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1.
Trials ; 21(1): 853, 2020 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-33059771

RESUMO

OBJECTIVES: To evaluate the efficacy of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac in symptomatic individuals, with virological confirmation of COVID-19, two weeks after the completion of the two-dose vaccination regimen, aged 18 years or older who work as health professionals providing care to patients with possible or confirmed COVID-19. To describe the occurrence of adverse reactions associated with the administration of each of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac up to one week after vaccination in Adults (18-59 years of age) and Elderly (60 years of age or more). TRIAL DESIGN: This is a Phase III, randomized, multicenter, endpoint driven, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac. The adsorbed vaccine COVID-19 (inactivated) produced by Sinovac (product under investigation) will be compared to placebo. Voluntary participants will be randomized to receive two intramuscular doses of the investigational product or the placebo, in a 1: 1 ratio, stratified by age group (18 to 59 years and 60 years or more) and will be monitored for one year by active surveillance of COVID-19. Two databases will be established according to the age groups: one for adults (18-59 years) and one for the elderly (60 years of age or older). The threshold to consider the vaccine efficacious will be to reach a protection level of at least 50%, as proposed by the World Health Organization and the FDA. Success in this criterion will be defined by sequential monitoring with adjustment of the lower limit of the 95% confidence interval above 30% for the primary efficacy endpoint. PARTICIPANTS: Healthy participants and / or participants with clinically controlled disease, of both genders, 18 years of age or older, working as health professionals performing care in units specialized in direct contact with people with possible or confirmed cases of COVID-19. Participation of pregnant women and those who are breastfeeding, as well as those intending to become pregnant within three months after vaccination will not be allowed. Participants will only be included after signing the voluntary Informed Consent Form and ensuring they undergo screening evaluation and conform to all the inclusion and exclusion criteria. All the clinical sites are located in Brazil. INTERVENTION AND COMPARATOR: Experimental intervention: The vaccine was manufactured by Sinovac Life Sciences (Beijing, China) and contains 3 µg/0.5 mL (equivalent to 600 SU per dose) of inactivated SARS-CoV-2 virus, and aluminium hydroxide as adjuvant. Control comparator: The placebo contains aluminium hydroxide in a 0.5 mL solution The schedule of both, experimental intervention and placebo is two 0.5 mL doses IM (deltoid) with a two week interval. MAIN OUTCOMES: The primary efficacy endpoint is the incidence of symptomatic cases of virologically confirmed COVID-19 two weeks after the second vaccination. The virological diagnosis will be confirmed by detection of SARS-CoV-2 nucleic acid in a clinical sample. The primary safety endpoint is the frequency of solicited and unsolicited local and systemic adverse reactions during the period of one week after vaccination according to age group in adult (18-59 years old) and elder (60 years of age or older) subjects. Adverse reactions are defined as adverse events that have a reasonable causal relationship to vaccination. RANDOMISATION: There will be two randomization lists, one for each age group, based on the investigational products to be administered, i.e., vaccine or placebo at a 1: 1 ratio. Each randomization list will be made to include up to 11,800 (18-59 year-old) adults, and 1,260 elderly (60 y-o and older) participants, the maximum number of participants needed per age group. An electronic central randomization system will be used to designate the investigational product that each participant must receive. BLINDING (MASKING): This trial is designed as a double-blind study to avoid introducing bias in the evaluation of efficacy, safety and immunogenicity. The clinical care team, the professionals responsible for the vaccination and the participants will not know which investigational product will be administered. Only pharmacists or nurses in the study who are responsible for the randomization, separation and blinding of the investigational product will have access to unblinded information. The sponsor's operational team will also remain blind. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The total number of participants needed to evaluate efficacy, 13,060 participants, satisfies the needed sample size calculated to evaluate safety. Therefore, the total number obtained for efficacy will be the number retained for the study. Up to 13,060 participants are expected to enter the study, with up to 11,800 participants aged 18 to 59 years and 1,260 elderly participants aged 60 and over. Half of the participants of each group will receive the experimental vaccine and half of them will receive the placebo. The recruitment of participants may be modified as recommended by the Data Safety Monitoring Committee at time of the interim unblinded analysis or blind assessment of the COVID-19 attack rate during the study. TRIAL STATUS: Protocol version 2.0 - 24-Aug-2020. Recruitment started on July 21st, 2020. The recruitment is expected to conclude in October 2020. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT0445659 . Registry on 2 July 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
Betacoronavirus/genética , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vacinação/métodos , Vacinas/uso terapêutico , Adolescente , Adulto , Idoso , Betacoronavirus/imunologia , Brasil/epidemiologia , Estudos de Casos e Controles , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/virologia , Gerenciamento de Dados , Método Duplo-Cego , Feminino , Pessoal de Saúde/estatística & dados numéricos , Humanos , Incidência , Consentimento Livre e Esclarecido/ética , Injeções Intramusculares , Masculino , Pessoa de Meia-Idade , Placebos/administração & dosagem , Pneumonia Viral/epidemiologia , Pneumonia Viral/imunologia , Pneumonia Viral/virologia , Segurança , Terapias em Estudo/métodos , Resultado do Tratamento , Vacinas/administração & dosagem , Vacinas/efeitos adversos , Adulto Jovem
4.
Lancet ; 396(10255): 898-908, 2020 09 26.
Artigo em Inglês | MEDLINE | ID: mdl-32919524

