Medicine:COVIran Barekat

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Short description: COVIran Barakat vaccine against COVID-19
COVIran Barekat
COVIran Barakat.jpg
A vial of COVIran Barakat
Vaccine description
Target diseaseSARS-CoV-2
TypeKilled/Inactivated
Clinical data
Other namesBIV1-CovIran[1]
COVIran Barakat
COVIran Barkat
کووایران برکت
Routes of
administration		Intramuscular
ATC code
  • None
Legal status
Legal status
  • Emergency use authorization: IRN

Full and emergency authorizations

Full list of COVIran Barekat authorizations

COVIran Barekat[2] (Persian: کووایران برکت‎) is a COVID-19 vaccine developed in Iran by Shifa Pharmed Industrial Group, a subsidiary of the Barkat Pharmaceutical Group.[3][4][5] It is an inactivated virus-based vaccine.[2] Iranian authorities have authorized its emergency use. This makes it the first locally developed COVID-19 vaccine to be approved for emergency use in the Middle East.[6]

Officials in charge say they are in the process to publish the results of the clinical trials in a peer-reviewed journal.[7] The interim results of the phases 1 and 2 trials showed Template:Estimate of the receivers of the vaccine have produced neutralizing antibodies against SARS-CoV-2.[8] Those results have not been peer-reviewed and describe the immunogenicity of the vaccine and not its efficacy. On 3 March 2022, peer-reviewed results have been published in the Clinical Microbiology and Infection.[9] [further explanation needed]

As of February 27, 2022, approximately 60 million doses have been produced according to Shifa Pharmed's CEO.[10] and the annual production capacity of this vaccine has reached 350 million doses.[11] Multiple Iranian personalities have received the vaccine, including the Supreme Leader, Ali Khamenei[4] and the President, Ebrahim Raisi.[12]

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.[13][14]

Medical uses

It is given by intramuscular injection and requires two doses given 28 days apart.[15]

Pharmacology

COVIran Barekat is an inactivated virus-based vaccine.[2][16] In other words, "it is made of a coronavirus that has been weakened or killed by chemicals, similar to how polio immunizations are made".[17]

Developers

The Execution of Imam Khomeini's Order (EIKO) and Barkat Pharmaceutical Group is parent company of Shifa Pharmed Industrial Group. It's reported to be "state-affiliated".[4] Shifa Pharmed products include seven drugs and three biologics besides their COVID-19 vaccine which is their first vaccine to be produced.[18] Around 650 people worked in three shifts, around the clock, to develop the vaccine.[19]

Dr. Minoo Mohraz has been selected as the lead of the "Corona vaccine project in Iran".[20] Mohraz is an Iranian physician, scientist, and AIDS specialist. She is a full professor (emeritus) of infectious diseases at Tehran University of Medical Sciences and head of the Iranian Centre for HIV/AIDS.[21] Mohraz has also served, within the World Health Organization, as an expert on HIV/AIDS in Iran and the Eastern Mediterranean.[22]

Manufacturing

First production line, March 2021.

Barkat Pharmaceutical Group started constructing a factory for vaccine production on 17 December 2020[7] with the goal to build it in 3 months.[16] 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".[23]

Mass production began on 15 March 2021.[24][25] The first produced batch was unveiled on 10 May 2021.[26][27]

There are three production lines for COVIran Barekat.[28][7]

  • Cumulate production capacity will be 25-30 million doses per month when all lines will start producing.[7]
  • The first line has a capacity of 3-4 million doses per month and started producing as of 15 March 2021.[29][28]
  • The second line has a capacity of 6-8 million doses per month.[28] On 17 August, it was in the process of producing its first batch.[7]
  • The third line has a capacity of 16-20 million doses per month.[28] On 17 August, 95% of its equipment were reported to be prepared and installed and officials in charge aimed to begin its operation as of end of September.[7]

By 3 July 2021, about 2.7 million doses of COVIran Barekat vaccine had been produced and 400,000 doses had been delivered to the Iranian Ministry of Health, according to Mohammad Mokhber, the Deputy Coordinator of the Execution of Imam Khomeini's Order.[30]

