Noora (vaccine)
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| Vaccine description | |
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| Target | SARS-CoV-2 |
| Vaccine type | Protein subunit |
| Clinical data | |
| Routes of administration | Intramuscular |
| Identifiers | |
| CAS Number | |
| Part of a series on the |
| COVID-19 pandemic |
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Noora (Persian: نورا) is a COVID-19 vaccine candidate developed by Baqiyatallah University of Medical Sciences in collaboration with Plasma Darman Sarv Sepid Co. (lit. White Cypress Plasma Treatment) in Iran.[1][2] Introduced in June 2021,[3] it was announced as having "successfully passed the first phase of its clinical trial" two months later.[4]
The clinical trial reported in the Journal of Medical Virology met a critical scrutiny in May 2023, after which the journal declared it as an invalid study and retracted it in March 2024.[5][6][7] Independent research in 2024 indicated that the vaccine is very weak (poor immunogenicity and neutralization efficacy) unlikely useful for the later variants of SARS-CoV-2.[8][9]
History
[edit]Noora vaccine was developed by an Iranian team led by Jafar Salimian and Jafar Amani at the Baqiyatallah University of Medical Sciences in Tehran,[10] which is supported by the Islamic Revolutionary Guard Corps.[11] Its design and preparation started in the early 2020 and completed in June 2021. The vaccine with its Phase I clinical trial was officially launched on 27 June 2021.[12] IRGC Commander-in-Chief Major General Hossein Salami and Health Minister Saeed Namaki officiated the unveiling, and Hossein Samadinia, head of the Baqiyatallah Hospital, received the first dose at the inaugural.[1][13] Phase I clinical trial involved 70 volunteers and was completed in August 2021.[4][12]
In March 2022, Hassan Abolqasemi, chancellor of Baqiyatallah University of Medical Sciences, announced that the Phase III clinical trial was completed that involved 10,000 participants.[14] Soon after which the Iranian Ministry of Health gave it a permit for emergency use, and became the sixth COVID-19 vaccine (after COVIran Barekat, Pasto Covac, Razi Cov Pars, SpikoGen, and FAKHRAVAC) produced in Iran.[14] The vaccine preparation and preclinical tests in mice, rabbits, and monkeys were reported in the journal Molecular Immunology in September 2022.[15]
The first clinical trial led by Salimian and Amani,[10] and supervised by Hassan Abolghasemi and Gholamhossein Alishiri, was published in the Journal of Medical Virology 27 August 2022.[16] The report claims that the vaccine is effective, safe and capable of providing immunity.[10] The report concludes:
The results of this Phase 1 trial showed acceptable safety without serious adverse events and significant seroconversions in the humoral and cellular immunity panel. The dose of 80 μg is an appropriate dose for injection in the next phases of the trial.[16]
Medical uses
[edit]Noora vaccine requires three doses given by intramuscular injection on days 0, 21 and 35.[17] Phase I clinical trial was claimed to indicate successful immunity against SARS-CoV-2 Omicron variant.[10]
Pharmacology
[edit]Noora is a recombinant RBD protein subunit vaccine.[17] It contains three truncated parts of SARS-CoV-2: spike protein, receptor-binding protein and nucleoprotein. The immune response is enhanced by the addition of alum as an adjuvant.[15][18]
Manufacturing
[edit]By early 2022, 3 million doses were produced monthly.[11] As of March 2022, 5 millions doses were produced.[14]
Clinical trials
[edit]| Phase | Registration number | Start | Number of participants | Age of participants | Ref | ||
|---|---|---|---|---|---|---|---|
| Total | Vaccine | Placebo | |||||
| I | IRCT20210620051639N1 | 25 June 2021 | 70 | 30 (80 μg)
30 (120 μg) |
10 (placebo) | 18–50 years | [17] |
| II | IRCT20210620051639N2 | 10 October 2021 | 300 | 240 | 60 | 18–40 years | [19] |
| III | IRCT20210620051639N3 | 23 December 2021 | 10000 | >18 years | [20] | ||
Controversy
