Gamaleya Center names date of post-registration tests of its anti-COVID vaccine
Post-registration clinical tests of the anti-coronavirus vaccine developed by the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Health Ministry will begin on September 4 or 5, the Center’s director Alexander Gintsburg said.
"It is planned that the vaccine will be supplied to all centers involved in the trials by September 3. So, vaccination will begin on September 4 or 5," he said, adding that the post-registration trials will be over in nine or ten months. However, in his words, the vaccine will be placed on the market earlier, along with tests on volunteers. A vaccine batch is currently being checked by the Russian sanitary watchdog.
"The new batch of the vaccine we have manufactured is currently being checked by the Russian sanitary authority. As soon as the check is over, it will be immediately put in civil circulation. It will be delivered to regions in small quantities. It will be done concurrently with the post-registration tests," TASS cited Gintsburg as saying. In his words, civil circulation may begin in a period from September 15 to 20.
The Gamaleya Center said earlier it has received a health ministry permit for post-registration tests of the anti-coronavirus vaccine. The tests will involve 40,000 volunteers aged older than 18 and a number of state-run medical establishments in Moscow.
On August 11, Russia registered the world’s first vaccine against the novel coronavirus. The vaccine, dubbed Sputnik V, was developed by the Gamalei National Research Center for Epidemiology and Microbiology of the Russian Health Ministry, and its clinical trials were successfully completed in June-July. The vaccine was developed on a platform that had been used for a number of other vaccines. The Russian health ministry on August 15 announced the launch of the vaccine production.
More than 160 anti-coronavirus vaccines are currently being developed across the globe, with more than 30 of them being at a stage of clinical tests.