Moscow – Russia plans to register a vaccine for the novel coronavirus by Aug. 10-12, clearing the way for what its backers say would be the world’s first official approval of an inoculation against the pandemic.
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 trials will still need to be conducted on another 1,600 people, Deputy Prime Minister Tatyana Golikova said in a televised meeting of officials with President Vladimir Putin on 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 United Arab Emirates.
Russia has over 800,000 confirmed cases of COVID-19, the fourth-most in the world. While the number of new daily infections is down by more than half from the initial peak, Putin said at the meeting some regions had moved too fast when reopening after a nationwide lockdown ended in May.
“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.”
Researchers and pharmaceutical companies in other countries, including the U.S., the U.K., Japan and China, are also racing to develop vaccines.
AstraZeneca PLC, Moderna Inc. and Pfizer Inc. have begun late-stage testing for Covid-19 vaccines, with initial results from some of the human trials expected as soon as October. Phase 3 tests typically take months to run in order to better understand a drug’s effectiveness.
The Russian vaccine will be provided to health professionals before clinical trials are complete, Health Minister Mikhail Murashko said in an interview with state television on Saturday. He and other officials have said the vaccine won’t be widely available before late in the year.
But scores of Russia’s business and political elite were given access to the experimental vaccine as early as April, according to people familiar with the effort. Military volunteers completed Phase 2 trials of the drug last week.
This week, Russia began clinical trials for a second vaccine, developed by the Vector laboratory in Novosibirsk, and another two will get permission to test soon, Murashko said Wednesday.
“Americans were surprised when they heard Sputnik’s beeping. It’s the same with this vaccine. Russia will have got there first,” said Kirill Dmitriev, the head of RDIF, in an interview with CNN.
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