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



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.


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.


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).


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.

Peer Review reports


The side effects of COVID-19 on public health are well known, especially if the necessary measures for social distancing are not taken to control transmission. Strict and compulsory social distancing restrictions have considerable effects on the economy, education, freedom of the people, and societies’ physical and mental health [1,2,3]. Therefore, the most desirable way to control the epidemic, which provides long-term protection against the outbreak of COVID-19, is to develop and distribute an effective and safe vaccine [4, 5]. With the rapid growth of vaccine research and entering the different types of vaccines into the third phase of clinical research and the issuance of emergency licenses for their global use, various ethical challenges have been raised, which are generally based on the four principles of bioethics: justice, non-maleficence, benefit, and autonomy [6]. These challenges can be classified into four general categories, including (1) safe and standard manufacturing and passing scientific and ethical stages, (2) evaluation and monitoring of safety and efficacy, (3) mass production, fair distribution, and (4) public acceptance [7]. Justice is a fair adjudication consisting of distributive justice, rights-based justice, and legal justice. Distributive justice means equal distribution of scarce resources among all; equality means the absence of avoidable or compensable disparities between different groups, countries, ethnicities and races, and societies in general [6, 8]. The principle of beneficence states that COVID-19 vaccines perform to benefit individuals and increase their well-being. Autonomy in health care gives the patient the right to make decisions regarding their health care independently based on their beliefs, attitudes, and judgments. The principle of non-maleficence or to do no harm means “not harming” the fundamental and vital principles in health care and research [8, 9]. In the past, vaccines have always been developed through a series of steps that may take years. At present, given the urgent need for COVID-19 vaccines, Human Challenge Trials (HCTs) are a potential way to accelerate the development of vaccines and treatments [10, 11]. Clinical trials raise several ethical issues, including human trials, placebo use, patent, participants’ consent, considerations for children and pregnant women, the right to post-trial access for the control group, access to affordable, safe, and effective vaccines that should be considered in the development and manufacture of COVID-19 vaccines [12].

The COVID-19 epidemic also showed that there are deep inequalities between communities and populations concerning health care, which relate to various factors, including different access to resources and socio-economic factors. After producing several COVID-19 vaccines and issuing emergency licenses for them, questions are raised about how to adhere to the ethical principle of justice and equitable distribution of vaccines among countries and even within a country to prioritize the access of different groups. These questions encompass complex and controversial issues such as economics, public perspectives/views, diplomacy, public health, and other considerations. Therefore, vaccination as an appropriate measure to prevent COVID-19 requires planning and implementation to achieve the principles of justice [13, 14]. Given the development of COVID-19 vaccines in a pandemic emergency, this can significantly affect ethical considerations in vaccine production as well as distribution and vaccination processes. So far, various studies have examined the ethical considerations of the COVID-19 vaccine, but most of them have examined ethical considerations in vaccine production or distribution and implementation of vaccination or in specific groups.

The primary objective of this study was to find out the ethical considerations related to the production, distribution, and vaccination processes. The secondary objective was realizing the ethical considerations in specific groups (i.e. children and adolescents, the elderly, health care workers, and ethnic and racial groups). The results of this study can be used as a comprehensive and integrated ethical framework for governments, international organizations, and stakeholders related to the development, distribution, and implementation of vaccination. Moreover, applying these results can lead to improving the safety and efficacy of vaccine production/development, fair distribution, and increased participation in the vaccination process.


A scoping review of the literature was conducted based on Arkesy and O’Malley to identify eligible studies published until November 2021. This protocol consists of six stages: (1) specifying research questions, (2) identifying relevant studies using valid databases, (3) selecting relevant studies, (4) charting data, (5) collating, summarizing, and reporting the results, and (6) voluntarily expert consultation [15].

Research question

The research questions of this study were: (1) what are the ethical considerations associated with vaccine production? (2) What ethical considerations are associated with vaccine distribution and vaccination? (3) What ethical considerations are associated with specific groups (children and adolescents, the elderly, HCWs, and ethnic and racial groups)?

Data sources and search strategy

Electronic databases searched were Web of Science, PubMed, Scopus, and SciELO. 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. Furthermore, we conducted searches on Google Scholar based on keywords and examined the reference lists of included articles and grey reviews for additional relevant articles. Search syntaxes are accessible in appendices. In addition to a comprehensive search in the databases, we searched gray literature, including theses from ProQuest, conferences from Scopus, and other papers and reports. Furthermore, the search procedure was completed with hand searching (See Additional file 1).

