COVIran Barekat
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]
Vaccine description
BIV1-CovIran[1]
COVIran Barakat
COVIran Barkat
کووایران برکت
- None
- Emergency use authorization: IRN
Full and emergency authorizations
Full list of COVIran Barekat authorizations
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 93.5% (95% CI, 88.4–99.6%) of the receivers of the vaccine have produced neutralizing antibodies against SARS-CoV-2.[8] Those results have not been peer-reviewed and describe the immunogenicity of the vaccine and not its efficacy.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]
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[edit]
It is given by intramuscular injection and requires two doses given 28 days apart.[15]
Pharmacology[edit]
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[edit]
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]
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]
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[edit]
Preclinical trials[edit]
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[edit]
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]