Background incidence rates of adverse events of special interest related to COVID-19 vaccines in Ontario, Canada, 2015 to 2020, to inform COVID-19 vaccine safety surveillance

Background: Background incidence rates are critical in pharmacovigilance to facilitate identification of vaccine safety signals. We estimated background incidence rates of nine adverse events of special interest related to COVID-19 vaccines in Ontario, Canada. Methods: We conducted a population-based retrospective observational study using linked health administrative databases for hospitalizations and emergency department visits among Ontario residents. We estimated incidence rates of Bells palsy, idiopathic thrombocytopenia, febrile convulsions, acute disseminated encephalomyelitis, myocarditis, pericarditis, Kawasaki disease, Guillain-Barre syndrome, and transverse myelitis during five pre-pandemic years (2015-2019) and 2020. Results: The average annual population was 14 million across all age groups with 51% female. The pre-pandemic mean annual rates per 100,000 population during 2015-2019 were 43.9 for idiopathic thrombocytopenia, 27.8 for Bells palsy, 25.0 for febrile convulsions, 22.8 for acute disseminated encephalomyelitis, 11.3 for myocarditis/pericarditis, 8.6 for pericarditis, 2.9 for myocarditis, 1.9 for Guillain-Barre syndrome, 1.7 for transverse myelitis, and 1.6 for Kawasaki disease. Females had higher rates of acute disseminated encephalomyelitis and transverse myelitis while males had higher rates of myocarditis, pericarditis, and Guillain-Barre syndrome. Bells palsy, acute disseminated encephalomyelitis, and Guillain-Barre syndrome increased with age. The mean rates of myocarditis and/or pericarditis increased with age up to 79 years; males had higher rates than females: from 12-59 years for myocarditis and 12 years and older for pericarditis. Febrile convulsions and Kawasaki disease were predominantly childhood diseases and generally decreased with age. Conclusions: Our estimated background rates will permit estimating numbers of expected events for these conditions and facilitate detection of potential safety signals following COVID-19 vaccination.

COVID-19 vaccine sceptics are persuaded by pro-vaccine expert consensus messaging

To further understand how to combat COVID-19 vaccination hesitancy, we examined the effects of pro-vaccine expert consensus messaging on lay attitudes of vaccine safety and intention to vaccinate. We surveyed N = 729 individuals from four countries. Regardless of its content, consensus messaging had an overall small positive effect. Most critically, the direction of the effect varied depending on the baseline attitudes of participants: consensus information improved the attitude of vaccine sceptics and uncertain individuals, while having no effect on vaccine supporters. We also analysed whether the persuasiveness of expert consensus would increase after puncturing an illusion of explanatory depth in individuals. This further manipulation had no direct effect, nor interacted with the type of expert consensus. We conclude that highlighting expert consensus may be a way to increase support toward COVID-19 vaccination in those already hesitant or sceptical with little risk of side-effects.

Low frequency of disease flare in patients with rheumatic musculoskeletal diseases who received SARS-CoV-2 mRNA vaccine

Background Little is known about the safety of SARS-CoV-2 vaccination in patients with rheumatic musculoskeletal disease (RMD). We evaluated the occurrence of adverse events following immunization (AEFI) in RMD patients and heathy subjects who received anti-SARS-CoV-2 mRNA vaccine. Methods We performed a telephone interview collecting any adverse event (AE) following immunization (AEFI) that occurred in RMD patients and healthy controls after the two doses of mRNA vaccine including common local reactogenicity and systemic events (for example, fever, fatigue/malaise, joint and muscle pain). We also investigated the onset of new signs or symptoms of the RMD after the vaccination. Results We evaluated 126 patients with RMDs [105 females and 19 males, median age 51(IQR 17)] and 85 controls [62 females and 23 males, (median age 49 (20)]. Seventy patients (55.6%) were taking immunosuppressants, conventional synthetic (n=31, 43.3%) and/or biological [TNF inhibitors (n=49, 68.6%)], and 30 (23.8%) were taking hydroxychloroquine; treatment remained unchanged in 77% of patients. Eleven out of 126 patients and none of the 85 controls previously contracted COVID-19. The median follow-up from the completion of vaccination was 15 (3) weeks both in patients and controls. We reviewed 5 suspected cases confirming mild articular flares in 3 women (2.8) with inflammatory arthritis (2 psoriatic arthritis and 1 rheumatoid arthritis) while no disease reactivation was recorded in patients with connective tissue diseases; the incidence rate of RMD reactivation was 0.007 person/month. Multivariable logistic regression analysis showed similar frequencies of local and systemic AEFI in patients and controls with no effect of therapies or previous COVID-19. Local reaction—pain in the injection site—was the most frequently reported AEFI both in RMD and controls (71% and 75% of all the AEFI, respectively) after the first dose. Overall, up to 66% of patients experienced at least one AEFI at the second dose and up to 62% in the control group. Most of AEFI occurred within 2 days of vaccine administration. Two RMD patients developed pauci-symptomatic COVID-19 after the first dose of vaccine. Conclusion The low incidence rate of disease reactivation and the similar AEFI occurrence compared to controls should reassure on mRNA vaccine safety in RMD patients.

