FAKHRAVAC

FAKHRAVAC
	A vial of FakhraVac
Vaccine description
Target disease	SARS-CoV-2
Type	Killed/Inactivated
Clinical data
Other names	Fakhra, MIVAC
Routes of; administration	Intramuscular
Legal status
Legal status	Emergency use authorization: IRN;

Short description: Vaccine against COVID-19

FAKHRAVAC (Persian: واکسن فخرا‎) is a COVID-19 vaccine developed in Iran by the Organization of Defensive Innovation and Research,^[1] a subsidiary of Iran's Ministry of Defense. It's the third Iranian COVID-19 vaccine reaching clinical trials.^[1]^[2]^[3] It's currently in phase III.^[4]^[5] It has received emergency use authorization in Iran on 9 September 2021.^[4]

The vaccine is named after the Iranian nuclear scientist Mohsen Fakhrizadeh.^[1] According to the Iranian authorities, he was working on a vaccine in response to the COVID-19 pandemic in Iran.^[1]^[6] Fakhrizadeh was assassinated in November 2020 in an attack Iran and US intelligence attributed to Israel.^[1]^[7]

Medical uses

It requiring two doses given by intramuscular injection 3 weeks apart.^[5]

Pharmacology

FAKHRAVAC is an inactivated virus-based vaccine.^[3]

Manufacturing

In August 2021, production capacity of the vaccine is reported to be 1 million dose per month and is planned to be "multiplied in a few months ".^[4] In October 2021, the production has reported to be stopped amid Iran's growing vaccine imports.^[8] In January 2022, the Director General of Health of the Ministry of Defense announced that the first shipment (around 462,000 doses) of the vaccine had been delivered to the Iranian Ministry of Health.^[9]

Clinical trials

Clinical trials of FAKHRAVAC
Phase	Registration number	Start	Number of participants			Age of participants
Phase	Registration number	Start	Total	Vaccine	Control	Age of participants
I	IRCT20210206050259N1	8 March 2021	135	96?	39? (placebo)	18–55 years
II	IRCT20210206050259N2	8 June 2021	500	250	250 (placebo)	18–70 years
III	IRCT20210206050259N3	29 August 2021	41,128	20,564	20,564 (Sinopharm BIBP vaccine)	>18 years

Authorizations

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Full authorization

Emergency authorization

FAKHRAVAC received emergency use authorization in Iran on 9 September 2021.^[4] In October 2021, Iran's Food and Drug Administration was considering giving full authorization to the vaccine for third/booster dose.^[8]

References

↑ ^1.0 ^1.1 ^1.2 ^1.3 ^1.4 "Iran starts human trials of its third domestic COVID vaccine". Al Jazeera. 16 March 2021. https://www.aljazeera.com/news/2021/3/16/iran-starts-human-trials-on-third-locally-developed-vaccine.
↑ "Phase 1, safety, immunogenicity and dose finding for two strengths of 0.5 × 10^6 and 2.5 × 10^6 (TCID50) inactivated SARS-CoV-2 vaccine FAKHRAVAC (MIVAC) injected in two schedules of two doses, 2 and 3 weeks apart in healthy adults aged 18-55 years: a randomized, double blind, placebo controlled, clinical trial". en.irct.ir. Iran Registry of Clinical Trials. Retrieved 21 March 2021.
↑ ^3.0 ^3.1 "Phase 2 trial of safety and immunogenicity of 10 micro gram inactivated SARS-CoV-2 vaccine (FAKHRAVAC), two doses two weeks apart in adults aged 18-70 years: a randomized, double-blind, placebo-controlled, clinical trial". en.irct.ir. Iran Registry of Clinical Trials. Retrieved 15 June 2021.
↑ ^4.0 ^4.1 ^4.2 ^4.3 "Iran Authorizes Emergency Use of Third Homegrown Vaccine - Defense news" (in en). https://www.tasnimnews.com/en/news/2021/09/09/2568712/iran-authorizes-emergency-use-of-third-homegrown-vaccine.
↑ ^5.0 ^5.1 "IRCT | Comparison of the safety, efficacy and immunogenicity of Fakhravac and Sinopharm SARS-CoV-2 vaccines, in adults aged 18 and over; a phase III randomised, non-inferiority clinical trial". https://en.irct.ir/trial/57980.
↑ "Research center run by Fakhrizadeh produced first COVID-19 test kits for Iranians: Defense minister". 28 November 2020. https://parstoday.com/en/news/iran-i130017.
↑ The Assassination of Fakhrizadeh: Considerations and Consequences
↑ ^8.0 ^8.1 Sinaee, Maryam (19 October 2021). "Iran Defense Ministry's Covid Vaccine Production To Be Discontinued". Iran International. https://www.iranintl.com/en/20211019602361.
↑ "تحویل نخستین محموله واکسن فخرا به وزارت بهداشت". 2022-01-19. https://www.yjc.news/00XiJR.

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[:0-1] 1.0 ^1.1 ^1.2 ^1.3 ^1.4 "Iran starts human trials of its third domestic COVID vaccine". Al Jazeera. 16 March 2021. https://www.aljazeera.com/news/2021/3/16/iran-starts-human-trials-on-third-locally-developed-vaccine.

[:1-2] "Phase 1, safety, immunogenicity and dose finding for two strengths of 0.5 × 10^6 and 2.5 × 10^6 (TCID50) inactivated SARS-CoV-2 vaccine FAKHRAVAC (MIVAC) injected in two schedules of two doses, 2 and 3 weeks apart in healthy adults aged 18-55 years: a randomized, double blind, placebo controlled, clinical trial". en.irct.ir. Iran Registry of Clinical Trials. Retrieved 21 March 2021.

[:2-3] 3.0 ^3.1 "Phase 2 trial of safety and immunogenicity of 10 micro gram inactivated SARS-CoV-2 vaccine (FAKHRAVAC), two doses two weeks apart in adults aged 18-70 years: a randomized, double-blind, placebo-controlled, clinical trial". en.irct.ir. Iran Registry of Clinical Trials. Retrieved 15 June 2021.

[:4-4] 4.0 ^4.1 ^4.2 ^4.3 "Iran Authorizes Emergency Use of Third Homegrown Vaccine - Defense news" (in en). https://www.tasnimnews.com/en/news/2021/09/09/2568712/iran-authorizes-emergency-use-of-third-homegrown-vaccine.

[:3-5] 5.0 ^5.1 "IRCT | Comparison of the safety, efficacy and immunogenicity of Fakhravac and Sinopharm SARS-CoV-2 vaccines, in adults aged 18 and over; a phase III randomised, non-inferiority clinical trial". https://en.irct.ir/trial/57980.

[6] "Research center run by Fakhrizadeh produced first COVID-19 test kits for Iranians: Defense minister". 28 November 2020. https://parstoday.com/en/news/iran-i130017.

[7] The Assassination of Fakhrizadeh: Considerations and Consequences

[:5-8] 8.0 ^8.1 Sinaee, Maryam (19 October 2021). "Iran Defense Ministry's Covid Vaccine Production To Be Discontinued". Iran International. https://www.iranintl.com/en/20211019602361.

[9] "تحویل نخستین محموله واکسن فخرا به وزارت بهداشت". 2022-01-19. https://www.yjc.news/00XiJR.

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