President Vladimir Putin announced the Health Ministry’s approval on Tuesday and said one of his two adult daughters already was inoculated.
He said the vaccine underwent the necessary tests and was shown to provide lasting immunity to the coronavirus, although Russian authorities have offered no proof to back up claims of safety or effectiveness.
“I know it has proven efficient and forms a stable immunity,” Putin said. “We must be grateful to those who made that first step very important for our country and the entire world.”
However, scientists in Russia and other countries sounded an alarm, saying that rushing to offer the vaccine before final-stage testing could backfire.
What’s called a Phase 3 trial – which involves tens of thousands of people and can take months – is the only way to prove if an experimental vaccine is safe and really works.
By comparison, vaccines entering final-stage testing in the US require studies of 30,000 people each. Two vaccine candidates already have begun those huge studies, with three more set to get under way.
While Russian officials have said large-scale production of the vaccine wasn’t scheduled until September, Deputy Prime Minister Tatyana Golikova said vaccination of doctors could start as early as this month.
Officials say they will be closely monitored after the injections. Mass vaccination may begin as early as October.
The vaccine developed by the Gamaleya Institute in Moscow with assistance from Russia’s Defence Ministry uses a different virus – the common cold-causing adenovirus — that’s been modified to carry genes for the “spike” protein that coats the coronavirus, as a way to prime the body to recognise if a real COVID-19 infection comes along.
The Associated Press couldn’t find documentation in the Russian Health Ministry’s records indicating that permission to start the advanced trials was granted. The ministry has not responded to a request for comment.
Putin said one of his daughters has received two doses, and had minor side effects such as slight fever, and is now “feeling well and has a high number of antibodies.” It wasn’t clear if she was one of the study volunteers.
The Health Ministry said in a statement Tuesday that the vaccine is expected to provide immunity from the coronavirus for up to two years, citing its experience with vaccines made with similar technology.
However, scientists around the world have been cautioning that even if vaccine candidates are proven to work, it will take even more time to tell how long the protection will last.
“The collateral damage from release of any vaccine that was less than safe and effective would exacerbate our current problems insurmountably,” Imperial College London immunology professor Danny Altmann said in a statement Tuesday.
The World Health Organisation has urged that all vaccine candidates go through full stages of testing before being rolled out, and said Tuesday it is in touch with the Russian scientists and “looks forward to reviewing” Russia’s study data.
Experts have warned that vaccines that are not properly tested can cause harm in many ways – from harming health to creating a false sense of security or undermining trust in vaccinations.
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