Coronavirus vaccine: The Russian vaccine has raised concerns because of the speed at which it is being pushed through. However, the Russian Defence Ministry clarified that tests of the vaccine against coronavirus were conducted in full compliance with methodological regulations
Clinical trials of coronavirus vaccine developed by Russia's Gamaleya Institute have been completed. Paperwork for its registration with Russia's regulatory body is underway.
However, Russian media has not specified which stage of the trials was over. Last month, a news report by Russia's Tass news agency said that the candidate vaccine had entered Phase-2 of its human clinical trials on July 13. Phase-2 trials in which the vaccine is tested for its ability to trigger an immune response in human beings take a few months to complete.
The Russian vaccine has raised concerns because of the speed at which it is being pushed through. However, the Russian Defence Ministry clarified that tests of the vaccine against coronavirus were conducted in full compliance with methodological regulations.
Russian Health Minister Mikhail Murashko has said that that a mass vaccination programme would be launched in Russia in October. He added that doctors and teachers would be the first to receive the vaccine.
Meanwhile, news agency Reuters, citing anonymous sources, said that Russia's first potential vaccine would be approved by regulators this month. Russia's vaccine might receive approval without a Phase-3 trial. In Phase-3 trials, vaccine doses are given to several thousand volunteers which take months or years to be completed.
Meanwhile, Bloomberg stated that the Gamaleya vaccine was likely to get a "conditional registration" in August, meaning it would be approved for use even as Phase-3 trials are carried out. The vaccine's production is expected to begin in September.
Scores of possible coronavirus vaccines are being developed around the world, more than 20 of which are currently in clinical trials.
Meanwhile, a committee at the Central Drug Standard Control Organisation (CDSCO) has asked the Drugs Standard Control Organisation (DCGI) to allow the Serum Institute of India (SII) for the second and third phases of human clinical trials of coronavirus vaccine.
SII has submitted a revised proposal to DGCI, in which it said that 16,000 people aged above 18 will participate in the trials across 17 cities. SII has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British Swedish pharma company AstraZeneca.