RESUMO

BACKGROUND: There is growing evidence of vaccine delays or refusals due to a lack of trust in the importance, safety, or effectiveness of vaccines, alongside persisting access issues. Although immunisation coverage is reported administratively across the world, no similarly robust monitoring system exists for vaccine confidence. In this study, vaccine confidence was mapped across 149 countries between 2015 and 2019. METHODS: In this large-scale retrospective data-driven analysis, we examined global trends in vaccine confidence using data from 290 surveys done between September, 2015, and December, 2019, across 149 countries, and including 284 381 individuals. We used a Bayesian multinomial logit Gaussian process model to produce estimates of public perceptions towards the safety, importance, and effectiveness of vaccines. Associations between vaccine uptake and a large range of putative drivers of uptake, including vaccine confidence, socioeconomic status, and sources of trust, were determined using univariate Bayesian logistic regressions. Gibbs sampling was used for Bayesian model inference, with 95% Bayesian highest posterior density intervals used to capture uncertainty. FINDINGS: Between November, 2015, and December, 2019, we estimate that confidence in the importance, safety, and effectiveness of vaccines fell in Afghanistan, Indonesia, Pakistan, the Philippines, and South Korea. We found significant increases in respondents strongly disagreeing that vaccines are safe between 2015 and 2019 in six countries: Afghanistan, Azerbaijan, Indonesia, Nigeria, Pakistan, and Serbia. We find signs that confidence has improved between 2018 and 2019 in some EU member states, including Finland, France, Ireland, and Italy, with recent losses detected in Poland. Confidence in the importance of vaccines (rather than in their safety or effectiveness) had the strongest univariate association with vaccine uptake compared with other determinants considered. When a link was found between individuals' religious beliefs and uptake, findings indicated that minority religious groups tended to have lower probabilities of uptake. INTERPRETATION: To our knowledge, this is the largest study of global vaccine confidence to date, allowing for cross-country comparisons and changes over time. Our findings highlight the importance of regular monitoring to detect emerging trends to prompt interventions to build and sustain vaccine confidence. FUNDING: European Commission, Wellcome, and Engineering and Physical Sciences Research Council.


Assuntos
Saúde Global , Vacinação em Massa/psicologia , Opinião Pública , Confiança , Vacinas , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Vacinação em Massa/efeitos adversos , Estudos Retrospectivos , Vacinas/efeitos adversos
5.
Artigo em Inglês | MEDLINE | ID: mdl-32796740

