The drug developed by Moscow’s Gamaleya Institute and the Russian Direct Investment Fund may be approved for civilian use within three to seven days of registration by regulators, according to a person familiar with the process, who asked not to be identified because the information isn’t public.
The Gamaleya vaccine is expected to get conditional registration in August, meaning it will still need to conduct trials on another 1,600 people, Deputy Prime Minister Tatyana Golikova said in a televised meeting of officials with President Vladimir Putin Wednesday. Production should begin in September, she said.
“The key requirements for a vaccine are its proven effectiveness and safety so everything needs to be done very carefully and accurately” Putin said at the end of the meeting. “Our confidence in the vaccine must be absolute.” Earlier, state news service RIA Novosti reported the vaccine may be approved Aug. 15-16. The Gamaleya Institute and RDIF declined to comment.
While the vaccine has been touted by its developers as safe and potentially the first to reach the public, the data hasn’t been published and the speed with which developers are moving has raised questions in other countries. Gamaleya is scheduled to begin Phase 3 trials next week in Russia, Saudi Arabia and the UAE.