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《Vaccine》2021,39(40):5968-5981
BackgroundIn 2010, the Australian seasonal influenza vaccination program for children under 5 years of age was suspended due to an unexpected increase in fever and febrile convulsions causally associated with one particular influenza vaccine brand. A subsequent national review made seven recommendations to improve vaccine pharmacovigilance. Ten years on, in advance of implementing the COVID-19 immunisation program, we evaluated views on the capacity of Australia’s vaccine pharmacovigilance system to promptly detect, examine and communicate a signal.MethodsSemi-structured interviews were conducted between July and October 2020 with individuals with expertise in vaccine safety in Australia using an interview guide informed by key Australian and international frameworks. Interviews were digitally recorded and transcribed verbatim. Thematic analysis was used to code data using a deductive approach.ResultsInterviews with seventeen participants enabled six themes to be identified. Participants described improvement and significant innovation within Australia’s vaccine pharmacovigilance system over the decade since 2010, particularly through establishment of a new active, cohort event monitoring system using short message service surveys. Participants thought Australia had a good foundation for COVID-19 vaccine safety surveillance; implementation of the COVID-19 immunisation program was seen as a potential driver for ongoing enhancement through: a) improved integration of the active surveillance and spontaneous reporting systems, and; b) development of population-level active surveillance, including through data linkage. Transparent communication was considered essential to address the unprecedented challenges of COVID-19 and broader vaccine safety concerns.ConclusionsVaccine safety experts in Australia convey confidence in the innovative pharmacovigilance systems implemented over the past 10 years. While Australia has a multifaceted system incorporating both active surveillance and spontaneous reporting systems, COVID-19 vaccine implementation represents an opportunity to enhance current systems and to develop new, systematic approaches to vaccine pharmacovigilance that should make both a local and global contribution.  相似文献   

3.
《Vaccine》2023,41(1):136-144
BackgroundCOVID-19 vaccine hesitancy has emerged as a major public health challenge. Although medical and scientific misinformation has been known to fuel vaccine hesitancy in the past, misinformation surrounding COVID-19 seems to be rampant, and increasing evidence suggests that it is contributing to COVID-19 vaccine hesitancy today. The relationship between misinformation and COVID-19 vaccine hesitancy is complex, however, and it is relatively understudied.MethodsIn this article, we report qualitative data from two related but distinct studies from a larger project. Study 1 included semi-structured, open-ended interviews conducted in October–November 2020 via phone with 30 participants to investigate the relationship between misinformation and COVID-19 vaccine hesitancy. Study 1′s results then informed the design of open-ended questions for Study 2, an online survey conducted in May–June 2021 to consider the relationship between misinformation and vaccine hesitancy further. The data were examined with thematic analysis.ResultsStudy 1 led to the identification of positive and negative themes related to attitudes toward COVID-19 vaccines. In Study 2, responses from vaccine-hesitant participants included six categories of misinformation: medical, scientific, political, media, religious, and technological. Across both Study 1 and Study 2, six vaccine hesitancy themes were identified from the data: concerns about the vaccines’ future effects, doubts about the vaccines’ effectiveness, commercial profiteering, preference for natural immunity, personal freedom, and COVID-19 denial.ConclusionsThe relationship between misinformation and vaccine hesitancy is complicated. Various types of misinformation exist, with each related to a specific type of vaccine hesitancy-related attitude. Personal freedom and COVID-19 denial are vaccine attitudes of particular interest, representing important yet understudied phenomena. Medical and scientific approaches may not be sufficient to combat misinformation based in religion, media, or politics; and public health officials may benefit from partnering with experts from those fields to address harmful misinformation that is driving COVID-19 vaccine hesitancy.  相似文献   

