events following immunization (AEFI): a prospective 3-year vaccine safety study.

BACKGROUND: Vaccines used in national immunization programs are considered safe and effective but immunization safety has become as important as the efficacy of vaccination programs. The objective of the study was to detect adverse events following immunization (AEFIs) to all vaccines administered to a pediatric population in India. METHODS: The prospective active vaccine safety surveillance study enrolled eligible children in the age group 0-5 years receiving vaccination from the immunization center at JSS Hospital, Mysuru. Study participants were monitored at the site for 30 min following vaccination and a telephonic survey was made after 8 days to identify all AEFIs. Causality assessment of the AEFIs were done using a new algorithm developed by the safety and vigilance department of the World Health Organization. RESULTS: The incidence of reported AEFIs was 13.7%. The most frequently reported AEFI was fever (n = 3095, 93.2%) with an incidence of 109.7 per 1000 doses of vaccine administered, followed by persistent crying (n = 69, 2.4 per 1000 doses of vaccine) and diarrhea (n = 57, 2.0 per 1000 doses of vaccine). The majorly implicated vaccine for AEFIs was Pentavac® followed by BCG. Consistent causal association to immunization was observed in 93.4% of cases. CONCLUSIONS: A high incidence rate of AEFI was observed in our study population when compared with previous published studies. AEFI surveillance studies help to detect changes in the frequency of adverse events, which may be an alert to consider vaccine quality or identify a specific risk among the local population.

Probable blueberry-induced haemolysis in a G6PD deficient child: A case report.

BACKGROUND: Blueberry is a North American native fruit increasingly popular as a source of health-promoting bioactive compounds. However, there is evidence in the literature stating that blueberries should be avoided in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency. CASE PRESENTATION: We report the first case of a G6PD deficient child who developed haemolysis approximately after half a day following the intake of fresh blueberry. He presented with the complaints of the passage of orange coloured urine and hurried breathing. The child had haemoglobin of 7.9 g/dl on admission day and the laboratory results were indicative of haemolytic process. OUTCOMES AND IMPLICATIONS: During the stay in the hospital, the child was managed conventionally, and he improved both clinically and symptomatically. The child was discharged after four days of treatment and diet counselling was provided to his parents. RECOMMENDATIONS: Our report should encourage further research on this fruit regarding the mechanism behind the development of haemolytic anaemia. Also, it is important in the case of G6PD deficient patients to take lifelong precautions to avoid the foods that can trigger haemolysis.

A pediatric case report of fixed drug eruption related to carmoisine colorant present in paracetamol syrup.

Various adverse drug reactions, including hypersensitivity skin reaction after the exposure to carmoisine colorant, have already been reported in the literature. This case report gives the details of a 5-year-old male child with a recurrent fixed drug eruption (FDE) over the neck and trunk after the use of paracetamol syrup containing carmoisine as a colorant. Patch test to the carmoisine colorant in the paracetamol syrup was positive. This case report adds an increased awareness of the probability of allergic skin reaction to carmoisine in a previously sensitized person. The report also emphasizes the necessity to consider artificial dyes in pharmaceutical products as a potential cause for FDE.