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FAKHRAVAC

From Wikipedia, the free encyclopedia
Vaccine against COVID-19

Pharmaceutical compound
FAKHRAVAC
A vial of FakhraVac
Vaccine description
TargetSARS-CoV-2
Vaccine typeInactivated
Clinical data
Other namesFakhra, MIVAC
Routes of
administration
Intramuscular
Legal status
Legal status
  • Emergency use authorization:IRN
Part ofa series on the
COVID-19 pandemic
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
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FAKHRAVAC (Persian:واکسن فخرا) is aCOVID-19 vaccine developed inIran by theOrganization of Defensive Innovation and Research,[1] a subsidiary ofIran's Ministry of Defense. It is the third Iranian COVID-19 vaccine reachingclinical trials.[1][2][3] It is currently inphase III.[4][5] It received emergency use authorization in Iran on 9 September 2021.[4]

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

Medical uses

[edit]

It requires two doses given byintramuscular injection 3 weeks apart.[5]

Pharmacology

[edit]

FAKHRAVAC is aninactivated virus-based vaccine.[3]

Manufacturing

[edit]

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 ".[4] In October 2021, the production was 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

[edit]
Clinical trials of FAKHRAVAC
PhaseRegistration numberStartNumber of participantsAge of participants
TotalVaccineControl
IIRCT20210206050259N1Archived 28 April 2021 at theWayback Machine8 March 202113596?39?(placebo)18–55 years
IIIRCT20210206050259N2Archived 16 June 2021 at theWayback Machine8 June 2021500250250(placebo)18–70 years
IIIIRCT20210206050259N3Archived 7 September 2021 at theWayback Machine29 August 202141,12820,56420,564(Sinopharm BIBP vaccine)>18 years

Authorizations

[edit]
See also:List of COVID-19 vaccine authorizations § FAKHRAVAC

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

[edit]

References

[edit]
  1. ^abcdeMotamedi M (16 March 2021)."Iran starts human trials of its third domestic COVID vaccine". Al Jazeera.
  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. Archived fromthe original on 28 April 2021. Retrieved21 March 2021.
  3. ^ab"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. Archived fromthe original on 16 June 2021. Retrieved15 June 2021.
  4. ^abcd"Iran Authorizes Emergency Use of Third Homegrown Vaccine - Defense news".Tasnim News Agency. Retrieved9 September 2021.
  5. ^ab"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".en.irct.ir. Archived fromthe original on 7 September 2021. Retrieved7 September 2021.
  6. ^"Research center run by Fakhrizadeh produced first COVID-19 test kits for Iranians: Defense minister".Pars Today. 28 November 2020.Archived from the original on 5 December 2020. Retrieved7 September 2021.
  7. ^The Assassination of Fakhrizadeh: Considerations and Consequences
  8. ^abSinaee, Maryam (19 October 2021)."Iran Defense Ministry's Covid Vaccine Production To Be Discontinued". Iran International. Retrieved24 October 2021.
  9. ^"تحویل نخستین محموله واکسن فخرا به وزارت بهداشت".YJC News. 19 January 2022.
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