The Russian of COVID-19 Vaccine Has Entered the Final Stage of Clinical Trials

13 July 2020

GMP News

The Russian Defense Ministry and the Gamalei National Research Center for Epidemiology and Microbiology have started the final stage of clinical trials of a vaccine against the novel coronavirus, the ministry stated on July 10.

According to the Defense Ministry, “an in-ward treatment of the first group of volunteers, who were tested for the safety and tolerability of the vaccine, will end on July 15.”

On Monday, July 13, the second group of volunteers, who are tested for the efficiency and immunogenicity of the vaccine, will be injected with the second component of the vaccine against the coronavirus,” the ministry stated.

“The booster scheme of the vaccination, which is intended for the second group of volunteers, will enable to strengthen the immune system and will also prolong its endurance,” according to the ministry.

The ministry also added that all volunteers feel well, have no complaints; they experience no side-effects at all and the first group of volunteers would be discharged from the Burdenko Military Hospital after undergoing the final tests.

Results of the COVID-19 vaccine tests, performed on a group of volunteers in Russia, show that they are developing immunity to the coronavirus, the ministry continued.

“In line with the research protocol, volunteers regularly take tests for antibody and cell-mediated immunity,” the ministry stated. “The data obtained by the Gamalei National Research Center for Epidemiology and Microbiology, proves that volunteers of the first and second groups are forming an immune response after injections of the vaccine against the coronavirus.”

The Defense Ministry announced in early June that two groups of volunteers had been selected for the clinical tests of an anti-coronavirus vaccine. The first group of 50 servicemen includes five women and ten medics. The second group is comprised of civilians.

Clinical testing of the vaccine developed by the Gamalei National Research Center for Epidemiology and Microbiology began on June 18. Eighteen volunteers were vaccinated against the novel coronavirus.




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