Russia has become the first country to have completed clinical trials of a Covid-19 vaccine candidate, after Sechenov University said that it had concluded its study.
According to Sechenov University Center for Clinical Research on Medications head and chief researcher Elena Smolyarchuk, study data showed the vaccine candidate’s effectiveness, reported Russian news agency TASS.
Smolyarchuk was quoted by the news agency as saying: “The research has been completed and it proved that the vaccine is safe. The volunteers will be discharged on 15 July and 20 July.”
The trial participants will be monitored on an outpatient basis after being discharged.
Last month, Russia granted authorisation for clinical trials of two formulations of the Covid-19 vaccine candidate, which was developed by the Gamaleya National Research Center for Epidemiology and Microbiology.
An intramuscular solution of the vaccine was tested at the Burdenko Military Hospital while Sechenov University assessed the vaccine in the form a powder for the preparation of an intramuscular solution.
The first stage of testing at the university commenced on 18 June in a group of 18 participants. The second group of the study involved 20 volunteers who were vaccinated on 23 June.
Institute for Translational Medicine and Biotechnology director Vadim Tarasov was quoted by Russian news agency Sputnik as saying: “Sechenov University in a pandemic situation acted not only as an educational institution but also as a scientific and technological research center that is able to participate in the creation of such important and complex products as drugs…
“We worked with this vaccine, starting with preclinical studies and protocol development, and clinical trials are currently underway.”
Prior to the human trials, the vaccine was tested for its toxicity, safety, immunogenicity and effectiveness in large and small animals at the Russian Defence Ministry’s 48th Central research institute.
Source: https://www.clinicaltrialsarena.com/news/russia-completes-covid19-vaccine-trial/