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Sputnik V vaccine to submit data to WHO by end of December
Russian covid-19 maker Sputnik V The vaccine is due to submit its latest clinical data by the end of December, and inspections of manufacturing sites are expected to follow in February, a World Health Organization (WHO) official said on Monday.
Moscow rushed to approve home-use shooting last year and it has been exported to countries all over the world, but it still has not been certified by the WHO or the European Medicines Agency, the EU medicines regulatory body.
Rogerio Gaspar, WHO’s director of regulation, gave the new timelines for the vaccine developed by the Gamaleya Institute, which is seeking the WHO’s emergency use list, during a briefing by WHO for Journalists in Geneva.
It was hoped that Gamaleya would complete the submission of his data and his two-part application, late December and late January, he said.
“We are already starting the planning exercise for the next GMP (Good Manufacturing Practices) inspections that will be needed to review the new data to be submitted,” said Gaspar, referring to on-site inspections for quality control.
“So our planning right now, provided that all the information is on board and the technical information is answered by the end of December, we would be able to carry out GMP inspections (good manufacturing practices) locally on Sputnik in February ”, he said.