[8] The interim results of the phases 1 and 2 trials showed 93.5% (95% CI, 88.4–99.6%) of the receivers of the vaccine have produced neutralizing antibodies against SARS-CoV-2.
[10] [further explanation needed] As of February 27, 2022, approximately 60 million doses have been produced according to Shifa Pharmed's CEO.
[12] Multiple Iranian personalities have received the vaccine, including the Supreme Leader, Ali Khamenei[5] and the President, Ebrahim Raisi.
[13] A version of the vaccine based on the Omicron variant and named CovIran Barkat Plus is in development and studied to be given as a third dose.
She is a full professor (emeritus) of infectious diseases at Tehran University of Medical Sciences and head of the Iranian Centre for HIV/AIDS.
[23] Barkat Pharmaceutical Group started constructing a factory for vaccine production on 17 December 2020[8] with the goal to build it in 3 months.
[17] According to Execution of Imam Khomeini's Order (EIKO), under the direct control of the Supreme Leader of Iran, "production of the vaccine developed by one of its companies, Shifa Pharmed, could reach 12 million doses per month, six months after a successful trial ends".
[11] The results of the preclinical study conducted on animals have been published in a preprint (not peer reviewed) on 10 June 2021.
[36][37][16] vaccine/ placebo 24 (5 μg) Iran Food and Drug Administration has approved the vaccine for testing on humans.
[4] Minister of Health Saeed Namaki and Vice President for Science and Technology Sorena Sattari participated at the ceremony of vaccine injection.
[9] Phase 3's primary outcome was efficacy assessment on preventing mild, moderate and severe disease.
[9] It was conducted on 20,000 participants[16] across 6 cities in Iran (Tehran, Karaj, Shiraz, Isfahan, Mashhad and Bushehr).
[9] Conventional Virus Neutralizing Test (cVNT) is reported to have shown 93.5% immunogenicity (95% confidence interval: 88.4 – 99.6%).
[53] There are claims of some issues with the vaccine's scientific documentation article according to the U.S. Agency for Global Media-owned broadcasting network Radio Farda.
[54][medical citation needed] On 27 July 2021, the Director of the Barkat Pharmaceutical Group stated that a paper with the result of the clinical trials have been prepared and submitted.
[10] On 9 April 2022, peer-reviewed results of the phases I and II of the clinical trials have been published in BMJ Open.
[58][further explanation needed] On 21 September 2023, peer-reviewed results of the phases III of the clinical trials have been published in BMJ Open.
Clinical trials on humans began in March 2022 after the Ministry of Health and Medical Education (of Iran) gave its approval following the studies on animals.