FAKHRAVAC

Short description: Vaccine against COVID-19

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

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]

## Contents

* 1 Medical uses
* 2 Pharmacology
* 3 Manufacturing
* 4 Clinical trials
* 5 Authorizations
* 6 See also
* 7 References

## 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

|
|
|
|

Total  | Vaccine  | Control
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]

## See also

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

## References

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.
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.`{{cite web}}`: CS1 maint: url-status (link)
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.`{{cite web}}`: CS1 maint: url-status (link)
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.
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
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.

* v
* t
* e

Artificial induction of immunity / Immunization: Vaccines, Vaccination, Infection, Biology:Inoculat, Inoculation (J07)

Development|

* Adjuvants
* List of vaccine ingredients
* Mathematical modelling
* Timeline
* Trials

Classes|

* Conjugate vaccine
* DNA vaccination
* Inactivated vaccine
* Live vector vaccine
* Attenuated vaccine
* Heterologous vaccine
* Subunit/component / Peptide / Virus-like particle
* Toxoid

Administration|

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Vaccines|

| Bacterial|

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|

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Controversy|

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Related|

* Epidemiology
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* Every Child by Two
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* #WHO-EM
* ‡Withdrawn from market
* Clinical trials:
* †Phase III
* §Never to phase III

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