Developed by the center of Gamaliel vaccine against coronavirus infection was registered by the Ministry of health of the Russian Federation. The planned delivery of the drug into circulation on 1 January 2021, reports TASS.
Earlier, the Association of clinical research (AOKI) said about the need to postpone state registration of domestic vaccines against coronavirus and wait for the results of clinical phase III studies. However, the health Ministry called the claims of pharmaceutical companies to the Russian vaccine is based on ignorance of research results, says RBC.
The head of the Department of pharmacovigilance of the Department of organization of state control of quality of medical products Roszdravnadzora Sergey Glagolev explained that the Protocol of [clinical trials] was agreed for an expert assessment. Laboratory confirmation studies will be held in the post-marketing period, which involves several thousand volunteers and total fixation of data about vaccinated on postwakcinalny complications and cases COVID-19, that is a great many thousands of the study, he said.