On Tuesday, Russia became the first country to declare a coronavirus vaccine ready for use in thousands of its citizens.
But while Russian President Vladimir Putin says the vaccine is “efficient” and forms a “stable immunity,” scientists around the world are expressing concerns about the lack of published data on how safe it is and how well it works.
Here’s what you need to know about the Russian vaccine.
Who makes it?
The vaccine, known as Sputnik V, was developed by the Gamaleya Institute in Moscow, and the Russian business conglomerate Sistema has said it will be put into mass production by the end of the year. A Brazilian firm has also announced a partnership with Russia to produce the vaccine.
Amid Russia’s rush to become the first to create a vaccine, the U.S., Britain and Canada last month accused Russia of using hackers to steal vaccine research from Western labs.
Researchers at the Gamaleya Institute raised eyebrows in May when they said that some researchers tried the vaccine on themselves before the start of human studies.
Human trials started only on June 17 with 76 volunteers. Half were injected with a vaccine in liquid form and the other half with a vaccine that came as soluble powder. Some in the first half were recruited from the military, which raised concerns that servicemen may have been pressured to participate.
Who can get it?
Although advanced clinical trials are only set to begin Wednesday, officials say that tens of thousands of volunteers will get the vaccine before these are completed.
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.
“We expect tens of thousands of volunteers to be vaccinated within the next months,” said Kirill Dmitriev, chief executive of the Russian Direct Investment Fund. “So people outside of clinical trials will have access to the vaccine in August, and some, already on the massive scale, in October.”
How well does it work?
Experts say they don’t really know how safe or effective the Sputnik V vaccine is.
According to Putin, the vaccine underwent the necessary tests and was shown to provide lasting immunity to the coronavirus. One of his own adult daughters has received the shot, he said.
“I know it has proven efficient and forms a stable immunity,” he said. “We must be grateful to those who made that first step very important for our country and the entire world.”
But scientists are less enthusiastic, saying that the vaccine has not completed all trials necessary to show that it is safe and effective. They’re also concerned about the lack of published results.
“Fast-tracked approval will not make Russia the leader in the (vaccine) race, it will just expose consumers of the vaccine to unnecessary danger,” said Russia’s own Association of Clinical Trials Organizations on Monday. It urged government officials to postpone clearing the vaccine without completed advanced trials.
According to records kept by the World Health Organization, the vaccine has only registered Stage 1 trials, which are typically done on small groups of people to assess basic safety information. Data on these trial results isn’t available on the public WHO site.
Several other vaccine candidates are currently undergoing Stage 3 trials, typically the last stage before approval.
Dr. Howard Njoo, Canada’s deputy chief public health officer, said at a press conference Tuesday that he found the speed of the Russian vaccine approval “surprising.”
“It seems quite short based on what we know about how normally vaccine trials go,” he said.
Phase 3 trials normally involve thousands of people and take time, he said. He thinks it is important for scientists to have access to the Russian data in order to “draw conclusions and have a better idea of the potential of this Russian vaccine.”
A WHO spokesperson said that they are in discussion with Russian authorities for prequalification of its vaccine — a process to allow it to be sold on the market — “But again prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data.”
“It is not possible to know if the Russian vaccine has been shown to be effective without submission of scientific papers for analysis and then there may be problems on data quality,” said Keith Neal, emeritus professor of the epidemiology of infectious diseases of the University of Nottingham, in a statement.
Using a vaccine before it’s proven to be safe carries the risk of undermining public confidence in all coronavirus vaccines, some say.
“The collateral damage from the release of any vaccine that was less than safe and effective would exacerbate our current problems insurmountably,” said Imperial College London immunology professor Danny Altmann in a statement Tuesday.
— With files from Reuters and the Associated Press