Today, Russia became the first country to declare a vaccine for COVID-19 safe and effective for the general population. President Vladimir Putin emphasized at a meeting this morning that the vaccine has passed all 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 tested vaccine was developed by Alexander Gintsburg, head of the Gamaleya Institute. Gintsburg made headlines in June right at the start of the testing when he publicly said he and other researchers at the institute had tested the vaccine on themselves before the start of human studies. After backlash, he said it was to protect themselves rather than test the product.
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.
According to The New York Times Coronavirus Vaccine Tracker, there are currently 8 vaccines in large-scale Phase 3 efficacy tests. Typically, Phase 3 trials are large enough to reveal any evidence of rare, potentially life-threatening side effects. The FDA has said a COVID-19 vaccine will need to protect at least 50 percent of vaccinated persons to receive agency approval in the United States.