Table 2 Ethical considerations in the vaccine production process

Justice

1- assuring fair access to affordable vaccines for all countries [46].

• Producing affordable vaccines

• Considering countries with limited financial capacity

• Providing affordable vaccines in the countries participating in the trials

2- Formulating ethical frameworks to ensure fair and non-exploitative trials in countries with limited resources [18, 46].

• Conducting fair and non-exploitative trials in countries with poor financial resources

3- Adherence to ethical considerations equally in all countries [12].

• Avoiding double standards for ethics in different countries

• Avoiding taking advantage of the legal weaknesses of research ethics in less developed countries

4- Priority of access for participants in the vaccine trials after approving emergency vaccine use [12, 45].

• Priority of access for participants in the vaccine trial

• Clarifying the benefits of the vaccine to participants in trials and making them aware of these benefits.

5- Comply with the ethical imperatives for issuing patents to manufacturers and issuing mandatory licenses in emergencies [40].

• Limiting the negative impact of patents on the availability and price of Covid-19 vaccines

• Revising how patent holders are monitored and controlled

• Issuing licenses for a national emergencies (according to ethical imperatives) for the production of vaccines by a third party without the need for licenses of patent owners for fair global access

Beneficence

1- Considering the race and demographic characteristics in study designs [16].

• Conducting clinical trials of vaccines at various locations as well as diverse populations at national and global levels

2- Obligating manufacturers to assure vaccines’ safety, efficacy, and quality [18].

• Considering safety, efficacy, and quality principles for vaccines by manufacturers

3- Social responsibility and health [19].

• Considering the accountability principle for vaccine manufacturers in countries with poor financial resources

4- Evaluation of the effectiveness, safety, and risk-benefit of new technologies in vaccine production [18].

• Risk-benefit assessment of new technologies in the production of vaccines

• Lack of evidence-based information on the long-term effects of new technologies

Non-maleficence

1- Evaluation of study methodology and results by a specialized committee [4].

• Evaluation of methods and results by an independent committee

2- Formulation of ethical imperatives for using a placebo [12].

• Considering the challenges of using placebos

• The right of access to vaccine for the control group after approval

• Not depriving participants of the vaccine and appropriate treatment

3- Transparency in all stages of vaccine development [10, 16, 19, 24, 44].

• Full transparency in vaccine development and production

• Dissemination of information by manufacturing companies

• Transparency of decision-making processes, including the coordination, development, and production of vaccines

• Transparency of information on the scientific method of development, risks, and benefits of vaccines

4- Respect for human vulnerability and personal integrity [5, 17].

• Protecting vulnerable populations against exploitation

Autonomy

1- Consent [6, 10, 16].

• Formulating and designing the informed consent form

• Receiving informed consent from participants

• Issues related to receiving compensation in the case of any occurrence of complications/side effects from the trials

• Awareness of participants about the risks and benefits of trial

• Considering issues related to study design in the informed consent form

• Considering issues related to the use of placebos in the formulation of the informed consent form

2- Assuring privacy and confidentiality [10, 32].

• Protecting the privacy of individuals during trials

• Protecting the personal information of the participants in trials

• Considerations related to access to participants’ medical history

3- Assuring autonomy and individual responsibility [10, 31].

• Having the right to participate in trials voluntarily Having the right to withdraw from the trial at any stage