Moral persuasion for value-laden objections to human papillomavirus vaccination.

The martial art of jiu jitsu capitalizes on the strength of a sparring partner by redirecting their momentum. Jiu jitsu persuasion similarly redirects the concerns motivating an objection in a manner that undermines the objection. This method of persuasion effectively addresses criticisms that motivate vaccine hesitancy, including moral criticisms. Critics argue that human papillomavirus vaccination causes young women to become more promiscuous. Evidence undermines this objection, but such evidence fails to persuade many objectors because of countervailing moral concerns regarding promiscuity. Healthcare professionals, therefore, need to consider supplementing evidence with moral arguments against the objection, using a framework that appeals to the core values motivating vaccine objections. A jiu jitsu model of persuasion is one such framework. By employing a jiu jitsu model healthcare professionals can facilitate collaborative, normative discussion that persuades more objectors and fulfills healthcare professionals' obligations with respect to patient care vis-à-vis vaccination.

Correspondencia vacunación-inmunización como necesidad social y reto para la ciencia y la educación médica / Vaccination-immunization correspondence as a social need and challenge for science and medical education

Introducción: La vacunación constituye el arma preventiva más efectiva para las enfermedades trasmisibles que conoce la humanidad. Hacer que las vacunas aplicadas sean realmente inmunizantes resulta la responsabilidad de los profesionales de la atención primaria. Del mismo modo, es importante que se acepte, sin recelo, la vacunación, sobre todo en la situación epidemiológica actual. Objetivo: Describir las implicaciones sociales, económicas y éticas relacionadas con la existencia de vacunas teóricamente no inmunizantes. Métodos: Se emplearon los resultados de un programa de intervención educativa en edades pediátricas en el Policlínico 13 de marzo. Se utilizó la prueba de rangos con signo de Wilcoxon, con índice de confianza del 95 por ciento. Resultados: Inicialmente, predominó el nivel inadecuado de conocimiento, que luego mejoró significativamente. Se recuperaron 48 niños no vacunados y 29 vacunaciones no inmunizados. Conclusiones: No existe correspondencia entre las coberturas vacunales y la inmunización. Están instauradas, como correctas, falsas contraindicaciones para la vacunación. La intervención educativa fue efectiva, y se hizo patente la pertinencia de programas de pregrado y posgrado que perfeccionen la formación de los profesionales y la calidad en el desempeño profesional(AU)

Introduction: Vaccination is the most effective preventive weapon for communicable diseases known to humanity. It is the responsibility of primary health care professionals to ensure that the administered vaccines are truly immunizing. Likewise, it is important that vaccination be accepted without hesitations, especially in the current epidemiological situation. Objective: To describe the social, economic and ethical implications related to the existence of theoretically nonimmunizing vaccines. Methods: The results of an educational intervention program in pediatric ages at 13 de Marzo Policlinic were used. The Wilcoxon signed-rank test was used, with a confidence index of 95 percent. Results: Initially, an inadequate level of knowledge predominated, which later improved significantly. Forty-eight unvaccinated children and 29 unimmunized children recovered. Conclusions: There is no correspondence between vaccination coverage and immunization. False contraindications for vaccination are established as correct. The educational intervention was effective, while the relevance became evident for undergraduate and postgraduate programs to improve the training of professionals and the quality of professional performance(AU)

¿Es posible obligar a las personas a vacunarse? Nudge contra el coronavirus / Is it possible to force people to be vaccinated? Nudge against coronavirus / É possível obrigar as pessoas a vacinar-se? Cutucar contra o coronavírus

Resumen: Sabemos que el mundo enfrenta una terrible pandemia. La ciencia, con esfuerzo y prontitud, ha podido desarrollar diversas vacunas contra el covid-19, generando ello grandes expectativas. Sin embargo, por diversos factores, los procesos masivos de vacunación no han avanzado a la velocidad requerida; uno de los principales es la resistencia de muchas personas a vacunarse, aduciendo diferentes razones. Frente a esta situación se ha oscilado entre la realización de campañas de publicidad hasta propuestas de imposición forzada. Una alternativa para ir más allá de lo meramente lírico y lo coercitivo es generar formas de motivación para que aquellas personas decidan voluntariamente vacunarse a través de diversas medidas, directas e indirectas, apelando a "Nudge" -o "teoría del pequeño empujón"-, con el fin de propiciar la mejor protección de la salud individual y colectiva, tema del que trata el presente artículo, a partir de la revisión bibliográfica sobre la materia y diversas experiencias en la lucha contra el coronavirus.

