Addressing conflicts of interest regarding the vaccine in infectious disease outbreaks based on good governance for health approach: a policy brief

Outbreaks significantly threaten public health and health policy-making [1]. The COVID-19 pandemic, one of the most critical crises in the last 50 years, has claimed millions of lives; As of July 5, 2023, the World Health Organization (WHO) COVID-19 dashboard reports a total of 6,948,764 deaths [2]. Vaccination and achieving herd immunity are crucial in combating infectious disease outbreaks [3, 4]. Within the medical field, discussions on vaccination have consistently been contentious, with various groups accusing one another of conflicts of interest (COI) [5, 6]. It is worth acknowledging that the necessity of achieving herd immunity, coupled with the substantial financial contracts involved in vaccine production, can create an environment susceptible to the influence of COI on vaccine development, guidelines, and policy-making [7]. Building Public trust serves as a fundamental pillar for successful vaccination campaigns. However, the low utilisation of vaccines such as measles, tetanus, and COVID-19 in various countries [8‐13]. indicates a decline in public trust towards scientific research and the guidelines provided by health organisations, which raises serious concerns [14, 15]. A significant factor contributing to this decreased public trust is the presence of COI within the vaccines field, leading to corruption in vaccine production and development and related policies [7, 16‐23]. As a result, one of the primary arguments by anti-vaccine groups revolves around the perceived COI of experts, researchers, and policymakers due to their financial connections with the industry [7]. Other factors contribute to the concern surrounding the potential detrimental effects of industry relationships on public health decisions. For instance, in the swine flu pandemic in 2009, there were debates about the adequacy of evidence supporting the declaration of a pandemic by the WHO and their prediction of infection in nearly two billion individuals [24]. Notably, vaccine production companies, as the primary stakeholders, reaped substantial benefits from the situation [25].

COI arise when public officials face a conflict between their public duties and private interests, where their private-capacity interests can potentially exert undue influence on fulfilling their official responsibilities [26]. Corruption, as defined by the World Bank, is the misuse of public office for personal and private interests [27]. Therefore, while COI can potentially lead to corruption, it is essential to acknowledge that corruption consistently stems from COI [28].

Research has demonstrated that existing policies about identifying and mitigating COI in developing and evaluating vaccines [28‐30] and policies addressing the COI of decision-making bodies are insufficient and require bolstering [24, 31‐38].

In Iran, notable policy measures specifically targeting COI regarding the vaccine during the COVID-19 pandemic were not formulated by the National Headquarters for COVID-19 and the Ministry of Health and Medical Education. Specific individuals who held positions within these organisations were also involved in vaccine development teams, including the “Barakat vaccine”, which sparked considerable discussions surrounding COI [39].

It is crucial to prioritise public health over industry interests, address COI in vaccine research and evaluation, and develop vaccine instructions and policies. These efforts prevent corruption, foster public trust, and enhance public health outcomes. Therefore, based on a scoping review, this policy brief aims to provide policy options for effectively addressing COI regarding the vaccine in infectious disease outbreaks. It takes the good governance for health approach, incorporating principles such as “Consensus Building’, “Participation”, “Transparency”, “Equality”, “The Rule of Law”, “Effectiveness and Efficacy”, “Responsibility”, and “Accountability” [40].

This study utilises the scoping review method, which is suitable for addressing “what” and “why” questions. As described in the definitions provided for scoping review, this approach is specifically designed to swiftly examine critical and fundamental concepts within a particular research field while identifying key sources and evidence. In this study, we employed the protocol¹ developed by O'Malley and Arksey to carry out the scoping review [41].

The research team searched international (Web of Science, Scopus, PubMed, and EMBASE) and national databases (MagIran and SID) to identify relevant studies from the inception of these databases until August 2022. We also mined Google Scholar to increase the chance of finding potentially relevant studies on the topic under scrutiny. Additionally, we searched Grey literature and thesis. The search was conducted in English and Persian languages. The reference list of the selected articles was hand-searched to increase the chance of not missing potential articles. We provide the search strategy for each database in (Appendix 1). Epidemic, pandemic, vaccine, conflicts of interest, outbreak, fraud, and corruption keywords were used to search the international databases. Additionally, the Persian counterparts of these keywords were employed to search national databases. All stages of the search process were conducted independently by two researchers.

