The new Italian National Immunization Technical Advisory Group (NITAG) and its commitment to endorse a new efficient National Immunization Plan in COVID-19 times.

Among the objectives of the WHO Global Vaccination Action Plan 2020-2025, there is the establishment, in all countries, of a National Immunization Technical Advisory Group (NITAG), an independent body with the aim of supporting and harmonising vaccination policies. Italy firstly established a NITAG in 2017; it contributed to the nation's immunization policies but fell short of its goal of becoming a true reference group. The newly appointed NITAG, made up of 28 independent experts, has the ambitious goal to promote the new National Immunization Prevention Plan (PNPV), to harmonise the current vaccination schedule with the anti-COVID-19 campaign, and to recover the vaccination coverage decline that occurred during the pandemic. The contact with the ECDC EU/EEA, the WHO Global NITAG networks, and all the national stakeholders needs to be reinforced in order to accomplish these aims. This paper describes the structure, organisation, and strategy of the new Italian NITAG.

Respeto por la autonomía individual y el beneficio colectivo: argumentación a favor de la vacunación obligatoria contra el SARS-CoV-2 para el personal de la salud / Respect for individual autonomy and a collective benefit: Arguments in favor of compulsory SARS-CoV-2 vaccination among health care professionals

Con la llegada de las vacunas contra el SARS-CoV-2, un nuevo aspecto a tener en cuenta en la pandemia es el rechazo a la vacunación. Como la recepción de la vacuna, es voluntaria, se plantea cómo abordar la situación de los miembros del equipo de salud que la rechazan. Se exponen argumentos bioéticos de diversas corrientes: el deontologismo kantiano y lo conceptos de universalidad, humanidad y autonomía; el utilitarismo de Mill, con la autoprotección como único fin por el cual la humanidad está habilitada para interferir con la libertad de acción de sus miembros; el principismo de Beauchamp y Childress y los conceptos de beneficencia y autonomía; el principio de oportunidad de Varo Baena; y el principio de solidaridad, derivado de la ética de los derechos humanos. Se incluyen aportes de filósofos contemporáneos como Roberto Espósito, Jean-Luc Nancy y Alberto Giubilini. Se exponen dos contrargumentos: el de no maleficencia y el de contraproducencia. Por último, se plantea que, dado que el bien común (la salud pública, en este caso) es el determinante íntimo y último de la libertad individual e igual para todos, está por encima del beneficio individual

With the development of SARS-CoV-2 vaccines, a new aspect to be taken into consideration in the midst of the pandemic is vaccine refusal. Since vaccination is voluntary, it is necessary to deal with the fact that some health care team members refuse to receive it. Here I put forward different bioethical arguments: Kantian deontology and the principles of universalizability, humanity, and autonomy; Mill's utilitarianism, with self-protection as the sole end for which humankind is authorized to interfere with its members' freedom of action; Beauchamp and Childress' principlism and the concepts of beneficence and autonomy; Varo Baena's principle of opportunity; and the principle of solidarity resulting from the ethics of human rights. The contributions of contemporary philosophers like Roberto Espósito, Jean-Luc Nancy, and Alberto Giubilini are also included. Two counter-arguments are presented: nonmaleficence and counter-production. Lastly, I suggest that, since common good (in this case, public health) is the intimate and final determining factor of individual freedom and is the same for all, it is above any individual benefit.

Considerations for fair prioritization of COVID-19 vaccine and its mandate among healthcare personnel.

