Russia has successfully become the first country that declared a vaccine for COVID-19 safe and effective for the general population. This was declared on Tuesday i.e., 11th of August 2020. The President Vladimir Putin emphasized at a meeting that the vaccine has passed all the necessary tests, and his adult daughter has even received two shots of the vaccine. However, the vaccine did not go through Phase 3 trials, only being tested in humans for two months. Results of that trial have not been released, but Russian officials said Phase 3 trials will begin alongside vaccination efforts. According to Reuters, the vaccine will be marketed under the name “Sputnik V” on foreign markets.
The Moscow-based Association of Clinical Trials Organizations (ACTO), a trade body representing the world’s top drug makers in Russia, released an open letter urging the Russian Health Ministry to postpone approval of the vaccine until Phase 3 trials had been successfully completed. “It is during this phase that the main evidence of a vaccine’s efficacy is collected, as well as information on adverse reactions that could appear in certain groups of patients: people with weakened immunity, people with concomitant diseases and so forth,” reads the letter from ACTO, published last Monday. In mid-June, the Russian Health Ministry announced the Gamaleya Institute, where the vaccine was developed, would start a clinical trial using two forms of the vaccine—a liquid and a powder. The vaccine was to be tested on two groups of volunteers with 38 people each.
Thus, the testing reached 76 people altogether—thousands less than the number typically enrolled in Phase 3 trials of a new drug. The Russian Health Ministry said in a statement that the vaccine is expected to provide immunity from COVID-19 for up to two years. According to the Associated Press, Russian health workers, teachers, and other high-risk groups will be given the chance to take the vaccine first—as early as this month. The Russian-based Interfax news agency has reported there will only be enough doses to conduct vaccination in 10 to 15 of Russia’s 85 regions, with large-scale production of the vaccine expected to start in September, and mass vaccination to begin as early as October.