The Burden of COVID-19 in Children and Its Prevention by Vaccination: A Joint Statement of the Israeli Pediatric Association and the Israeli Society for Pediatric Infectious Diseases

As of October 2021, SARS-CoV-2 infections were reported among 512,613 children and adolescents in Israel (~33% of all COVID-19 cases). The 5–11-year age group accounted for about 43% (223,850) of affected children and adolescents. In light of the availability of the Pfizer-BioNTech BNT162b2 vaccine against COVID-19 for children aged 5–11 years, we aimed to write a position paper for pediatricians, policymakers and families regarding the clinical aspects of COVID-19 and the vaccination of children against COVID-19. The first objective of this review was to describe the diverse facets of the burden of COVID-19 in children, including the direct effects of hospitalization during the acute phase of the disease, multisystem inflammatory syndrome in children, long COVID and the indirect effects of social isolation and interruption in education. In addition, we aimed to provide an update regarding the efficacy and safety of childhood mRNA COVID-19 vaccination and to instill confidence in pediatricians regarding the benefits of vaccinating children against COVID-19. We reviewed up-to-date Israeli and international epidemiological data and literature regarding COVID-19 morbidity and its sequelae in children, vaccine efficacy in reducing COVID-19-related morbidity and SARS-CoV-2 transmission and vaccine safety data. We conducted a risk–benefit analysis regarding the vaccination of children and adolescents. We concluded that vaccines are safe and effective and are recommended for all children aged 5 to 11 years to protect them from COVID-19 and its complications and to reduce community transmissions. Based on these data, after weighing the benefits of vaccination versus the harm, the Israeli Ministry of Health decided to recommend vaccination for children aged 5–11 years.

Socio-Demographic Characteristics of COVID-19 Vaccine Recipients in Kwara State, North Central Nigeria

Understanding key socio-demographic variables of 2019 coronavirus disease (COVID-19) vaccine recipients is crucial to improving its acceptance and Nigeria's COVID-19 control strategy. The survey was conducted as a non-probability cross-sectional survey of 2,936 COVID-19 vaccine recipients in Kwara State. Our findings revealed that 74% (n = 2,161) of the vaccine recipients were older than 40 years. Forty percent (n = 1,180) of the vaccine recipients earned a monthly income >100,000 Naira (equivalent to US $200). Most of the vaccine recipients (64%, n = 1,880) had tertiary education, while 15% (n = 440) of them had no formal education. Almost half of the recipients (47%, n = 1,262) were government employees and 28.8% (n = 846) of them had health-related backgrounds. Only 17% (n = 499) of the vaccine recipients have been screened for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), of which 21% (n = 105/499) of them were tested positive. Only 47% (n = 1,378) had been fully immunized. The prevalence of confirmed COVID-19 cases among COVID-19 vaccine recipients in Kwara State was 3.6% (n = 105/2,936). The most recurrent adverse events following immunization (AEFIs) among vaccine recipients were fever (14%, n = 411), pain at injection site (47%, n = 1,409), headache (19%, n = 558), and body weakness (9%, n = 264). The need to protect themselves from the deadly virus was the main reason that prompted people to voluntarily accept the COVID-19 vaccine. There is a high level of COVID-19 vaccine acceptance among respondents across all social classes including those with no formal education, those with very low monthly income (< US $2 per day), and in untested population. Hence, vaccine donors should prioritize equitable distribution to Low-and-Middle-income Countries (LMICs) such as Nigeria, and health authorities should improve vaccine advocacy to focus on vaccine safety and efficacy.

