FAKHRAVAC explained

Type:	vaccine
Target:	SARS-CoV-2
Vaccine Type:	inactivated
Legal Status:	Emergency use authorization:
Routes Of Administration:	Intramuscular
Synonyms:	Fakhra, MIVAC

FAKHRAVAC (fa|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 is the third Iranian COVID-19 vaccine reaching clinical trials. It is currently in phase III.^[2] It received emergency use authorization in Iran on 9 September 2021.

The vaccine is named after the Iranian nuclear scientist Mohsen Fakhrizadeh. According to the Iranian authorities, he was working on a vaccine in response to the COVID-19 pandemic in Iran.^[3] Fakhrizadeh was assassinated in November 2020 in an attack Iran and US intelligence attributed to Israel.^[4]

Medical uses

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

Pharmacology

FAKHRAVAC is an inactivated virus-based vaccine.

Manufacturing

In August 2021, production capacity of the vaccine was reported to be 1 million dose per month and was planned to be "multiplied in a few months ". In October 2021, the production was reported to be stopped amid Iran's growing vaccine imports.^[6] 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.^[7]

Clinical trials

Phase! rowspan="2"

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

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

See also

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

Notes and References

1. News: Motamedi M . Iran starts human trials of its third domestic COVID vaccine . Al Jazeera . 16 March 2021.
2. Web site: Iran Authorizes Emergency Use of Third Homegrown Vaccine - Defense news. 2021-09-09. Tasnim News Agency. en.
3. Web site: 28 November 2020. Research center run by Fakhrizadeh produced first COVID-19 test kits for Iranians: Defense minister. live. https://web.archive.org/web/20201205205346/https://parstoday.com/en/news/iran-i130017-research_center_run_by_fakhrizadeh_produced_first_covid_19_test_kits_for_iranians_defense_minister. 5 December 2020. 7 September 2021. Pars Today.
4. https://www.inss.org.il/publication/fakhrizadeh/ The Assassination of Fakhrizadeh: Considerations and Consequences
5. Web site: 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. 2021-09-07. en.irct.ir. 7 September 2021. https://web.archive.org/web/20210907090130/https://en.irct.ir/trial/57980. dead.
6. News: Sinaee . Maryam . Iran Defense Ministry's Covid Vaccine Production To Be Discontinued . 24 October 2021 . Iran International . 19 October 2021.
7. Web site: 2022-01-19. تحویل نخستین محموله واکسن فخرا به وزارت بهداشت. YJC News.