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Photo: TimesofIndia.com

The vaccine has been approved ahead of a large scale advanced study that was scheduled to start in November or December. The results of the early-stage human trials of the vaccine have not yet been published.

What is called "EpiVacCorona"?

Russia has given regulatory approval to a second Covid-19 vaccine, named ‘EpiVacCorona’, after early-stage studies. The new coronavirus vaccine comes two months after a similar move for Russia’s first vaccine Sputnik V prompted widespread criticism from scientists both at home and abroad.

Russia became the first country to give regulatory approval to a Covid-19 vaccine in August when Sputnik V was officially registered ahead of the large-scale clinical trial. Russian President Vladimir Putin announced that the country has registered the second Covid-19 vaccine. (currentaffairs.adda247.com)

What are the pharmaceutical companies that produce the vaccine?

EpiVacCorona was developed by The State Research Center of Virology and Biotechnology VECTOR in Siberia, often known as the Vector Institute. The institute opened in 1974 and was involved in biological warfare research during the Cold War. The facilities maintain all levels of Biological Hazard, with CDC Levels 1-4. It is one of two official repositories for the now eradicated smallpox virus, and it was once part of a laboratory network known as Biopreparat. In 2019, there was an explosion there that spooked the internet due to the presence of smallpox.

TrialSite recently reported on the East/West divide in dealing with COVID-19 vaccine development, noting concerns with the Sputnik V process. Echoing that story, we think caution is warranted about this new vaccine as well. - Noted by trialsitenews.com.

How many volunteers registered for the trial?

Putin has revealed that the vaccine has undergone an early phase of human trials involving 100 volunteers. The outcomes of this clinical have been successful, as per a report by Moscow Times.

Russian Deputy Prime Minister has informed President Putin that the large-scale human trials of EpiVacCorona will involve 40,000 volunteers across the country. The Siberian biotech company Vektor is also planning to manufacture 60,000 doses of EpiVacCorona “in the nearest future”, she was quoted as saying the Moscow Times. - According to financialexpress.com.

EpiVacCorona Vaccine clinical trials

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Photo: IndiaTVNews.com

On October 13, 2020, a government statement indicated 'Vector will begin post-registration clinical trials in various regions of Russia with the participation of 40,000 volunteers. At the same time, I want to say that at the same time "Vector" plans to conduct a clinical study among 150 people over 60 years old.' (precisionvaccinations.com:)

Clinical Trial NCT04527575: Study of the Safety, Reactogenicity and Immunogenicity of "EpiVacCorona" Vaccine for the Prevention of COVID-19 (EpiVacCorona)

  • According to information in registry Russian clinical trials, the combined first and second phase trials of the EpiVacCorona vaccine were registered on July 24, 2020. Simple-blind, placebo-controlled, randomized trials will involve 100 volunteers aged 18 to 60 years. Last Update Posted: September 22, 2020.
  • The Center received approval to conduct a clinical trial of the EpiVacCorona vaccine candidate on July 27, 2020. Five people aged 18 to 30 take part in the first stage of the test. They are vaccinated in turn, with an interval of 72 hours.
    • The first phase of the clinical trial is an open trial. The study will enroll 14 men and women aged 18 to 30 years, inclusive, who meet the inclusion criteria and have no exclusion criteria, whose data will be used for subsequent analysis of safety and immunogenicity.
    • The second phase of the clinical trial is a simple, blind, placebo-controlled, randomized, parallel-group study. The study will enroll 86 men and women aged 18 to 60 years, inclusive, who meet the inclusion criteria and have no exclusion criteria whose, data will be used for subsequent analysis of safety and immunogenicity.
    • If volunteers drop out of the study, they will not be replaced.

The upcoming phase III

A delighted President Vladimir Putin announced the news at a government meeting on Wednesday. The jab was developed by the Vector Institute in Siberia and completed early-stage human trials last month. However, results have not been published yet and a large-scale trial, known as Phase III, has not yet begun. (cnbc.com)

Experts had already raised the alarm in August over Russia’s first vaccine, a vector vaccine developed by Gamaleya Institute called their vaccine Sputnik V, a nod to Russia’s early success in the space race. Putin touted the safety and efficacy of this vaccine by reassuring the people that one of his own daughters was a recipient of the vaccine, which is just now ramping up Phase III testing. The Phase III testing of Sputnik started with residents of Siberia and has since administered the vaccine to trial participants in Belarus and soon the UAE. Further expansion is expected soon in Venezuela. (biospace.com)

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