Ethical considerations of the vaccine development process and vaccination: a scoping review

Abstract

Background Various vaccines have been developed and distributed worldwide to control and cope with COVID-19 disease. To ensure vaccines benefit the global community, the ethical principles of beneficence, justice, non-maleficence, and autonomy should be examined and adhered to in the process of development, distribution, and implementation. This study, therefore, aimed to examine ethical considerations of vaccine development and vaccination processes. Methods A scoping review of the literature was conducted based on the Arkesy and O’Malley protocol to identify eligible studies published until November 2021. We searched Web of Science, PubMed, Scopus, and SciELO databases. The search was conducted using combinations of Medical Subject Heading (MeSH) search terms and keywords for Ethics, COVID-19, and vaccines in abstract, keywords, and title fields to retrieve potentially relevant publications. We included any study that reported one of the four principles of medical ethics: autonomy, justice, non-maleficence, and beneficence in the COVID-19 vaccine development and distribution and implementation of vaccinations. Letters, notes, protocols, and brief communications were excluded. In addition, we searched gray literature to include relevant studies (ProQuest database, conferences, and reports). Data were analyzed using framework analysis. Results In total, 43 studies were included. Ethical considerations concluded two themes: (1) production and (2) distribution and vaccination. The production process consisted of 16 codes and 4 main Categories, distribution and vaccination process consisted of 12 codes and 4 main Categories. Moreover, the ethical considerations of special groups were divided into four main groups: health care workers (HCWs) (five codes), children and adolescents (five codes), the elderly (one code), and ethnic and racial minorities (three codes). Conclusion Due to the externalities of pandemics and the public and social benefits and harms of vaccination, it is not feasible to adhere to all four principles of medical ethics simultaneously and perfectly. This issue confronts individuals and policymakers with several moral dilemmas. It seems that decision-making based on the balance between social benefit and social harm is a better criterion in this regard, and the final decision should be made based on maximizing the public benefit and minimizing the public harm.

Ethics and strategy in vaccination: A review of public health policies and practices

“…Beneficence is best realized through the development and implementation of equitable allocation strategies (Jalilian et al,2023). Ethical vaccination policies strive to ensure that the benefits of immunization are distributed fairly across diverse socio-economic and demographic groups.…”

Analysing vaccine efficacy evaluated in phase 3 clinical trials carried out during outbreaks

“…Second, by ethical reasons one should not expect more than the necessary time to eventually offering the vaccine to the placebo group. These ethical aspects are particularly critical when the vaccine had already demonstrated some efficacy ( Jalilian et al., 2023 ). With this time protocol, the two groups suffer the same attack rate of the infection (the force of infection, defined latter), vaccine efficacy is easier to estimate.…”