Abstract: We all know that the world is facing a terrible pandemic. Science, with effort and promptness, has been able to develop various vaccines against Covid-19, generating great expectations. However, mass vaccination processes have not advanced at the required speed due to various factors; one of the main ones is the resistance of many people to get vaccinated, for different reasons. Faced with this situation, it has oscillated between carrying out advertising campaigns to proposals for forced imposition. An alternative to go beyond the merely lyrical and coercive is to generate forms of motivation for those people to voluntarily decide to be vaccinated through various measures, direct and indirect, appealing to "Nudge" -or the "little push theory" - in order to promote the best protection of individual and collective health, the subject of this article, based on the bibliographic review on the matter and various experiences in the fight against coronavirus.

Resumo: Sabemos que o mundo enfrenta uma terrível pandemia. A ciência, com esforço e prontidão, pode desenvolver diversas vacinas contra a Covid-19, gerando grandes expectativas. Sem dúvida, os processos massivos de vacinação não avançaram à velocidade requerida por diversos fatores; um dos principais é a resistência de muitas pessoas a vacinar-se, alegando diferentes razões. Frente a esta situação, observou-se uma oscilação entre a realização de campanhas de publicidade a propostas de imposição forçada. Uma alternativa para ir além do meramente lírico e do coercitivo é gerar formas de motivação para que as pessoas decidam voluntariamente vacinar-se através de diversas medidas, diretas e indiretas, apelando a "Nudge" -ou a "teoria do pequeno empurrão"- a fim de propiciar a melhor proteção da saúde individual e coletiva, tema do que trata o presente artigo, a partir da revisão bibliográfica sobre a matéria e diversas experiências na luta contra o coronavírus.

Ethical Considerations in Chemotherapy and Vaccines in Cancer Patients in Times of the COVID-19 Pandemic.

The COVID-19 situation is a worldwide health emergency with strong implications in clinical oncology. In this viewpoint, we address two crucial dilemmas from the ethical dimension: (1) Is it ethical to postpone or suspend cancer treatments which offer a statistically significant benefit in quality of life and survival in cancer patients during this time of pandemic?; (2) Should we vaccinate cancer patients against COVID-19 if scientific studies have not included this subgroup of patients? Regarding the first question, the best available evidence applied to the ethical principles of Beauchamp and Childress shows that treatments (such as chemotherapy) with clinical benefit are fair and beneficial. Indeed, the suspension or delay of such treatments should be considered malefic. Regarding the second question, applying the doctrine of double-effect, we show that the potential beneficial effect of vaccines in the population with cancer (or those one that has had cancer) is much higher than the potential adverse effects of these vaccines. In addition, there is no better and less harmful known solution.

Aspectos bioéticos sobre el consentimiento informado en el uso de las vacunas en Pediatría / Bioethical aspects of informed consent for the use of vaccines in Pediatrics

Introducción: El consentimiento informado en Pediatría, es un proceso de toma de decisiones progresivo, consensuado y dialogado, centrado en una relación tripartita (pediatra, niño y padres), en virtud de la cual, estos últimos, aceptan o no las acciones de vacunación, las cuales han mejorado la prevención de distintas enfermedades infecciosas que afectan la salud de la población infantil y provocan gran morbilidad, mortalidad y secuelas. Objetivo: Exponer los principales aspectos bioéticos relacionados con el consentimiento informado en el uso de las vacunas en Pediatría. Material y Métodos: Se realizó una revisión de la literatura en español e inglés acerca del tema utilizando motores de búsqueda como Google Académico, y se consultaron 42 artículos de libre acceso en las bases de datos SciELO y Pubmed. Se analizó la bibliografía de los últimos 20 años, fundamentalmente de los últimos 5 años, desde 2000 hasta 2020. Desarrollo: Las vacunas son intervenciones preventivas que tienen una historia centenaria que demuestra su bondad y su eficacia, pero han planteado problemas éticos desde su comienzo. El consentimiento informado para su administración no se implementa con el mismo rigor en todas las regiones del mundo. Conclusiones: La vacunación en Pediatría constituye una práctica frecuente, por lo que es necesario el uso del consentimiento informado debidamente redactado y autorizado por los tutores legales o el paciente, que incluya la explicación de los propósitos, los procedimientos a que será sometido, los posibles daños y beneficios, y los posibles resultados de la misma(AU)

