SWITZERLAND, JULY 13 – Russian scientists said on Monday that they hope the world’s first coronavirus vaccine will be distributed to patients as soon as next month after a medical university in Moscow said it completed clinical trials using human volunteers.
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 center’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 center, 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.
However, Amitabh Sinha of Indian Express reported that, like all the other potential candidates, the one being developed in Russia is also far from being ready at this point. According to Sinha, what these reports did not specifically mention is that only phase-I of the clinical trials had been completed. Phase-II trials are supposed to start today (June 13), while there is no clarity over phase-III trials.
A report by the TASS news agency of Russia on July 10 said the phase-I clinical trials will end on July 15, while the phase-II will begin July 13.
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, there 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 would involve the injection of the vaccine amongst civilian volunteers as well.
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.
“The Russian Health Ministry will make a decision on the substance effectiveness based on the results of biochemical tests,” the university said in a July 3 press release.
The ministry “hopes to finalize the trials … before fall,” it added.
The Gamalei Research Center said earlier in May that its own scientists were self-administering the vaccine, a move criticized by some experts.
The decision to involve the general public in vaccine trials underscores Russia’s desire to move ahead fast with its testing of the sought-after coronavirus vaccine.
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.