In our study, original articles, reviews, and case studies that were published in any language and examined at least one of the four principles of medical ethics (e.g. autonomy, justice, non-maleficence, and beneficence in the production, distribution, and implementation of vaccinations) were included. Reviewers excluded letters, notes, protocols, and brief/short communications. The eligible studies were entered into Endnote, and duplicates were removed. After removing duplicate records, two independent researchers (H J and M A) independently reviewed the title of the articles and irrelevant ones were removed. In the case of disagreement, the selection was evaluated by a third reviewer (F F-K). Before the final step, the abstract of included studies was reviewed based on the inclusion and exclusion criteria. Finally, the full text of the studies was reviewed, and the final studies were identified to enter the final analysis. Ultimately, 43 papers were deemed adequate for this scoping review.

Data summary and synthesis

We extracted the following data from the included studies: authors’ name, year of publication, study location (s), objective (s), type of article, intervention, ethical principles, and key findings. Data were analyzed using framework analysis based on bioethics principles (justice, beneficence, non-maleficence, and autonomy) in two separate stages of vaccine production as well as distribution and vaccination [8]. Finally, after summarizing and preparing the report, the Triangulation technique, which included researcher surveys, expert opinion polls, and documentation review, was used to validate and enrich the reported data. Figure 1 indicates the main bioethics framework used in this study.

Fig. 1
figure 1

Bioethics framework


As shown in Fig. 2, search strategies provided 1335 articles, from which 336 duplicates were removed. Based on the title, 946 were excluded. After screening abstracts using inclusion/exclusion criteria, 69 studies remained for further assessment. Finally, a total of 43 articles underwent a full-text review.

Fig. 2
figure 2

Data acquisition flowchart based on PRISMA

The characteristics of included studies are summarized in Table 1. Most of the included studies addressed the principle of justice (n = 33), beneficence (n = 30), non-maleficence (n = 21), and autonomy (n = 19), respectively. In addition, most of the studies addressed the ethical considerations of the process of distribution and vaccination (n = 35), and only a small number addressed the process of vaccine production (n = 14).

Table 1 Characteristics of the included studies

Table 2 presents the ethical considerations of the vaccine production process. In our study, the production process consisted of 16 codes and 4 main categories. According to the results of studies, the first ethical imperative is the production and distribution of safe, effective, available, and affordable vaccines, which requires ensuring the use of safe and scientific methodology and technology in vaccine production. Therefore, vaccine production should be performed scientifically and in reputable institutions and comply with the principles, standards, and valid guidelines published worldwide, such as the European Union and the European Medicines Agency (EMA) [4, 8, 10]. Although the vaccine distribution approved by regulatory agencies without completing phase three is not ethically problematic, the risk and benefits of using new technologies must be carefully assessed. They can start using these technologies before finishing clinical trials in order to reduce the harmful and dangerous effects; for the reason that always may be odds of unidentified or not immediate (delayed) hazards that did not be considered in early trial studies [5, 19, 20].

Table 2 Ethical considerations in the vaccine production process

In the setting of a clinical trial, vaccine manufacturers should take into consideration inclusion and exclusion criteria such as laboratory and clinical evaluations for including healthy participants in the study. The right of access to vaccine for participants receiving a placebo in a clinical trial should be protected and assured as soon as safety and temporary efficacy are confirmed by the sponsors and health department inspectors, and this right should be clearly stated in the informed consent forms. Furthermore, in the process of inclusion of individuals in clinical trials in the study, any direct or indirect payment for participants should be removed because it may encourage poor people to be exposed to possible risks of these studies solely for economic incentives [2, 6, 10, 12, 18]. Another issue is the availability of a comprehensive treatment center to ensure that trial subjects have access to treatment and care in the case of any serious adverse events related to clinical trial outcomes [19].

Table 3 presents the ethical considerations of the vaccine distribution process and vaccination. The distribution and vaccination process consisted of 12 codes and 4 main Categories. Access to different types of vaccines poses challenges to equitable distribution and prioritization of individuals and communities worldwide. Given that low- and middle-income countries (LMICs) are incapable of producing vaccines and lack sufficient resources to provide vaccines, high-income countries (HICs), the global community, and vaccine companies should provide them with the required logistic support for the implementation of the successful vaccination program.

Table 3 Ethical considerations of the vaccine distribution process and vaccination

In vaccine distribution, two main considerations need to be taken into account: (1) the ability of vaccine development and trial and (2) purchasing power. These two principles should be considered in the justice and beneficence of vaccine distribution [12, 13, 26, 35, 40]. According to the Advisory Committee, the four principles, including maximizing benefits and minimizing harm, promoting justice, mitigating health inequalities, and promoting transparency, should be taken into account for the allocation of the COVID-19 vaccine [6, 34].