By 27 July 2021, about 5 million doses had been produced and 1.3 million had been delivered to the Ministry of Health, according to Mokhber.[31]

By 30 August 2021, about 8 million doses had been produced and 4.2 million had been delivered to the Ministry of Health, according to EIKO.[32]

By 10 October 2021, about 16 million doses have been produced and 7.5 million had been delivered to the Ministry of Health, according to Shifa Pharmed's CEO.[33]

By 26 February 2022, about 60 million doses have been produced, according to Shifa Pharmed's CEO.[10]

History

Preclinical trials

The results of the preclinical study conducted on animals have been published in a preprint (not peer reviewed) on 10 June 2021.[34] According to the developers of the vaccine, trials showed that the vaccine was safe and effective in animals.[34]

On 26 October 2021, the results of the preclinical study have been published in the peer-reviewed Journal of Medical Virology.[1]

Clinical trials

Iran's first domestic COVID-19 vaccine candidate started clinical trials in late December 2020.
Vaccines for clinical trials.

Clinical trials are tests done in humans, to see whether a treatment is safe and effective. There are different phases of clinical research, and each phase has its own primary focus. For example, the focus of Phase I clinical trials is basic safety and dose information. All studies were randomized, double-blind, parallel arms, placebo-controlled and have been conducted on healthy volunteers.[35][36][15]

Clinical trials of COVIran Barekat vaccine
Phase Registration Number of participants Age of participants Ref
Number Date Total Vaccine Placebo Ratio

vaccine/

placebo

Trials on adults
I IRCT20201202049567N1 15 December 2020 56 24 (3 μg)

24 (5 μg)

8 7:1 18–50 years [35]
IRCT20201202049567N2 13 March 2021 32 24 8 3:1 51–75 years [36]
II IRCT20201202049567N3 13 March 2021 280 224 56 5:1 18–75 years [15][37]
III 21 April 2021 20,000 13,333 6,666 2:1
Trials on children
I IRCT20171122037571N3 11 November 2021 60 30 30 (Sinopharm BIBP vaccine) 1:1 12–18 years [38]
II 440 220 220 (Sinopharm BIBP vaccine) 1:1

Phase I

Iran Food and Drug Administration has approved the vaccine for testing on humans.[39][40][41] According to reports, more than 65,000 Iranians volunteered to test the vaccine while only 56 people were needed.[3]

On 29 December 2020, human trials of Iran's first domestic COVID-19 vaccine candidate were started.[3][17] The first volunteer who received a shot of COVIran Barekat was Tayyebeh Mokhber, the daughter of Mohammad Mokhber, director of Setad.[3] Minister of Health Saeed Namaki and Vice President for Science and Technology Sorena Sattari participated at the ceremony of vaccine injection.[citation needed]

Phase 1's primary outcome was safety assessment.[8] A first phase 1 study was conducted on 56 healthy volunteers who were at the age of 18–50.[42][43][44][35] Last injections of the second doses occurred on 4 March 2021.[8] A second phase 1 study was conducted on 32 volunteers aged 51–75 years.[36] First injections occurred on March 15 and last injections on April 9.[8]

Phase II/III

COVIran Barekat -- Phases II and III of the clinical trials

Phases II and III of the clinical trials were combined,[45][46] allowing to start the third phase before the second completed. Participants were aged between 18 and 75 years.[15]

Phase 2's primary outcome was immunogenicity assessment.[8] It was conducted on 280 volunteers.[15] The first volunteers were inoculated on March 15[45] and the last injections of the second doses occurred on May 25.[8]

Phase 3's primary outcome was efficacy assessment on preventing mild, moderate and severe disease.[8] It was conducted on 20,000 participants[15] across 6 cities in Iran (Tehran, Karaj, Shiraz, Isfahan, Mashhad and Bushehr).[46] Phase III testing began on June 16, 2021.[47]

