A lack of transparency could hold back Iran’s covid-19 vaccination campaign, say Mahan Ghafari, Mohammad Saeid Rezaee-Zavareh, Stefan Dascalu, and Aris Katzourakis
The production, allocation, and deployment of current covid-19 vaccines are faced with many challenges across the world, and more clearly defined vaccination strategies are still required in many countries.1 2 Iran was among the first countries outside mainland China to experience a major outbreak of covid-19, with four waves so far, which led to one of the highest per head rates of excess mortality in the Eastern Mediterranean region.3 4
Despite facing such a heavy toll, the Ministry of Health and Medical Education of Iran does not release data on the daily number of cases and deaths for each province to the public. This has hindered important epidemiological and clinical investigations for understanding the pattern of spread and burden of covid-19 across the country.5 6 Now, similar problems have started to affect the covid-19 immunisation campaign in Iran. For example, no detailed information is given about the daily number of administered vaccine doses per province, the type of vaccine used, or the age groups of immunised individuals. The same applies to the evaluation reports on the emergency use authorisation of currently approved vaccines by the Iranian Food and Drug Administration (IFDA). Greater transparency and a science driven vaccination campaign that is not hindered by pre-existing political tensions are paramount for the effectiveness of public health measures and increasing public trust in the immunisation programme.7 8
Understanding pre-existing political tensions is important for dealing with the current challenges Iran is facing with its covid-19 vaccination campaign. For example, on 8 January 2021, the Supreme Leader of Iran announced his decision to ban imports of vaccines produced in the US and UK.9 He also said that he is “not optimistic about [vaccines produced by] France either.” As such, on the day of the announcement, Iran cancelled the import of 150 000 doses of the Pfizer-BioNTech covid-19 vaccine from the US. In the meantime, authorities such as Iran’s health minister and some news media outlets in the country supported this decision by promoting and disseminating misinformation about mRNA vaccines.10 In response, both Michael Ryan, the executive director of the World Health Organization’s health emergencies programme, and the Medical Council of Iran asked the Iranian officials not to politicise the vaccination programme.
Tackling the spread of misinformation will be crucial for the covid-19 vaccination campaign in Iran to succeed. One way to overcome these challenges could be to encourage a science driven vaccine implementation strategy, led by Iranian scientists. Improving bilateral communications between the international community and Iranian authorities so that public health efforts are not halted owing to pre-existing geopolitical tensions could be another way.
Despite the attempts of several national and international public health authorities, the IFDA and the Ministry of Health and Medical Education did not overturn their decision and instead laid out a programme to test and produce several locally made vaccines in addition to purchasing vaccines from other countries through bilateral agreements and the COVAX facility. However, questions have arisen about the transparency of the decision making process.
First, the IFDA decided to grant the emergency use authorisation to Covaxin, Sinopharm’s BBIBP-CorV, and Sputnik V vaccines before any interim phase 3 results had been released. More importantly, the agency did not make its evaluation reports available to the public. These actions may contribute to vaccine hesitancy grounded in concerns that the approval process is being rushed, to the detriment of the health and safety of citizens. Under such circumstances, more transparency and better communication from the IFDA would not only deal with the public’s potential concerns, but also aid the establishment of trust in the process.
Second, during the early stages of the immunisation programme, logistical challenges arose around both the distribution and the administration of available vaccine doses. As a result, the government did not meet its initial aim to administer 1.3 million doses by 20 March. Now, six months after the start of the immunisation programme, Iran has received nearly 20.4 million vaccine doses (of which 1.5 million are from COVIran Barakat and 130 000 are from Pasteau-Covac, two homegrown vaccines), administered 13.1 million doses, and nearly 3.2% of the population is fully vaccinated. These numbers still do not meet the expected goal to vaccinate 13.3 million individuals by 22 July 2021.
Since 14 April, the health ministry has been announcing the number of vaccine doses administered on a daily basis at the national level. While we still do not know the daily numbers by vaccine type, geographical region, age group, and other priorities, the daily announcement has been a key step towards introducing more transparency into the immunisation programme. By further implementing a publicly accessible online platform that tracks such statistics in real time, we can increase vaccine acceptance and also improve epidemiological analyses aimed at managing the pandemic at the local and national levels. We can also use this platform to record and update any possible adverse events during and after the administration of vaccines, which is currently lacking.
Third, Iran is pursuing the development and manufacture of several homegrown vaccine candidates, five of which are at the clinical trial stage, using various platforms such as inactivated SARS-CoV-2 virus, viral vector, mRNA, stem cell, protein subunit, and plant derived virus-like particles. Given the economic sanctions imposed on the country, these research and development efforts can be challenging, especially during a public health crisis, when the healthcare system is under immense pressure and in need of medical supplies.
