Russian CoviVac vaccine overseas approval is largely political issue, developer says
MOSCOW, September 23. / TASS /. The overseas approval of Russia’s CoviVac coronavirus vaccine is largely political, Aidar Ishmukhametov, director-general of the Federal Scientific Research Center Chumakov which developed the vaccine, told Rossiya-24 television on Thursday.
“This is largely a political question because there are two aspects that we do not always fully understand,” he said. âThe first concerns the registration of the vaccine in other countries. This is a complicated question that takes a long time and involves inspections of the production site, primary documents <...> and verification of compliance of preclinical and clinical trials. with global standards. We are there and I hope we do the job well. Another aspect is related to the trips abroad of our citizens vaccinated with Russian vaccines. I think this issue is more related to the relevant policy and agreements, âIshmukhametov explained. According to him, decisions about the entry of vaccinated people should be taken “on a mutual basis” by governments.
He noted that the Chumakov Center had submitted preliminary documents for the approval of the jab to the World Health Organization, but it was a rather lengthy process. “The point is that the expertise is not only about the documents. It is also about the production site, which is a substantial problem,” noted Ishmukhametov. “The so-called prequalification process is quite complicated and in many ways concerns the assessment of the site’s technological capabilities and its compliance with global standards,” he added.
CoviVac, an inactivated whole virion vaccine developed by the Federal Science Center Chumakov of the Russian Academy of Sciences for Research and Development of Immune and Biologics, was registered with the Russian Ministry of Health on February 19. Whole virion vaccines either use artificially weakened viruses. that cannot cause disease or inactivated viruses.