Issues and Challenges of, Factors that Affect, and the Primary Influences of Parents’ Decisions to Vaccinate their Adolescents: A Case of a Local National High School in Cagayan de Oro City, Philippines

Vaccines are considered to be the center of the prevention and management of viral diseases. Even with the wide acceptance that vaccines are safe, vaccine hesitancy is still rampant in various parts of the world. Several historical, social, religious, and moral factors were identified and observed to have influence parent’s vaccine acceptance or hesitance. Parent’s vaccine hesitance or acceptance is crucial since adolescents constitute the ideal group for immunization. This study aims to uncover the issues and challenges of parents on vaccination, the factors that affect their decision to vaccinate their children, and parents' primary influences to vaccinate their children. A descriptive-survey research design utilizing a questionnaire floated to parents of adolescents in a local high school. It was found out that the level of education and type of occupation was significantly associated with parent's decision to vaccinate their children. The major issue and challenge of parents toward vaccination is that they don't find vaccines important and have a high level of distrust towards the government's health agency and medical professionals. The primary factor affecting their decision-making is the negative news on vaccination and vaccine safety. Respondents also reported that even they distrust the government's health agency, they still consider it influential towards their vaccine decision-making. With this, it is recommended that efforts be strengthened in restoring the public's trust towards the government health agency to address vaccine hesitancy.

Factors associated with COVID-19 vaccine receipt at two integrated healthcare systems in New York City: a cross-sectional study of healthcare workers

ObjectivesTo examine the factors associated with COVID-19 vaccine receipt among healthcare workers and the role of vaccine confidence in decisions to vaccinate, and to better understand concerns related to COVID-19 vaccination.DesignCross-sectional anonymous survey among front-line, support service and administrative healthcare workers.SettingTwo large integrated healthcare systems (one private and one public) in New York City during the initial roll-out of the COVID-19 vaccine.Participants1933 healthcare workers, including nurses, physicians, allied health professionals, environmental services staff, researchers and administrative staff.Primary outcome measuresThe primary outcome was COVID-19 vaccine receipt during the initial roll-out of the vaccine among healthcare workers.ResultsAmong 1933 healthcare workers who had been offered the vaccine, 81% had received the vaccine at the time of the survey. Receipt was lower among black (58%; OR: 0.14, 95% CI 0.1 to 0.2) compared with white (91%) healthcare workers, and higher among non-Hispanic (84%) compared with Hispanic (69%; OR: 2.37, 95% CI 1.8 to 3.1) healthcare workers. Among healthcare workers with concerns about COVID-19 vaccine safety, 65% received the vaccine. Among healthcare workers who agreed with the statement that the vaccine is important to protect family members, 86% were vaccinated. Of those who disagreed, 25% received the vaccine (p<0.001). In a multivariable analysis, concern about being experimented on (OR: 0.44, 95% CI 0.31 to 0.6), concern about COVID-19 vaccine safety (OR: 0.39, 95% CI 0.28 to 0.55), lack of influenza vaccine receipt (OR: 0.28, 95% CI 0.18 to 0.44), disagreeing that COVID-19 vaccination is important to protect others (OR: 0.37, 95% CI 0.27 to 0.52) and black race (OR: 0.38, 95% CI 0.24 to 0.59) were independently associated with COVID-19 vaccine non-receipt. Over 70% of all healthcare workers responded that they had been approached for vaccine advice multiple times by family, community members and patients.ConclusionsOur data demonstrated high overall receipt among healthcare workers. Even among healthcare workers with concerns about COVID-19 vaccine safety, side effects or being experimented on, over 50% received the vaccine. Attitudes around the importance of COVID-19 vaccination to protect others played a large role in healthcare workers’ decisions to vaccinate. We observed striking inequities in COVID-19 vaccine receipt, particularly affecting black and Hispanic workers. Further research is urgently needed to address issues related to vaccine equity and uptake in the context of systemic racism and barriers to care. This is particularly important given the influence healthcare workers have in vaccine decision-making conversations in their communities.