Lack of trust in the beneficence and safety of the COVID-19 vaccine stemming from distrust in scientific research, insufficient evidence and information and exposure to invalid information about the vaccine, fear of politicization, and misuse of vaccine by the pharmaceutical industry can affect the public acceptance of COVID 19 vaccine. A possible unintended effect of compulsory vaccination can reduce people’s desire to get the vaccine. Therefore, a valid information system to provide information on vaccines to the community is required for their informed decision [25, 28]. The allocation and distribution of the COVID-19 vaccine should maximize the benefits of vaccination for both individual recipients and the general population [6, 34]. Moreover, if everyone has access to the vaccine, there will be a considerable ethical justification for enforcing vaccination passports, as it creates a safer environment for work, travel, and other routine activities. It is unethical to prevent unvaccinated people upon arriving in a country. Therefore, immunity passports should allow the holder to travel freely within the country, and unvaccinated travelers should be subject to restrictions upon arrival in a country and should undergo quarantine [33, 36, 37].

Table 4 presents ethical considerations for specific groups. According to the results, out of 43 studies, 13 examined ethical considerations related to HCWs, 7 examined children and adolescents, 4 examined the elderly, and 4 examined ethnic and racial groups. Most of the included studies examined ethical considerations related to healthcare workers (Fig. 3).

Table 4 Ethical considerations for specific groups based on each of the included studies
Fig. 3
figure 3

Frequency of articles published in each group

Table 5 presents the ethical considerations of specific groups. Given that most medicines used for children have never independently undergone specific clinical trials, it would be inappropriate to provide strict standards for the approval and authorization of COVID-19 vaccines. However, parents and adult children need to be informed about the side effects of vaccines. Moreover, one of the ethical concerns of the allocation of vaccines is vaccinations for children and adolescents who are less prone to severe COVID-19 but still consume vaccine resources that can be used more efficiently for immunization of high-risk groups. This is especially important in developing and underdeveloped countries with limited resources. Considering that children volunteering for a new vaccine that is not a serious threat to them, and mandatory vaccination for them depends on detailed information about the nature of the disease and its severity and prevalence, we must consider the expected usefulness to society and the child ethically [2, 21, 30, 32].

Table 5 Ethical considerations related to specific groups

Given the close relationship between HCWs and the patient and the importance of healthcare system resilience and assuring continuity of health service provision in emergencies, there are strong and valid ethical justifications to give priority access to HCWs for COVID-19 vaccination [5, 29, 31, 41]. However, mandatory vaccination for HCWs conflicts with the principles of autonomy and beneficence because they may prefer a known disease to unknown side effects of vaccines. Further, providing false and non-transparent information contributes to their vaccine hesitancy [22]. Considerations of the principles of beneficence and non-maleficence to the patient necessitate the vaccination of HCWs, which justifies some intrusion on staff autonomy [24]. Additionally, in the condition that the vaccination rate was required for ensuring disease control and it was not achieved through voluntary vaccination, compulsory vaccination of health workers could be justified ethically [28]. Hospitals that lack sufficient resources to vaccinate entire their staff should morally prioritize their staff and take into account considerations such as the possibility of infection and transmitting contagion as well as the rate of absenteeism [29, 34]. The codes categorized in Table 5 are in accordance with the “Respect for cultural diversity and pluralism”, “Persons without the capacity to consent” and “Protecting future generations” principles in the UNESCO Universal Declaration on Bioethics and Human Rights [47].

After the synthesis of the findings, we developed the final framework of ethical considerations related to emergency vaccination (pandemics and epidemics) (Fig. 4).

Fig. 4
figure 4

Matrix of ethical considerations of the vaccine development process and vaccination


Our study aimed to integrate the results of different studies on the COVID-19 vaccine to clarify and classify the ethical considerations into two categories: (1) Vaccine development, and (2) Distribution and implementation of vaccination. The results showed that considerations related to the four principles of bioethics, including justice, non-maleficence, autonomy, and beneficence, should be considered at each stage of COVID-19 vaccine development and in the process of distribution and vaccination.

In concern of the justice principle, equitable vaccine distribution may be very difficult or even impossible due to the limited production of approved COVID-19 vaccines and the high demand of countries and nationalism. The capacity and capability of the health systems in different countries, especially LMICs, in comparison with HICs that have the ability to produce and distribute vaccines widely, poses fundamental challenges to the principle of justice. To establish equality and equitable distribution, the COVAX initiative was established to provide fair access for all countries and prioritize vulnerable groups such as the elderly and HCWs [26].

Despite the global epidemic, granting patents to manufacturers could impede the fair distribution of the vaccine worldwide and monopolize the price of the vaccine. Therefore, global and pandemic emergencies can be a factor in revising the degree of control of patent holders and allowing third parties to produce based on some emergency licenses without the need for a license from a patented manufacturer. According to the “Social responsibility and health” principle of the UNESCO Universal Declaration [47], the main purpose of governments is health promotion and social development for their people. Consequently, they need to neutralize patents’ negative effects in cases such as pandemics. To cope with the problem, COVAX, a platform to support the research, development, and manufacturing of a wide range of COVID-19 vaccine candidates and negotiate their pricing, has been established to accelerate the development, allocation, and equitable access to COVID-19 vaccines through a global collaboration between governments, intergovernmental organizations, and private sectors [48].