Inclusion criteria for this study encompassed research articles written in English and/or Persian that provided examples or solutions addressing COI regarding the vaccine in the context of infectious disease outbreaks. Conversely, studies that lacked relevance to the research topic or offered incomplete information were excluded based on the exclusion criteria.

The articles underwent screening based on the PRISMA framework [42]. Initially, duplicate articles were eliminated. Subsequently, two independent researchers screened the titles and abstracts of all articles based on the predefined inclusion and exclusion criteria. In line with the anticipated objectives of this article, any studies considered irrelevant were excluded from further analysis. In the following stage, articles that were considered relevant based on their title and abstract, as well as those for which the determination of relevance solely based on title and abstract was not feasible, were selected for full-text retrieval. Subsequently, two individuals reviewed these articles, and those that closely corresponded with the objectives of our study were included for further analysis. In instances of disagreement, consensus was achieved through discussions, and if needed, a third reviewer was consulted to facilitate resolution. Initially, the search strategy yielded a total of 1,635 articles, of which 80 were duplicates.

Consequently, the title and abstract of 1,555 articles and the full text of 223 articles were assessed, resulting in the inclusion of 43 eligible articles (Appendix 2). Then, we subjected the included articles to quality appraisal, using a specific assessment checklist for each category: “The JBI Critical Appraisal Checklist for Text and Opinion Papers” for evaluating theoretical-analytical, commentary, editorial, and news articles [43] “qualitative CASP checklist” for evaluating qualitative studies [44]; and, the “CASP checklist for review” for evaluating review articles [45]. Due to the limited literature on the topic, excellent and average-quality articles were included. Following the extraction of primary data, eligible articles were assessed to address the following inquiries:

Data analysis was conducted using a qualitative approach (i.e., content analysis) utilising ATLAS.ti9 software. Themes and sub-themes were extracted from the data and underwent a review, refinement, and classification process. Through this process, bottlenecks and inferred policy options were identified. In three sessions with the research team, we followed these steps: Similar bottlenecks of COI and inferred policy options were grouped. Next, based on the identified origins of COI regarding the vaccine in infectious disease outbreaks, nine policy options were categorised into three distinct categories.

Based on the scoping review conducted by the research team, the prominent cases of COI regarding the vaccines in infectious disease outbreaks were found to be originated from “relationships with the industry”. This category can be further divided into two subcategories:

After reviewing articles and available evidence, ten bottlenecks of COI regarding the vaccine in infectious disease outbreaks were identified. These bottlenecks were categorised into two groups based on their origin, as outlined in (Table 1). Inferred Policy options derived from the literature review to address these bottlenecks are presented in (Table 2).

Based on the research team sessions, the policy options for addressing COI regarding the vaccine in infectious disease outbreaks, as categorised by origin and approach to strengthening good governance for health, are as follows:

This policy brief, based on a scoping review study, highlights the bottlenecks and COI cases regarding vaccines in infectious disease outbreaks that demand the attention of policymakers and health sector managers. As previously mentioned, ten bottlenecks rooted in the “relationships with the industry” were identified and categorised as “relationships between the industry and government/ policymakers” and “relationships between the industry and academic institutions/ researchers”.

COI stemming from the “relationships between industry and academic institutions/researchers” can result in vested interest, leading to inadequate attention to the public interest and biased technical recommendations. These COIs can further influence research and guidelines, leading to ineffective outbreak management and resource wastage, ultimately risking lives. Similarly, COI arising from the “relationships between the industry and government/ policymakers” regarding budget allocations for vaccine import or domestic production, licensing, and post-market services can lead to inappropriate budget allocation, resource wastage, incorrect licensing decisions, delayed vaccination, and insufficient monitoring of vaccine safety, efficacy, and supply chain quality.