Introduction: Informed consent in Pediatrics is a progressive, consensual and dialogue-based decision-making process focused on a tripartite relationship (pediatrician-child-parents), under which the latter accept or do not accept the actions towards vaccination that have improved the prevention of different infectious diseases that affect the health of the child population and cause great morbidity, mortality and sequelae. Objective: To state the main bioethical aspects related to informed consent for the use of vaccines in Pediatrics. Material and Methods: A review of literature on the topic in Spanish and English was carried out using search engines such as Google Scholar. Also, 42 open access articles were consulted in the SciELO and Pubmed databases. The bibliography of the last 20 years was analyzed. It mainly included articles published during the last 5 years (from 2000 to 2020). Development: Vaccines are preventive interventions that have a centuries-old history that demonstrates their goodness and effectiveness, but have posed ethical problems since the very beginning. Informed consent for their administration is not implemented with the same rigor in all regions of the world. Conclusions: Vaccination in Pediatrics is a frequent practice, so a duly drafted informed consent authorized by the legal guardians or the patient is necessary. It should include the explanation of the aims, the procedures to which the patient will be submitted, the possible damages and benefits, and the possible results(AU)

The controversy on HPV vaccination in Japan: Criticism of the ethical validity of the arguments for the suspension of the proactive recommendation.

The Human Papillomavirus (HPV) vaccine was integrated into Japan's national immunization program (NIP) in April 2013. However, numerous instances of serious adverse reactions were widely reported in the media, resulting in the Ministry of Health, Labor, and Welfare (MHLW) suspending the official recommendation of the HPV vaccine on June 14, 2013. Investigating the reported incidents, the Vaccine Adverse Reactions Review Committee (VARRC)-an MHLW advisory committee-found no high-quality evidence supporting a causal relationship between the reported events and the HPV vaccination. However, rather than lifting the suspension, they have opted to maintain a "pseudo informed consent" confirming the perceptions of Japanese citizens regarding the vaccine. Accordingly, there appears to be a fundamental difference in the approach to vaccine policymaking between Japan (MHLW/VARRC) and other countries and the World Health Organization, which base policy decisions on the effectiveness and safety of the vaccine. Consequently, the arguments for the suspension of the HPV vaccine recommendation are not ethically appropriate. Relevant bodies must make a clear decision regarding the HPV vaccine and its status in the NIP: the proactive recommendation must either be reinstated or the HPV vaccine legal framework altered to rely entirely on voluntary individual decisions.

Whither Cochrane?

The ouster of Professor Peter Gotzsche who headed the Nordic Cochrane Centre, from Cochrane, a respected international research organisation, has provoked a crisis of confidence in the organisation's future. Disputant and bystander reactions on this issue are presented, as well as concerns regarding conflicts of interest and the reliability of Cochrane reviews. Cochrane's crisis mirrors the larger crisis of confidence that pervades the entire enterprise of medical research. We note that within weeks after Gotzsche was expelled from Cochrane, the HPV vaccine (whose Cochrane review he had publicly criticised for conflicts of interest and poor science) received a license expansion in the United States that might be worth billions of dollars to the manufacturer. Finally, we suggest a variety of new approaches that could strengthen the value of Cochrane analyses, broaden Cochrane's approach to include additional methodologies, and enhance its independence from financial interests.

Screening for infectious diseases of asylum seekers upon arrival: the necessity of the moral principle of reciprocity.

BACKGROUND: With a large number of forcibly displaced people seeking safety, the EU is facing a challenge in maintaining solidarity. Europe has seen millions of asylum seekers crossing European borders, the largest number of asylum seekers since the second world war. Endemic diseases and often failing health systems in their countries of origin, and arduous conditions during transit, raise questions around how to meet the health needs of this vulnerable population on arrival in terms of screening, vaccination, and access to timely and appropriate statutory health services. This paper explores the potential role of the principle of reciprocity, defined as the disposition 'to return good in proportion to the good we receive, and to make reparations for the harm we have done', as a mid-level principle in infectious disease screening policies. MAIN TEXT: More than half of the European countries implemented screening programmes for newly arrived asylum seekers. Screening may serve to avoid potential infectious disease risks in the receiving countries as well as help identify health needs of asylum seekers. But screening may infringe upon basic rights of those screened, thus creating an ethical dilemma. The use of the principle of reciprocity can contribute to the identification of potential improvements for current screening programmes and emphasizes the importance of certain rights into guidelines for screening. It may create a two way moral obligation, upon asylum seekers to actively participate in the programme, and upon authorities to reciprocate the asylum seekers' participation and the benefits for the control of public health. CONCLUSION: The authors argue that the reciprocity principle leads to a stronger ethical justification of screening programmes and help achieve a balance between justifiable rights claims of the host population and the asylum seekers. The principle deserves a further and more thorough exploration of its potential use in the field of screening, migration and infectious diseases.

Lessons learnt in Japan from adverse reactions to the HPV vaccine: a medical ethics perspective.

The human papillomavirus (HPV) vaccine has been linked to a number of serious adverse reactions. The range of symptoms is diverse and they develop in a multi-layered manner over an extended period of time. The argument for the safety and effectiveness of the HPV vaccine overlooks the following flaws: (i) no consideration is given to the genetic basis of autoimmune diseases, and arguments that do not take this into account cannot assure the safety of the vaccine; (ii) the immune evasion mechanisms of HPV, which require the HPV vaccine to maintain an extraordinarily high antibody level for a long period of time for it to be effective, are disregarded; and (iii) the limitations of effectiveness of the vaccine. We also discuss various issues that came up in the course of developing, promoting and distributing the vaccine, as well as the pitfalls encountered in monitoring adverse events and epidemiological verification.

Ethical Challenges and Lessons Learned During the Clinical Development of a Group A Meningococcal Conjugate Vaccine.

BACKGROUND: The group A meningococcal vaccine (PsA-TT) clinical development plan included clinical trials in India and in the West African region between 2005 and 2013. During this period, the Meningitis Vaccine Project (MVP) accumulated substantial experience in the ethical conduct of research to the highest standards. METHODS: Because of the public-private nature of the sponsorship of these trials and the extensive international collaboration with partners from a diverse setting of countries, the ethical review process was complex and required strategic, timely, and attentive communication to ensure the smooth review and approval for the clinical studies. Investigators and their site teams fostered strong community relationships prior to, during, and after the studies to ensure the involvement and the ownership of the research by the participating populations. As the clinical work proceeded, investigators and sponsors responded to specific questions of informed consent, pregnancy testing, healthcare, disease prevention, and posttrial access. RESULTS: Key factors that led to success included (1) constant dialogue between partners to explore and answer all ethical questions; (2) alertness and preparedness for emerging ethical questions during the research and in the context of evolving international ethics standards; and (3) care to assure that approaches were acceptable in the diverse community contexts. CONCLUSIONS: Many of the ethical issues encountered during the PsA-TT clinical development are familiar to groups conducting field trials in different cultural settings. The successful approaches used by the MVP clinical team offer useful examples of how these problems were resolved. CLINICAL TRIALS REGISTRATION: ISRCTN17662153 (PsA-TT-001); ISRTCN78147026 (PsA-TT-002); ISRCTN87739946 (PsA-TT-003); ISRCTN46335400 (PsA-TT-003a); ISRCTN82484612 (PsA-TT-004); CTRI/2009/091/000368 (PsA-TT-005); PACTR ATMR2010030001913177 (PsA-TT-006); PACTR201110000328305 (PsA-TT-007).

HPV and the Ethics of CDC's Vaccination Requirements for Immigrants.

The United States may justifiably exclude unvaccinated aliens, perhaps even under the assumption of Open Borders, according to which people should generally be permitted to settle in countries of their choosing. Furthermore, there are good reasons to endorse the Centers for Disease Control and Prevention's (CDC's) current vaccination-related exclusion criteria, which were last revised in 2009. I frame my discussion around CDC's 2008 decision to permit immigrant girls and women to be excluded if they were not vaccinated against human papillomavirus (HPV)-a decision that was quickly reversed and that led to the 2009 revisions to CDC's vaccination-related immigrant exclusion criteria.

Immigration Justice and the Grounds for Mandatory Vaccinations.

For over a century, a foreign national seeking permission to immigrate to the U.S. could have her application for immigration denied on the ground that she suffers from a serious contagious disease. For just under two decades, a foreign national seeking permission to immigrate could also have her application denied on the ground that she has not been vaccinated against each of a list of vaccination-preventable diseases. Two recently developed moral justifications for the use of such "vaccination-related exclusion criteria" have focused on (a) the right and need of a society to prevent the spread of disease to others and (b) the public good of developing and protecting herd immunity. Herein I accept these two general justifications-especially as they are developed by Mark Navin-and explore their limits. In particular, with a focus on the recently developed vaccine against several strains of HPV, as well the short-lived requirement by the CDC that it, too, be required of prospective immigrants, I argue that neither of the two main justifications for the use of vaccination-related exclusion criteria support their use for diseases such as HPV (or even HIV), the transmission of which, unlike airborne diseases such as measles, pertussis and polio, is subject to a considerable degree of individual control.

Informed consent for HPV vaccination: a relational approach.