4.
Although clinical trials are necessary for vaccine approval, observational epidemiology will be required to evaluate the long-term effectiveness, safety, and population impacts of newly approved COVID-19 vaccines under real-world field conditions. In this commentary, I argue that a hybrid approach that combines new data sources and tools, including COVID-19 vaccine registries, with traditional epidemiological methods will be needed to evaluate COVID-19 vaccines using observational epidemiology. Wherever possible, primary data collection, active surveillance, and linkage with existing population-based cohorts should be leveraged to supplement secondary data sources and passive surveillance systems. Evidence-informed public health decision making around provincial COVID-19 immunization programs will need to account for potential biases, incomplete or conflicting information, and heterogeneity across subpopulations.  相似文献   

5.
《Vaccine》2021,39(29):4006-4012
BackgroundThe coronavirus disease 2019 (COVID-19) pandemic has greatly affected daily life. COVID-19 often causes asymptomatic or mild disease in children; however, delayed routine childhood immunization is a concern, as it could increase the risk of vaccine-preventable disease. No study has evaluated the status of childhood vaccinations in Japan during the COVID-19 pandemic.MethodsThis retrospective observational study evaluated the number of vaccine doses administered to children in 4 Japanese cities (2 cities in the Tokyo metropolitan area and 2 cities far from Tokyo) during the period from 2016 to 2020. Vaccine doses administered between January and September 2020 during the COVID-19 pandemic were compared, by month, with those given during 2016–2019. Age-stratified demographic data were collected to determine whether factors other than change in the child population over time affected vaccination trends.ResultsIn all cities the decrease in vaccine doses administered was most apparent in March and April 2020, i.e., just before or coincident with the declaration of a nationwide COVID-19 emergency on April 7, 2020. The decrease started as early as February in the Tokyo metropolitan area. As child age increased, the decrease became more apparent. Before the lift of national emergency on May 25, catch-up of the vaccination was observed in all age groups in all cities. Vaccine doses persistently increased in older age groups but not in infants. The overall vaccination trends did not differ significantly among the 4 cities.ConclusionsThe COVID-19 pandemic significantly affected routine childhood immunization in Japan. Thus, a nationwide electronic surveillance system and announcements for guardians to encourage timely routine immunization are warranted.  相似文献   

6.
《Vaccine》2023,41(28):4138-4143
IntroductionThe COVID-19 pandemic has contributed to declines in routine childhood and adolescent vaccination coverage globally. While the declines in Australia have been less, they are a concern, given steady increases in coverage prior to the pandemic. Given limited evidence on how the experiences of parents during the pandemic affected their attitudes about and intentions towards adolescent vaccinations, with this study we aimed to explore these.MethodsThis was a qualitative study. We invited parents of adolescents eligible for school-based vaccinations in 2021 from metropolitan, regional and rural areas of New South Wales and Victoria (the most affected States) and South Australia (less affected) to half hour-long online semi-structured interviews. We analysed data thematically and applied a conceptual model of trust in vaccination.ResultsIn July 2022 we interviewed 15 accepting, 4 hesitant and two parents who refused adolescent vaccinations. We identified three themes: 1. Pandemic impacting on professional and personal lives and routine immunisations; 2. Pandemic strengthening preexisting vaccine hesitancy, with perceived lack of clarity in governmental information about vaccination and stigma around non-vaccinating as contributing factors; 3. Pandemic raising awareness of the benefits of COVID-19 and routine vaccinations, with communication campaigns and one’s trusted doctor’s vaccination recommendations as contributing factors.ConclusionsFor some parents, experiences of poor system readiness and growing distrust towards health and vaccination systems strengthened their pre-existing vaccine hesitancy. We offer recommendations on how trust in the health system and immunisation can be optimised post-pandemic to increase uptake of routine vaccines. These include improving access to vaccination services and clear, timely information about vaccines; supporting immunisation providers in their immunisation consultations; working alongside communities, and building capacity of vaccine champions.  相似文献   

