CoviVac (Russia COVID-19 vaccine) explained
| Type: | vaccine |
| Target: | SARS-CoV-2 |
| Vaccine Type: | Inactivated |
| Drug Name: | CoviVac
КовиВак |
| Routes Of Administration: | Intramuscular |
| Atc Prefix: | None |
| Legal Status: | Registered in Russia on 20 February 2021Full list of CoviVac vaccine authorizations |
CoviVac (Russian: КовиВак) is an inactivated virus-based COVID-19 vaccine developed by the,[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. It obtained a permission for phase III clinical trial on 2 June 2021.[3]
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).
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
On 20 February 2021, President Vladimir Putin announced that the vaccine was approved.[1]
Notes and References
- News: Ivanova P . 20 February 2021 . Russia approves its third COVID-19 vaccine, CoviVac. en. Reuters. 13 March 2021 .
- Web site: Abbany Z . Deutsche Welle . Two more Russian vaccines: What we do and don't know . 9 March 2021 . 13 March 2021 . en-GB.
- http://grls.rosminzdrav.ru/CiPermitionReg.aspx?DateBeg=02.06.2021&RegNm=279 Реестр разрешений на проведение клинических исследований лекарственных средств.
- Web site: КовиВак (Вакцина коронавирусная инактивированная цельновирионная концентрированная очищенная) . CoviVac (Inactivated whole-virion concentrated, purified coronavirus vaccine) . vidal.ru . 2021-05-19 . Russian . 2021-02-24.
- Kozlovskaya L, Pinyaeva A, Kovpak A, Gordeichuk I, Volok V, Ignatiev G . Vodovozov . Alexey . «КОВИВАК»: инактивированный, но активный . "COVIVAC": inactivated but active . Interview . 2021-05-19 . indicator.ru . 2021-04-01 . Russian.
- Web site: 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 . 16 September 2021 . live. https://web.archive.org/web/20210919122623/https://clinicaltrials.gov/ct2/show/NCT05046548 . 19 September 2021 .
- Web site: № 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 . live. https://web.archive.org/web/20210609220640/https://clinline.ru/reestr-klinicheskih-issledovanij/502-21.09.2020.html . 9 June 2021 .
- Web site: Реестр разрешений на проведение клинических исследований лекарственных средств . Register of approvals for clinical trials of medicinal products . rosminzdrav.ru . 2021-07-02 . Russian . 2021-07-02.