Moreover, vaccine developers have taken into account principles of corporate social responsibility (CSR), as a ‘win–win’ strategic management tool for accomplishing sustainable development [49] during COVID-19. A study suggested that corporate social sustainability in addition to reducing the risk of litigation and financial difficulties can protect companies from boycotts and other actions by different stakeholders [50]. CSR also has some ethical practices such as equity, justice, and social care without benefiting the company’s economic and financial situation [51] which are morally obligatory.

It has been shown that the participation of pharmaceutical companies through COVAX is significantly low [52]. This can be due to sidestepping of COVAX by rich and developed countries, as they have made bilateral agreements directly and often with multiple vaccine manufacturers, and have bought most of the doses now and for years to come [53]. A strategy that can lead to an increase in the global supply of COVID-19 vaccines worldwide is making manufacturing know-how and formulas openly and freely available by removing patent protections temporarily [53]. Based on the principles of “Sharing of benefits”, “Respect for cultural diversity and pluralism” and “Non-discrimination and non-stigmatization”, it is necessary to share benefits from any scientific research and its applications with the international community, especially with LMICs [47]. Another strategy is the waiver of intellectual property (IP) protections on Covid-19 vaccines [53]. A temporary patent waiver can save more lives of individuals, especially those living in LMICs. Undoubtedly, IP law can exacerbate both global and domestic inequalities, which in turn, is a violation of states’ human rights obligations to respect, protect and fulfill the right to health. Also, the commodification of essential medicines, such as vaccines, pushes poorer countries into extreme debt. The best way to address the inequalities and injustices is through a decolonized approach to human rights [54]. Patent right is accepted by all parties, while, establishing “prime the pump” mechanisms in market-based economies to provide incentives to the pharmaceutical industry to research vaccine development needs a more scrutinized process in developed countries. Implementing programs such as ‘Operation Warp Speed’ that aimed to provide substantial quantities of safe and effective vaccines for Americans based on government financial support requires localization studies and adjustments in developing countries [55].

Ensuring fair access and distribution of vaccines both among countries and within communities based on high-risk and at-risk groups are ethical imperatives of the distribution and vaccination process requiring special attention and planning. The challenge of access to vaccination is the most important problem in the solving of COVID-19 difficulties. All countries do not have equal access to the vaccine, and there is a hegemony in access to vaccines, as third-world countries lack the power to procure the vaccine [56]. vaccine nationalism hinders the world’s poorest countries to have access to vaccines and can be a threatening factor to vaccine distribution [47, 57]. A common hindrance is the lack of enforcement mechanisms for human rights or the lack of funding with WHO [56]. This may not be possible for all people to have access to the vaccine during a pandemic like COVID-19 when due to vaccine nationalism, rich countries purchase the majority of vaccines. Hence vaccine nationalism can prevent the vaccine from reaching vulnerable people in poor countries [57]. Enforceable frameworks for vaccine development and distribution are needed in order to encourage the international sharing of vaccines (6R) [57]. The human right of equal access to the vaccine can be achieved through the collaborative help of WHO and all governments across the world. Further, under Article 19 of the WHO Constitution, this organization should adopt a convention for access to vaccines during a pandemic [56]. Furthermore, prioritization processes must be rational, need-based, and fairly given communities’ social, geographical, and biomedical factors.

According to the principle of beneficence, it is necessary to have a comprehensive approach to the principles of beneficence and non-maleficence. In this way, public benefits overweight public harms. Therefore, the principle of beneficence deserves particular attention both in clinical trials and in vaccinations. To do so, researchers should, both at the vaccine development, and vaccination stage, take measures that the accumulative benefit of public health interventions outweighs the side effects and have a considerable role in preventing and controlling the COVID-19 outbreak. Further, according to the principle of non-maleficence, researchers should minimize the possibility of adverse effects of the COVID-19 vaccine on participants through various ways such as the use of scientific and valid methods, the use of accepted international standards, and monitoring the process of development of new technologies in vaccine development. This is implied in the “human vulnerability” article of the UNESCO Universal Declaration on Bioethics and Human Rights that Individuals and groups of special vulnerability should be protected and taken into account [47].

