Phase III tears that now say 1,600 to 2,000 subjects will now have 40,000.
Roughly 10 days after he became the first nation to approve a COVID-19 vaccine, an announcement was greeted with skepticism by many in the international community, now Russia said it intends to conduct major drug investigations with tens of thousands of subjects from to expand.
Tests that originally said that only 1,600 to 2,000 people will now use 40,000, including a control group, which is much more in line with the 30,000 people examined in similar Phase III trials by the drugmakers Moderna, Pfizer / Biontech and AstraZeneca / Oxford.
Russia’s announcement on August 11 included the fact that Vladimir Putin’s daughter received the vaccine, with the Russian president later adding that the drug, named Sputnik V in a call to the Space Race, “had passed all the necessary tests.”
Russia now calls that authorization just a ‘conditional registration certificate’ in the wake of scientists and fax experts worldwide who said there were not enough data yet to prove the effectiveness as a safety of Sputnik V.
Dr. Paul Offit, a member of the FDA’s advisory panel on vaccines, told ABC’s Vaccine Watch that Russia’s vaccine was not tested enough.
“If I were in Russia at the moment, I would not roll up my sleeves and get this vaccine for the simple reason that it is not adequately tested,” Offit said. “I mean, it can be safe and it can work, but why take that chance? Why should you be lucky?”
Russia’s vaccine was developed by the Gamaleya Research Institute of Epidemiology and Microbiology. It was only tested in two small-scale studies, the results of which have not been published.
In an online briefing with reporters on Thursday, Denis Logunov, deputy director of scientific work at Gamaleya, said the vaccine was approved under a “conditional registration certificate,” meaning the government is required to conduct additional extensive clinical trials.
Russia, as previously announced, intends to scale up further for a massive vaccination campaign in October.
Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told ABC News after Russia’s first announcement that he had his doubts.
“I hope the Russians have actually, definitively proven that the vaccine is safe and effective,” he said. “I seriously doubt they did.”
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