Results

On 16 June 2021, a summary of the results obtained in the phase 1 and phase 2 of the clinical trials have been published in the press.[48][49] A peer-reviewed article was submitted for publication in August 2021.[47] According to the reports, only mild adverse effects were registered except one case of hypotension, one case of level-2 headache and one case of diminution of platelets that didn't need medical care.[8] Conventional Virus Neutralizing Test (cVNT) is reported to have shown 93.5% immunogenicity (95% confidence interval: 88.4 – 99.6%).[8] On 23 June 2021, the production project manager of the vaccine stated that the results of the second phase have shown "the serum of the people who received the vaccine has 93.5% power to neutralize the virus; thus meaning the vaccine has a very good efficacy that will be shown after the end of the third phase".[50]

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.[51]

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. "It will be sent to 10 important scientific journals of the world but it may take time before they publish it".[7]

In February 2021 (while phase 1 study was ongoing), the head of the vaccine production team at the Setad stated that the vaccine also neutralizes the British mutated COVID-19 virus.[52][53][54]

On 3 March 2022, clinical results have been published in Clinical Microbiology and Infection, a peer-reviewed medical journal.[9]

On 9 April 2022, peer-reviewed results of the phases I and II of the clinical trials have been published in BMJ Open.[55][further explanation needed]

Trial on children aged 12-18

A phase I-II clinical trial on children aged 12–18 years began on 23 November 2021.[56][38] It consist of a comparison study where half of the 500 participants receive a Coviran Barkat vaccine and the other half a Sinopharm BIBP vaccine. Primary outcome is safety and immunogenicity assessment.[38]

Other countries

As official in charge of manufacturing Iran Barekat vaccines, Mohammad Reza Salehi said, "some neighboring countries tend to enter the third phase of the clinical trial of the Iranian COVIran Barekat". They are reviewing recommendations to let them participate.[42] On 17 March 2022 Iran signed an agreement with Nicaragua to export this vaccine.[57][58] on 22 June 2022 Nicaragua received 200,000 doses of vaccines.[59][60][61]

Authorizations

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  Full authorization
  Emergency authorization
  Allowed for travel
See also: List of COVID-19 vaccine authorizations#COVIran BarakatThe vaccine received its authorization license from the Iran Food and Drug Administration on June 13, 2021.[62]

CovIran Barkat is in the process to be registered by the World Health Organization.[63] Presubmission meeting held on 26 January 2022.[64][65]

Society and culture

Ali Khamenei, the Supreme Leader of Iran, received his first dose of Iran's locally made COVIran Barekat vaccine on 25 June 2021 (twelve days after it received its public use authorization from Iranian authorities).[4][66][67] He received his second dose on 23 July 2021.[68]

Ebrahim Raisi,[69][12] Mohammad Bagher Ghalibaf,[70] Ali Larijani,[71] and Amoli Larijani,[72] have been vaccinated with COVIran Barekat.

Controversy

Under pressure the vaccine was approved before it started phase III trials.[73]

CovIran Barkat Plus

CovIran Barkat Plus (also named BIV1-CovIran Plus) is a COVID-19 vaccine candidate based on the Omicron variant.[13][74] It is currently in development and studied as a third dose.[14]

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.[13][75][10][76] Clinical trials are conducted on 210 volunteers with a history of two-dose vaccination of either the standard CovIran Barkat or the Sinopharm BIBP vaccine. CovIran Barkat Plus will be given as a third dose.[14]

See also

  • Pharmaceuticals in Iran
  • COVID-19 pandemic in Iran
  • COVID-19 vaccine clinical research