7.
《Vaccine》2022,40(15):2292-2298
IntroductionChildhood vaccination rates have decreased significantly during the COVID-19 pandemic. The Brazilian immunization program, Programa Nacional de Imunização (PNI), is a model effort, achieving immunization rates comparable to high-income countries. This study aimed to evaluate the impact of the COVID-19 pandemic in pediatric vaccinations administered by the PNI, as a proxy of adherence to vaccinations during 2020.MethodsData on the number of vaccines administered to children under 10 years of age nationally and in each of Brazil’s five regions were extracted from Brazil’s federal health delivery database. Population adjusted monthly vaccination rates from 2015 through 2019 were determined, and autoregressive integrated moving average (ARIMA) models were used to forecast expected vaccinated rates in 2020. We compared the forecasts to reported vaccine administrations to assess adequacy of pediatric vaccine delivery during the COVID-19 pandemic.ResultsFrom January 2015 to February 2020, the average rate of vaccine administration to children was 53.4 per 100,000. After February 2020, this rate decreased to 50.4, a 9.4% drop compared to 2019 and fell outside of forecasted ranges in December 2020. In Brazil's poorest region, the North, vaccine delivery fell outside of the forecasted ranges earlier in 2020 but subsequently rebounded, meeting expected targets by the end of 2020. However, in Brazil's wealthiest South and Southeast regions, initial vaccine delivery fell and remained well below forecasted rates through the end of 2020.ConclusionIn Brazil, despite a model national pediatric vaccination program with an over 95% national coverage, vaccination rates decreased during the COVID-19 pandemic. Coordinated governmental efforts have ameliorated some of the decrease, but more efforts are needed to ensure continued protection from preventable communicable diseases for children globally.  相似文献   

8.
《Vaccine》2022,40(52):7622-7630
IntroductionThe safety profiles of COVID-19 vaccines are incompletely evaluated in Japan.ObjectivesTo examine the risk of serious adverse effects after COVID-19 mRNA vaccination (BNT162b2 and mRNA-1273) in cohort studies and self-controlled case series (SCCS).MethodsUsing an administrative claims database linked with the COVID-19 vaccination registry in a city in Japan between September 2020 and September 2021, we identified health insurance enrolees aged ≥ 18 years. We evaluated the risk of acute myocardial infarction, appendicitis, Bell’s palsy, convulsions/seizures, disseminated intravascular coagulation, immune thrombocytopenia, pulmonary embolism, haemorrhagic or ischemic stroke, venous thromboembolism, and all-cause mortality, 21 days following any COVID-19 mRNA vaccination, compared with non-vaccination periods. For the cohort studies, we estimated incidence rate ratios (IRRs) by Poisson regression and rate differences (IRDs) by weighted least-squares regression, adjusting for sex, age, and Charlson comorbidity index. We applied a modified SCCS design to appropriately treat outcome-dependent exposures. For the modified SCCS, we estimated within-subject IRRs by weighted conditional Poisson regression. Subgroup analyses stratified by sex and age were also conducted.ResultsWe identified 184,491 enrolees [male: 87,218; mean (standard deviation) age: 64.2 (19.5) years] with 136,667 first and 127,322 s dose vaccinations. The risks of any outcomes did not increase in any analyses, except for the fact that the modified SCCS indicated an increased risk of pulmonary embolism after the first dose in women (within-subject IRR [95%CI]: 3.97 [1.18–13.32]).ConclusionThe findings suggested that the COVID-19 mRNA vaccine was generally safe, whilst a signal of pulmonary embolism following the first dose of the COVID-19 mRNA vaccine was observed.  相似文献   