[edit]In May 2023, Donald Forthal, chief of infectious diseases at the University of California, Irvine, wrote a commentary on the Phase I clinical trial paper in the Journal of Medical Virology,[21] severely criticising the validity of the study.[22] Forthal pointed out several data inconsistency, misrepresentation, vague experimental methods and conflict of interest that would have used to reject the paper in the first place.[7][23] He made a concern that "a manuscript containing so many serious flaws would have been accepted for publication following peer review, and given these issues, a retraction may be in order".[21] As the criticism was posted on PubPeer, other scientists also raised other concerns in the study.[5][23] Australian epidemiologist Gideon Meyerowitz-Katz stated that the report had several other "impossible" and "contradictory" results.[7]
While the authors and the Baqiyatallah University remained silent, Journal of Medical Virology's editor-in-chief Shou-Jiang Gao invited justifications from the authors. The authors submitted the rebuttal, but after the third round of peer reviewing, they gave up on the final dateline of 23 November 2023 for revision.[23] With no further response from the authors, the journal announced retraction of the paper on 2 March 2024,[7][22] with a note:
The retraction has been agreed due to concerns raised by third parties regarding issues with the data presented in the article. Several inconsistencies concerning the information provided about the analyzed subjects were additionally identified. Furthermore, the authors failed to disclose the presence of potential conflicts of interest that may have affected the interpretation of the results presented. Accordingly, the editors consider the conclusions of this manuscript to be invalid. The authors have been informed of the decision to retract but did not agree with it.[6]
One of the supervisors of the clinical trial, Abolghasemi claimed that the criticism and retraction were not of scientific causes but of prejudices, and his team was not given a chance for explanation. As he wrote to Retraction Watch: "Retraction of our article was a political decision not a scientific decision because there was a pressure on journal based on [apartheid] scientific issue. Our response to the comment never accepted by [PubPeer] and journal to be published."[7]
An independent research team from Tehran University of Medical Sciences and Avicenna Research Institute experimentally analysed four COVID-19 vaccines developed in Iran. Their report in Iranian Journal of Immunology, published in March 2024, showed that Noora and SpikoGen do hot have the expected efficacy (as indicated by poor immunogenicity and neutralization efficacy).[8] As the two vaccines do not provide protection from SARS-CoV-2 Delta variant, it is unlikely useful for the later variants of SARS-CoV-2.[9]
See also
[edit]References
[edit]- ^ a b "IRGC starts clinical trial of "Noora" coronavirus vaccine". Tehran Times. 27 June 2021. Retrieved 1 July 2021.
- ^ "IRGC Commander: Iran-Made 'Noora' Coronavirus Vaccine Ready for 2nd Stage of Human Trial". Fars News Agency. 22 August 2021. Retrieved 30 August 2021.
- ^ Hashemi S (27 June 2021). "Iran unveils Covid-19 vaccine "Noora"". Iranian Students' News Agency. Retrieved 18 June 2024.
- ^ a b Rahmani T (11 August 2021). "Termination of 1st phase of "Noora" vaccine clinical trial". Mehr News Agency. Retrieved 18 June 2024.
- ^ a b Joelving F (7 March 2024). "Iran COVID-vaccine paper with 'serious flaws' retracted". Retraction Watch. Retrieved 18 June 2024.
- ^ a b "Retraction: "Safety and immunogenicity of a recombinant receptor-binding domain-based protein subunit vaccine (Noora vaccine) against COVID-19 in adults: A randomized, double-blind, placebo-controlled, Phase 1 trial"". Journal of Medical Virology. 96 (3): e29509. March 2024. doi:10.1002/jmv.29509. PMC 11062063. PMID 38430205.
- ^ a b c d e "Iran Covid Vaccine Report now Retracted by Journal". Iran Times. 10 May 2024. Retrieved 18 June 2024.
- ^ a b Dashti N, Golsaz-Shirazi F, Jeddi-Tehrani M, Zarnani AH, Amiri MM, Shokri F (March 2024). "Comparative Immunogenicity and Neutralization Potency of Four Approved COVID-19 Vaccines in BALB/c Mice". Iranian Journal of Immunology. 21 (1): 1–14. doi:10.22034/iji.2024.101060.2728. PMID 38433582.
