Russia became the first country to approve a coronavirus vaccine for use in tens of thousands of its citizens.
The announcement on Tuesday came despite international skepticism about injections that have not completed clinical trials and were studied in only dozens of people for less than two months.
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 U.S. require studies of 30,000 people each. Two vaccine candidates already have begun those huge studies, with three more set to get underway by fall.
Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said he’s concerned anything that goes wrong with Russia’s vaccine will undermine public confidence in any COVID-19 vaccine.
“We have to worry not only about making a safe and effective vaccine, but creating confidence in the public so that they desire to actually take this vaccine,” he told the Associated Press. “So if something happens in this Russian experience in terms of a new safety signal, or maybe it doesn’t show to be as effective as possible, that’s going to color all of the other vaccines and make the public health messaging much harder.”
President Vladimir Putin said while announcing the approval that 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 the claim of its safety or effectiveness.
The vaccine developed by the Gamaleya Institute in Moscow 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 recognize if a real COVID-19 infection comes along.
That’s similar to vaccines being developed by China’s CanSino Biologics and Britain’s Oxford University and AstraZeneca.
Advanced clinical trials are set to start Wednesday, Kirill Dmitriev, chief executive of the Russian Direct Investment Fund, told reporters. The fund bankrolled the development of the vaccine.
In the meantime, the vaccine will be offered to tens of thousands of people. Deputy Prime Minister Tatyana Golikova said the vaccination of doctors could start as early as this month.
Russian authorities have said that medical workers, teachers and other risk groups will be the first to undergo vaccination.
According to officials, large-scale production of the vaccine will start in September, and mass vaccination may begin as early as October.
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