FAKHRAVAC

{{short description|Vaccine against COVID-19}}

{{Use dmy dates|date=June 2021}}

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| target = SARS-CoV-2

| vaccine_type = inactivated

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| legal_status = Emergency use authorization: {{abbr|IRN|Iran}}

| routes_of_administration = Intramuscular

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| synonyms = Fakhra, MIVAC

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FAKHRAVAC ({{langx|fa|واکسن فخرا}}) is a COVID-19 vaccine developed in Iran by the Organization of Defensive Innovation and Research,{{cite news | vauthors = Motamedi M |title=Iran starts human trials of its third domestic COVID vaccine |url=https://www.aljazeera.com/news/2021/3/16/iran-starts-human-trials-on-third-locally-developed-vaccine |publisher=Al Jazeera |date=16 March 2021}} a subsidiary of Iran's Ministry of Defense. It is the third Iranian COVID-19 vaccine reaching clinical trials.{{Cite web |title=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 |url=https://en.irct.ir/trial/54133 |website=en.irct.ir |publisher=Iran Registry of Clinical Trials |access-date=21 March 2021 }}{{Cite web |title=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 |url=https://en.irct.ir/trial/56027 |website=en.irct.ir |publisher=Iran Registry of Clinical Trials |access-date=15 June 2021 }} It is currently in phase III.{{Cite web|title=Iran Authorizes Emergency Use of Third Homegrown Vaccine - Defense news|url=https://www.tasnimnews.com/en/news/2021/09/09/2568712/iran-authorizes-emergency-use-of-third-homegrown-vaccine|access-date=2021-09-09|website=Tasnim News Agency|language=en}} 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.{{Cite web|date=28 November 2020|title=Research center run by Fakhrizadeh produced first COVID-19 test kits for Iranians: Defense minister|url=https://parstoday.com/en/news/iran-i130017|url-status=live|archive-url=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|archive-date=5 December 2020|access-date=7 September 2021|website=Pars Today}} Fakhrizadeh was assassinated in November 2020 in an attack Iran and US intelligence attributed to Israel.[https://www.inss.org.il/publication/fakhrizadeh/ The Assassination of Fakhrizadeh: Considerations and Consequences]

Medical uses

It requires two doses given by intramuscular injection 3 weeks apart.{{Cite web|title=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|url=https://en.irct.ir/trial/57980|access-date=2021-09-07|website=en.irct.ir|archive-date=7 September 2021|archive-url=https://web.archive.org/web/20210907090130/https://en.irct.ir/trial/57980|url-status=dead}}

Pharmacology

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.{{cite news |last1=Sinaee |first1=Maryam |title=Iran Defense Ministry's Covid Vaccine Production To Be Discontinued |url=https://www.iranintl.com/en/20211019602361 |access-date=24 October 2021 |publisher=Iran International |date=19 October 2021}} 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.{{Cite web|date=2022-01-19|title=تحویل نخستین محموله واکسن فخرا به وزارت بهداشت|url=https://www.yjc.news/00XiJR|website=YJC News}}

Clinical trials

class="wikitable"

|+Clinical trials of FAKHRAVAC

! rowspan="2" |Phase

! rowspan="2" |Registration number

! rowspan="2" |Start

! colspan="3" |Number of participants

! rowspan="2" |Age of participants

Total

!Vaccine

!Control

I

|[https://en.irct.ir/trial/54133 IRCT20210206050259N1] {{Webarchive|url=https://web.archive.org/web/20210428190456/https://en.irct.ir/trial/54133 |date=28 April 2021 }}

|8 March 2021

|135

|96?

|39? (placebo)

|18–55 years

II

|[https://en.irct.ir/trial/56027 IRCT20210206050259N2] {{Webarchive|url=https://web.archive.org/web/20210616180400/https://en.irct.ir/trial/56027 |date=16 June 2021 }}

|8 June 2021

|500

|250

|250 (placebo)

|18–70 years

III

|[https://en.irct.ir/trial/57980 IRCT20210206050259N3] {{Webarchive|url=https://web.archive.org/web/20210907090130/https://en.irct.ir/trial/57980 |date=7 September 2021 }}

|29 August 2021

|41,128

|20,564

|20,564 (Sinopharm BIBP vaccine)

|>18 years

Authorizations

{{See also|List of COVID-19 vaccine authorizations#FAKHRAVAC}}

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

References

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{{Vaccines}}

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Category:Iranian COVID-19 vaccines

Category:Science and technology in Iran

Category:Inactivated vaccines