Numerous reports on Sunday claimed that Moscow’s Sechenov University had completed clinical trials of a vaccine for the novel coronavirus. However, the reports did not specifically mention that it was just the phase one trials that had been completed.
Phase two trials are supposed to start Monday. There is only one vaccine candidate being developed in Russia that has reached the human clinical trial stage. That candidate, being developed by the Gamalei National Research Centre for Epidemiology and Microbiology, in partnership with the Russian Defence Ministry, had begun phase I human trials on June 18 on 18 volunteers from the armed forces.
A report by the TASS news agency of Russia on July 10 said the phase I clinical trials would end on July 15, while the second phase would begin on July 13.
“…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,” the TASS agency quoted Russian Defence Ministry as saying.
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‘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 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. Large number of volunteers, usually numbering several thousands, 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.
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