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Russia’s Covid-19 vaccine, The truth?

Some media channels on Sunday (12th July) reported that Russia’s Sechenov University had completed clinical trials of a vaccine for the novel coronavirus (SARS-CoV-2), claiming it as the ‘first vaccine in the world to complete human trials for Covid-19.’

We are here to tell you that it’s not true and they misstated it.

Sputnik News was one of the media channels which stated that the clinical trials of the “world’s first coronavirus vaccine” had been completed.

Update– It will be marketed and produced as ‘Sputnik V’ after the Soviet satellite name. It is developed jointly by Gamaleya Research Institute and the Russian Defence Ministry.

It is an adenoviral-based vaccine against SARS-CoV-2, containing the SARS-CoV-2 S protein(spike protein) gene.

According to the data on clinicaltrials.gov , the vaccine candidate by Sechenov University produced by Gamaleya Research Institute of Epidemiology and Microbiology named as ‘Gam-COVID-Vac Lyo’ states the estimated study completion date to be on 15th August.

It might be possible that it has completed only the Phase I of clinical trials. Russian News Agency, states that Chief researcher Elena Smolyarchuk told TASS on Sunday that

“Clinical trials of vaccine against the novel coronavirus were completed on volunteers at Sechenov University, and the results of research proved the medication’s effectiveness.”

“The research has been completed and it proved that the vaccine is safe. The volunteers will be discharged on July 15 and July 20,” Smolyarchuk stated.

However, it should be noted that this vaccine candidate has only completed the Phase I clinical studies.

The purpose of the study was to evaluate the safety, tolerability and immunogenicity of the drug “Gam-COVID-Vac Lyo”. It is an lyophilizate (Powdered form from which solution is prepared) and injected in healthy individuals via intramuscular route.

The Phase I study was non-randomized two-stage study with the participation of healthy individuals.

Table 01, made as per data on clinicaltrials.gov

Phase I StagesObjectiveAdministrationVolunteers
(People)
Time of InjectionDate
Stage 1Safety and tolerability assessmentIntramuscular, Single dose of Lyophilisate
(Say Component I)
Total=18 people;
Stage I(receive component I)- 9,

Stage II(with Comp. II)-9
Both
monitored for 5 days
18th June 2020
Stage 2Safety and tolerability assessmentIntramuscular, Lyophilisate using prime-boost immunization (Component II)Total=20 people;
Comp. I on Day 1, Component 2 on 21st day,
Follow-up on 7, 14, 28, 42 days
On 5th day after it is assessed to be safe23rd June 2020
The total number of volunteers in Phase I is 38.

“Throughout the inpatient observation and the follow-up period (180 days) of visits during the entire study, safety information will be collected”

graph on confirmed cases of Covid-19 by countries on 18 July 2020.
Graphical representation of Covid-19 confirmed cases by countries.

Currently, Russia has 752,797 confirmed cases of Covid-19 making it the 4th most affected country by Covid-19. The others on the top countries in order are U.S. with 3,472,659 confirmed cases, Brazil with 1,966,748 confirmed cases and India with 1,003,832 confirmed cases of Covid-19 on 17th July 2020 as per WHO reports.

Conclusion: 

The Vaccine is yet to complete Clinical trials, supposedly Phase II and Phase III. It is said to complete clinical trials and completion of the study by August 15, 2020.

Read More- Russia’s Sputnik V became World’s First Covid-19 Vaccine |


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