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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.
Chief Researcher 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. The Sechenov First Moscow State Medical University launched clinical trials of the potential Covid-19 vaccine on 38 paid volunteers in June.
Around the same time, Russia’s military began a parallel two-month clinical trial of the same vaccine developed by the state-run Gamalei National Research Center for Epidemiology and Microbiology.
The Gamalei centre’s head Alexander Gintsburg told the state-run TASS news agency that he hopes the vaccine will “enter civil circulation” on Aug. 12-14.
He added that he hopes private companies would begin mass production by September. “The research has been completed and it proved that the vaccine is safe,” Yelena Smolyarchuk, the head of Sechenov University’s clinical research centre, told TASS of its trial.
The Sechenov University’s two groups of volunteers will be discharged Wednesday and next Monday after spending 28 days in isolation to protect them from exposure to other infections, she added.
The volunteers, aged 18 to 65, will be monitored for six more months after their release. Earlier in July, Smolyarchuk said that some participants experienced typical responses to injections, such as headaches and an elevated body temperature, which resolved within 24 hours.
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.
Safety and tolerability’ of a vaccine is tested in phase I on a small group of volunteers. The news report said the ministry had claimed that none of the volunteers had reported any complaints, experienced no side-effects and would be discharged from the hospital soon.
“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 agency further said.
This round will involve the injecting the vaccine amongst civilian volunteers as well. “Efficiency and immunogenicity (generation of the immune response)” is tested in phase two of trials.
It is in this stage that researchers try to see whether the vaccine is triggering the desired immune response in human beings, and what could be the suitable dose to generate this response.
Vaccine development usually involves a third phase as well. A large number of volunteers, usually numbering several thousand, are enrolled for the third phase in which researchers try to ascertain whether the immune response is able to fight the virus in real-life situations.
This process can take several months. As of now, even the success of phase II trials is not certain. It will have to be assessed after the completion of the trials. It is not clear whether the Russian candidate vaccine will go through phase III trials as well.
A candidate vaccine developed in China has been approved for use after phase II trials itself but is supposed to be administered only on Army personnel as of now.
It will depend on the Russian regulatory authorities to decide whether the Russian vaccine will need phase III trials as well. Russia has the world’s fourth-highest number of coronavirus infections after the United States, Brazil and India.
The Kremlin has previously said the nation’s scientists are working on almost 50 different vaccine projects, while scientists have said developing a vaccine is a question of national prestige.
Though the race to develop a vaccine that would help the population develop herd immunity is in full swing around the world, recent research suggests that asymptomatic patients could have a weaker immune response to Covid-19 because their antibodies fade as early as two months after infection.
Article Written By Ishani Panda
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