At the same time, some concerns have been raised over the approval process of COVIran Barakat, a homegrown vaccine. Although it has not completed all three phases of clinical trials nor generated any detailed reports on its safety and efficacy, the IFDA’s speaker announced that the emergency use authorisation was granted to this vaccine on 15 June 2021.11 While countries such as Russia, China, and Cuba made similar decisions to roll out vaccines to their populations before all three phases of the clinical trials had been completed, such decisions do not incorporate all available evidence that a completed phase 3 trial would bring. Indeed, the results of the phase 3 clinical trials can diverge completely from those of the phase 2 trials.12 Such decisions therefore have the potential to increase vaccine hesitancy as the public might view them as pressure being put on regulators to accelerate the vaccine approval process before the rigorous examination can be completed.
Finally, after local transmission of the alpha variant of SARS-CoV-2 were reported in all provinces of Iran by mid-April, new reports indicate that the beta and delta variants are also in circulation in some provinces.13 This highlights the need for an immediate acceleration of the immunisation programme as many parts of the country remain vulnerable to another wave of the pandemic.14
While the economic sanctions against Iran have greatly affected the capacity of the country to initiate an appropriate public health response during the pandemic, a lack of transparency and the risks of politicising public health measures may be seriously detrimental for the outcomes of the covid-19 vaccination campaign and can have long term public health consequences that extend beyond the current pandemic, such as losing trust in vaccination programmes.15 16 The challenges outlined above therefore need to be tackled promptly, as the short term and long term consequences of the pandemic for Iran’s population strictly depend on the outcomes of the vaccination campaign.
Mahan Ghafari, Department of Zoology, University of Oxford, Oxford, UK
Mohammad Saeid Rezaee-Zavareh, Middle East Liver Diseases (MELD) Center, Tehran, Iran
Stefan Dascalu, Department of Zoology, University of Oxford, Oxford, UK and Avian Influenza Research Group, Pirbright Institute, UK
Aris Katzourakis, Department of Zoology, University of Oxford, Oxford, UK
Competing interests: none declared.
- Wouters, O. J. et al. Challenges in ensuring global access to covid-19 vaccines: production, affordability, allocation, and deployment. Lancet (2021) doi:10.1016/S0140-6736(21)00306-8.
- Burgess, R. A. et al. The covid-19 vaccines rush: participatory community engagement matters more than ever. Lancet 397, 8–10 (2021).
- Karlinsky, A. & Kobak, D. The World Mortality Dataset: Tracking excess mortality across countries during the covid-19 pandemic. medRxiv (2021) doi:10.1101/2021.01.27.21250604.
- Ghafari, M., Kadivar, A. & Katzourakis, A. Excess deaths associated with the Iranian covid-19 epidemic: a province-level analysis. International Journal of Infectious Diseases 107, 101-115 (2021).
- Ghafari, M., Kadivar, A. & Katzourakis, A. Estimates of anti-SARS-CoV-2 antibody seroprevalence in Iran. The Lancet Infectious Diseases 21, 602-603 (2021).
- Ghafari, M., Hejazi, B., Karshenas, A., Dascalu, S. et al. Lessons for preparedness and reasons for concern from the early covid-19 epidemic in Iran. Epidemics 100472 (2021). doi: https://doi.org/10.1016/j.epidem.2021.100472
- Nature COVID vaccine confidence requires radical transparency. Nature 586, 8 (2020).
- Angus Dawson, Transparency, Accountability, and Vaccination Policy, 35 J. Med. Ethics 274, 274 (2009).
- Hafezi, P. Iran leader bans import of U.S., UK covid-19 vaccines, demands sanctions end. Reuters https://www.reuters.com/article/health-coronavirus-iran-int idUSKBN29D0YC (2021).
- Tasnim News Agency. Health minister hails Leader’s decision to ban purchase of US, UK vaccines. Tasnim News Agency https://www.tasnimnews.com/en/news/2021/01/10/2429789/health-minister-hails leader-s-decision-to-ban-purchase-of-us-uk-vaccines (2021).
- Speaker of IFDA. Iran authorises emergency use of COVIran Barakat vaccine. https://twitter.com/drjahanpur/status/1404885500201218054?s=20
- 22 case studies where phase 2 and phase 3 trials had divergent results. FDA (2017). https://www.fda.gov/media/102332/download
- Jam-e Jam Online News. Announcement made by the speaker of MoHME: 17 new cases of covid-19 with the Delta variant across the country and 5 new cases with the Beta variant in Hormozgan.
- Poustchi, H. et al. SARS-CoV-2 antibody seroprevalence in the general population and high-risk occupational groups across 18 cities in Iran: a population-based cross-sectional study. Lancet Infect. Dis. (2020) doi:10.1016/S1473- 3099(20)30858-6.
- Murphy, A., Abdi, Z., Harirchi, I., McKee, M. & Ahmadnezhad, E. Economic sanctions and Iran’s capacity to respond to covid-19. Lancet Public Health 5, e254 (2020).
- Takian, A., Raoofi, A. & Kazempour-Ardebili, S. Covid-19 battle during the toughest sanctions against Iran. Lancet 395, 1035–1036 (2020).