References

  1. ↑ 1.0 1.1 "Safety and potency of BIV1-CovIran inactivated vaccine candidate for SARS-CoV-2: A preclinical study". Reviews in Medical Virology 32 (3): e2305. May 2022. doi:10.1002/rmv.2305. PMID 34699647. 
  2. ↑ 2.0 2.1 2.2 "Iran hopes to defeat COVID with home-grown crop of vaccines". Nature 596 (7873): 475. August 2021. doi:10.1038/d41586-021-02216-z. PMID 34404947. Bibcode: 2021Natur.596..475M. 
  3. ↑ 3.0 3.1 3.2 3.3 "COVIran Barakat: Iran launches human trials of its COVID vaccine". Al Jazeera. 29 December 2020. https://www.aljazeera.com/news/2020/12/29/iran-covid-vaccine-trials-start. 
  4. ↑ 4.0 4.1 4.2 4.3 "Iran's leader gets locally made coronavirus vaccine shot" (in en). Reuters. 2021-06-25. https://www.reuters.com/world/middle-east/irans-leader-gets-locally-made-coronavirus-vaccine-shot-2021-06-25/. 
  5. ↑ "About - شرکت گروه صنایع شفافارمد" (in en-US). 2021-04-15. http://www.shifapharmed.com/about/?lang=en. 
  6. ↑ "Iran issues license on its coronavirus vaccine" (in en). 14 June 2021. https://en.trend.az/iran/society/3439812.html. 
  7. ↑ 7.0 7.1 7.2 7.3 7.4 7.5 7.6 "زیرساخت تولید ماهانه 25 تا 30 میلیون دوز واکسن برکت فراهم شده است + پاسخ به شبهات- اخبار پزشکی - اخبار اجتماعی تسنیم" (in fa). خبرگزاری تسنیم (Tasnim Social News). https://www.tasnimnews.com/fa/news/1400/05/26/2556006/زیرساخت-تولید-ماهانه-25-تا-30-میلیون-دوز-واکسن-برکت-فراهم-شده-است-پاسخ-به-شبهات. 
  8. ↑ 8.0 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 Setad (EIKO) (2021-06-16). "خلاصه نتایج تست انسانی واکسن کوو ایران برکت". https://setad.ir/d/2021/06/16/0/8831.pdf. 
  9. ↑ 9.0 9.1 "Assessment of BIV1-CovIran inactivated vaccine-elicited neutralizing antibody against the emerging SARS-CoV-2 variants of concern" (in English). Clinical Microbiology and Infection 28 (6): 882.e1–882.e7. June 2022. doi:10.1016/j.cmi.2022.02.030. PMID 35248745. 
  10. ↑ 10.0 10.1 10.2 "تولید ۶۰ میلیون دُز واکسن برکت در شفافارمد/ آغاز مطالعه بالینی واکسن اختصاصی اُمیکرون | خبرگزاری فارس" (in fa). 2022-02-26. https://www.farsnews.ir/news/14001207000854. 
  11. ↑ The production capacity of the Barakat vaccine reached 350 million doses per year Tasnimnews.com, Retrieved 26 April 2022
  12. ↑ 12.0 12.1 "دکتر رئیسی نخستین دُز واکسن کوو ایران برکت را دریافت کرد" (in fa). 2021-08-08. https://www.irna.ir/news/84431053/دکتر-رئیسی-نخستین-دز-واکسن-کوو-ایران-برکت-را-دریافت-کرد. 
  13. ↑ 13.0 13.1 13.2 "Iranian-made vaccine against Omicron begins clinical trial" (in en). 2022-03-02. https://www.tehrantimes.com/news/470646/Iranian-made-vaccine-against-Omicron-begins-clinical-trial. 
  14. ↑ 14.0 14.1 14.2 "IRCT | A Clinical trial to evaluate the immunogenicity and safety of Omicron-Based CovIran Barkat vaccine as a third injection dose in vaccinated population over 18 years of age". https://en.irct.ir/trial/62022. 
