Introduction
In 2019, Wuhan province, China, was the first place where the novel human coronavirus (COVID-19), also known as Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) emerged. Reference Baniasad, Mofrad, Bahmanabadi and Jamshidi1 From the beginning of the pandemic until October 27, 2021, almost 291 million people were infected with COVID-19, and more than 4.5 million of the infected people passed away. 2 During the initial period of the disease, attempts were made to prevent and retard its transmission. Reference Kumar, Pandi-Perumal, Trakht and Thyagarajan3 Despite taking preventative public health measures, including physical distancing, mask usage, and improved sanitation procedures to ease the strain on the health system and diminish community transmission, COVID-19 is still 1 of the most critical health challenges around the globe. Reference Shah, Marks and Hahn4 The commencement of the pandemic in China presented a major threat to other countries, including Iran. On February 19, 2 cases of death resulting from COVID-19 were confirmed in Iran. Despite an early identification of the disease, measures aimed at preventing the pandemic from spreading have been inadequate. Reference Raoofi, Takian, Sari, Olyaeemanesh, Haghighi and Aarabi5 On October 27, 2021, statistics for patients with COVID-19 showed that Iran was ranked 8th in the world. The total number of COVID-19 patients in Iran reached 588 million, with more than 126000 deaths. 6 To respond to the pandemic, the national committee for COVID-19 management was established. The main measures include preventing mass gatherings, closing educational institutions, national screening programs, and physical distancing coupled with national coordination by volunteers, civilians, and armed forces. Reference Salimi, Gomar and Heshmati7 It is now known that the long-term solution to the effective fight against the COVID-19 pandemic is worldwide vaccination. Reference DeRoo, Pudalov and Fu8 Immunization through vaccines has prohibited premature disease, perpetual disability, and suffering in all regions in the world more than any other medical intervention. Without vaccination, many of the health, economic, and social gains of the past 200 years would not have been possible. Reference Medaglini, De Azero, Leroy, Bietrix and Denoel9 The launch of vaccination programs across the world has revealed that the COVID-19 vaccines have been effective in preventing symptomatic and asymptomatic SARS-CoV-2 infections and COVID-19-related hospitalizations, severe COVID-19 infections, and death across all ages. Reference Jain, Iyengar and Ish10
An auspicious solution to this public health calamity has been provided by recent announcements about developing multiple, safe, and effective vaccines for COVID-19. However, production, distribution, and convincing people to accept a COVID-19 vaccine are key challenges. Reference Hyland, Vallières and Shevlin11 In addition to these obstacles, the COVID-19 vaccine in Iran has been faced with several other major challenges, including economic and political sanctions. Reference Heidari and Jafari12
Some countries have already deployed mass vaccination campaigns, which can take place in sizeable off-site vaccination centers set up in car parks, stadiums, commercial centers, and so on. Reference Kumar, Pandi-Perumal and Trakht13 Nevertheless, the mere accessibility of a vaccine is not sufficient to assure broad immunological protection. Reference DeRoo, Pudalov and Fu8 Research has indicated that diminishing friction (e.g., having trouble signing up for programs) and hassle factors (e.g., troublesome service locations, waiting times, and paperwork) enhances the acceptance of services. Reference Kumar, Pandi-Perumal and Trakht13
Some studies related to COVID-19 vaccination have been conducted. Maserat et al., in a research study, developed a multi-dimensional framework to show current interventions and areas in which technology could be used for bettering vaccine communication in Iran. Reference Maserat, Keikha, Davoodi and Mohammadzadeh14 DeRoo, in a study entitled ‘Planning for a COVID-19 Vaccination Program,’ has pointed to the need to provide and distribute vaccines quickly and fairly, tackle the potential impediments to vaccine acceptance, and develop a strong educational campaign related to the COVID-19 vaccine by social media. Reference DeRoo, Pudalov and Fu8 Kumar et al. reviewed strategies for COVID-19 vaccination and examined the various aspects of the vaccination program in India as well as the vaccines in use. Reference Kumar, Pandi-Perumal, Trakht and Thyagarajan3
Content-wise, a roadmap generally refers to the systematic representation of pathways according to a specific interest. Reference Kleine and Braun15,Reference Phaal16 Its major purpose is the identification, bundling and assessment of expert opinion to predict specific future developments. Road-mapping is a method to structure and visualize possible or expected development paths to reach a specific goal in the future. Reference Kleine and Braun15–Reference Lurie, Saville, Hatchett and Halton17
Due to the multidimensional and complex nature of the vaccination process, the need for a roadmap to support the vaccination program seems essential. Therefore, this study aimed to present a comprehensive and practical roadmap to promote the vaccination program in Iran.