The aim of this study was to explore the relational aspects of the consent process for HPV vaccination as experienced by school nurses, based on the assumption that individuals have interests related to persons close to them, which is not necessarily to be apprehended as a restriction of autonomy; rather as a voluntary and emotionally preferred involvement of their close ones. Thirty Swedish school nurses were interviewed in five focus groups, before the school based vaccination program had started in Sweden. The empirical results were discussed in light of theories on relational autonomy. The school nurses were convinced that parental consent was needed for HPV vaccination of 11-year-old girls, but problems identified were the difficulty to judge when a young person is to be regarded as autonomous and what to do when children and parents do not agree on the decision. A solution suggested was that obtaining informed consent in school nursing is to be seen as a deliberative process, including the child, the parents and the nurse. The nurses described how they were willing strive for a dialogue with the parents and negotiate with them in the consent process. Seeing autonomy as relational might allow for a more dialogical approach towards how consent is obtained in school based vaccination programs. Through such an approach, conflicts of interests can be made visible and become possible to deal with in a negotiating dialogue. If the school nurses do not focus exclusively on accepting the individual parent's choice, but strive to engage in a process of communication and deliberation, the autonomy of the child might increase and power inequalities might be reduced.

Ethical considerations of universal vaccination against human papilloma virus.

BACKGROUND: From an epidemiological perspective, the practice of universal vaccination of girls and young women in order to prevent human papilloma virus (HPV) infection and potential development of cervical cancer is widely accepted even though it may lead to the neglect of other preventive strategies against cervical cancer. DISCUSSION: It is argued that removing the deterrent effect--the fear of developing cancer--could encourage teenage sex. This paper reflects on the ethical legitimacy of the universal vaccination of girls and young women against HPV infection, especially regarding safety issues, the need to vaccinate people who have opted to abstain from sex, the presumption of early onset of sexual relations, the commercial interests of the companies that manufacture the vaccine, and the recommendation of universal vaccination in males. SUMMARY: Based on the aforementioned information, we believe that the universal vaccination against HPV in young women is acceptable from an ethical point of view, given the medical advantages it presents.

Vaccines to promote and protect sexual health: policy challenges and opportunities.

Vaccines aim to improve the well-being of everyone and are seen as a public health success story in the prevention and control of communicable infections. However, decisions to use vaccinations are not without controversy, and the introduction of vaccines targeting sexually transmitted infections (STIs) is particularly contentious. In this paper we investigate the underlying policy challenges and opportunities for rolling out STI vaccines. Looking in detail at the experience of delivering HPV vaccine, we explore the lessons that can be learnt, including policy and human rights dimensions, for future STI vaccine introduction and scale up. Policies arise from the interaction of ideas, interests and institutions. In the case of HPV vaccine, ideas have been particularly contested, although interests and institutions have impacted on policy too. A review of human rights in relation to STI vaccine policies highlights the specific needs and rights of adolescents, and the paper details concepts of consent and evolving capacity which can be used to ensure that adolescents have full access to health interventions. Policy options for vaccines include mandatory approaches - and these have been utilized in some settings for HPV vaccines. The paper argues, and outlines the rationale, against adopting mandatory STI vaccine policy approaches. The paper concludes by identifying policy opportunities for introducing new vaccines targeting STIs.

The sexual ethics of HPV vaccination for boys.

Human papillomavirus (HPV) is one of the most common sexually transmitted infections. It is a leading cause of cervical cancer in women but the virus is increasingly being linked to several other cancers in men and women alike. Since the introduction of safe and effective but also expensive vaccines, many developed countries have implemented selective vaccination programs for girls. Some however argue that these programs should be expanded to include boys, since (1) HPV constitutes non-negligible health risks for boys as well and (2) protected boys will indirectly also protect girls. In this paper we approach this discussion from an ethical perspective. First, on which moral grounds can one justify not reimbursing vaccination for the male sex? We develop an ethical framework to evaluate selective vaccination programs and conclude that, in the case of HPV, efficiency needs to be balanced against non-stigmatization, non-discrimination and justice. Second, if vaccination programs were to be expanded to boys as well, do the latter then also have a moral duty to become immunized? Two arguments in favor of such a moral duty are well known in vaccination ethics: the duty not to harm others and to contribute to the public good of public health. However, we argue that these are not particularly convincing in the context of HPV. In contrast, we believe a third, more powerful but also more controversial argument is possible. In our view, the sexual mode of transmission of HPV constitutes an additional reason to believe that boys in fact may have a moral obligation to accept vaccination.