9.
Since coronavirus disease 2019 (COVID-19) has continued to spread globally, many countries have started vaccinations at the end of December 2020. This research examines the relationship between COVID-19 vaccine distribution and two macro-socioeconomics measures, including human development index and gross domestic product, among 25 countries for two points in time, including February and August 2021. The COVID-19 dataset is a collection of the COVID-19 data maintained by Our World in Data. It is a daily updated dataset and includes confirmed cases, vaccinations, deaths, and testing data. Ordinary Least Squares was applied to examine how macro-socioeconomic measures predict the distribution of the COVID-19 vaccine over time.ResultsThe results indicate that a higher gross domestic product per capita is positively associated with higher COVID-19 vaccine distribution, and this relationship becomes more robust over time. However, some countries may have more successful vaccine distribution results regardless of their gross domestic product. In addition, the result shows human development index does not have a significant relationship with vaccine distribution.ConclusionEconomic measures may be counted as a more vital indicator for vaccine distribution as they have a more direct relationship distribution with health infrastructure than social measures such as human development index.  相似文献   

10.
BackgroundVaccinations are an effective choice to stop disease outbreaks, including COVID-19. There is little research on individuals' COVID-19 vaccination decision-making.ObjectiveWe aimed to determine individual preferences for COVID-19 vaccinations in China, and to assess the factors influencing vaccination decision-making to facilitate vaccination coverage.MethodsA D-efficient discrete choice experiment was conducted across six Chinese provinces selected by the stratified random sampling method. Vaccine choice sets were constructed using seven attributes: vaccine effectiveness, side-effects, accessibility, number of doses, vaccination sites, duration of vaccine protection, and proportion of acquaintances vaccinated. Conditional logit and latent class models were used to identify preferences.ResultsAlthough all seven attributes were proved to significantly influence respondents’ vaccination decision, vaccine effectiveness, side-effects and proportion of acquaintances vaccinated were the most important. We also found a higher probability of vaccinating when the vaccine was more effective; risks of serious side effects were small; vaccinations were free and voluntary; the fewer the number of doses; the longer the protection duration; and the higher the proportion of acquaintances vaccinated. Higher local vaccine coverage created altruistic herd incentives to vaccinate rather than free-rider problems. The predicted vaccination uptake of the optimal vaccination scenario in our study was 84.77%. Preference heterogeneity was substantial. Individuals who were older, had a lower education level, lower income, higher trust in the vaccine and higher perceived risk of infection, displayed a higher probability to vaccinate.ConclusionsPreference heterogeneity among individuals should lead health authorities to address the diversity of expectations about COVID-19 vaccinations. To maximize COVID-19 vaccine uptake, health authorities should promote vaccine effectiveness; pro-actively communicate the absence or presence of vaccine side effects; and ensure rapid and wide media communication about local vaccine coverage.  相似文献   

11.
BackgroundObservational data enables large-scale vaccine safety surveillance but requires careful evaluation of the potential sources of bias. One potential source of bias is the index date selection procedure for the unvaccinated cohort or unvaccinated comparison time (“anchoring”).ObjectiveHere, we evaluated the different index date selection procedures for 2 vaccinations: COVID-19 and influenza.MethodsFor each vaccine, we extracted patient baseline characteristics on the index date and up to 450 days prior and then compared them to the characteristics of the unvaccinated patients indexed on (1) an arbitrary date or (2) a date of a visit. Additionally, we compared vaccinated patients indexed on the date of vaccination and the same patients indexed on a prior date or visit.ResultsCOVID-19 vaccination and influenza vaccination differ drastically from each other in terms of the populations vaccinated and their status on the day of vaccination. When compared to indexing on a visit in the unvaccinated population, influenza vaccination had markedly higher covariate proportions, and COVID-19 vaccination had lower proportions of most covariates on the index date. In contrast, COVID-19 vaccination had similar covariate proportions when compared to an arbitrary date. These effects attenuated, but were still present, with a longer lookback period. The effect of day 0 was present even when the patients served as their own controls.ConclusionsPatient baseline characteristics are sensitive to the choice of the index date. In vaccine safety studies, unexposed index event should represent vaccination settings. Study designs previously used to assess influenza vaccination must be reassessed for COVID-19 to account for a potentially healthier population and lack of medical activity on the day of vaccination.  相似文献   

