CoviVac (Russia COVID-19 vaccine)

Last updated

CoviVac
КовиВак
Vaccine description
Target SARS-CoV-2
Vaccine type Inactivated
Clinical data
Routes of
administration
Intramuscular
ATC code
  • None
Legal status
Legal status
  • Registered in Russia on 20 February 2021

CoviVac (Russian : КовиВак) is an inactivated virus-based COVID-19 vaccine developed by the Chumakov Centre  [ ru ], [1] which is an institute of the Russian Academy of Sciences. [2] It was approved for use in Russia in February 2021, being the third COVID-19 vaccine to get approval in Russia. [1] It obtained a permission for phase III clinical trial on 2 June 2021. [3]

Contents

Medical use

The CoviVac shot is given in two doses, 14 days apart. It is transported and stored at normal refrigerated temperatures, of 2 to 8 degrees Celsius (35.6 to 46.4 Fahrenheit). [1]

Efficacy has not yet been established in a phase III clinical trial.

Chemistry

One dose of 0.5 ml is composed only of 3 μg or more of SARS-CoV-2 strain AYDAR-1 antigen inactivated by beta-propiolactone and the following excipients: [4]

Manufacturing

As an inactivated vaccine, CoviVac uses a more traditional technology that is similar to the inactivated polio vaccine. Initially, a sample of SARS-CoV-2 strain AYDAR-1 was isolated by the Chumakov Center at the Russian Academy of Sciences and used to grow large quantities of the virus using vero cells. From then on, the viruses are soaked in beta-propiolactone, which deactivates them by binding to their genes, while leaving other viral particles intact. The resulting inactivated viruses are then mixed with an aluminium-based adjuvant. [5]

History

Clinical trials

On September 21, 2020, phase I/II trials started and was expected to last through October 15, 2020. [6] [7]

In early 2021, phase III trials started and is expected to end on 30 December 2022. [8]

Authorization

  Full authorization
  Emergency authorization

On 20 February 2021, President Vladimir Putin announced that the vaccine was approved. [1]

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References

  1. 1 2 3 4 Ivanova P (20 February 2021). "Russia approves its third COVID-19 vaccine, CoviVac". Reuters. Retrieved 13 March 2021.
  2. Abbany Z (9 March 2021). "Two more Russian vaccines: What we do and don't know". Deutsche Welle. Retrieved 13 March 2021.
  3. Реестр разрешений на проведение клинических исследований лекарственных средств. (in Russian), Catalogue of permissions for conducting clinical trials of pharmaceuticals, 2 June 2021, Minzdrav
  4. "КовиВак (Вакцина коронавирусная инактивированная цельновирионная концентрированная очищенная)" [CoviVac (Inactivated whole-virion concentrated, purified coronavirus vaccine)]. vidal.ru (in Russian). 24 February 2021. Retrieved 19 May 2021.
  5. Kozlovskaya L, Pinyaeva A, Kovpak A, Gordeichuk I, Volok V, Ignatiev G (1 April 2021). "«КОВИВАК»: инактивированный, но активный" ["COVIVAC": inactivated but active]. indicator.ru (Interview) (in Russian). Interviewed by Vodovozov A. Retrieved 19 May 2021.
  6. "Clinical Trial of Immunogenicity Bridging of a Recombinant New Coronavirus(COVID-19)Vaccine (CHO Cell)". clinicaltrials.gov. United States National Library of Medicine. 16 September 2021. Retrieved 16 September 2021.
  7. "№ Двойное слепое плацебо-контролируемое рандомизированное исследование переносимости, безопасности и иммуногенности вакцины КовиВак (Вакцина коронавирусная инактивированная цельновирионная концентрированная очищенная), производства ФГАНУ ФНЦИРИП им. М.П. Чумакова РАН (Институт полиомиелита), на добровольцах в возрасте 18-60 лет". clinline.ru. ClinLine. 21 September 2020.
  8. "Реестр разрешений на проведение клинических исследований лекарственных средств" [Register of approvals for clinical trials of medicinal products]. rosminzdrav.ru (in Russian). 2 July 2021. Retrieved 2 July 2021.