With current COVID-19 vaccine demand outweighing supply and the emergency authorization/rollout of three novel vaccines in the United States, discussions continue regarding fair prioritization among various groups for this scarce resource. The US federal government's recommended vaccination schedule, meant to assist states with vaccine allocation, demonstrates fair ethical considerations; however, difficulties remain comparing various groups to determine fair vaccine access and distribution. Although strides have been taken to analyze risks versus benefits of early vaccination across certain high-risk populations, prioritizing vulnerable populations versus essential workers remains challenging for multiple reasons. Similarly, as COVID-19 vaccine allocation and distribution continues in the US and in other countries, topics that require continued consideration include sub-prioritization among currently prioritized groups, prioritization among vulnerable groups disproportionately affected by the COVID-19 pandemic, like ethnic minorities, and holistic comparisons between groups who might receive various and disparate benefits from vaccination. Although all current COVID-19 vaccines are emergency authorization use only and a vaccine mandate would be considered only once these vaccines are licensed by the US Food and Drug Administration, future vaccination policies require time and deliberation. Similarly, given current vaccine hesitancy, mandatory vaccination of certain groups, like healthcare personnel, may need to be considered when these vaccines are licensed, especially if voluntary vaccination proves insufficient. Continued discussions regarding risks versus benefits of mandatory COVID-19 vaccination and the unique role of healthcare personnel in providing a safe healthcare environment could lead to better deliberation regarding potential policies. This commentary aims to address both questions of fair prioritization and sub-prioritization of various groups, as well as ethical considerations for mandatory COVID-19 vaccination among healthcare personnel.

Global Ethical Considerations Regarding Mandatory Vaccination in Children.

Whether children should be vaccinated against coronavirus disease-2019 (COVID-19) (or other infectious diseases such as influenza) and whether some degree of coercion should be exercised by the state to ensure high uptake depends, among other things, on the safety and efficacy of the vaccine. For COVID-19, these factors are currently unknown for children, with unanswered questions also on children's role in the transmission of the virus, the extent to which the vaccine will decrease transmission, and the expected benefit (if any) to the child. Ultimately, deciding whether to recommend that children receive a novel vaccine for a disease that is not a major threat to them, or to mandate the vaccine, requires precise information on the risks, including disease severity and vaccine safety and effectiveness, a comparative evaluation of the alternatives, and the levels of coercion associated with each. However, the decision also requires balancing self-interest with duty to others, and liberty with usefulness. Separate to ensuring vaccine supply and access, we outline 3 requirements for mandatory vaccination from an ethical perspective: (1) whether the disease is a grave threat to the health of children and to public health, (2) positive comparative expected usefulness of mandatory vaccination, and (3) proportionate coercion. We also suggest that the case for mandatory vaccine in children may be strong in the case of influenza vaccination during the COVID-19 pandemic.

The moral dilemma of the polio eradication programme.

During the last five years, globally, cases of polio caused by vaccine viruses have outnumbered those of polio caused by natural (wild) polioviruses, posing a moral dilemma. Public health ethics should ensure the best interests of the community, with equity in sharing benefits and risks irrespective of socioeconomic disparities. Vaccine viruses in oral polio vaccine (OPV) cause vaccine-associated paralytic polio (VAPP), while paralytic polio is also caused by vaccine-derived polioviruses (VDPVs). By its policy of the use of OPV in low and middle-income countries, while rich countries use the safe inactivated polio vaccine (IPV), the Global Polio Eradication Programme has been responsible for social injustice. In 2017 and 2018, there were outbreaks of polio in Syria and Papua New Guinea due to circulating VDPVs, after many years of these countries remaining free of polio due to wild polioviruses. The only ethical way forward for global polio eradication is to replace OPV with IPV in all countries.

Challenges in conducting a community-based influenza vaccine trial in a rural community in northern India.