12.
《Vaccine》2022,40(10):1404-1412
COVID-19 vaccine hesitancy is a significant public health issue. While vaccines are not yet available for children, clinical trials are underway, and children will likely be an important factor in the U.S. reaching herd immunity. However, little research has been conducted to examine parents’ intention to vaccinate their young children for COVID-19.MethodAn online survey with a national U.S. sample of 682 primary caregivers of children under age six assessed variables associated with intention to accept the COVID-19 vaccine for their children from November 13, 2020, to December 8, 2020.ResultsCaregivers whose child received a recent influenza vaccine, as well as those with previous experience COVID-19, were more likely to express COVID-19 vaccination intention for their young child. Identifying as female was associated with lower COVID-19 vaccination intention, while identifying as Hispanic or Latino was associated with higher intention. Health Belief Model variables of perceived severity of COVID-19 for their child, as well as vaccine confidence, were positive predictors of COVID-19 vaccine intention and mediated the relationship between prior behavior, demographic variables, and intention.ConclusionsThe findings highlight the importance of early, proactive COVID-19 vaccination education efforts directed at caregivers, including those with young children. Vaccines for young children will likely become a necessary part of ending the pandemic’s impact in school settings. Operationally, COVID-19 vaccination may also become a part of childhood vaccination schedules. Understanding the beliefs and intentions of caregivers of young children before vaccinations are recommended for children will enable public health officials and medical practitioners to prepare in advance.  相似文献   

13.
BackgroundMany countries and organizations recommended people living with HIV/AIDS (PLWHA) receive the COVID-19 vaccine. However, vaccine hesitancy still exists and becomes a barrier for promoting COVID-19 vaccination among PLWHA.ObjectiveThis study aims to investigate factors that contributed to COVID-19 vaccine hesitancy among PLWHA.MethodsThe study used a multicenter cross-sectional design and an online survey mode. We recruited PLWHA aged 18-65 years from 5 metropolitan cities in China between January 2021 and February 2021. Participants completed an online survey through Golden Data, a widely used encrypted web-based survey platform. Multiple linear regression models were used to assess the background characteristics in relation to COVID-19 vaccine hesitancy, and structural equation modeling was performed to assess the relationships among perceived benefits, perceived risks, self-efficacy, subjective norms, and COVID-19 vaccine hesitancy.ResultsAmong 1735 participants, 41.61% (722/1735) reported COVID-19 vaccine hesitancy. Older age, no other vaccinations in the past 3 years, and having chronic disease history were positively associated with COVID-19 vaccine hesitancy. Structural equation modeling revealed a direct relationship of perceived benefits, perceived risks, and subjective norms with self-efficacy and vaccine hesitancy and an indirect relationship of perceived benefits, perceived risks, and subjective norms with vaccine hesitancy. Moreover, self-efficacy toward COVID-19 vaccination was low. PLWHA had concerns of HIV disclosure during COVID-19 vaccination. Family member support could have an impact on COVID-19 vaccination decision-making.ConclusionsCOVID-19 vaccine hesitancy was high among PLWHA in China. To reduce COVID-19 vaccine hesitancy, programs and strategies should be adopted to eliminate the concerns for COVID-19 vaccination, disseminate accurate information on the safety and efficacy of the COVID-19 vaccine, encourage family member support for COVID-19 vaccination, and improve PLWHA’s trust of medical professionals.  相似文献   

