Russia becomes world’s first country to grant regulatory approval for a coronavirus vaccine
pharmafile | August 11, 2020 | News story | Manufacturing and Production | COVID, COVID-19, Vaccine, coronavirus
President Putin has announced that Russia is the first country to grant regulatory approval for a COVID-19 vaccine.
The final trials into its safety continue and the approval comes just two months after human trials began. The speed of its development and approval has left many concerned political motivations are the driving factor behind the vaccine. Putin himself commented on the vaccine, saying: “I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks.”
Russia now want to start mass producing the vaccine and carry out a mass inoculation of the populace. Phase III trials and data are usually required for regulatory approval around the world, but Russia have skipped this step and instead are conducting it after.
Russia has also offered the vaccine to other countries. Despite safety concerns, Rodrigo Duterete, the President of the Philippines, has accepted Russia’s offer and promises to public inject himself with the vaccine. He said at a press briefing: “When the vaccine arrives, I will have myself injected in public. Experiment on me first, that’s fine with me.” The country is currently dealing with the highest number of coronavirus cases in Southeast Asia.
Russia’s vaccine is still largely surrounding in mystery. In July, clinical trials were conducted on volunteers at the Sechenov First Moscow State Medical University and involved 38 people in two separate groups. Allegedly, the vaccine proved to be effective and safe and is being developed and produced by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology along with the Russian defence ministry.
But there is no public data available on this trial and the only information on the completion of clinical trials is from the Russian state. There are also rumours that the vaccine has already been giving to Russia’s elite and researchers may have dosed themselves as part of the clinical trials.
Conor Kavanagh
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