RESUMO

The aim of this paper was to investigate the level of influence of online media on the parents' attitudes toward vaccination of children in three countries of the Western Balkans-Montenegro, Serbia, and Bosnia and Herzegovina, in order to use the potentials of this form of communication effectively and efficiently. Online media are a critical factor of influence on the formation of attitudes in many areas of modern society, which is why their proper use plays an important role in strengthening vaccine confidence and which may further contribute to improvement of public health. On the other side, having in mind the fact that communication is an integral part of marketing, it is clear that social marketing has an extremely important role regarding the analyzed topic, especially because of the fact that social marketing activities tend to change or maintain people's behavior for the benefit of individuals and society as a whole. For the purpose of this research, a conceptual model was developed. Quantitative research was conducted online in the first quarter of 2020 using the survey method. Statistical analysis was applied to data collected from 1593 parents in the analyzed countries. The relevance of the hypotheses was tested using standard statistical tests, ANOVA test, eta coefficient, and logistic regression. The research showed that all analyzed variables from the model have a significant impact on the parents' attitudes toward the vaccination of children and that they correlate with the degree of trust in vaccines. The results also approved that online media have a significant influence on the formation of parents' attitudes toward the vaccination of children (obtained values of eta coefficient η2 = 0.216, η2 = 0.18, η2 = 0.167, η2 = 0.090, reliability Cronbach's Alpha 0.892), which confirms the importance of the use of social marketing in order to direct communication properly and to strengthen the level of trust in vaccines. Additionally, the results of logistic regression showed that the following groups of parents are particularly vulnerable to the influence of online media on attitudes toward vaccines: women, parents of younger age ("millennials"), and parents who are in common law marriage, as well as parents who have more children. In addition, the results showed that there is no statistically significant difference in the attitudes of parents in the observed countries (η2 = 0.000, F = 0.85). Based on the results of the research, the authors suggest that decision makers should pay more attention to modern forms of online communication and social marketing in order to use their potential for improvement of public health, as well as avoid the harmful impact that certain forms of communication may have on the formation of attitudes and loss of confidence in vaccines. The findings provide an important contribution for public health policy makers to identify and understand properly the impact of online media and social marketing and thus to better adapt their initiatives to changes in modern society.


Assuntos
Conhecimentos, Atitudes e Prática em Saúde , Pais/psicologia , Saúde Pública , Marketing Social , Mídias Sociais , Vacinação/psicologia , Vacinas/efeitos adversos , Bósnia e Herzegóvina , Criança , Feminino , Comunicação em Saúde , Humanos , Masculino , Montenegro , Reprodutibilidade dos Testes , Sérvia , Vacinas/administração & dosagem
6.
PLoS One ; 15(8): e0236691, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32785248

RESUMO

Vaccine hesitancy-the reluctance to receive recommended vaccination because of concerns and doubts about vaccines-is recognized as a significant threat to the success of vaccination programs and has been associated with recent major outbreaks of vaccine-preventable diseases. Moreover, the association between complementary and alternative medicine (CAM) use and vaccine hesitancy and/or refusal has been frequently reported in the literature. To date, significant gaps persist in our understanding of contemporary Canadian CAM providers' beliefs regarding vaccination and how socio-professional influences may shape their vaccine-related attitudes and behaviours. To address the latter gap, the current study aims to explore the content of professional guidelines, recommendations and other discourses among CAM providers as they concern vaccination by analyzing both academic, peer-reviewed literature and Canadian organizational webpages prepared by and/or for practicing chiropractors, naturopaths and homeopaths. In the academic literature, we identified a number of complex and diverging views on vaccination that spanned topics of effectiveness; safety; theoretical, empirical, and ethical soundness; political justifiability; and compatibility with CAM philosophy and professional boundaries. However, in its current state the CAM literature cannot be described in broad strokes as being either pro- or anti-vaccination without considering finer areas of disagreement. Compared to the academic literature, which focuses more on the conceptual and evidentiary basis of vaccination, a greater proportion of vaccine-related content on Canadian CAM organizations' webpages seems to be dedicated to offering specific directives and prescriptions to providers. Guidelines and standards of practice address a number of issues, including vaccine administration, counsel, education and marketing. As CAM organizations further evolve in Canada and elsewhere as part of a broader "professionalization" initiative, greater attention will need to be directed at their role in shaping providers' beliefs and practices that both support and undermine vaccine promotion efforts.