14.
《Vaccine》2022,40(45):6481-6488
BackgroundActive monitoring of safety outcomes following COVID-19 vaccination is critical to understand vaccine safety and can provide early detection of rare outcomes not identified in pre-licensure trials. We present findings from an early warning rapid surveillance system in three large commercial insurance databases including more than 16 million vaccinated individuals.MethodsWe evaluated 17 outcomes of interest following COVID-19 vaccination among individuals aged 12–64 years in Optum, HealthCore, and CVS Health databases from December 11, 2020, through January 22, 2022, January 7, 2022, and December 31, 2021, respectively. We conducted biweekly or monthly sequential testing and generated rate ratios (RR) of observed outcome rates compared to historical (or expected) rates prior to COVID-19 vaccination.FindingsAmong 17 outcomes evaluated, 15 did not meet the threshold for statistical signal in any of the three databases. Myocarditis/pericarditis met the statistical threshold for a signal following BNT162b2 in two of three databases (RRs: 1.83–2.47). Anaphylaxis met the statistical threshold for a signal in all three databases following BNT162b2 vaccination (RRs: 4.48–10.86) and mRNA-1273 vaccination (RRs: 7.64–12.40).DiscussionConsistent with published literature, our near-real time monitoring of 17 adverse outcomes following COVID-19 vaccinations identified signals for myocarditis/pericarditis and anaphylaxis following mRNA COVID-19 vaccinations. The method is intended for early detection of safety signals, and results do not imply a causal effect. Results of this study should be interpreted in the context of the method’s utility and limitations, and the validity of detected signals must be evaluated in fully adjusted epidemiologic studies.  相似文献   

15.
BackgroundThe COVID-19 pandemic has prevailed over a year, and log and register data on coronavirus have been utilized to establish models for detecting the pandemic. However, many sources contain unreliable health information on COVID-19 and its symptoms, and platforms cannot characterize the users performing searches. Prior studies have assessed symptom searches from general search engines (Google/Google Trends). Little is known about how modeling log data on smell/taste disorders and coronavirus from the dedicated internet databases used by citizens and health care professionals (HCPs) could enhance disease surveillance. Our material and method provide a novel approach to analyze web-based information seeking to detect infectious disease outbreaks.ObjectiveThe aim of this study was (1) to assess whether citizens’ and professionals’ searches for smell/taste disorders and coronavirus relate to epidemiological data on COVID-19 cases, and (2) to test our negative binomial regression modeling (ie, whether the inclusion of the case count could improve the model).MethodsWe collected weekly log data on searches related to COVID-19 (smell/taste disorders, coronavirus) between December 30, 2019, and November 30, 2020 (49 weeks). Two major medical internet databases in Finland were used: Health Library (HL), a free portal aimed at citizens, and Physician’s Database (PD), a database widely used among HCPs. Log data from databases were combined with register data on the numbers of COVID-19 cases reported in the Finnish National Infectious Diseases Register. We used negative binomial regression modeling to assess whether the case numbers could explain some of the dynamics of searches when plotting database logs.ResultsWe found that coronavirus searches drastically increased in HL (0 to 744,113) and PD (4 to 5375) prior to the first wave of COVID-19 cases between December 2019 and March 2020. Searches for smell disorders in HL doubled from the end of December 2019 to the end of March 2020 (2148 to 4195), and searches for taste disorders in HL increased from mid-May to the end of November (0 to 1980). Case numbers were significantly associated with smell disorders (P<.001) and taste disorders (P<.001) in HL, and with coronavirus searches (P<.001) in PD. We could not identify any other associations between case numbers and searches in either database.ConclusionsNovel infodemiological approaches could be used in analyzing database logs. Modeling log data from web-based sources was seen to improve the model only occasionally. However, search behaviors among citizens and professionals could be used as a supplementary source of information for infectious disease surveillance. Further research is needed to apply statistical models to log data of the dedicated medical databases.  相似文献   