Evidence on influenza vaccine effectiveness from low and middle countries (LMICs) is limited due to limited institutional capacities; lack of adequate resources; and lack of interest by ministries of health for influenza vaccine introduction. There are concerns that the highest ethical standards will be compromised during trials in LMICs leading to mistrust of clinical trials. These factors pose regulatory and operational challenges to researchers in these countries. We conducted a community-based vaccine trial to assess the efficacy of live attenuated influenza vaccine and inactivated influenza vaccine in rural north India. Key regulatory challenges included obtaining regulatory approvals, reporting of adverse events, and compensating subjects for trial-related injuries; all of which were required to be completed in a timely fashion. Key operational challenges included obtaining audio-visual consent; maintaining a low attrition rate; and administering vaccines during a narrow time period before the influenza season, and under extreme heat. We overcame these challenges through advanced planning, and sustaining community engagement. We adapted the trial procedures to cope with field conditions by conducting mock vaccine camps; and planned for early morning vaccination to mitigate threats to the cold chain. These lessons may help investigators to confront similar challenges in other LMICs.

La vacuna contra el virus del papiloma humano: estado de la cuestión, principio de proporcionalidad y consentimiento informado / The vaccine against human papilloma virus: state of the question, proportionality principle and informed consent / A vacina contra o virus do papiloma humano: situação da questão, princípio de proporcionalidade e consentimento informado

Entre los debates actuales en torno a las prácticas de vacunación, la vacuna contra el Virus de Papiloma Humano (VPH) formula diversos desafíos desde la bioética: por una parte, existen controversias en cuanto al perfil de eficacia y seguridad de las vacunas comercializadas, así como respecto de su costo-efectividad. Es evidente en estudios empíricos que el proceso de consentimiento informado no ofrece los elementos necesarios para que las pacientes y sus representantes legales puedan participar de forma significativa en el proceso de toma de decisiones en torno a la vacunación. El presente artículo presenta una revisión sobre el estado de la cuestión, ofrece un análisis desde la bioética a partir del principio de proporcionalidad y el método deliberativo-sincrético y sugiere algunos aportes para optimizar el proceso de consentimiento informado para la vacuna contra el VPH.

Within the current discussions on immunization practices, Human Papillomavirus (HPV) made various challenges from bioethics: firstly, there are controversies regarding the efficacy and safety profile of marketed vaccines, and with respect to their cost-effectiveness. Around the discussion is evident in empirical studies that the informed consent process does not provide the necessary elements for the patients and their legal representatives can participate meaningfully in the process of making decisions about vaccination. This article presents an overview of the status of the issue, with an analysis from bioethics from the principle of proportionality and the deliberative syncretic method and suggests some input to optimize the process of informed consent for the HPV vaccine.

Entre os debates atuais em torno das práticas de vacinação, a vacina contra o vírus do Papiloma Humano (HPV) formula diversos desafios a partir da bioética: por uma parte, existem controvérsias quanto ao perfil de eficácia e segurança das vacinas comercializadas, assim como a respeito de seu custo-efetividade. É evidente em estudos empíricos que o processo de consentimento informado não oferece os elementos necessários para que as pacientes e seus representantes legais possam participar de forma significativa no processo de tomada de decisões em torno da vacinação. O presente artigo apresenta uma revisão sobre a situação da questão, oferece uma análise a partir da bioética, tendo como base o princípio da proporcionalidade e o método deliberativo-sincrético e sugere algumas contribuições para otimizar o processo de consentimento informado para a vacina contra o HPV.

Aspectos bioéticos da vacinação em massa no Brasil / Bioethic aspects of mass vaccination in Brazil / Aspectos bioéticos de la vacunación en masa en Brasil

A vacinação em massa consiste na realização coletiva da prática vacinal, utilizando como estratégias as campanhas, mutirões e bloqueios, realizadas sem considerar os riscos epidêmicos e outras questões, implicando na perda da autonomia e vulnerabilidade dos indivíduos. Este estudo tem como objetivo realizar uma discussão referentes à prática da vacinação em massa sob a ótica da Bioética Principialista considerado o papel do Estado e os aspectos culturais relacionados a essa prática. Trata-se de uma revisão de literatura com recorte temporal de 1999 a 2013 em periódicos nacionais. Concluiu-se que ocorre desvalorização dos princípios éticos relacionados a autonomia, não-maleficência, beneficência e justiça, bem como uma desconsideração dos aspectos culturais dos vacinados por parte do Estado e dos profissionais de saúde. O Estado ainda é hoje o maior incentivador das práticas de vacinação em massa por serem medidas mais simples de prevenção das doenças uma vez que ainda existe uma precariedade nas infraestruturas sanitárias no país, no entanto, em contra partida, seria necessário estimular a conscientização da população e o aperfeiçoamento do controle sanitário que seriam a longo prazo opções necessárias para que em certos lugares se descontinuassem essa prática.

