As reported at the meeting, the Director of the research center of epidemiology and Microbiology named Gamalei Alexander Gintsburg, experts expect “roughly by 15 June to go on the possibility of state registration of the drug”.
Now, he said, are preclinical studies in mice and Guinea pigs, they demonstrate “the absolute immunogenicity data vaccine preparations”. “And they cause very high titer neutralizing antibodies, sufficient for protection against high doses COVID-19. At the same time demonstrated the absence of toxic effects in animals,” – said the scientist.
According to the working plan, the doctors plan to complete preclinical studies by 31 may and from 1 June to begin clinical trials of the drug.
also proposed to accelerate out of the vaccine in circulation to make changes in the corresponding government resolution. “We are talking about that on the website of the state registration of the use of more than one series of vaccines, and three. Then it will allow the expert Agency to control the three series vaccine. And then, after passing the control, these series immediately release into the public market, and not wait for the Ministry within 21 days, will supervise the new series, which will continue to do. This can save at least three weeks,” he explained.
the Scientist was also asked to simplify procedures for importing equipment needed for the production of vaccines against coronavirus. According to him, the domestic pharmaceutical industry is capable to produce up to 4-5 million doses per year, and if you pass a filling and packaging to outsourcing of 8-10 million doses.
“we Need everything that is suggested by Aleksandr Leonidovich, organize. I prepare the relevant proposals”, – said Vladimir Putin, addressing to the Minister of health. “This concerns the acceleration of licensing procedures of healthcare, and all other customs, on the importation of necessary equipment”, – he explained.
the Head of state also ordered to allocate the necessary preparation for production of the vaccine. “We will do everything possible to expedite the necessary administrative procedures. If need be, and I understand that there is such a need, allocate additional resources,” – said Vladimir Putin.