Method
Review of literature and documents
Searching and reviewing the available pieces of evidence, including the literature, documents, and reports/guidelines developed by relevant organizations, we determined the characteristics of the core information to be included in the COVID-19 vaccination.
Scientific databases and gray literature from January 2020 to August 2021 were utilized to conduct a comprehensive literature search (see Table 1). The bibliographies of all the articles germane to our study were also reviewed to find further studies.
Databases and Key words
Interview with experts for consultation
We interviewed the main members of the national committee for COVID-19 management and some experts in this field. Participants were experts from various disciplines, namely hospitalists, health administrators, and health managers, as well as disaster managers, internal medical specialists, pulmonary diseases specialists, and infectious diseases specialists. Researchers, emergency medicine specialists, academics, and virologists who had had direct experience in COVID-19 management and vaccination, were also involved. We undertook individual semi-structured interviews with some experts. Some of them were members of the National Committee for COVID-19 management. By reason of the limitations during the COVID-19 pandemic, face-to-face interviews were impossible in some cases, and we employed telephone and video connections via Skype to conduct interviews, which were audio-recorded and transcribed in full. The discussed topics chiefly focused on the effective management of mass vaccination for COVID-19 and the strengths and weaknesses of the health system. The participants received the interview guide in advance, and the questions covered gaps and challenges of mass vaccination, practical recommendations, and available capacities, as well as threats and opportunities, the main strategies, and actions required.
We used a thematic method for data analysis, and the collected data were coded by 2 researchers independently. In the first example, coding was made based on immersion in the data (listening to complete interview recordings and working with transcripts). Subsequently, themes and sub-themes emerging from data analysis were given to expert panel participants. Their validation assisted us in establishing the credibility of our themes. Furthermore, online panel discussions brought about additional data, indicating useful lines for further detailed analysis.
The expert panel for roadmap development
We used a 3-step modified consensus meeting involving a multidisciplinary expert panel of relevant stakeholder groups to develop the roadmap of mass vaccination for COVID-19. The findings of the literature review and interviews were additionally accompanied by expert comments and practical advice. Initially, the experts reviewed present toolkits and evidence-based recommendations about the best mass vaccination for COVID-19 practices.
We conducted 3 expert panels. Panel 1 involved PhD students and faculty members of health in disaster and emergencies department and healthcare management. Panel 2 involved the managers and experts of the Vice Chancellor for Health, University of Medical Sciences, and Panel 3 involved the members of the Academy of Medical Sciences. Panel members were selected based on their nationally recognized expertise in the health sector and mass vaccination. All the experts were known nationally for their research in the health sector and clinical expertise in COVID-19 vaccination, or they were in leadership positions in national or regional organizations (Figure 1).
Roadmap development process.
In the meetings through video connections, the members of the panel were allocated to 5 groups, and they were instructed to examine summarized toolkits and literature using context-specific aspects (outcomes; planning and preparation; strategies; preparation and implementation; and monitoring and evaluation). After each meeting, the groups were requested to generate a list of evidence-based items necessary for COVID-19 vaccination, considering the assigned aspect of each group. There was a consensus among the subgroups on items peculiar to the context. The first draft of the roadmap was prepared based on the input from all the subgroups. The draft roadmap was then submitted to the panel members to get their input. In the following meeting, an opportunity for offering individual comments and feedback on the initial draft roadmap was created. After completing 3 cycles of checklist revisions, the exchange of comments and feedback through email and mobile applications was done. A final meeting led to the agreement among experts on every element of the mass vaccination for the COVID-19 roadmap. In this meeting, the approval of the roadmap was achieved.
The meeting was conducted by an independent facilitator. Expert panel members were requested to explore any further topic they deemed to be important. If the panel members could not join the meeting, an individual interview with them was administered by the researchers to discuss their comments and bring them into discussion in the group meetings. Afterward, the researchers’ reports of the meeting were emailed to all panel members to comment upon them. In the next consensus meeting, ambiguous issues and comments of panel members were also discussed until a consensus was achieved.
In total, 3 panel discussions took place, during which the experts’ comments were discussed. The discussions sometimes conceded extra comments of attention due to the interaction between the expert panel members of various professions. However, a unanimous consensus was developed for all items in the consensus meetings.
Results
The content provided in this roadmap is based on a systematic search in scientific databases to extract documents and articles published as well as reviews of guides, instructions, documents, and protocols, a well as processes, lessons learned, and experiences developed by the WHO and other international organizations. Also, opinions, comments, and experiences of important and prominent persons were received and applied by the interview and expert panel.
Based on the literature review, interview, and 3 stages of the expert panel, the final roadmap was developed with 5 dimensions including outcomes, planning and preparation, strategies, preparation and implementation, and monitoring and evaluation (Table 2).