  15. ↑ 15.0 15.1 15.2 15.3 15.4 15.5 "IRCT | A double-blind, randomized, placebo-controlled Phase II/III Clinical trial to evaluate the safety and efficacy of COVID-19 inactivated vaccine (Shifa-Pharmed) in a population aged 18 to 75 years". Iranian Registry of Clinical Trials (IRCT). https://en.irct.ir/trial/54881. 
  16. ↑ 16.0 16.1 "COVID-19 Vaccine (pharmaceutical product)" (in en-US). شرکت گروه صنایع شفافارمد (Shafafarmad Industries Group Company). 2021-04-19. http://www.shifapharmed.com/covid-19-vaccine-pharmaceutical-product/?lang=en. 
  17. ↑ 17.0 17.1 "Iran begins first human trial of locally made virus vaccine". 29 December 2019. https://health.economictimes.indiatimes.com/news/industry/iran-begins-first-human-trial-of-locally-made-virus-vaccine/80009280. 
  18. ↑ "Growth Factor" (in en-US). شرکت گروه صنایع شفافارمد (Shafafarmad Industries Group Company). 2021-04-19. http://www.shifapharmed.com/growth-factor/?lang=en. 
  19. ↑ "دانش فنی واکسن برکت صد درصد ایرانی است/ تلاش ۶۵۰ نفر در ساخت واکسن ایرانی کرونا" (in Persian). Tasnim News Agency. https://www.tasnimnews.com/fa/news/1400/03/26/2521950. 
  20. ↑ "واکسن ایرانی کرونا تا 'تیر ماه آینده می‌رسد'" (in fa). 6 December 2020. https://www.bbc.com/persian/iran-55209902. 
  21. ↑ "Good News About AIDS" (in en). February 6, 2016. https://www.yjc.ir/en/news/5489289/News-Good-About-AIDS. 
  22. ↑ "علامه طباطبایی استاد مينو محرز: هرچه دارم از دانشگاه علوم پزشكي تهران است" (in Persian). Tehran University of Medical Sciences Alumni Communication Office. http://alumni.tums.ac.ir/en/ndt/5480/Master-Mino-Mehrez-What-I-have-is-from-Tehran-University-of-Medical-Sciences. 
  23. ↑ "Iran starts human testing of first domestic COVID-19 vaccine". Reuters. 29 December 2019. https://www.reuters.com/article/health-coronavirus-iran-vaccine/iran-starts-human-testing-of-first-domestic-covid-19-vaccine-idUSL1N2J90BZ. 
  24. ↑ "Iran starts mass-production of homegrown coronavirus vaccine" (in en). 2021-03-15. https://www.tehrantimes.com/news/459155/Iran-starts-mass-production-of-homegrown-coronavirus-vaccine. 
  25. ↑ "اولین تصاویر از خط تولید واکسن کووایران برکت" (in fa). 2021-03-15. https://setad.ir/photo/1363/اولین-تصاویر-از-خط-تولید-واکسن-کووایران-برکت. 
  26. ↑ "رونمایی ازمحموله تولید انبوه واکسن "کوو ایران برکت"" (in fa). 2021-05-11. https://setad.ir/photo/1483/رونمایی-ازمحموله-تولید-انبوه-واکسن-کوو-ایران-برکت. 
  27. ↑ "نخستین محصول تولید انبوه واکسن "کوو ایران برکت" فردا رونمایی می‌شود" (in Persian). 10 May 2021. https://www.irna.ir/news/84324801/نخستین-محصول-تولید-انبوه-واکسن-کوو-ایران-برکت-فردا-رونمایی. 
  28. ↑ 28.0 28.1 28.2 28.3 "فاز یک خط تولید واکسن برکت" (in fa). 2021-08-14. https://setad.ir/photo/2162/فاز-یک-خط-تولید-واکسن-برکت. 
  29. ↑ "Iran to kick off production of 3mn doses of COVIRAN" (in en). 2021-03-15. https://en.mehrnews.com/news/171121/Iran-to-kick-off-production-of-3mn-doses-of-COVIRAN. 
  30. ↑ "ببینید | تحویل 50 میلیون دُز واکسن "کوو ایران برکت" تا پایان شهریور - خبرآنلاین". 2021-07-03. https://www.khabaronline.ir/amp/1531622/. 