Assuntos
Terapias Complementares , Pessoal de Saúde/psicologia , Recusa de Vacinação/psicologia , Vacinação/psicologia , Canadá/epidemiologia , Quiroprática , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Homeopatia/psicologia , Humanos , Masculino , Naturopatia/psicologia , Vacinas/efeitos adversos
7.
Neurology ; 95(3): e226-e238, 2020 07 21.
Artigo em Inglês | MEDLINE | ID: mdl-32611632

RESUMO

OBJECTIVE: To compare the developmental and behavioral outcomes of children experiencing an initial vaccine-proximate (VP) febrile seizure (FS) to those having a non-VP-FS (NVP-FS) and controls who have not had a seizure. METHODS: In this prospective multicenter cohort study, children with their first FS before 30 months of age between May 2013 and April 2016 were recruited from 4 Australian pediatric hospitals and classified as having VP-FS or NVP-FS. Similar-aged children with no seizure history were recruited as controls. The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) was administered to participants with FS 12 to 24 months after their initial FS and to controls 12 to 42 months of age at the time of assessment. The primary outcome was the Bayley-III cognitive score. Children's preacademic skills were assessed with the Woodcock-Johnson Tests of Achievement, Third Edition, and their behavior and executive functioning were obtained from parent questionnaires. RESULTS: There was no significant difference in cognitive function between children with VP-FS (n = 62), those with NVP-FS (n = 70), and controls (n = 90) (F 2,219 = 2.645, p = 0.07). There were no differences between the groups for all other measures and no increased risk of borderline/significant impairment or behavior in the clinical range in children with VP-FS compared to those with NVP-FS or controls. CONCLUSION: VP-FS was not associated with an increased risk of developmental or behavioral problems in young children compared to children with NVP-FS or controls. Parents and providers should be reassured by the absence of adverse effects of VP-FS on the development of children.


Assuntos
Desenvolvimento Infantil/efeitos dos fármacos , Desenvolvimento Infantil/fisiologia , Convulsões Febris/induzido quimicamente , Convulsões Febris/epidemiologia , Vacinas/efeitos adversos , Adulto , Austrália/epidemiologia , Estudos de Casos e Controles , Pré-Escolar , Estudos de Coortes , Feminino , Seguimentos , Humanos , Lactente , Masculino , Estudos Prospectivos , Convulsões Febris/diagnóstico
8.
Autoimmun Rev ; 19(9): 102603, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32659478

RESUMO

More than one-fourth of all Persian gulf war coalition soldiers remain seriously ill. Several epidemiological studies suggest a link between multiple vaccinations at the time of the military operation and the illness development. Macrophagic Myofasciitis and post-HPV vaccination syndrome are two newer controversial vaccine-related disabling ailments. OBJECTIVES: 1) To systematically review all original articles investigating the association of vaccines with gulf war illness, 2) To discuss gulf war illness, Macrophagic Myofasciitis, and post-HPV vaccination syndrome clinical similarities, 3) To discuss emergent pathogenetic mechanisms proposed for post-HPV vaccination syndrome that may be also relevant to gulf war illness and Macrophagic Myofasciitis. RESULTS: All original epidemiological studies (n = 11) found a positive association between vaccination and gulf war illness development. Chronic fatigue, widespread pain and cognitive impairment characterize the three syndromes under discussion. Anti-adrenergic receptor antibodies, dysautonomia and small fiber neuropathy have been recently described in patients with post-HPV vaccination syndrome. CONCLUSION: post-HPV vaccination syndrome, Macrophagic Myofasciitis, and gulf war illness analogy suggests that some vaccines or multiple vaccinations in a very short period of time may induce, in susceptible individuals, chronic pain, fatigue and dyscognition. Vaccine-induced autoimmune dysautonomia is hypothesized as the common pathogenetic mechanism for this symptom cluster. Further research on the presence of small fiber neuropathy, adrenergic receptor antibodies, and abnormal autonomic function tests in the three syndromes under discussion may help to elucidate this hypothesis.