Routine Vaccine Simulation for Infants in a Mobile Environment

Purpose–Thisstudy aimed to develop and evaluate the Routine Vaccine Simulation for Infants. The routine vaccine simulation application was developed for the health workers and parents to provide basic information and press the importance of the vaccination to infants.Method–The researchers used the fourth-generation technique (4GT) for the software development life cycle of the application. The technique adapted contains four major parts namely, requirements gathering, design strategy, implementation, and testing.Results–The application was tested and evaluated by health workers, parents, and IT practitioners from the academe and the industry. The evaluation was based on criteria for core app quality. Descriptive and inferential statistics were employed for data presentation and interpretation. As a whole, the evaluation of the android-based routine vaccine simulation application was found excellent in most of its features. The finding asserts the adherence to the standards of android developmentapplicationsand conforms to the expectations of the app’s potentialusers. Conclusion–The development of a routine vaccine app for infants serves as a new platform for immunization awareness and education. Once information given in the app is taken earnestly, infants will be protected against diseases. Thus, controversies surrounding vaccination hesitancies can be decreased.Recommendations–A thorough information dissemination and education campaign regarding vaccine safety can be initiated in the local communities to address the issues on vaccine safety and hesitancy.Research Implications–The healthcare system in the communities through the local government unit (LGU) willbe able to benchmark and implement the information dissemination and education to mothers and health workers using the app.

COVID-19 Vaccination Acceptance among Healthcare Workers and General Population at the Very Beginning of the National Vaccination Program in Poland: A Cross-Sectional, Exploratory Study

The aim of the study was to assess the acceptance level of COVID-19 vaccination among healthcare workers (HCW) and the general population in Poland at the start of the national COVID-19 vaccination program from 18–31 December 2020. A cross-sectional anonymous survey was conducted in a group of 1976 people: 1042 health professionals and 934 non-medical professionals using an on-line questionnaire. The most skeptical about the COVID-19 vaccine were students of non-medical faculties, non-medical professions, and administrative–technical health service staff (26.2%, 38.7% and 41.2%, respectively). The most positive attitude to vaccination was reported by doctors, medical students and pharmacists (80.6%, 76.9% and 65.7%, respectively). Doctors (64.7%) and medical students (63.7%) most often declared confidence in vaccines compared to nurses (34.5%). Distrust about vaccine safety was declared by nurses (46.6%) and pharmacists (40.0%). HCW encouraged others to vaccinate more eagerly (65.8%) than non-medical professions (28.3%). Thus, a considerable proportion of HCW in Poland expressed concern about vaccines just prior to the beginning of the COVID-19 immunization program. The significant decrease in the willingness to vaccinate observed in Poland towards the end of 2021 must be considered in the light of the serious COVID-19 vaccination hesitancy in the Polish population.

Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry

ObjectivesTo describe the safety of vaccines against SARS-CoV-2 in people with inflammatory/autoimmune rheumatic and musculoskeletal disease (I-RMD).MethodsPhysician-reported registry of I-RMD and non-inflammatory RMD (NI-RMDs) patients vaccinated against SARS-CoV-2. From 5 February 2021 to 27 July 2021, we collected data on demographics, vaccination, RMD diagnosis, disease activity, immunomodulatory/immunosuppressive treatments, flares, adverse events (AEs) and SARS-CoV-2 breakthrough infections. Data were analysed descriptively.ResultsThe study included 5121 participants from 30 countries, 90% with I-RMDs (n=4604, 68% female, mean age 60.5 years) and 10% with NI-RMDs (n=517, 77% female, mean age 71.4). Inflammatory joint diseases (58%), connective tissue diseases (18%) and vasculitis (12%) were the most frequent diagnostic groups; 54% received conventional synthetic disease-modifying antirheumatic drugs (DMARDs), 42% biological DMARDs and 35% immunosuppressants. Most patients received the Pfizer/BioNTech vaccine (70%), 17% AstraZeneca/Oxford and 8% Moderna. In fully vaccinated cases, breakthrough infections were reported in 0.7% of I-RMD patients and 1.1% of NI-RMD patients. I-RMD flares were reported in 4.4% of cases (0.6% severe), 1.5% resulting in medication changes. AEs were reported in 37% of cases (37% I-RMD, 40% NI-RMD), serious AEs in 0.5% (0.4% I-RMD, 1.9% NI-RMD).ConclusionThe safety profiles of SARS-CoV-2 vaccines in patients with I-RMD was reassuring and comparable with patients with NI-RMDs. The majority of patients tolerated their vaccination well with rare reports of I-RMD flare and very rare reports of serious AEs. These findings should provide reassurance to rheumatologists and vaccine recipients and promote confidence in SARS-CoV-2 vaccine safety in I-RMD patients.