Mass vaccination is the collective achievement of immunization practice, using strategies such as campaigns, task forces and locks, made without considering the epidemic risks and other issues, resulting in the loss of autonomy and vulnerability of individuals. This study aims to conduct a discussion regarding the practice of mass vaccination from the perspective of bioethics principialist considered the role of the state and the cultural aspects of this practice. This is a review of literature with time frame 1999-2013 in national journals. It was concluded that occurs devaluation of ethical principles related to autonomy, non-maleficence, beneficence and justice, as well as a disregard of cultural aspects of vaccinees by the state and health professionals. The state is still the biggest supporter of mass vaccination practices by being simpler measures of disease prevention since there is still a precarious health infrastructure in the country, however, although, it would be necessary to stimulate public awareness and the improvement of sanitary control that would be long-term options needed for certain places if they stopped this practice.

La vacunación masiva es un logro colectivo de la práctica de la inmunización, utilizando estrategias como campañas, grupos de trabajo y aislamientos realizados, sin considerar los riesgos de epidemias y otras cuestiones, lo que resulta en la pérdida de la autonomía y la vulnerabilidad de los individuos. Este estudio tiene como objetivo llevar a cabo una discusión sobre la práctica de vacunación masiva desde la perspectiva de la bioética principialista, considerado el papel del Estado y los aspectos culturales de esta práctica. Se trata de una revisión de la literatura entre los años 1999 y 2013 en revistas brasileras. Se concluyó que hay una devaluación de principios éticos relacionados con la autonomía, no maleficencia, beneficencia y justicia, y una falta de respeto a los aspectos culturales de los vacunados por parte de los funcionarios de salud pública. El Estado sigue siendo el mayor encargado del mantenimiento de las prácticas de vacunación masiva, con medidas simples para prevenir la enfermedad, aunque todavía hay una deficiente infraestructura sanitaria en el país; sin embargo, sería necesario aumentar la conciencia pública y mejorar el control sanitario, y definir las medidas a largo plazo en ciertos lugares en caso de cese esta práctica.

Vacunas / Vaccines

Las vacunas son un instrumento extraordinario de inmunización de la población frente a las enfermedades infecciosas. En torno a ellas se plantean muchas cuestiones éticas. Una de las más debatidas es la que tiene que ver con la oposición de algunos colectivos a la vacunación de sus hijos. Los Estados han gestionado de maneras distintas el conflicto entre el deber de vacunar y la negativa a utilizarlas: unos imponen la vacunación y otros simplemente la promueven. En este artículo nos ocupamos de cuál de estos dos planteamientos es el más adecuado desde el punto de vista ético y jurídico. Al apostar por la segunda de las opciones, que es la vigente en España, proponemos algunas medidas que se deberían tener en cuenta para mejorar los programas de vacunación (AU)

Vaccines are an extraordinary instrument of immunization of the population against infectious diseases. Around them there are many ethical issues. One of the most debated is what to do with certain groups opposition to vaccination of their children. States have managed in different ways the conflict between the duty of vaccination and the refusal to use vaccines: some impose the vaccination and others simply promote it. In this article we deal with which of these two approaches is the most suitable from an ethical and legal point of view. We stand up for the second option, which is the current one in Spain, and we propose some measures which should be kept in mind to improve immunization programs (AU)

J'accuse desde la bioética: análisis de la discusión sobre el timerosal en Chile / A bioethical j’accuse: analysis of the discussion around thiomersal in Chile