16.
《Vaccine》2023,41(12):1961-1967
In spring 2021, several countries, among which the Netherlands, suspended vaccinations against COVID-19 with the Vaxzevria vaccine from AstraZeneca after reports of rare but severe adverse events. This study investigates the influence of this suspension on the Dutch public’s perceptions of COVID-19 vaccinations, trust in the government’s vaccination campaign, and COVID-19 vaccination intentions. We conducted two surveys in a population of general Dutch public (18 + ), one shortly before the pause of AstraZeneca vaccinations and one shortly thereafter (N eligible for analysis = 2628). Our results suggest no changes in perceptions nor intentions regarding the COVID-19 vaccines in general but do suggest a decline in trust in the government’s vaccination campaign. In addition, after the suspension, perceptions of the AstraZeneca vaccines were more negative in comparison to those of COVID-19 vaccinations in general. AstraZeneca vaccination intentions were also considerably lower. These results stress the need to adapt vaccination policies to anticipated public perceptions and responses following a vaccine safety scare, as well as the importance of informing citizens about the possibility of very rare adverse events prior to the introduction of novel vaccines.  相似文献   

17.
《Vaccine》2021,39(12):1693-1700
BackgroundHealth care personnel have been identified by the ACIP as a priority group for COVID-19 vaccination. We conducted a survey in November-December 2020 at two large, academic hospitals in Philadelphia to evaluate the intention of hospital employees to be vaccinated.MethodsThe survey was sent electronically to all employees (clinical and nonclinical staff) at a children’s hospital and an adult hospital. The survey was voluntary and confidential. Questions focused on plans to receive a COVID-19 vaccine when available, reasons why employees would/would not get vaccinated, when employees planned to be vaccinated, vaccine safety and efficacy features that would be acceptable, and past history of receipt of other vaccines by the employee and family. Responses were analyzed using univariate and multiple logistic regression methods.ResultsA total of 12,034 hospital employees completed the survey (a 34.5% response rate). Overall, 63.7% of employees reported that they planned to receive a COVID-19 vaccine, 26.3% were unsure, and 10.0% did not plan to be vaccinated. Over 80% of those unsure or unwilling to be vaccinated expressed concerns about vaccine side effects and the vaccines’ newness. In multivariable logistic regression, persons planning to take a COVID-19 vaccine were more likely to be older, male, more educated, Asian or White, up-to-date on vaccinations, without direct patient contact, and tested for COVID-19 in the past. No significant difference in intention to be vaccinated was found between those with higher versus lower levels of exposure to COVID-19 patients or the number of previous exposures to patients with COVID-19.ConclusionsWhile the majority of hospital employees are planning to receive a COVID-19 vaccine, many are unsure or not planning to do so. Further education of hospital employees about the safety, efficacy, and value of the currently available COVID-19 vaccines is critical to vaccine acceptance in this population.  相似文献   

18.
《Vaccine》2022,40(40):5791-5797
ObjectiveTo investigate the association between Guillain-Barré syndrome (GBS) and COVID-19 vaccination.BackgroundOn July 13, 2021, the US Food and Drug Administration (FDA) released a new warning that Johnson & Johnson COVID-19 vaccine could increase the risk of developing GBS.MethodsThe reporting rate of adult GBS after COVID-19 vaccination, ascertained with Brighton criteria, was compared with the reporting rate after other vaccinations during the same time period, and also compared with the reporting rate during control periods. Statistical methods such as proportion tests, and Pearson’s chi-squared test were utilized to identify significant relationships. Self-controlled and case centered analyses were conducted. A machine learning model was utilized to identify the factors associated with a worse outcome defined as emergency room (ER) or doctor visits, hospitalizations, and deaths.ResultsThe reporting rate of GBS after COVID-19 vaccination was significantly higher than after influenza and other vaccinations (49.7, 0.19, 0.16 per 10 million, p < 0.0001). However, the reporting rate was within the incidence range of GBS in the general population. Using self-controlled and case centered analyses, there was a significant difference in the reporting rate of GBS after COVID-19 vaccination between the risk period and control period (p < 0.0001). There was an estimated 0.7–1.7 per million excess reports of GBS within 6 weeks of COVID-19 vaccination. Machine learning model demonstrated that female gender and age between 18 and 44 are associated with worse outcome. No association was found between the onset interval of GBS and its prognosis.ConclusionsAlthough the reporting rate of GBS after COVID-19 vaccination was not statistically different than that of the general population, the increased reporting of GBS within the first 6 weeks after COVID-19 vaccination, more so than with other vaccinations, suggests that some cases of GBS are temporally associated with COVID-19 vaccination. However, there is a reduction in the reporting rate of GBS after other vaccines, compared to reporting rates pre-COVID-19, highlighting limitations inherent in any passive surveillance system. These findings warrant continuous analysis of GBS after COVID-19 vaccination. Further improvement of the machine learning model is needed for clinical use.  相似文献   

