View source for Medicine:FAKHRAVAC

{{short description|Vaccine against COVID-19}}
{{Infobox drug
| Verifiedfields     =
| verifiedrevid      =
| drug_name          =
| INN                =
| type               = vaccine
| image              = FakhraVac vaccine 01 (cropped).jpg
| alt                =
| caption            = A vial of FakhraVac
| target             = [[Biology:Severe acute respiratory syndrome coronavirus 2|SARS-CoV-2]]
| vaccine_type       = inactivated
<!-- Clinical data -->| pronounce          =
| tradename          =
| Drugs.com          =
| MedlinePlus        =
| licence_EU         =
| licence_US         =
| pregnancy_AU       = <!-- A/B1/B2/B3/C/D/X -->
| pregnancy_category =
| legal_AU           = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled-->
| legal_AU_comment   =
| legal_BR           = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F-->
| legal_BR_comment   =
| legal_CA           = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_UK           = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM -->
| legal_US           = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| legal_UN           = <!-- N I, II, III, IV / P I, II, III, IV-->
| legal_NZ           = <!--Class A, B, C -->
| legal_status       = Emergency use authorization: {{abbr|IRN|Iran}}
| routes_of_administration = [[Biology:Intramuscular injection|Intramuscular]]
<!-- Identifiers -->| CAS_number         =
| ATCvet             =
| ATC_prefix         =
| ATC_suffix         =
| PubChem            =
| DrugBank           =
| synonyms           = Fakhra, MIVAC
}}
'''FAKHRAVAC''' ({{lang-fa|واکسن فخرا}}) is a [[Medicine:COVID-19 vaccine|COVID-19 vaccine]] developed in [[Religion:Iran|Iran]] by the Organization of Defensive Innovation and Research,<ref name=":0">{{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}}</ref> a subsidiary of Iran's Ministry of Defense. It's the third Iranian COVID-19 vaccine reaching [[Engineering:Clinical trial|clinical trial]]s.<ref name=":0" /><ref name=":1">{{#invoke: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 |url-status=live}}</ref><ref name=":2">{{#invoke: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 |url-status=live}}</ref> It's currently in [[Medicine:Phases of clinical research|phase III]].<ref name=":4">{{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}}</ref><ref name=":3" /> It has received emergency use authorization in Iran on 9 September 2021.<ref name=":4" />

The vaccine is named after the Iranian nuclear scientist Mohsen Fakhrizadeh.<ref name=":0" /> According to the Iranian authorities, he was working on a vaccine in response to the COVID-19 pandemic in Iran.<ref name=":0" /><ref>{{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}}</ref> Fakhrizadeh was assassinated in November 2020 in an attack Iran and US intelligence attributed to Israel.<ref name=":0" /><ref>[https://www.inss.org.il/publication/fakhrizadeh/ The Assassination of Fakhrizadeh: Considerations and Consequences]</ref>

== Medical uses ==
It requiring two doses given by [[Biology:Intramuscular injection|intramuscular injection]] 3 weeks apart.<ref name=":3">{{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}}</ref>

== Pharmacology ==
FAKHRAVAC is an [[Medicine:Inactivated vaccine|inactivated virus-based vaccine]].<ref name=":2" />

== 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 ".<ref name=":4" /> In October 2021, the production has reported to be stopped amid Iran's growing vaccine imports.<ref name=":5">{{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}}</ref> 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.<ref>{{Cite web|date=2022-01-19|title=تحویل نخستین محموله واکسن فخرا به وزارت بهداشت|url=https://www.yjc.news/00XiJR|url-status=live|website=YJC News}}</ref>

== 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]'''
|8 March 2021
|'''135'''
|96?
|39? <small>(placebo)</small>
|18–55 years
|-
|'''II'''
|'''[https://en.irct.ir/trial/56027 IRCT20210206050259N2]'''
|8 June 2021
|'''500'''
|250
|250 <small>(placebo)</small>
|18–70 years
|-
|'''III'''
|'''[https://en.irct.ir/trial/57980 IRCT20210206050259N3]'''
|29 August 2021
|'''41,128'''
|20,564
|20,564 <small>([[Medicine:Sinopharm BIBP COVID-19 vaccine|Sinopharm BIBP vaccine]])</small>
|>18 years
|}

==Authorizations==
{{image frame|content={{Graph:Map|scale=50|defaultValue=gainsboro
|IR=dodgerblue
|NZ=turquoise
|HU=turquoise
}}
|caption=
{{leftlegend|blueviolet|Full authorization}}
{{leftlegend|dodgerblue|Emergency authorization}}
}}
FAKHRAVAC received emergency use authorization in Iran on 9 September 2021.<ref name=":4" /> In October 2021, Iran's Food and Drug Administration was considering giving full authorization to the vaccine for third/booster dose.<ref name=":5" />

== See also ==
* Pharmaceuticals in Iran
* COVID-19 pandemic in Iran
* COVID-19 vaccine clinical research

== References ==
{{reflist}}


{{Vaccines}}

[[Category:Clinical trials]]

{{Sourceattribution|FAKHRAVAC|1}}