Assuntos
Fasciite/etiologia , Guerra do Golfo , Miosite/etiologia , Infecções por Papillomavirus/prevenção & controle , Disautonomias Primárias/etiologia , Vacinação/efeitos adversos , Vacinas/efeitos adversos , Fasciite/epidemiologia , Humanos , Miosite/epidemiologia , Infecções por Papillomavirus/imunologia , Disautonomias Primárias/epidemiologia , Disautonomias Primárias/imunologia , Vacinação/estatística & dados numéricos
9.
Artigo em Inglês | MEDLINE | ID: mdl-32575879

RESUMO

Thanks to vaccines, many people are not exposed to the risks associated with vaccine-preventable diseases (VPDs). This, however, results in growing popularity of antivaccine movements and affects global and local epidemiological situation. Vaccine hesitancy has become a significant problem not only for epidemiologists but also for practitioners. Fortunately, the hesitant group seems to be vulnerable to intervention, and studies indicate that these patients can be persuaded to undergo vaccinations. The aim of the present study was to determine the factors most strongly affecting vaccination-related attitudes and decisions. An anonymous, self-administered survey consisting of demographic data and single select multiple-choice questions regarding vaccination was conducted. The voluntary study included secondary school pupils, medical and nonmedical students, healthcare professionals, hospital and clinic patients as well as parents. A total of 7950 survey forms were distributed between January 2018 and June 2019 in south-eastern Poland. A total of 6432 respondents (80.2%) completed a questionnaire that was eligible for analysis. The positive attitude toward vaccination was significantly affected by older age, by the fact of obtaining information on vaccinations from a physician, this information's higher quality (assessed in school grade scale), higher level of knowledge on vaccines and by the fact of denying the association between vaccination and autism in children (p < 0.001). The probability of supporting vaccinations was almost eight-fold lower among respondents believing the vaccine-autism relationship. Chance of supporting vaccination doubled in the group with a higher knowledge level. The individuals not provided with expert information on vaccination were twice as often unconvinced. Age, education and having children significantly affected the attitude toward influenza immunization (p < 0.001). Older, better educated respondents and those having children were more positive about vaccinations. The medical community still exert decisive effects on attitudes toward vaccinations. High-quality information provided by them is of great importance. Skillful and competent provision of evidence-based information disproving the myth about vaccine-autism connection and proper education of medical staff is essential in molding positive attitudes toward vaccinations.


Assuntos
Conhecimentos, Atitudes e Prática em Saúde , Vacinação , Feminino , Humanos , Masculino , Polônia , Inquéritos e Questionários , Vacinas/efeitos adversos
10.
Tex Med ; 116(4): 24-25, 2020 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-32353160

RESUMO

Preventable diseases are back on the map, and Peter Hotez, MD, Texas' most outspoken vaccine researcher, says physicians need to think globally to help stop the trend.


Assuntos
Movimento contra Vacinação , Liderança , Médicos , Medicina Preventiva , Saúde Pública , Doenças Preveníveis por Vacina , Vacinas , Transtorno Autístico/etiologia , História do Século XXI , Humanos , Masculino , Texas , Vacinas/efeitos adversos
11.
PLoS One ; 15(5): e0233334, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32437376

RESUMO

To update the landscape analysis of vaccine injuries no-fault compensation programmes, we conducted a scoping review and a survey of World Health Organization Member States. We describe the characteristics of existing no-fault compensation systems during 2018 based on six common programme elements. No-fault compensation systems for vaccine injuries have been developed in a few high-income countries for more than 50 years. Twenty-five jurisdictions were identified with no-fault compensation programmes, of which two were recently implemented in a low- and a lower-middle-income country. The no-fault compensation programmes in most jurisdictions are implemented at the central or federal government level and are government funded. Eligibility criteria for vaccine injury compensation vary considerably across the evaluated programmes. Notably, most programmes cover injuries arising from vaccines that are registered in the country and are recommended by authorities for routine use in children, pregnant women, adults (e.g. influenza vaccines) and for special indications. A claim process is initiated once the injured party or their legal representative files for compensation with a special administrative body in most programmes. All no-fault compensation programmes reviewed require standard of proof showing a causal association between vaccination and injury. Once a final decision has been reached, claimants are compensated with either: lump-sums; amounts calculated based on medical care costs and expenses, loss of earnings or earning capacity; or monetary compensation calculated based on pain and suffering, emotional distress, permanent impairment or loss of function; or combination of those. In most jurisdictions, vaccine injury claimants have the right to seek damages either through civil litigation or from a compensation scheme but not both simultaneously. Data from this report provide an empirical basis on which global guidance for implementing such schemes could be developed.