Dimensions of roadmap
The strategies were categorized into 11 sections: (1) organization and coordination of the inner and outer sectors, (2) training, (3) risk communication and public information, (4) finance and logistics, (5) facilitation of the efficiency of the supply chain and distribution, (6) human resource management, (7) management of vulnerable groups, (8) documentation, reporting and management of knowledge and research, (9) information systems, (10) monitoring and evaluation, as well as (11) reporting adverse effects, security, and safety (Figure 2).
Roadmap development process.
Implementing the roadmap
Some strategies and measure of the roadmap were implemented completely while some of them were partially used or running continuously. Main strategies such as security, safety, vulnerable groups, and human resource management, as well as risk information and communication, training, inner sector and outer sector organization and coordination, and the facilitation of the efficiency of the supply chain (distribution, financial, and logistic information systems) belong to all stages of the vaccination process as well as to all areas.
Implementing some measures including vaccine side effect evaluation, monitoring of vaccination performance and process, studying and evaluating vaccine effectiveness, and changing the structure of the vaccine following possible vaccine mutations have significant role in effective management of the vaccination process.
Using strategies and measures such as strengthening stakeholder cooperation, attracting public participation, pursuance of improvement in foreign vaccine import, and strengthening inter-sector and cross-sector cooperation and coordination, as well as establishing the incident command system in all universities and health centers for proper vaccination management, supporting the production and development of domestically produced vaccines and production lines with other countries, formation of scientific and executive working groups, and developing required guidelines for general training, vaccine advertisement, staff specific training, side effects treatment, pre- and post-injection cares rate of vaccination in all countries was raised significantly.
Discussion
This study aimed at developing a roadmap for mass vaccination of COVID-19 to effectively manage the mass vaccination of the COVID-19 process in Iran.
We represented the findings with an emphasis on increasing the capacity of units involved in the vaccination process to provide consumable and non-consumable supplies for vaccination and personal protective equipment and make timely provision of required supplies approved in the roadmap for COVID-19 Vaccination. This roadmap describes such aspects to be considered in a vaccination program as planning and setting up a vaccination center including logistics and vaccine distribution, legal consideration, and documentation. 18
In a study, Zozani et al. concluded that negative actions to face COVID-19 disease include the delays and cancelations of international flights and ignoring the importance of the disease, confirming that the organization and coordination of the inner and outer sectors are not done properly. Without a doubt, coordination between policymakers at the national, regional, and local levels is the main principle in planning, which can affect performance. Reference Arab-Zozani, Ghoddoosi-Nejad and Preparedness19
Research on India’s resurgence of COVID-19 suggests that using appropriate technologies for the management of resources, evidence-based information in management, active collaboration with NGOs, and governmental organizations help to promote vaccinations. Findings also showed that health workers need data on hospitalization, mortality rate, and coverage rate of people’s vaccination to measure the effectiveness of treatment protocols. It means that the strategies applicable to information systems, reporting adverse effects, and research management can be essential. Reference Aiyar, Chandru and Chatterjee20
Training for medical personnel has been 1 of the results of this study. The results of other studies indicate that the implementation of cold chain management and vaccination is not easy, and it is necessary for health and medical forces to be trained on how to maintain and transport the vaccines and manage their side effects according to the instructions and standards. Moreover, these types of training have been done through virtual programs. The results of these studies are consistent with the present study. Reference Kumar, Pandi-Perumal and Trakht13,Reference Park, Kim, Helble and Roth21
Based on the present findings, the vulnerable groups were 1 of the most effective people, and vaccination for this group should be given priority. In a study conducted in 2021, with the aim of prioritizing the COVID-19 vaccine for vulnerable groups, Rachel Strodel et al. showed that prison and prison workers (49%), law enforcement officers (63%), the elderly (65+ years, 59%), and residents of long-term care centers (100%), are a priority in COVID-19 vaccine allocation programs. Reference Strodel, Dayton and Garrison-Desany22 Also, another study by Alberto Giubilini et al. aimed at vaccination against COVID-19 to protect the elderly or young people, made it clear that the elderly and high-risk groups are more vulnerable to the virus. Nevertheless, this is not necessarily the case. Shielding the most vulnerable groups may necessitate vaccination prioritization, by which the benefits of indirect immunity for the elderly and other vulnerable groups can be maximized. This strategy, as the best from a public health perspective, hinges on the features of the vaccine and the virus, which are presently enigmatic. Reference Giubilini, Savulescu and Wilkinson23 Furthermore, Govind Persad et al. found that the priority of vaccination is first with health care providers, followed by people over 75 years of age, people from 65-74 years of age, and finally by people with high-risk medical conditions. Reference Persad, Emanuel, Sangenito, Glickman, Phillips and Largent24 Our study is in line with the findings of this research.