Our results showed that in the process of vaccine production and development for Risk assessment and management, specialized committees should address the methodology, safety, and efficacy of vaccines for evaluation, as well as access and transparency of information about vaccine production, efficacy, and side effects should be assured. Ensuring the safety and efficacy of vaccines is also a necessary precondition for mandatory vaccination, requiring access to information based on credible evidence that must be available publicly. Addressing bioethical issues such as transparency seems necessary in vaccine safety and effectiveness for appropriate sharing of knowledge and avoiding conflicts of interest, in addition, it can increase the desire of people to receive vaccines by resolving vaccine hesitancy and uncertainty. Therefore, neutral third parties must evaluate safety and effectiveness outcomes at the national and international levels.

According to the principle of autonomy, participants need to sign an informed consent during trials. The content of these forms should include various ethical considerations such as side effects and consequences of trial, how to compensate for damages, and the use of placebos in order to increase participants’ informed decision-making power. Autonomy, priority, and protection against the exploitation of individuals and contributing countries need to be factored in. furthermore, it is necessary that governments, public and private institutions as well as professionals related to transnational activities act according to international laws, standards, and ethical principles [47]. In the process of distribution and vaccination, while paying attention to the autonomy of individuals, the priority of the principle of beneficence over the principle of autonomy in vaccination should be considered due to the existence of external consequences. Moreover, in case of a pandemic threat at a national level, the principle of beneficence can affect the principle of autonomy. Reliable information about vaccines’ immunogenicity should be available to vaccinate children and adolescents. Given the role of parents in deciding about accepting the vaccine, vaccine trials should guarantee the ethical principles of autonomy and non-maleficence for both children and adolescents after their informed consent.

Because HCWs are more vulnerable and at a higher risk of being infected, they should be a top priority in accessing the COVID-19 vaccine. HCWs also have concerns about the safety and effectiveness of vaccines that should be considered. Furthermore, given that their mandatory vaccination conflicts with the ethical principles of autonomy and beneficence, there must be sufficient moral justification in this regard. The COVID-19 pandemic showed that HCWs are the most important pillar of health care systems in the face of pandemics, and maintaining their safety and health leads to leads to ensuring continuity of health care provision. Therefore, governments should formulate programs to support them in increasing the resilience of health systems and managing future pandemics.

Ethnic and racial minorities are hesitant to get the vaccine owing to institutional and structural discrimination such as religious concerns, institutionalized health inequalities, inequalities in access to information and racial injustices in the vaccine production and trial process, fears and suspicions of the exercise of power, the compulsion to be vaccinated, the legitimacy and access to vaccine-related messages and information. In order to reduce doubts and uncertainty and reduce health inequalities and fair distribution of vaccines among them, these barriers should be removed.

Given the urgent need of communities in emergencies for safe treatments and vaccines, the role of ethics committees in adhering to ethical principles and frameworks in vaccine clinical trials is highly important than ever. Given the responsibilities for protecting the rights and health of participants, continuously monitoring and evaluating trial protocols and guidelines, and ultimately monitoring the proper implementation of these principles, ethics committees should be more prepared for similar cases and provide ethical frameworks for the development, distribution, and appropriate vaccination processes of pandemics and epidemics for faster decision-making. International health organizations should also play a more active role in regional epidemics and pandemics and anticipate and prepare policymaking frameworks in cooperation with national governments and the commitment of political leaders. In similar cases and regional epidemics, the implementation of ethical considerations related to the development, distribution, and vaccination of countries should be recognized as an obligation to ensure the realization of the principle of beneficence, justice, and non-maleficence to the safety of communities. Moreover, in line with international cooperation, states should build solidarity, and encourage the free dissemination of information and access to technologies [47].

In developing and formulating these frameworks, countries’ cultural and moral differences should be taken into account. Therefore, we recommend that countries develop and formulate ethical guidelines and frameworks that are consistent with their own countries’ ethical imperatives during pandemics and emergencies. Moreover, our suggestion is that future studies formulate executive ethics guidelines based on the ethical principles presented in this study for future pandemics.

The examination of the quadruple ethical principles associated with COVID-19 vaccination shows that policymakers in this regard face numerous ethical dilemmas stemming from a conflict between these four principles. Therefore, it seems that the realization of these principles simultaneously is very difficult and impossible, and policymakers should prioritize some principles over others. Dividing ethical principles into three levels: individual, national, and international can solve some of these ethical dilemmas. At the individual level, the ethical principles of non-maleficence and autonomy are made a priority, while at the national level, the ethical principles of justice and beneficence are prioritized over the principle of autonomy. At the national level, the dominant political ideology in society is very decisive. Importantly, at this level, issues of nationalism should not affect the fair distribution of vaccines among vulnerable groups. Finally, given the international nature of the pandemic and the need for coordinated and integrated international action to control the pandemic, the principle of beneficence is a priority. Therefore, the final criterion for deciding should be based on a comparison between the public benefits and the public risks of vaccination, although this criterion conflicts with the principle of autonomy.


Due to the persistence of the COVID-19 pandemic, there are still unknown numbers of studies in progress or in print that were not available at the time of our search. However, we tried to minimize this limitation using the triangulation technique.


Given the externalities of pandemics (transmissibility of disease to others) and the collective and social benefits and harms, it is impossible to adhere to all four principles of medical ethics simultaneously and completely. This may confront individuals and policymakers with many ethical 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 benefits and minimizing the public harm. This principle can be used as a general guiding principle for deciding when ethical dilemmas arise. As a whole, it can be concluded that the principle of beneficence is the predominant principle of bioethics concerning COVID-19 vaccination and can affect other principles (e.g. justice, autonomy, and non-maleficence). In regional epidemics and similar pandemics, ethics committees and international health-related organizations need to play a more active role and consider more comprehensive, efficient, and effective ethical frameworks for responding to emergencies.

Data Availability

All data generated or analyzed during this study are included in this published article.


HCWs :

Healthcare workers

HCTs :

Human Challenge Trials


Low- and middle-income countries

HICs :

High-income countries


  1. Gupta R, Morain SR. Ethical allocation of future COVID-19 vaccines. J Med Ethics. 2021;47(3):137–41.

    Article  Google Scholar 

  2. Vashishtha VM, Kumar P. Emergency use authorisation of Covid-19 vaccines: an ethical conundrum. Indian J Med ethics. 2021;VI(1):1–3.

    PubMed  Google Scholar 

  3. Wang DWL, Moribe G, Arruda AL. Is mandatory vaccination for COVID-19 constitutional under brazilian law? Health Hum Rights. 2021;23(1):163–74.

    PubMed  PubMed Central  Google Scholar 

  4. Calina D, Hartung T, Docea AO, Spandidos DA, Egorov AM, Shtilman MI et al. COVID-19 vaccines: ethical framework concerning human challenge studies. DARU, Journal of Pharmaceutical Sciences. 2020;28(2):807 – 12.

  5. John TJ, Dharmapalan D. Covid-19 vaccine trials and ethics: Protection delayed is protection denied. Indian J Med ethics. 2021;VI(1):1–5.

    PubMed  Google Scholar 

  6. Kumar V, Aranha V, Rajgarhia R, Royal A, Mehta K. Expanded principles of ethics and its implementation during COVID-19 vaccine trials: a scoping evidence based research synthesis. Human Vaccines and Immunotherapeutics; 2021.

  7. Saeedi Tehrani S, Bahmani F, Forouzandeh M, Hashemi A. Ethical issues in COVID-19 Vaccine Rollout. J Med Ethics History Med. 2021;14(1):232–44.

    Google Scholar 

  8. Sharma P, Pardeshi G. COVID-19 vaccination in India: An ethical perspective.Diabetes and Metabolic Syndrome: Clinical Research and Reviews. 2021;15(6).

  9. Giubilini A. Vaccination ethics. Br Med Bull. 2021;137(1):4–12.

    Article  CAS  PubMed  Google Scholar 

  10. Daverio M. Ethical and regulatory issues in vaccine research in the pandemic context and in the case of human challenge studies: implications for informed consent. BioLaw J. 2021;2021(SpecialIssue 2):63–84.

    Google Scholar 

  11. Manheim D, Więcek W, Schmit V, Morrison J. Exploring risks of human challenge trials for COVID-19. Risk Anal. 2021;41(5):710–20.

    Article  PubMed  PubMed Central  Google Scholar 

  12. Greco DB. Ethical limits to placebo use and access to Covid-19 vaccines as a human right. Indian J Med ethics. 2021;VI(2):1–14.

    PubMed  Google Scholar 

  13. Bolcato M, Rodriguez D, Feola A, Di Mizio G, Bonsignore A, Ciliberti R et al. Covid-19 pandemic and equal access to vaccines.Vaccines. 2021;9(6).

  14. Emanuel EJ, Persad G, Kern A, Buchanan A, Fabre C, Halliday D, et al. An ethical framework for global vaccine allocation. Sci (New York NY). 2020;369(6509):1309–12.

    Article  CAS  Google Scholar 

  15. Westphaln KK, Regoeczi W, Masotya M, Vazquez-Westphaln B, Lounsbury K, McDavid L, et al. From Arksey and O’Malley and Beyond: Customizations to enhance a team-based, mixed approach to scoping review methodology. MethodsX. 2021;8:101375.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Dal-Ré R, Bekker LG, Gluud C, Holm S, Jha V, Poland GA, et al. Ongoing and future COVID-19 vaccine clinical trials: challenges and opportunities. Lancet Infect Dis. 2021;21(11):e342–e7.

