Researchers Question Russia’s COVID-19 Vaccine Approval

Article

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.

Recent Videos
Behind the Headlines episode 5
Pharm Tech Group looks at the challenges surrounding the development and manufacture of ATMPs in more detail with Agne Vaitkeviciene, CEO of Memel Biotech.
Pharm Tech Group sits down with Bernard Sagaert, CEO of etherna, to examine the role of mRNA in the treatment of autoimmune diseases.
Pharm Tech Group chats with Dr. Monika Paulė, CEO and co-founder of Caszyme about the evolution of CRISPR.
Related Content
© 2024 MJH Life Sciences

All rights reserved.