  31. ↑ "افتتاح اولین صندوق قرض‌الحسنه اشتغال کشور توسط ستاد اجرایی فرمان امام/ تولید 5 میلیون واکسن "برکت" تاکنون" (in fa). farsnews.ir. https://www.farsnews.ir/news/14000505000435/افتتاح-اولین-صندوق-قرض%E2%80%8Cالحسنه-اشتغال-کشور-توسط-ستاد-اجرایی-فرمان-امام. 
  32. ↑ "تعداد واکسن‌های تولید شده کوو ایران برکت به ۸ میلیون دز رسید" (in fa). 2021-08-30. https://www.mojnews.com/بخش-%D8%A7%D8%AC%D8%AA%D9%85%D8%A7%D8%B9%DB%8C-5/393747-. 
  33. ↑ "تولید 16 میلیون دوز واکسن برکت تا امروز/ ارائه مستندات برای اخذ مجوز سازمان جهانی بهداشت- اخبار پزشکی - اخبار اجتماعی تسنیم | Tasnim" (in fa). https://www.tasnimnews.com/fa/news/1400/07/18/2587056. 
  34. ↑ 34.0 34.1 Abdoli A, Aalizadeh R, Aminianfar H, Kianmehr Z, Azimi E, Emamipour N, et al. (January 2021). "Safety and Potency of COVIran Barekat Inactivated Vaccine Candidate for SARS-CoV-2: A Preclinical Study". bioRxiv 10.1101/2021.06.10.447951.
  35. ↑ 35.0 35.1 35.2 "IRCT | A double-blinded, randomized, placebo-controlled Phase I Clinical trial to evaluate the safety and immunogenicity of COVID-19 inactivated vaccine (Shif-Pharmed) in a healthy population". https://en.irct.ir/trial/52701. 
  36. ↑ 36.0 36.1 36.2 "IRCT | A double-blind, randomized, placebo-controlled Phase I Clinical trial to evaluate the safety and immunogenicity of COVID-19 inactivated vaccine (Shifa-Pharmed) in a healthy population aged 51-75 years". https://en.irct.ir/trial/54885. 
  37. ↑ "آغاز مرحله سوم تست انسانی کووایران برکت" (in Persian). Islamic Republic of Iran News Network. https://www.irinn.ir/fa/news/815160/آغاز-مرحله-سوم-تست-انسانی-کووایران-برکت. 
  38. ↑ 38.0 38.1 38.2 "IRCT | Comparison of the tolerability, safety, and immunogenicity of Shifa-Pharmed COVID-19 inactivated vaccine (CovIran) and Sinopharm vaccine in the healthy population aged 12 to 18 years: a double-blind, randomized, active-controlled, Phase I-II clinical trial.". https://en.irct.ir/trial/59490. 
  39. ↑ "Iranians demand a COVID-19 vaccine, not politics, from their leaders". 19 January 2021. https://www.latimes.com/world-nation/story/2021-01-19/iranians-demand-covid-19-vaccine-not-politics. 
  40. ↑ "Coronavirus Tzar Forced to Apologize to Clergy". 21 January 2021. https://iranwire.com/en/special-features/8673. 
  41. ↑ "Iran begins human trials for locally made coronavirus vaccine". Times of Israel. 29 December 2020. https://www.timesofisrael.com/iran-begins-human-trials-for-locally-made-coronavirus-vaccine/. 
  42. ↑ 42.0 42.1 "Some foreign states willing to cooperate in COVIran Barakat clinical test: Official". 30 March 2021. https://en.irna.ir/news/84279546/Some-foreign-states-willing-to-cooperate-in-COVIran-Barakat-clinical. 
  43. ↑ "تست انسانی واکسن ایرانی کرونا آغاز شد/ وزیر بهداشت: ما با ۱۰۰ سال سابقه، اولین واکسن‌ساز آسیا هستیم" (in Persian). Tasnim News Agency. https://www.tasnimnews.com/fa/news/1399/10/09/2420346. 
  44. ↑ "پایان تزریق فاز یک مطالعات واکسن کووایران برکت" (in Persian). Young Journalists Club. https://www.yjc.ir/fa/news/7657243. 
