Claims of pharmaceutical companies to the Russian vaccine against coronavirus based on ignorance of research results. This was stated in Roszdravnadzor, reminding about the serious scientific and industrial base for the production of drugs in the country.
“Before the completion of the research to register the vaccine is impossible. No one is breaking the law”, – quotes RBC Deputy head of Department Valentina Kosenko.
hundreds of volunteers were vaccinated by the vaccine, developed by scientists of the center. Gamalei. No adverse reactions to the drug were not. The head of the Department of pharmacovigilance of the Department of organization of state control of quality medical products of the Ministry Sergei Glagolev explained that the Protocol for the clinical trials was agreed for an expert assessment. But laboratory confirmation studies will be held in the post-marketing period. It will be attended by several thousand volunteers. The doctors will conduct an all-out fixation data postwakcinalny complications and cases COVID-19.
Experience with MERS will reduce the time of development of the vaccine against coronavirus. Glagolev said that the registration of the drug in the early stages of a clinical study allowed the EU and the USA. Thus in our case we are talking about “early access to the market in the tightly controlled conditions”.
earlier, the Association of clinical research applied to the health Ministry with a proposal to postpone the state registration of the first developed in Russia vaccine against coronavirus infection COVID-19 to the successful completion of the third phase of its clinical trials.