    Article  PubMed  PubMed Central  Google Scholar 

  17. Kashte S, Gulbake A, El-Amin Iii SF, Gupta A. COVID-19 vaccines: rapid development, implications, challenges and future prospects. Hum Cell. 2021;34(3):711–33.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  18. Monrad JT. Ethical considerations for epidemic vaccine trials. J Med Ethics. 2020;46(7):465–9.

    Article  PubMed  Google Scholar 

  19. Wibawa T. COVID-19 vaccine research and development: ethical issues. Tropical Med Int Health. 2021;26(1):14–9.

    Article  CAS  Google Scholar 

  20. Brusa M, Barilan YM. Voluntary COVID-19 vaccination of children: a social responsibility. J Med Ethics. 2021;47(8):543–6.

    Article  PubMed  Google Scholar 

  21. Dembiński Ł, Vieira Martins M, Huss G, Grossman Z, Barak S, Magendie C, et al. SARS-CoV-2 Vaccination in Children and Adolescents-A Joint Statement of the European Academy of Paediatrics and the european Confederation for Primary Care Paediatricians. Front Pead. 2021;9:721257.

    Article  Google Scholar 

  22. Hamidian Jahromi A, Stoehr JR, Thomason C. COVID-19 vaccination: ethical issues regarding mandatory vaccination for healthcare providers. Pathogens and global health. 2021;115(5):277–8.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Hughes K, Gogineni V, Lewis C, Deshpande A. Considerations for fair prioritization of COVID-19 vaccine and its mandate among healthcare personnel. Curr Med Res Opin. 2021;37(6):907–9.

    Article  CAS  PubMed  Google Scholar 

  24. Kates OS, Stock PG. Ethical review of COVID-19 vaccination requirements for transplant center staff and patients. 2021.

  25. Carson SL, Casillas A, Castellon-Lopez Y, Mansfield LN, Morris D, Barron J et al. COVID-19 Vaccine Decision-making Factors in Racial and Ethnic Minority Communities in Los Angeles, California.JAMA network open. 2021;4(9).

  26. Adejumo OA. Recalling the universal health coverage vision and equity in the covid-19 vaccine distribution plan.Pan African Medical Journal. 2021;39.

  27. Binagwaho A, Mathewos K, Davis S. Time for the ethical management of COVID-19 vaccines. The Lancet Global Health. 2021;9(8):e1169–e71.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  28. Martin-Fumadó C, Aragonès L, Esquerda Areste M, Arimany-Manso J. Medico-legal, ethical and deontological considerations of vaccination against COVID-19 in healthcare professionals. Med Clin. 2021;157(2):79–84.

    Article  Google Scholar 

  29. Reis-Dennis S, Applewhite MK. Ethical considerations in Vaccine Allocation. Immunol Investig. 2021;50(7):857–67.

    Article  CAS  Google Scholar 

  30. Savulescu J, Giubilini A, Danchin M. Global ethical considerations regarding mandatory vaccination in children. J Pediatr. 2021;231:10–6.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  31. Thorsteinsdottir B, Madsen BE. Prioritizing health care workers and first responders for access to the COVID19 vaccine is not unethical, but both fair and effective – an ethical analysis.Scandinavian journal of trauma, resuscitation and emergency medicine. 2021;29(1).

  32. Williamson L. The ethical impact of mandating childhood vaccination: the importance of the clinical encounter. Clin Ethics. 2021;16(4):271–7.

    Article  Google Scholar 

  33. Brown RCH, Kelly D, Wilkinson D, Savulescu J. The scientific and ethical feasibility of immunity passports. Lancet Infect Dis. 2021;21(3):e58–e63.

    Article  CAS  PubMed  Google Scholar 

  34. McClung N, Chamberland M, Kinlaw K, Matthew DB, Wallace M, Bell BP, et al. The Advisory Committee on Immunization Practices’ ethical principles for allocating initial supplies of COVID-19 Vaccine—United States, 2020. Am J Transplant. 2021;21(1):420–5.

    Article  CAS  PubMed  Google Scholar 

  35. Mirocha L. The possibility of introducing conscientious exemption from mandatory vaccination in Poland: a critical perspective. Eur J Health Law. 2021;28(4):359–76.

    Article  Google Scholar 

  36. Sharun K, Tiwari R, Dhama K, Rabaan AA, Alhumaid S. COVID-19 vaccination passport: prospects, scientific feasibility, and ethical concerns.Human vaccines & immunotherapeutics. 2021:1–4.

  37. Voo TC, Reis AA, Thomé B, Ho CW, Tam CC, Kelly-Cirino C, et al. Immunity certification for COVID-19: ethical considerations. Bull World Health Organ. 2021;99(2):155–61.

    Article  PubMed  Google Scholar 

  38. Woodhead C, Onwumere J, Rhead R. Race, ethnicity and COVID-19 vaccination: a qualitative study of UK healthcare staff. 2021:1–20.

