Exclusive; VOA Report on the Discrediting of the Vaccine Article Produced by the University of the IRGC

The only published article regarding the safety and efficacy of the COVID-19 vaccine produced by Baqiyatallah University, affiliated with the Islamic Revolutionary Guard Corps (IRGC), named "Noura," which was published in August 2022 in the American journal "Medical Virology," has been discredited following the emergence of contradictions and scientific flaws, as well as the failure to disclose conflicts of interest. The Iranian Ministry of Health issued an emergency use authorization for the "Noura" vaccine in Esfand 1400 (February-March 2022), and millions of doses of this vaccine have been administered in Iran. Iranian health officials announced the efficacy of this vaccine as 94 percent. The now-discredited article was published in the "Medical Virology" journal and pertained to the first phase of clinical trials and was the only report published regarding the clinical trials of this vaccine. What are the "serious" flaws of the Noura article? Donald Fortal, head of the infectious diseases department at the University of California-Irvine, wrote a detailed piece in the form of a "letter to the editor" last year, raising several major concerns about the Noura vaccine article. He expressed surprise that this article, despite containing "serious flaws," was accepted for publication after collective review. In an interview with VOA's Persian section regarding the serious flaws of this article, Dr. Fortal stated, "A combination of several different issues has reinforced the poor quality of this study," adding, "One of the biggest issues is that it seems several individuals in the placebo group are producing neutralizing antibodies, even though they did not receive the vaccine. This should not have happened unless their testing methods were incorrect or some neutralizing activity in the blood was a result of contracting the virus rather than vaccination, which is also true for the vaccinated group." The head of the infectious diseases department at UC-Irvine added that the methods used to measure neutralizing antibody activity in the blood were also described "poorly" in this article, making it difficult to determine their reliability. Donald Fortal stated, "It seems the authors may have omitted some data when reporting neutralizing antibodies, and we do not know whether they did this intentionally because they did not like the results or if it was merely a weakness in data reporting." Other flaws raised by Dr. Fortal include the report of neutralizing antibody titers, which he stated were "often very low," indicating that "the vaccine does not work very well." He added that all these flaws, along with the existence of a "conflict of interest," make it difficult to assess the vaccine's efficacy. In January, an epidemiologist in Australia also raised other issues, including "impossible" and "contradictory" figures related to the Noura vaccine article. The peer review process and the editor's explanation. Shou Jiang Gao, the editor of the journal, told "Retraction Watch" that the journal had submitted the article twice for "thorough review" to experts in the field before publication. He also stated that the authors' responses to the criticisms were evaluated three times, with two experts reviewing them each time. The editor of the journal did not respond to VOA's request for further explanation regarding these reviews by the time this report was prepared, but a spokesperson for the reputable database "Wiley," where the Noura vaccine trial article was published, told VOA: "The article was retracted following reviews conducted by our research team in collaboration with the journal's editors." He added, "As stated in the retraction statement, the research revealed significant discrepancies with the reported results in the article, and the authors were unable to adequately address these concerns." Dr. Donald Fortal also commented on the pre-publication review process to VOA, saying, "I have not seen the evaluations conducted prior to publication, so it is very difficult for me to respond about them. But my guess is that the main reviewers did not dedicate much time or energy to evaluating the article." He pointed out that this issue is relatively common, stating, "People are busy, and finding good reviewers can be difficult. I have also worked as an editor and have often had to request reviews from 20 or more people to find one or two." In March, the journal decided to retract or discredit this article, stating that the authors failed to disclose potential conflicts of interest and emphasized that this could affect the interpretation of the results presented. Hassan Abolghasemi from Baqiyatallah University described the discrediting of this article in an email to "Retraction Watch" as a "political decision rather than a scientific one." A spokesperson for the "Wiley" database stated, "All research we conduct is in accordance with the best practices set forth by the "Committee on Publication Ethics" and is based solely on the scientific analyses presented in the article." The head of the infectious diseases department at UC-Irvine also commented on Abolghasemi's reaction to VOA, stating, "My comments are solely based on what was written in the article. I absolutely have no political disagreement or conflict with my colleagues in Iran." Experts expressed concern after the discrediting of the Noura vaccine article regarding the possibility that the Iranian Food and Drug Administration issued approvals for subsequent phases based on the same data and ultimately granted it consumption authorization. Abolghasemi recently told the Tasnim news agency that the Iranian Ministry of Health purchased 3 million doses of the Noura vaccine while the amount produced was 5 million doses. He added, "These vaccines have remained in warehouses, and if not purchased and expiration dates are reached, they will be destroyed." Bahram Einollahi, the health minister of Ebrahim Raisi's government, had introduced the "Noura" vaccine as "one of the best vaccines in the world." This is while the technology of this vaccine is based on recombinant protein, and various studies worldwide have shown that vaccines based on "mRNA" technology demonstrate the highest efficacy for COVID-19. Many experts and the Iranian Immunology and Allergy Association have called for the procurement of effective vaccines based on "mRNA," which have been banned since the beginning by Ali Khamenei, the Supreme Leader of the Islamic Republic, with the aim of focusing on domestic production. At the same time, an open letter from 2,500 "professors and faculty members of medical sciences universities in the country," of which Bahram Einollahi was one, also made headlines, in which they raised ambiguities regarding the approval process and side effects of American and British vaccines. None of the COVID-19 vaccines produced in Iran have received approval from the World Health Organization so far.