El Poder Legislativo chileno propone una ley que elimine el timerosal como preservante de las vacunas parenterales del Programa Nacional de Inmunizaciones, proyecto que el Poder Ejecutivo se ha propuesto vetar. El mundo científico informa mayoritariamente que la sospecha de neurotoxicidad atribuida al timerosal es infundada. Pese a ello, las autoridades médicas han oscilado entre sostener que la precaución sugiere apoyar la ley y en otros momentos han manifestando que es más precautorio mantener los programas de vacunación actualmente vigentes. Estas contradicciones y oposiciones ilustran que materias que conciernen a la ciudadanía, requieren una reflexión bioética acabada sobre las políticas públicas sanitarias. Han quedado claro las deficiencias de la deliberación política y la falta de participación social en decisiones que, dado el grado de incertidumbre involucrada en temas como inmunización, requieren no sólo la inclusión de la ciudadanía sino el respeto de la autonomía individual para aceptar o rechazar la inclusión en los programas de vacunación propuestos por las políticas sanitarias. La participación ciudadana en nuestro país se ve severamente limitada por la falta de instrumentos sociales como el plebiscito, el ombudsman y, especialmente, la desidia en crear la Comisión Nacional de Bioética exigida por la Ley 20.120 de 2006, una de cuyas funciones más importantes es mediar deliberativamente entre legos, expertos y políticos en la generación de políticas sanitarias legitimadas por la participación ciudadana.

Chilean legislators have voted to ban vaccines preserved with thiomersal, an initiative that the Executive has vetoed. Most scientific evidence has dismissed the alleged toxicity of this substance, in accordance with the formal and publicly expressed opinion of local experts, and yet, medical authorities have issued contradictory statements. Some have argued that the principle of precaution suggests eliminating thiomersal preserved vaccines; others have declared that current vaccines should be maintained to protect the population. From the perspective of bioethics, this polemic is another example of the shortcoming of the deliberation process leading to controversial laws in lieu of including citizens in the discussion of regulations that harbor uncertainties, and respect for individual autonomy to accept or reject public immunization programs. The Chilean legal system has been unwilling to implement participatory democratic procedures like plebiscites or institutions such as the ombudsman. In 2006 a law was enacted that creates a National Commission of Bioethics, but successive governments have failed to create such a commission, which is an efficient social instrument to conduct deliberation on bioethical issues that require a balanced participation of the public, experts, and politicians.

Lay people's interpretation of ethical values related to mass vaccination; the case of A(H1N1) vaccination campaign in the province of Quebec (French Canada).

BACKGROUND: Pandemic influenza ethics frameworks are based on respect of values and principles such as regard for autonomy, responsibility, transparency, solidarity and social justice. However, very few studies have addressed the way in which the general population views these moral norms. OBJECTIVES: (i) To analyse the receptiveness of the population of French-speaking Quebecers to certain ethical principles promoted by public health authorities during the AH1N1 vaccination campaign. (ii) To add to the limited number of empirical studies that examine the population's perception of ethical values. DESIGN: Eight months after the end of the AH1N1 vaccination campaign in the Province of Quebec (Canada), 100 French-speaking Quebecers were assembled in ten focus groups. Discussions focussed on the level of respect shown by public health authorities for individual autonomy, the limits of appeals for solidarity, the balance between vaccination efficiency and social justice towards non-prioritized subpopulations, vaccination as a demonstration of civic duty and social responsibility. RESULTS: The population acknowledged a high level of individual responsibility towards family members and agreed to vaccination to protect children and ageing parents. However, the concepts of civic duty and solidarity did not elucidate unanimous support, despite the fact that social justice stood out as a dominant value of public morals. CONCLUSION: The ethical principles promoted in influenza pandemic ethics frameworks are subject to reinterpretation by the population. An ethic of public health must consider their understanding of the fundamental values that legitimize mass vaccination.