Assuntos
Seguro de Responsabilidade Civil , Vacinas/efeitos adversos , Adulto , Criança , Compensação e Reparação , Feminino , Saúde Global , Política de Saúde/economia , Política de Saúde/legislação & jurisprudência , Humanos , Responsabilidade Legal/economia , Masculino , Imperícia/economia , Imperícia/legislação & jurisprudência , Programas Nacionais de Saúde/economia , Programas Nacionais de Saúde/legislação & jurisprudência , Gravidez , Inquéritos e Questionários , Vacinação/efeitos adversos , Vacinação/economia , Vacinação/legislação & jurisprudência , Vacinas/economia , Organização Mundial da Saúde
12.
Emerg Top Life Sci ; 4(2): 241-245, 2020 09 08.
Artigo em Inglês | MEDLINE | ID: mdl-32463081

RESUMO

Skepticism and misinformation relating to vaccines is not new. The benefits of all our present routinely used vaccines outweigh any risks. In relatively recent times there has been a 'war on science' and relating to this, is the present antivaccine movement. Today, social media is a major contributor to vaccine misinformation. A recent Gallup poll noted that public support for vaccines today is significantly lower than it was in 2001. Social scientists have presented the problem of the antivaccine movement quite well; but mechanisms for addressing it are far from clear. We suggest that physicians and other health care workers should not use social media for vaccine messages. A long-term approach would be to introduce science/epidemiological education in grade school and high school as well as in college.


Assuntos
Movimento contra Vacinação , Sociologia , Vacinação/tendências , Comunicação , Programas Governamentais , Pessoal de Saúde , Humanos , Saúde Pública , Mídias Sociais , Vacinas/efeitos adversos , Vacinas/provisão & distribução
13.
Tex Med ; 116(3): 47, 2020 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-32271936

RESUMO

One persistent anti-vaccine argument goes like this: Getting a disease gives a person stronger or longer-lasting "natural" immunity to that illness than taking the vaccine. It is true that many illnesses confer future immunity to those who get them. But to get that immunity, patients first have to survive pathogens that can permanently destroy their health or end their lives. The quest to obtain natural immunity can cause parents to endanger their children unnecessarily.


Assuntos
Educação em Saúde , Imunidade Inata , Vacinas/imunologia , Humanos , Risco , Vacinas/efeitos adversos
14.
Lancet Infect Dis ; 20(5): e80-e89, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32278359

RESUMO

This Review updates the scientific evidence assessing possible causal associations of adverse events following immunisation (AEFI) compiled in the 2012 report from the Institute of Medicine and the 2014 report from the Agency for Healthcare Research and Quality. For 12 of 46 AEFI examined, a causal relationship has been established with at least one vaccine currently routinely recommended to the general USA population: anaphylaxis, arthralgia or arthritis (mild, acute, and transient, not chronic), deltoid bursitis (when vaccine is administered improperly), disseminated varicella infection (in immune deficient individuals for whom the varicella vaccine is contraindicated), encephalitis, febrile seizures, Guillain-Barré syndrome, hepatitis (in immune deficient individuals for whom the varicella vaccine is contraindicated), herpes zoster, immune thrombocytopenic purpura, meningitis, and syncope. Other than mild acute and transient arthralgia or arthritis, which is very common in adult women after rubella vaccine, these adverse reactions are rare or very rare. Vaccines have an excellent safety profile overall and provide protection against infectious diseases to individuals and the general population.


