Researchers Question Russia’s COVID-19 Vaccine Approval
Questions about safety and efficacy surround Putin’s announced approval of a COVID-19 vaccine with no supporting clinical trial results.
The Aug. 11, 2020 announcement by Russian President Vladimir Putin that the country’s health ministry would approve a COVID-19 vaccine without conducting large-scale clinical trials prompted criticism and alarm from researchers and healthcare groups around the world in various media outlets.
Arguing that the vaccine, Gam-COVID-Vac Lyo, developed by Moscow’s Gamaleya Institute was safe, Putin was quoted on Russian State television saying he knew the vaccine worked effectively, forms strong immunity, and passed all needed checks.
Scientists from other countries noted that the effectiveness of the Russian vaccine cannot be known without independent review of scientific papers on clinical trial results.
The World Health Organization, in a report dated Aug. 10, 2020, listed the Gamaleya vaccine in Phase I trials. ClinicalTrials.gov listed a Phase I study with 38 participants; no results were posted.
Leading vaccine candidates from AstraZeneca, Sinovac, Wuhan Institute of Biological Products/Sinopharm, Moderna, and Pfizer/BioNTech are conducting Phase III trials involving tens of thousands of patients. Another dozen vaccine programs are in Phase I/II trials.
