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Overseas approval of Russia's CoviVac vaccine largely political issue, developer says

Director General of the Chumakov Federal Scientific Center for Research noted that the Chumakov Center had submitted preliminary documents for the jab’s approval to the World Health Organization, but it was a rather long process

MOSCOW, September 23. /TASS/. The overseas approval of Russia's CoviVac coronavirus jab is largely political, Aidar Ishmukhametov, Director General of the Chumakov Federal Scientific Center for Research that developed the vaccine, told the Rossiya-24 TV channel on Thursday.

"It is largely a political matter because there are two aspects that we don't always get right," he said. "The first one concerns the registration of the vaccine in other countries. It is a complicated issue that takes a long time and involves inspections of the production site, primary documents <...> and the verification of the preclinical and clinical trials' compliance with global standards. We are on it and hopefully we are doing the job well. Another aspect is related the overseas trips of our citizens inoculated with Russian vaccines. I think that this issue relates more to politics and the relevant agreements," Ishmukhametov explained. According to him, decisions concerning the entry of vaccinated people should be made "on a mutual basis" by governments.

He noted that the Chumakov Center had submitted preliminary documents for the jab’s approval to the World Health Organization, but it was a rather long process. "The matter is that the expertise is not just about documents. It is also about the production site, which is a substantial issue," Ishmukhametov noted. "The so-called prequalification process is rather complicated and in many ways concerns the assessment of the site's technological capacities and its compliance with global standards," he added.

CoviVac, an inactivated whole-virion vaccine developed by the Russian Academy of Sciences’ Chumakov Federal Scientific Center for Research and Development of Immune and Biological Products, was registered with the Russian Health Ministry on February 19. Whole-virion vaccines use either artificially weakened viruses that cannot cause disease or inactivated viruses.