100 Indian volunteers for Sputnik V - Russian COVID vaccine!
Galatta | Oct 25, 2020, 09:40 pm
With the entire world racing to find a vaccine to put an end to the COVID-19 Novel Corona Virus Pandemic, Russia was the first to announce the registration of a COVID-19 vaccine. This vaccine, named Sputnik V after the famous USSR satellite, was developed jointly by the Gamaleya Institute, Russia's Defence Ministry and the Russian Direct Investment Fund (RDIF)! Russian President Vladimir Putin expressed his supreme confidence in the vaccine and even went on to state that one of his own daughters had been inoculated with it. However, there have been differing opinions from many people in the medical fraternity across the globe, as Sputnik V was approved even before it cleared the most important Phase 3 clinical trials! The makers of the vaccine have now started the Phase 3 trials and one of India's biggest pharma companies - Dr. Reddy's Laboratories, had earlier mentioned that they would be tying up with RDIF to bring Sputnik V to India!
It was announced by Dr. Reddy's on October 17th, that they have obtained permission from the Drug Controller General of India - VG Somani, to conduct the Phase 2 and Phase 3 trials of the Sputnik V vaccine, in India! They had then mentioned that the date and time of the trials would be announced later and now, they have! We hear that Dr. Reddy's are first planning to conduct the Phase 2 clinical trials on about 100 volunteers. Once they submit the safety and immunogenicity data of the Phase 2 trials, an expert panel would analyse it and if they find it ok, Phase 3 trials would begin! Dr. Reddy's has announced that the Phase 3 trials would include 1,400 volunteers as a larger sample is needed for the accumulation of the efficacy data of the vaccine!
We hear that, if the Phase 3 trials also succeed, according to a deal between Dr. Reddy's Laboratories and the Russian Direct Investment Fund, they would supply 100 million doses of Sputnik V to India. This vaccine is said to be based on a modified human adenovirus as the vector which carries the SARS-CoV-2 virus protein. Successful completion of the Phase 2 and 3 trials will obtain regulatory approval for Sputnik V and Dr. Reddy's will also receive 100 million doses of Sputnik V from the RDIF. However, it could take quite some time to complete both the phases of the trials. Meanwhile, there are quite a few other vaccine candidates too, which are in the late stages of clinical testing and could get regulatory approval and move into the production stage. Stay tuned for updates...