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Russian President Vladimir Putin announced Tuesday that Russia has cleared the world’s first coronavirus vaccine and that it will be ready for widespread use by October.
Putin announced the vaccine at a Russian government meeting Tuesday, The Associated Press reported. The vaccine is still in Phase 3 trials, but Putin said it is safe and ready for use and said one of his daughters had already taken. The World Health Organization and other medical bodies have warned vaccines should go through all testing stages before being entering use.
“I know it has proven efficient and forms a stable immunity, and I would like to repeat that it has passed all the necessary tests,” Putin said of the vaccine. “We must be grateful to those who made that first step very important for our country and the entire world.”
Putin also described how one of his daughters was one of the first to use the vaccine.
“She has taken part in the experiment,” Putin said. He said she had a fever of 38 degrees Celsius (100.4 Fahrenheit) on the day of the first vaccine injection, and that her fever dropped the next day to around 37 degrees (98.6 Fahrenheit).
Putin said his daughter saw a slight increase in temperature after her second shot but that her temperature soon recovered. “She’s feeling well and has a high number of antibodies,” Putin added.
Professor Alexander Gintsburg, head of the Gamaleya Institute which developed the vaccine said Russia plans to roll out vaccination even while Phase 3 trials are still ongoing in the country.
Russia’s human studies started on June 17 with 76 volunteers. Half were injected with a liquid vaccine and half were administered a vaccine in a soluble powder form.
Former U.S. Food and Drug Administration Commissioner Scott Gottlieb criticized the Russian vaccine development process Tuesday.
“Russia was reported to be behind disinformation campaigns to sow doubts in U.S. about our Covid vaccines; and today’s news that they ‘approved’ a vaccine on the equivalent of phase 1 data may be another effort to stoke doubts or goad U.S. into forcing early action on our vaccine,” Gottlieb tweeted.
Russia was reported to be behind disinformation campaigns to sow doubts in U.S. about our Covid vaccines; and today’s news that they “approved” a vaccine on the equivalent of phase 1 data may be another effort to stoke doubts or goad U.S. into forcing early action on our vaccines https://t.co/WR6xPkFcfJ
— Scott Gottlieb, MD (@ScottGottliebMD) August 11, 2020
Russia’s plan to go forward with vaccinations without completing Phase 3 trials puts it ahead of U.S. vaccine candidates being speedily developed under Operation Warp Speed. Dr. Anthony Fauci said the results of a Phase 3 trial on one Moderna vaccine candidate likely won’t be ready until some time in November or December. After Phase 3 results are in, a U.S. vaccine candidate may hit production and the U.S. can begin vaccinations.
Epidemiologist and health economist Dr. Eric Feigl-Ding warned that Russia’s decision to go forward without a Phase 3 trial could limit people’s confidence in the vaccine.
“This is irresponsible of Russia. This is clearly not good to rush ahead without full Phase 3 trial results. Phase 3’s larger sample size allows much better study of safety signals & in wider range of patients. Waiting for P3 will allow greater confidence,” Ding wrote.
This is irresponsible of Russia. This is clearly not good to rush ahead without full Phase 3 trial results. Phase 3’s larger sample size allows much better study of safety signals & in wider range of patients. Waiting for P3 will allow greater confidence 🧵https://t.co/1vQzUA7tvw
— Eric Feigl-Ding (@DrEricDing) August 11, 2020