Assuntos
Vacinação/efeitos adversos , Vacinas/efeitos adversos , Doenças Transmissíveis/imunologia , Humanos , Segurança , Vacinas/imunologia
16.
Zhonghua Er Ke Za Zhi ; 58(4): 308-313, 2020 Apr 02.
Artigo em Chinês | MEDLINE | ID: mdl-32234138

RESUMO

Objective: To investigate the coverage rate and the adverse reactions of National Immunization Program vaccines in children with spinal muscular atrophy (SMA). Methods: A cross-sectional retrospective cohort study was carried out from July 2016 to June 2019, 192 children (116 boys and 76 girls) with SMA registered by Capital Institute of Pediatrics and 191 healthy children (115 boys and 76 girls) vaccinated in Chaoyang Olympic Village Community Health Service Center from July 2016 to December 2018 were included. Questionnaire survey was designed to investigate the vaccination coverage rate and associated adverse events. The t-test and χ(2) test were used to compare the difference between SMA patients and healthy children. Results: The coverage rate of age-appropriate immunization in SMA children was 62.0% (119/192) in general, and were 52.2% (12/23), 55.7% (68/122), and 83.0% (39/47) for SMA type 1-3 patients, respectively (χ(2)=12.23, P=0.002). The vaccination coverage rates of Bacillus Calmette-Guerin (BCG) vaccine, the 3(rd) dose of hepatitis B, the 3(rd) dose of polio, the 3(rd) dose of diphtheria-pertussis-tetanus, the 1(st) dose of meningococcal polysaccharide group A, the 1(st) dose of measles or measles and rubella vaccine, the 1(st) dose of Japanese encephalitis vaccine, hepatitis A, measles-mumps-rubella, and group A+C meningococcal polysaccharide vaccine were 100.0% (192 cases), 94.3% (181 cases), 81.8% (157 cases), 88.5% (170 cases), 83.9% (161 cases), 76.6% (147 cases), 80.2% (154 cases), 68.2% (131 cases), 69.8% (134 cases), 54.7% (105 cases), respectively. Among the 73 patients who did not have their planned immunization completed, 57 cases (78.1%) gave up the vaccination due to parents' concern of potential aggravation of their disease, and 16 cases (21.9%) had the plan discontinued by the immunization department because of the disease. Fever, local redness and swelling were the most common side-effects after vaccination both in SMA patients and healthy children (19.8% (38/192) vs. 18.8% (36/191) , χ(2)=0.055, P=0.815). The main abnormal reactions of vaccination were rash and neurovascular edema, without significant difference between these two groups (2.6% (5/192) vs. 3.7% (7/191), χ(2)=0.355, P=0.551). The coverage rate of Influenza and pneumococcal vaccine in SMA patients were 22.4% (43 cases) and 31.8% (61 cases), respectively. The incidence of pneumonia in the SMA patients decreased from 59.0% (23/39) to 41.0% (16/39) after vaccination. And none of the Influenza vaccinated patients had the flu in the year of vaccination. Conclusions: The coverage rate of National Immunization Program vaccines in the SMA children is low, especially in type 1 SMA patients, which is mainly due to their guardians' concern of potential adverse events, even though the incidence of adverse reactions is similar in SMA patients and healthy children. Influenza and pneumococcal vaccine can reduce the risk of pneumonia and flu in children with SMA effectively.


Assuntos
Programas de Imunização , Atrofia Muscular Espinal , Vacinação/estatística & dados numéricos , Vacinas/efeitos adversos , Criança , China , Estudos Transversais , Feminino , Humanos , Masculino , Estudos Retrospectivos
17.
Paediatr Drugs ; 22(2): 105-111, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32072472

RESUMO

Vaccines are one of the great achievements of medical science. They have eradicated or drastically reduced the incidence of once common diseases. It is estimated that vaccines save between 2 and 6 million lives each year, but 1.5 million more lives could be saved if coverage was increased. Vaccine hesitancy, defined by the World Health Organization as "the reluctance or refusal to vaccinate despite the availability of vaccines", is a barrier to increasing coverage that has received a great deal of attention from the media and public health academics in recent years. It is argued that many parents are reluctant to vaccinate their children because of concerns about vaccine safety, despite reassurances from doctors and public health authorities. Vaccine hesitancy is a particularly big problem in high-income countries. Observers have noted that the internet and social media play an important role in spreading fears about vaccine safety. It is, however, important to understand how the wider social and political context has influenced concerns about vaccine safety. Vaccine hesitancy appears to be one aspect of a broader breakdown in trust between some sections of the population on the one hand, and elites and experts on the other.