  45. ↑ 45.0 45.1 "Clinical trials of COVIRAN vaccine enter phases 2, 3". 15 March 2021. https://en.isna.ir/photo/99122519442/Clinical-trials-of-COVIRAN-vaccine-enter-phases-2-3. 
  46. ↑ 46.0 46.1 "واکسن ایران برکت احتمالا تا پایان خرداد ۱۴۰۰ به دست هموطنان می‌رسد" (in Persian). 24 March 2021. https://www.irna.ir/news/84273354. 
  47. ↑ 47.0 47.1 Minoo Mohraz et al. Safety and immunogenicity of aninactivated virus particle vaccine forSARS-CoV-2, BIV1-CovIran: findingsfrom double-blind, randomised, placebo-controlled, phase I and IIclinical trials among healthy adults BMJ Open, 2022
  48. ↑ "جزئیات مطالعه بالینی واکسن "کووایران برکت" منتشر شد + نتایج" (in fa). 2021-06-16. https://www.isna.ir/news/1400032619382/جزئیات-مطالعه-بالینی-واکسن-کووایران-برکت-منتشر-شد-نتایج. 
  49. ↑ "انتشارخلاصه نتایج تست انسانی واکسن کوو ایران برکت برای نخستین‌بار" (in fa). 2021-06-16. https://setad.ir/news/1665/انتشارخلاصه-نتایج-تست-انسانی-واکسن-کوو-ایران-برکت-برای-نخستین-بار. 
  50. ↑ "ایمنی‌زایی ۹۳.۵درصدی واکسن برکت در فاز دوم/ ۱۲ کشور برای خرید درخواست دادند" (in Persian). Tasnim News Agency. https://www.tasnimnews.com/fa/news/1400/04/02/2526504. 
  51. ↑ "خامنه‌ای پس از دریافت "واکسن ایرانی کرونا": واکسن خارجی هم ایرادی ندارد" (in fa). https://www.radiofarda.com/a/31325701.html. 
  52. ↑ "جلیلی: واکسن کوو ایران برکت، ویروس انگلیسی را خنثی می‌کند" (in Persian). Young Journalists Club. https://www.yjc.news/fa/news/7647589/جلیلی-واکسن-کوو-ایران-برکت-ویروس-انگلیسی-را-خنثی-می-کند. 
  53. ↑ "موفقیت واکسن ایرانی در خنثی کردن "ویروس جهش‌یافته انگلیسی"" (in Persian). Iranian Students News Agency. https://www.isna.ir/news/99111107581/موفقیت-واکسن-ایرانی-در-خنثی-کردن-ویروس-جهش-یافته-انگلیسی. 
  54. ↑ "Iran Vaccine Boasts Total Protection Against U.K. Covid Strain". 17 February 2021. https://www.bloomberg.com/news/articles/2021-02-17/iran-vaccine-boasts-total-protection-against-u-k-covid-strain. 
  55. ↑ "Safety and immunogenicity of an inactivated virus particle vaccine for SARS-CoV-2, BIV1-CovIran: findings from double-blind, randomised, placebo-controlled, phase I and II clinical trials among healthy adults". BMJ Open 12 (4): e056872. April 2022. doi:10.1136/bmjopen-2021-056872. PMID 35396297. 
  56. ↑ "COVIRAN begins clinical trial on children aged 12-18" (in en). 2021-11-23. https://www.tehrantimes.com/news/467335/COVIRAN-begins-clinical-trial-on-children-aged-12-18. 
  57. ↑ "COVIran Barekat to be exported to Nicaragua" (in en). http://iranpress.com/content/56574/coviran-barekat-exported-nicaragua. 
  58. ↑ "Irán dona a Nicaragua 200.000 dosis de vacunas contra la covid-19". https://www.efe.com/efe/america/sociedad/iran-dona-a-nicaragua-200-000-dosis-de-vacunas-contra-la-covid-19/20000013-4764787. 
  59. ↑ "Iran exports COVID-19 vaccines to Nicaragua" (in en). 2022-06-22. https://www.tehrantimes.com/news/473934/Iran-exports-COVID-19-vaccines-to-Nicaragua. 
  60. ↑ Actual, Prensa Nicaragua (2022-06-22). "Nicaragua recibe primer lote de vacuna iraní contra el coronavirus COVIran Barekat" (in es). https://nicaraguaactual.tv/nicaragua-recibe-primer-lote-vacuna-iran-coronavirus-coviran-barekat/. 
  61. ↑ "Nicaragua recibe 200 mil dosis de la vacuna Coviran donadas por Irán" (in es). https://www.el19digital.com/articulos/ver/titulo:129361-nicaragua-recibe-200-mil-dosis-de-la-vacuna-coviran-donadas-por-iran. 
  62. ↑ "مجوز مصرف واکسن "کووایران برکت" صادر شد" (in Persian). Young Journalists Club. https://www.yjc.news/fa/news/7788537/. 
  63. ↑ "COVIRAN BAREKAT in process to WHO's registration" (in en). 2021-07-25. https://www.tehrantimes.com/news/463380/COVIRAN-BAREKAT-in-process-to-WHO-s-registration. 
  64. ↑ "Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process". 2 March 2022. https://extranet.who.int/pqweb/key-resources/documents/status-covid-19-vaccines-within-who-eulpq-evaluation-process. 
  65. ↑ "COVIRAN vaccine begins global registration process" (in en). 2022-01-28. https://www.tehrantimes.com/news/469544/COVIRAN-vaccine-begins-global-registration-process. 
  66. ↑ "FarsNews Agency Ayatollah Khamenei Receives Iran-Made Coronavirus Vaccine". 2021-06-25. https://www.farsnews.ir/en/news/14000404000230/Ayallah-Khamenei-Receives-Iran-Made-Crnavirs-Vaccine. 
  67. ↑ "Iran's Supreme Leader Khamenei receives local COVID vaccine" (in en). 2021-06-21. https://www.aljazeera.com/news/2021/6/25/irans-supreme-leader-receives-local-covid-vaccine. 
  68. ↑ "Leader receives second dose of Iranian COVID-19 vaccine" (in en). 2021-07-23. https://en.isna.ir/photo/1400050100346/Leader-receives-second-dose-of-Iranian-COVID-19-vaccine. 
  69. ↑ "Iran records over 500 Covid deaths, hits new high" (in en). 2021-08-08. https://www.france24.com/en/live-news/20210808-iran-records-over-500-covid-deaths-hits-new-high. 
  70. ↑ "قالیباف واکسن برکت دریافت کرد" (in fa). 2021-08-07. https://www.isna.ir/news/1400051611463/قالیباف-واکسن-برکت-دریافت-کرد. 
  71. ↑ "علی لاریجانی واکسن ایرانی تزریق کرد" (in fa). 2021-08-03. http://www.alef.ir/news/4000512090.html. 
  72. ↑ "عکس/ تزریق واکسن برکت به آملی لاریجانی" (in fa). 2021-08-04. https://www.mashreghnews.ir/photo/1254559/عکس-تزریق-واکسن-برکت-به-آملی-لاریجانی. 
  73. ↑ Torbati, Yeganeh (20 August 2022). "Amid covid surge, Iran cut corners to approve yet-unproven vaccine". The Washington Post. https://www.washingtonpost.com/world/2022/08/20/iran-covid-vaccine-approval/. 
  74. ↑ "CovIran Plus elicits protective neutralization against Omicron: study" (in en). 2022-02-16. https://www.tehrantimes.com/news/470186/CovIran-Plus-elicits-protective-neutralization-against-Omicron. 
  75. ↑ "خبرگزاری فارس - آغاز کارآزمایی بالینی واکسن برکت پلاس". 2022-03-02. https://www.farsnews.ir/photo/14001211000544/آغاز-کارآزمایی-بالینی-واکسن-برکت-پلاس. 
  76. ↑ Omicron-specific Barkat vaccine was developed IRNA, Retrieved 6 March 2022

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