- ^ a b Daungsupawong H, Wiwanitkit V (May 2024). "Letter to the Editor Regarding "Comparative Immunogenicity and Neutralization Potency of Four Approved COVID-19 Vaccines in BALB/c Mice"". Iranian Journal of Immunology. 21 (2): 184–185. doi:10.22034/iji.2024.101947.2764. PMID 38803238.
- ^ a b c d "Clinical studies of Noora vaccine published in Medical Virology". Tehran Times. 12 October 2022. Retrieved 18 June 2024.
- ^ a b "IRGC's "Noora" vaccine awaiting emergency use license". Tehran Times. 9 February 2022. Retrieved 19 June 2024.
- ^ a b ""Noora" vaccine successfully passing first phase of clinical trial". Iran News Daily. 27 June 2021. Retrieved 20 June 2024.
- ^ "IRGC Commander-In-Chief General Hossein Salami At Unveiling Of The 'Noora' COVID-19 Vaccine: If The U.S. Has A Vaccine Shortage, We Are Willing To Help Them Out". MEMRI. Retrieved 21 June 2024.
- ^ a b c ""Noora" vaccine receives emergency use license". Tehran Times. 1 March 2022. Retrieved 19 June 2024.
- ^ a b Nazarian S, Olad G, Abdolhamidi R, Motamedi MJ, Kazemi R, Kordbacheh E, et al. (September 2022). "Preclinical study of formulated recombinant nucleocapsid protein, the receptor binding domain of the spike protein, and truncated spike (S1) protein as vaccine candidates against COVID-19 in animal models". Molecular Immunology. 149: 107–118. doi:10.1016/j.molimm.2022.06.007. PMC 9222294. PMID 35802999.
- ^ a b Salimian J, Ahmadi A, Amani J, Olad G, Halabian R, Saffaei A, et al. (February 2023) [2022-08-27]. "Safety and immunogenicity of a recombinant receptor-binding domain-based protein subunit vaccine (Noora vaccine) against COVID-19 in adults: A randomized, double-blind, placebo-controlled, Phase 1 trial". Journal of Medical Virology. 95 (2): 28097. doi:10.1002/jmv.28097. PMC 9539327. PMID 36029105. (Retracted, see doi:10.1002/jmv.29509, PMID 38430205, Retraction Watch)
- ^ a b c "A randomized, double-blinded, placebo-controlled phase I clinical trial to evaluate the safety and immunogenicity of three dose regimens of COVID-19 RBD protein recombinant vaccine (AmitisGen; 80 μg and 120 μg) in a healthy population". Iranian Clinical Trials Registry. 25 June 2021. IRCT20210620051639N1. Retrieved 1 July 2021.
- ^ Soleymanitabar A, Gharekhanloo MA, Khalaj MP, Radfar MM, Mansour Kiaei D, Bolouriyan A, et al. (2022). "Efficacy and Adverse Effects of the Most Common COVID-19 Vaccines: a Rapid Review Study". Journal of Applied Biotechnology Reports. 9 (4): 790–798. doi:10.30491/jabr.2022.354528.1553.
- ^ "IRCT | A double-blind, randomized, placebo-controlled Phase II clinical trial to evaluate the immunogenicity and safety of covid-19 recombinant RBD protein vaccine (80 microgram) of Plasma Darman Sarve Sepid Co. in healthy population". en.irct.ir. Retrieved 27 November 2021.
- ^ "IRCT |Phase 3 Clinical Trial to evaluate the Immunogenicity and Safety of Covid19 Recombinant RBD Protein Vaccine (Noora Vaccine) as a Booster Vaccine after injection of existing Vaccines in IRAN". en.irct.ir. Retrieved 23 December 2021.
- ^ a b Forthal DN (May 2023). "Comment on the immunogenicity of the Noora vaccine against SARS-CoV-2". Journal of Medical Virology. 95 (5): e28731. doi:10.1002/jmv.28731. PMC 10618008. PMID 37212298.
- ^ a b "Virology Journal Retracts Paper On Iran-Made COVID-19 Vaccine Trials". Iran International. 3 October 2024. Retrieved 21 June 2024.
- ^ a b c Joelving F (26 October 2023). "Publisher looking into COVID vaccine paper with 'serious flaws'". Retraction Watch. Retrieved 21 June 2024.