Assuntos
Saúde Pública/métodos , Vacinação/efeitos adversos , Vacinas/efeitos adversos , Humanos
18.
Trop Med Int Health ; 25(5): 540-557, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32034985

RESUMO

Canine leishmaniosis is an important vector-borne zoonosis caused mainly by Leishmania infantum. Diagnosis and treatment of affected individuals can be particularly complex, hindering infection control in endemic areas. Methods to prevent canine leishmaniosis include the use of topical insecticides, prophylactic immunotherapy and vaccination. Four vaccines against canine leishmaniosis have been licensed since 2004, two in Brazil (Leishmune®, the production and marketing licence of which was withdrawn in 2014, and Leish-Tec®) and two in Europe (CaniLeish® and LetiFend®). After several years of marketing, doubts remain regarding vaccine efficacy and effectiveness, potential infectiousness of vaccinated and infected animals or the interference of vaccine-induced antibodies in L. infantum serological diagnosis. This review summarises the scientific evidence for each of the vaccines commercially approved for canine leishmaniosis, while discussing possible weaknesses of these studies. Furthermore, it raises the need to address important questions related to vaccination impact in Leishmania-endemic countries and the importance of post-marketing pharmacological surveillance.


Assuntos
Doenças do Cão/prevenção & controle , Leishmaniose/veterinária , Animais , Anticorpos Antiprotozoários/sangue , Brasil , Comércio , Doenças do Cão/sangue , Cães , Europa (Continente) , Leishmania infantum/imunologia , Leishmaniose/prevenção & controle , Vigilância de Produtos Comercializados , Vacinação/veterinária , Vacinas/efeitos adversos
19.
Rev Esp Salud Publica ; 942020 Feb 13.
Artigo em Espanhol | MEDLINE | ID: mdl-32051392

RESUMO

The rapid diffusion of the jennerian method was founded in simplicity to practice, in its apparent effectiveness in combating smallpox and its epidemiological opportunity, as it appeared at the time of greatest recrudescence of the disease. The initial impulse for it's propagation, which originated a recognized movement to protect population health, was not without controversy. At the same time that defenders of the vaccine were added, opposite opinions appeared that used diverse critics to discredit it. The most common was to reveal their alleged failures using the media of the time, so cases were reported that occurred in the children of notable people in society. Ignacio María Ruiz de Luzuriaga (1763-1822), as secretary of the Royal Academy of Medicine he assumed a catalytic role, becoming the protagonist of the initial history of vaccination in Spain. It has been considered as an introducer, disseminator and ardent defender of the vaccine, as can be seen from the analysis of the bulky correspondence generated between 1801 and 1802 cataloged as "Papeles sobre la vacuna". These documents, preserved in the Academy library, show their activity as a propagator of the method and its capacity to respond to the doubts and concerns related to their possible adverse effects, avoiding jeopardizing the continuity of vaccines.


Assuntos
Movimento contra Vacinação/história , Recusa de Vacinação/história , Vacinação/história , Vacinas/história , Movimento contra Vacinação/psicologia , História do Século XVIII , História do Século XIX , Humanos , Espanha , Vacinação/efeitos adversos , Vacinação/psicologia , Recusa de Vacinação/psicologia , Vacinas/efeitos adversos
20.
N Z Med J ; 133(1510): 83-87, 2020 02 21.
Artigo em Inglês | MEDLINE | ID: mdl-32078604

RESUMO

The purpose of this article is to offer evidence that vaccine safety is taken very seriously and various examples to support this premise are described. The article covers adverse event reporting following vaccination, the difference between events which occur after vaccination and events which are caused by vaccination, the comprehensive safety monitoring required when vaccines are first introduced, international vaccine withdrawals because of safety concerns and some vaccine changes in New Zealand where safety was an important consideration. Finally, recent developments in vaccine safety monitoring are outlined. It is hoped that this will be a useful resource for those involved in the complex issue of counteracting vaccine hesitancy.


Assuntos
Política de Saúde , Segurança do Paciente/normas , Vigilância de Produtos Comercializados/métodos , Vacinas/efeitos adversos , Humanos , Nova Zelândia , Vigilância de Produtos Comercializados/normas
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