MOSCOW: President Vladimir Putin Tuesday declared Russia the first country to approve a coronavirus vaccine, but scientists and the World Health Organization said it still needed a rigorous safety review.
Putin said the vaccine was safe and that one of his own daughters had been inoculated, though clinical trials were not yet complete and final stage testing involving more than 2,000 people was to start only on Wednesday (today). Western scientists were sceptical, with some warning that moving too quickly on a vaccine could be dangerous, but Russia denounced criticism as an attempt to undermine Moscow´s research.
Putin has pushed hard for Russia to be the first to announce a vaccine and officials dubbed it "Sputnik V" after the Soviet-era satellite that was the first launched into space.
"This morning, for the first time in the world, a vaccine against the new coronavirus was registered" with Russia´s health regulator, Putin told a televised video conference call with government ministers.
"I know that it is quite effective, that it gives sustainable immunity," he said, adding that one of his two daughters had received the vaccine developed by the Gamaleya research institute in coordination with the Russian defence ministry.
"In this sense she took part in the experiment," Putin said, adding that she had a slight temperature after a second injection and "that´s all".
Reacting to the announcement, the WHO´s spokesman in Geneva Tarik Jasarevic said it was in "close contact" with Russian health authorities but that it was too soon for any WHO stamp of approval.
"Pre-qualification of any vaccine includes the rigorous review and assessment of all the required safety and efficacy data," he said.
Western scientists have previously raised concerns about the speed of development of Russian vaccines, suggesting that researchers might be cutting corners.
Many scientists Tuesday warned of the risks of rushing to approve a vaccine.
"This is a reckless and foolish decision," said Francois Balloux of University College London.
"Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population."
The chief of Russia´s sovereign wealth fund, which is financing and helping to coordinate the vaccine efforts, told reporters that Phase 3 trials would start on Wednesday.
Kirill Dmitriyev, who heads the Russian Direct Investment Fund (RDIF), said industrial production was expected from September and that 20 countries had made "preliminary applications for over one billion doses" of the vaccine.
He said that along with foreign partners Russia was ready to manufacture 500 million doses of vaccine per year in five countries.
Sputnik V is a so-called viral vector vaccine, meaning it employs another virus to carry the DNA encoding of the needed immune response into cells.
Gamaleya´s vaccine is based on the adenovirus, a similar technology to the coronavirus vaccine prototype developed by China´s CanSino.
Meanwhile, Germany Tuesday raised doubts over the quality and safety of Russia´s coronavirus vaccine, stressing that drug approval is granted in the European Union only after full clinical trials.
"Patient safety is of the highest priority," a health ministry spokeswoman told German newspaper network RND. "There is no known data on the quality, efficacy and safety of the Russian vaccine."