The consequences of COI, regardless of its origin, include a trust crisis and weakened health governance foundations. This weakness, in turn, contributes to vaccine hesitancy, hindering immunisation efforts and impeding the control of infectious diseases. The COVID-19 pandemic has demonstrated the compromise of public trust in scientists, governments, the healthcare system, and other related organisations, posing a significant challenge to accepting public health measures and vaccination [73]. Trust in public health interventions, including vaccines, relies on various factors and is closely linked to the institutions’ credibility in their development, approval, and administration [74‐76].

In part, the challenge of addressing vaccine hesitancy can be attributed to the limited measures taken to align the interests of professionals, vaccine manufacturers, governments, and the public interest [77]. Vaccine manufacturers have not taken explicit and practical actions to build trust within societies. As a result, it is crucial to collectively work towards reevaluating the norms governing vaccine discovery, research evaluation, and vaccination decision-making; upholding the integrity and accuracy of vaccine research and policy-making demands significant effort and a transformative shift in communicating with the industry.

In our scoping review, we have identified several documents encompassing international experiences that are either fully or partially relevant to addressing COI regarding the vaccine in infectious disease outbreaks. These experiences have been remarkable and worthy of highlighting. Two of these experiences are related to The Innovative Medicines Initiative’s Accelerated Development of VAccine benefit-risk Collaboration in Europe (ADVANCE) consortium. The first experience is the “Guidance for the governance of public–private collaborations in vaccine post-marketing settings in Europe”. This guidance was developed after the 2009 influenza pandemic based on the need for appropriate infrastructures to strengthen public–private collaborations (PPCs), improve stakeholder interactions, and enhance the collection and analysis of safety and effectiveness data [55]. The ADVANCE consortium also released a “Code of Conduct for collaborative vaccine studies”. The development of this code of conduct was guided by three core values: best science, strengthening public health, and transparency. It involved a thorough review of existing guidance and relevant published articles. The ADVANCE Code of Conduct includes ten topics, including COI [30]. Another significant document is a supplementary document about the vaccine, which contains detailed descriptions of the experiences and processes of 15 well-established National Immunization Technical Advisory Committees from all world regions. These committees are crucial in providing national governments with information for evidence-based decisions regarding vaccine and immunisation policy [33]. These documents highlight the importance of addressing COI regarding the vaccine, establishing effective governance, promoting transparency, and making evidence-based decisions in vaccine-related collaborations and policy development during infectious disease outbreaks.

In Iran, there is a growing focus on COI within the health system, as evidenced by official documents and papers addressing COI (for example Islamic Parliament Research Center (IPRC) report on COI in the health sector) [78]. However, there is a lack of official documentation and academic papers dedicated explicitly to COI regarding the vaccine in infectious disease outbreaks. Our research primarily yielded news articles and expert critiques on this topic. During the COVID-19 pandemic in Iran, cases of COI emerged in various areas, including allocating funds to domestic vaccine producers, vaccine importation, and vaccine-related research. These COIs raised concerns about potential biases, fairness, and transparency in decision-making processes. However, despite these COIs, Iran has not implemented a comprehensive policy strategy to address them effectively. This lack of a robust policy approach to managing COIs may have impeded efforts to ensure fair and unbiased decision-making throughout the pandemic response [54, 62, 79].

Iranian Policymakers need to acknowledge the importance of managing COI regarding the vaccine in infectious disease outbreaks and prioritise developing and implementing appropriate policies and strategies.

Finally, it is essential to acknowledge the limitations of this study. Firstly, a scoping review methodology in this policy brief may narrow the available data coverage, limiting the overall understanding breadth. Additionally, it should be noted that while the optional consultation with stakeholders and experts for additional insights is recommended in the O'Malley and Arksey protocol, we have chosen not to pursue this step in our project. Consequently, there is a possibility of failing to fully capture the diverse perspectives of stakeholders involved in the decision-making process.

Lastly, including articles with average quality due to the limited availability of literature on the topic can introduce uncertainty or inconsistency in the findings and recommendations presented in the policy brief.

Regarding the necessity of establishing relationships with the industry, it is crucial to take appropriate measures to address COI while fully recognising the COI that may arise from such relationships. In this regard, following sessions conducted by the research team and expert consultations and with consideration given to the principles underpinning good governance for health, the proposed policy options in this policy brief are summarised and prioritised as follows: