Setad (EIKO) (2021-06-16), خلاصه ی یافته های مطالعات کوویران برکت (منطبق با گزارشات ارایه شده به سلزمان غذا و دارو) [Summary of the findings of the COVIran Barekat studies (according to the reports submitted to the Food and Drug Administration)] (PDF) (in Persian), archived from the original (PDF) on 2021-06-16, retrieved 2021-09-05

^[1]

Trial

All studies were randomized, double-blind, parallel arms, placebo-controlled and have been conducted on healthy volunteers.

Phase I

Iran Food and Drug Administration has approved the vaccine for testing on humans. ^{[2] [3] [4]} According to reports, more than 65,000 Iranians volunteered to test the vaccine while only 56 people were needed. ^[5]

On 29 December 2020, human trials of Iran's first domestic COVID-19 vaccine candidate were started. ^{[5] [6]} The first volunteer who received a shot of COVIran Barekat was Tayyebeh Mokhber, the daughter of Mohammad Mokhber, director of Setad. ^[5] Minister of Health Saeed Namaki and Vice President for Science and Technology Sorena Sattari participated at the ceremony of vaccine injection.

Phase 1's primary outcome was safety assessment. ^[1] A first phase 1 study was conducted on 56 healthy volunteers who were at the age of 18–50. ^{[7] [8] [9] [10]} Last injections of the second doses occured on 4 March 2021. ^[1] A second phase 1 study was conducted on 32 volunteers aged 51-75 years. ^[11] First injections occured on March 15 and last injections on April 9. ^[1]

Phase II/III

Phases II and III of the clinical trials were combined, ^{[12] [13]} allowing to start the third phase before the second completed. Participants were aged between 18 and 75 years. ^[14]

Phase 2's primary outcome was immunogenicity assessment. ^[1] It was conducted on 280 volunteers. ^[14] The first volunteers were inoculated on March 15 ^[12] and the last injections of the second doses occured on May 25. ^[1]

Phase 3's primary outcome was efficacy assessment on preventing mild, moderate and severe disease. ^[1] It was conducted on 20,000 participants ^[14] accross 6 cities in Iran ( Tehran, Karaj, Shiraz, Isfahan, Mashhad and Bushehr). ^[13] Phase III has been reached on April 21; ^[15] and the first injections occurred on April 25. ^[16] Up to June 14, 18,000 volunteers received their first dose and 2,000 received their second dose of the vaccine or placebo. ^[1]

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. ^{[17] [18]} According to the report, only mild adverse effects were registered execept one case of hypotension, one case of level-2 headache and one case of diminution of platelets that didn't need medical care. ^[1] Conventionnal Virus Neutralizing Test (cVNT) is reported to have shown 93.5% immunogenicity (95% confidence interval: 88.4%, 99.6%). ^[1] 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". ^[19]

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, ^[20]

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". ^[21]

On 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. ^{[22] [23] [24]}

Ad

on the basis of phases 1 and 2 data which assessed the vaccine safety and immunogenicity; while phase 3 was still ongoing and assessed the efficacy.

Mohraz phase III

12 achetr ^[19]

var ^[19]

کمیته بالینی و اخلاق، وزارت بهداشت

factory ^[25]

احداث کارخانه تولید ماسک و تجهیزات پزشکی گرفته تا تولید رمدیسیویر و واکسن کرونا. ^[25]

Del

The second/third group of volunteers were also injected with the vaccine. ^{[26] [27]}

The first phase of the trials completed on 7 February 2021. ^[28]

and results have been presented to the Ministry of Health on March 2021. ^[29]

The Phase II-III of the clinical trials began on 13 March 2021. ^[14] The first volunteers of phase II were inoculated on March 29 ^{[30] [30]}

10,500 ^[31]

On 23 June 2021, 20000 dose 1. ^[19]

93.5% power to neutralize the virus ^{[25] [32]}

Original

Phase I

Iran Food and Drug Administration has approved the vaccine for testing on humans. ^{[2] [3] [4]}

On 29 December 2020, human trials of Iran's first domestic COVID-19 vaccine candidate were started. ^{[5] [6]}

Tayyebeh Mokhber, the first volunteer who receives a shot of COVIran Barekat was the daughter of Mohammad Mokhber director of Setad. ^[5] Minister of Health Saeed Namaki and Vice President for Science and Technology Sorena Sattari participated at the ceremony of vaccine injection. According to reports, there are more than 65,000 Iranians volunteered to test the vaccine and 56 selected people took part in the first phase of human trials which last 45 to 60 days. ^[5] The initial phase of human-testing for this vaccine started with the injection of 56 volunteers who were at the age of 18–50. ^{[7] [8] [9]} The second/third group of volunteers were also injected with the vaccine. ^{[26] [27]} The first phase of the trials completed on 7 February 2021. ^[28]

The results of Phase I study have been presented to the Ministry of Health on March 2021. ^[29] According to the head of the vaccine production team at the Setad, the results show that this vaccine also neutralizes the British mutated COVID-19 virus. ^{[22] [23] [24]}

A second phase I clinical trial have been conducted on people aged 51-75 years at the same time phase II/III. ^[11]

Phase II/III

The Phase II-III of the clinical trials began on 13 March 2021 with 280 participants for phase II and 20,000 participants for phase III. ^[14] Participants were aged between 18 and 75 years. ^[14] According to the allowance of medical equipment department, the second phase coincided with third phase. ^{[12] [13]} The first volunteers of phase II were inoculated on March 29; ^[30] phase III has been reached on April 21; ^[15] and the first injection(s) of the 3rd phase occurred on April 25. ^[16]

On 16 June 2021, a summary of the results obtained so far in the clinical trials have been published in the press. ^{[17] [18]} 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". ^{[19] [25] [32]}

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, ^[20] 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 will be sent to 10 important scientific journals of the world but it may take time before they publish it. ^[21]

Other

On 29 December 2020, a Phase 1 clinical trial of COVIran Barekat, an inactivated whole virus COVID-19 vaccine made by Barkat Pharmaceutical Group subsidiary Shifa Pharmed, began with 56 volunteers. ^{[33] [34]} The second group of the volunteers was also injected with the vaccine. ^{[35] [36] [37]} According to the head of the vaccine production team at the Setad, the results show that this vaccine also neutralizes the British mutated COVID-19 virus. ^{[38] [39] [40]} The vaccine has passed the phase(s) 2 and 3 of clinical studies; ^{[41] [42]} and currently it has reached its final phase. ^[43] According to the Deputy Coordinator of the Execution of Imam Khomeini's Order: So far, about 5 million doses of COVIran Barekat vaccine have been produced in Shifa Pharmed factory. ^[44]

COVIran Barekat is Iran's first domestic COVID-19 vaccine. ^[34] It's made by Shifa Pharmed Industrial Group, a subsidiary of Barkat Pharmaceutical Group. ^{[34] [45]} Clinical trials began on December 2020 ^{[34] [46]} and the vaccine received emergency use authorization on 13 June 2021. ^[47] According to the Execution of Imam Khomeini's Order, about 8 million doses of COVIran Barekat have been produced up to 30 August 2021. ^[48]

COVIran Barekat, The first COVID-19 vaccine produced by Iranian researchers has been produced by Shifa-Pharmed Company (a subsidiary of Barakat Pharmaceutical Group). ^[49] The human-injection of the first phase of clinical studies of the Iranian corona vaccine on December 29, 2020; The first phase of human testing of the vaccine began with the injection for 56 volunteers. ^{[50] [51] [52]} The second group of the volunteers was also injected with the vaccine. ^{[53] [54] [55]} According to the head of the vaccine production team at the Setad, the results show that this vaccine also neutralizes the British mutated COVID-19 virus. ^{[56] [57] [58] [59]} The vaccine has passed the phase(s) 2 and 3 of clinical studies; ^[60] and currently it has reached its final phase. ^{[61] [62]} The production line of 25 million doses per month of the vaccine was discharged on 26 April 2021. ^[63]

With the signing of a memorandum (of understanding) of cooperation between the Barakat Foundation and the Deputy Minister of "Cultural Heritage, Handicrafts and Tourism", the process of creating 3,000 jobs began with the support of 1,000 handicraft production projects with priority given to the victims of COVID-19. ^[64] According to the Deputy Coordinator of the Execution of Imam Khomeini's Order: On 27 July 2021, about 5 million doses of Iran Barakat vaccine have been produced in Shafa-farmad factory so far. ^[65]

ref

tabl pr, del, adm

challenge, prior covid

Preclinical.

2eme ph 2

placebo, db blind,

Summary of phase 1 and 2

variants

Auth based on results of phase 1 and 2, comm to moh

refu etrgr

sanct

effect, price, imp

atr pys

ts vir

Ref