19.
《Vaccine》2023,41(36):5304-5312
AimThis paper investigates the prevalence and determinants of three main states of people’s willingness to be vaccinated (WTBV) against COVID-19 – willing, unwilling and hesitant – and the occurrence and predictors of shifts between these states over time. Understanding the dynamics of vaccine intentions is crucial for developing targeted campaigns to increase uptake and emergency response preparedness.Study designA panel survey consisting of 9 quarterly waves of data collected between April 2020 and January 2022. Baseline data included 24 952 adults from Germany, UK, Denmark, the Netherlands, France, Portugal, and Italy recruited from online panels to construct census-matched nationally representative samples.Methods and measuresSelf-reported COVID-19 vaccine intention was the main outcome. Multinomial logit random effects models were used to analyze the relationships of interest. All results reported as relative risk ratios (RRR).ResultsHesitancy to get vaccinated was the most unstable vaccine intention, with on average 42% of ever hesitant respondents remaining in this state through future waves, followed by the ‘unwilling’ (53%) and ‘willing (82%). Following COVID-19 news, trust in information from the government, GPs and the WHO, risk preferences, risk perceptions, and confidence in vaccines (or lack thereof) predicted vaccination intention reversals. Risk preferences acted both as an impediment and as a facilitator for the vaccine uptake depending on the initial vaccine intention.Conclusions and relevanceThis study revealed the dynamic nature of COVID-19 vaccine intentions and its predictors in 7 European countries. The findings provide insights to policymakers for designing more effective communication strategies, particularly targeted at hesitant and unwilling to vaccinate population groups, to increase vaccine uptake for future public health emergencies.  相似文献   

20.
ObjectivesThe Holmes County Amish have low vaccination rates, an increasingly diverse population, and have an increased incidence of certain inherited diseases. The objectives were to evaluate; the rate and influences of vaccine hesitancy compared to a decade ago, vaccination patterns between Amish affiliations, vaccine practices of Amish special needs children, and the Amish’s acceptance of a COVID-19 vaccine.Study design.In April of 2020, a survey assessing vaccination patterns and beliefs were mailed to 1000 Amish families, including ultra-conservative Amish sects and special needs families.ResultsThe response rate was 39%. Among 391 respondents, 59% did not vaccinate their children, compared to only 14% that refused all vaccinations reported by Wenger et al in the same community only a decade ago. The ultra-conservative Amish rejected vaccines more often. Amish special needs children were more likely to receive vaccines than healthy Amish children. 75% responded they would reject a COVID-19 vaccine. Fear of adverse effects was the most common reason to reject vaccines. Families that accepted vaccines were more likely to cite a healthcare worker as the primary influence to vaccinate. Wives were more likely to cite their spouse as the primary influence to vaccinate. Families that rejected vaccines were more likely to state their bishop was the most influential person on vaccination.ConclusionThe Holmes County Amish have decreasing vaccine acceptance. Efforts to improve vaccination will require a targeted focus on the primary influences and beliefs of sub-populations within the Amish. Physician advocacy, peer mentorship, father-directed education, and close partnership with Church leadership will be needed to limit vaccine-preventable disease. The Amish may be at risk for low uptake of a COVID-19 vaccine.  相似文献   

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