Russia aims to file a coronavirus vaccine by 10-12 August, paving the way for what its supporters are saying will be the world’s first official inoculation approval against the outbreak.
The medication, developed by Moscow’s Gamaleya Institute and the Russian Direct Investment Fund, could be approved by regulators for civilian use within three to seven days of approval, according to a person familiar with the procedure, who pleaded anonymity because the information is not public.
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The Gamaleya vaccine is scheduled to get conditional approval in August, meaning it will still need to perform trials on an additional 1,600 people, Deputy Prime Minister Tatyana Golikova said yesterday in a televised official meeting with President Vladimir Putin. They will start production 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 might be approved August 15-16. The Gamaleya Institute and RDIF declined to comment.
Although the vaccine has been regarded as secure by its creators and possibly the first to hit the public, the data have not been released and the pace at which creators travel has raised concerns. In other nations, Phase 3 trials in Russia, Saudi Arabia and the United Arab Emirates are scheduled to begin next week in Gamaleya.
Russia has more than 800,000 confirmed COVID-19 cases, the world’s fourth-most. Although the number of new daily infections decreases by more than half from the peak, Putin said at the meeting that some regions were going too quickly when reopening after a national lockout in May ended.
“The situation remains difficult and can, as they say, swing in any direction,” Putin said. “There is no reason for complacency, to relax, to forget about the recommendations of doctors.”
Phase 3 clinical trials of a COVID-19 vaccine have also begun in the United States.
According to Moderna, the investigational vaccine test developed by the biotechnology company Moderna and the U.S. National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health ( NIH), will be performed at nearly 100 U.S. research sites.
At a facility in Savannah, Georgia, the first patient was being dosed.
Approximately 30,000 adult volunteers are to be included in the trial to determine the efficacy of the Moderna / NIH vaccine, and whether it can avoid symptomatic COVID-19 after two doses, among other findings.