The study conducted by DeRoo et al. focused on training for the members of the media. The role of the media is very important in creating right or wrong beliefs. Therefore, the media should be aware of their role. The result of this study also reinforces our findings. Reference Schaffer DeRoo, Pudalov and Fu25
The need to educate people has been another finding of this study. The results of the study suggest the need to increase public awareness about vaccines and create campaigns aimed at educating people by religious leaders, health workers, and influential people in the community. These results reinforce the findings of the present study. Reference Al Awaidy and Khamis26
Other findings of this study were the distribution and supply chain of necessities. The need to plan for the distribution of vaccines in urban and rural areas as well as the distribution of essentials such as syringes, personal protective equipment, cold boxes, and ice packs, as well as alcohol and other items, has been indicated in a study. It also mentions the temperature control of vaccines digitally in all stages of transmission, the use of food refrigerators, the need to increase capacity, and the role of the private sector in vaccination. The results of this study also confirm our results. Reference Kumar, Pandi-Perumal and Trakht13
Safety was another finding mentioned in other studies in which the ongoing assessment of the true safety of FDA-approved vaccines is crucial. Reference McMurry, Lenehan and Awasthi27 A study by Xing et al. aiming at the efficacy and safety of COVID-19 vaccines found that most COVID-19 vaccines are effective and safe. 2-dose vaccination is recommended. Reference Xing, Tu and Liu28 Based on the results of a study performed by Gee et al., vaccine safety monitoring should be considered the most severe and comprehensive measures for health care personnel and long-term care residents after injection, using the vaccine adverse event reporting system. The adverse event reporting system, an automated reporting system, and an active monitoring system were employed during the early stages of the COVID-19 national vaccination program which performed descriptive analysis of safety data from the first month of vaccination. The data system provides reliable and useful information about what health care providers and vaccine recipients might expect after vaccination. Reference Gee, Marquez and Su29
Risk communication was another finding which is in line with some similar studies. The other studies stated that people should be given accurate and clear information about the speed and time of distribution and the side effects of the vaccine without any worries according to the culture and language of the people of the region. The presence of religious leaders is considered effective in establishing appropriate communication and success in vaccination. The results of these studies were in line with the present study. Reference Park, Kim, Helble and Roth21,Reference Karafillakis, Van Damme, Hendrickx and Larson30
Personnel management was another important finding. In a study, trained human resource management were identified as a key factor in the proper management of the COVID-19 vaccination program. This study also recommended the use of different types of occupations and specialties such as doctors, nurses, support staff including firefighters, and people familiar with information management technology. The results of this study also confirm our findings. Reference Asgary, Najafabadi, Karsseboom and Wu31
Another finding from security research is that vaccination plays an important role in global health security. In cases where public health law is important for the prevention, diagnosis, and response to infectious diseases, it is necessary to amend the public health law to implement the global health security agenda. Reference Mbindyo, Kioko and Siyoi32
Conclusion
This roadmap has been developed to improve mass vaccination during the COVID-19 pandemic. Iran, like other countries, has been affected by the devastating economic and social consequences of the COVID-19 global pandemic. Statistics show that Iran has been 1 of the countries with the highest number of patients and deaths. Nowadays, along with maintaining physical distance, vaccination is 1 of the main ways to save people’s lives and the best approach to end this pandemic. After the challenge of producing effective and safe vaccines against COVID-19, the most important challenge of the current stage in the pandemic is the mismatch between the demand and supply of COVID-19 vaccines. The disproportion between demand and supply of vaccines is an important challenge for the control of the COVID-19 pandemic, and the vaccination roadmap document is critical to more effective access to health care services. All aspects in this study were presented to foster equal access, fair vaccination allocation, and the principle of transparency and trust in the vaccine. Therefore, it is strongly recommended that the vaccination roadmap with all the above-mentioned features and comprehensive structure should be applied to make the most profit and the least loss.
Acknowledgements
We thank the School of Health Management and Information Sciences of Iran University of Medical Sciences.
Competing interests
The authors declared that they have no competing interests.
Author contribution
HS designed the main ideas and aims of the research and supervised the study. MD and HS designed the methodology of the research, and were responsible for leadership of the study management and coordination. MR and SB collected the data. MD, MR, and MB wrote and collaborated in editing the original draft. SB, HA, FB, and MR analyzed the data. They also prepared the manuscript for publication. MB revised the manuscript to English. All authors reviewed the manuscript. The author(s) read and approved the final manuscript.
Abbreviations
NGO, Non - Governmental Organization