  39. Zhu XG, Gitzendanner MA, Soltis DE, Soltis PS, Gayle HD, Childress JF. Race, racism, and structural injustice: Equitable Allocation and distribution of vaccines for the COVID-19. Plant Biotechnol J. 2021;21(3):4–7.

    Google Scholar 

  40. Liu Y, Salwi S, Drolet BC. Multivalue ethical framework for fair global allocation of a COVID-19 vaccine. J Med Ethics. 2020;46(8):499–501.

    Article  PubMed  Google Scholar 

  41. McMahon A. Global equitable access to vaccines, medicines and diagnostics for COVID-19: the role of patents as private governance. J Med Ethics. 2021;47(3):142–8.

    Article  Google Scholar 

  42. Rhodes R. Justice in COVID-19 vaccine prioritisation: rethinking the approach. J Med Ethics. 2021;47(9):623–31.

    Article  PubMed  Google Scholar 

  43. Hughes JA, Hannah W, Kikkert P, MacKenzie B, Ashlock W, Houghten S, et al. editors. We Are Not Pontius Pilate: Acknowledging Ethics and Policy. 2020 IEEE Symposium Series on Computational Intelligence, SSCI 2020; 2020.

  44. world Health Organization (WHO). COVID-19 and mandatory vaccination: ethical considerations and caveats. World Health Organization; 2021.

  45. World Health Organization (WHO). Ethical Framework for WHO’s work in the ACT-Accelerator. World Health Organization; 2021.

  46. World Health Organization (WHO). Emergency Use Designation of COVID-19 candidate vaccines: ethical considerations for current and future COVID-19 placebo-controlled vaccine trials and trial unblinding. World Health Organization; 2020.

  47. UNESCO. The UNESCO Universal Declaration on Bioethics and Human Rights: UNESCO. ; 2005 [Available from:

  48. World Health Organization (WHO). COVAX Facility Explainer: World Health Organization. 2020 [Available from:

  49. Mahmud A, Ding D, Kiani A, Hasan MM. Corporate social responsibility programs and community perceptions of societal progress in Bangladesh: a multimethod approach. Sage Open. 2020;10(2):2158244020924046.

    Article  Google Scholar 

  50. Lins KV, Servaes H, Tamayo A. Social capital, trust, and firm performance: the value of corporate social responsibility during the financial crisis. J Finance. 2017;72(4):1785–824.

    Article  Google Scholar 

  51. De George RT. Moral responsibility and the corporation. Philosophic Exch. 1981;3(2):41–53.

    Google Scholar 

  52. Sung M, Huang Y, Duan Y, Liu F, Jin Y, Zheng Z. Pharmaceutical Industry’s Engagement in the Global Equitable Distribution of COVID-19 Vaccines: Corporate Social Responsibility of EUL Vaccine Developers. Vaccines. 2021;9(10).

  53. Zielinska AC, Venkatapuram S. Covid Vaccine Patent Waivers are for Health Sovereignty. 2021.

  54. Sekalala S, Forman L, Hodgson T, Mulumba M, Namyalo-Ganafa H, Meier BM. Decolonising human rights: how intellectual property laws result in unequal access to the COVID-19 vaccine. BMJ global health. 2021;6(7).

  55. Kim JH, Hotez P, Batista C, Ergonul O, Figueroa JP, Gilbert S, et al. Operation Warp Speed: implications for global vaccine security. The Lancet Global Health. 2021;9(7):e1017–e21.

    Article  Google Scholar 

  56. Alexander A, Daga M. Equitable Access to COVID-19 Vaccine: Voices from International Human Rights Law. SSRN Electronic Journal. 2022.

  57. Murhula PBB, Singh SB. The impact of COVID-19 Vaccine Nationalism on Global Health and Human Rights to Health Standards. Orient Anthropol. 2022;22(1):93–101.

    Article  Google Scholar 

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HJ and FF-K were involved in the research design. HJ, FF-K, and EJ were involved in the analysis and interpretation of data. MA and EJ were involved in the screening of the retrieved articles. MA, EJ, and KHJ were involved in data extraction. MA and KHJ were involved in drafting the manuscript. HJ and FF-K were involved in developing the search strategy. HJ and FF-K were involved in manuscript writing, reviewing, and revising it critically. All authors have read and approved the manuscript.

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Correspondence to Farzad Faraji-Khiavi.

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Jalilian, H., Amraei, M., Javanshir, E. et al. Ethical considerations of the vaccine development process and vaccination: a scoping review. BMC Health Serv Res 23, 255 (2023).

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  • Bioethics
  • Beneficence
  • Non-maleficence
  • Autonomy
  • Medical ethics
  • COVID-19
  • Vaccination
  • Justice