To do this, create a National research center. N. F.Gamalei the vaccine already has been tested in Sechenovskiy University and the Burdenko hospital. In early August, it must run in the civil turnover.
volunteers under the supervision of doctors of the vaccine trials were successful. Is that enough to start a mass vaccination is not already in laboratories and hospitals?
As explained “the Russian newspaper” the leading expert of the Center for molecular diagnostics (CMD) of Central research Institute of Epidemiology of Rospotrebnadzor Mikhail Lebedev, any new drug goes through several stages of the study.
First, must be carried out preclinical studies on laboratory animals (mice, hamsters, ferrets and lower primates). Only in case of success in the preclinical stage can proceed to clinical studies on volunteers. So, on July 27 this year, said Lebedev, State research center of Virology and biotechnology “Vector” has begun a clinical study of peptide vaccine “Apiversion” with the participation of volunteers.
“Apiversion” created on one of the most promising synthetic platforms. In the preclinical stage vaccine has already shown its efficiency and safety. Only upon completion of a comprehensive study of safety and efficacy on clinical stage, perhaps the introduction of vaccines into medical practice,” – said the expert. And adds that different vaccines the transition to widespread use requires a different time. “The timing of conducting clinical trials regulated and develop, including the timing of the observation of the volunteers before and after vaccination (from 3 to 6 weeks, depending on the scheme). There is also the timing of all necessary laboratory studies, allowing to establish compliance with the basic criteria for the official registration of the vaccine product”, – says Mikhail Lebedev.
the Expert reminds: it is necessary to consider that the agent COVID-19 have been identified recently (December 2019) and molecular mechanisms of pathogenesis and the formation of population immunity are still to be studied. This is the main difficulty in developing a vaccine against the new coronavirus and may require additional time. However, according to him, already accumulated a certain experience with a related coronavirus that had previously caused outbreaks of severe acute respiratory syndrome and middle East respiratory syndrome (SARS and MERS).
“a Final conclusion about the “readiness” of the vaccine can only be done after tests on volunteers. State research center of Virology and biotechnology “Vector” of Rospotrebnadzor conducts clinical trials of the vaccine “Apiwiki��on” to assess the safety, reactogenicity and immunogenicity with the participation of 100 volunteers. Evaluation of the effectiveness of the vaccine is carried out in the laboratory. To do this volunteers at certain time intervals is examined blood for the presence of specific antibodies and their titer (number), assessment of cellular immunity. The higher the titer, the higher immunogenicity and stronger protection. If there is sufficient seroconversion (production of antibodies), high levels of cell-mediated immunity, it is possible to speak about formation of antiviral immunity after vaccination and to conclude that “preparedness” of the organism of the vaccinated person to meet circulating coronavirus,” said Lebedev.