FAKHRAVAC

Last updated

FAKHRAVAC
FakhraVac vaccine 01 (cropped).jpg
A vial of FakhraVac
Vaccine description
Target SARS-CoV-2
Vaccine type Inactivated
Clinical data
Other namesFakhra, MIVAC
Routes of
administration
Intramuscular
Legal status
Legal status
  • Emergency use authorization: IRN

FAKHRAVAC 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]

Contents

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]

Medical uses

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

Pharmacology

FAKHRAVAC is an inactivated virus-based vaccine. [3]

Manufacturing

On 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]

Clinical trials

Clinical trials of FAKHRAVAC
PhaseRegistration numberStartNumber of participantsAge of participants
TotalVaccineControl
I IRCT20210206050259N1 8 March 202113596?39? (placebo)18-55 years
II IRCT20210206050259N2 8 June 2021500250250 (placebo)18-70 years
III IRCT20210206050259N3 29 August 202141,12820,56420,564 (Sinopharm BIBP vaccine)>18 years

Authorizations

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]



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References

  1. 1 2 3 4 5 Motamedi 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. Retrieved 21 March 2021.
  3. 1 2 "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.
  4. 1 2 3 4 "Iran Authorizes Emergency Use of Third Homegrown Vaccine - Defense news". Tasnim News Agency. Retrieved 9 September 2021.
  5. 1 2 "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. Retrieved 7 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. Retrieved 7 September 2021.
  7. The Assassination of Fakhrizadeh: Considerations and Consequences
  8. 1 2 Sinaee, Maryam (19 October 2021). "Iran Defense Ministry's Covid Vaccine Production To Be Discontinued". Iran International. Retrieved 24 October 2021.