MOSCOW — A Russian health care regulator has become the first in the world to approve a vaccine for the coronavirus, President Vladimir V. Putin announced on Tuesday, though the vaccine has yet to complete clinical trials.
The Russian dash for a vaccine has already raised international concerns that Moscow is cutting corners on testing to score political and propaganda points.
Mr. Putin’s announcement came despite a caution last week from the World Health Organization that Russia should not stray from the usual methods of testing a vaccine for safety and effectiveness.
Mr. Putin’s announcement became essentially a claim of victory in the global race for a vaccine, something Russian officials have been telegraphing for several weeks now despite the absence of published information about any late-phase testing.
“It works effectively enough, forms a stable immunity and, I repeat, it has gone through all necessary tests,” Mr. Putin told a cabinet meeting Tuesday morning. He thanked the scientists who developed the vaccine for “this first, very important step for our country, and generally for the whole world.”
Western regulators have said repeatedly that they do not expect a vaccine to become widely available before the end of the year at the earliest. Regulatory approval in Russia, well ahead of that timeline, could become a symbol of national pride and provide a much needed political lift for Mr. Putin.
The Russian vaccine, along with many others under development in a number of countries in the effort to alleviate a worldwide health crisis that has killed at least 734,900 people, sped through early monkey and human trials with apparent success.
Vaccines generally go through three stages of human testing before being approved for widespread use. The first two phases test the vaccine on relatively small groups of people to see if it causes harm and if it stimulates the immune system. The last phase, known as Phase 3, compares the vaccine to a placebo in thousands of people.
This final phase is the only way to know with statistical certainty whether a vaccine prevents an infection. And because it’s testing a much larger group of people, a Phase 3 trial can also pick up more subtle side effects of a vaccine that earlier trials could not.
The Food and Drug Administration in the United States has said that a new coronavirus vaccine would need to be 50 percent more effective than a placebo in order to be approved.
The Russian scientific body that developed the vaccine, the Gamaleya Institute, has yet to conduct Phase III tests on tens of thousands of volunteers in highly controlled trials, a process seen as the only method of ensuring a vaccine is actually safe and effective. Around the world, more than 30 vaccines out of a total of more than 165 under development are now in various stages of human trials.
The Russian vaccine uses two strains of adenovirus that typically cause mild colds in humans. They are genetically modified to cause infected cells to make proteins from the spike of the new coronavirus. The approach is similar to a vaccine developed by Oxford University and AstraZeneca that has shown promise in early testing and is now undergoing Phase III tests in Britain, Brazil and South Africa.
Russia’s minister of health, Mikhail Murashko, has said the country will begin a mass vaccination campaign in the fall, and said on Tuesday that it would start with teachers and medical workers this month.
The World Health Organization maintains a comprehensive list of worldwide vaccine trials. In the latest version of the list, there is no Russian Phase III trial.
The organization is in close contact with Russian authorities and discussing its prequalification procedures, Tarik Jasarevic, a spokesman, told reporters in Geneva on Tuesday, but he emphasized that to obtain this seal of approval would require “rigorous review of safety and efficacy data” derived from clinical trials.
Last week, a spokesman for the organization, Christian Lindmeier, cautioned that all vaccines should go through full testing before being released to the public. “There are established practices and there are guidelines,” he said. Any vaccine, he added, “should be, of course, going through all the various trials.”
The Coronavirus Outbreak ›
Frequently Asked Questions
Updated August 6, 2020
Why are bars linked to outbreaks?
- Think about a bar. Alcohol is flowing. It can be loud, but it’s definitely intimate, and you often need to lean in close to hear your friend. And strangers have way, way fewer reservations about coming up to people in a bar. That’s sort of the point of a bar. Feeling good and close to strangers. It’s no surprise, then, that bars have been linked to outbreaks in several states. Louisiana health officials have tied at least 100 coronavirus cases to bars in the Tigerland nightlife district in Baton Rouge. Minnesota has traced 328 recent cases to bars across the state. In Idaho, health officials shut down bars in Ada County after reporting clusters of infections among young adults who had visited several bars in downtown Boise. Governors in California, Texas and Arizona, where coronavirus cases are soaring, have ordered hundreds of newly reopened bars to shut down. Less than two weeks after Colorado’s bars reopened at limited capacity, Gov. Jared Polis ordered them to close.
I have antibodies. Am I now immune?
- As of right now, that seems likely, for at least several months. There have been frightening accounts of people suffering what seems to be a second bout of Covid-19. But experts say these patients may have a drawn-out course of infection, with the virus taking a slow toll weeks to months after initial exposure. People infected with the coronavirus typically produce immune molecules called antibodies, which are protective proteins made in response to an infection. These antibodies may last in the body only two to three months, which may seem worrisome, but that’s perfectly normal after an acute infection subsides, said Dr. Michael Mina, an immunologist at Harvard University. It may be possible to get the coronavirus again, but it’s highly unlikely that it would be possible in a short window of time from initial infection or make people sicker the second time.
I’m a small-business owner. Can I get relief?
- The stimulus bills enacted in March offer help for the millions of American small businesses. Those eligible for aid are businesses and nonprofit organizations with fewer than 500 workers, including sole proprietorships, independent contractors and freelancers. Some larger companies in some industries are also eligible. The help being offered, which is being managed by the Small Business Administration, includes the Paycheck Protection Program and the Economic Injury Disaster Loan program. But lots of folks have not yet seen payouts. Even those who have received help are confused: The rules are draconian, and some are stuck sitting on money they don’t know how to use. Many small-business owners are getting less than they expected or not hearing anything at all.
What are my rights if I am worried about going back to work?
What is school going to look like in September?
- It is unlikely that many schools will return to a normal schedule this fall, requiring the grind of online learning, makeshift child care and stunted workdays to continue. California’s two largest public school districts — Los Angeles and San Diego — said on July 13, that instruction will be remote-only in the fall, citing concerns that surging coronavirus infections in their areas pose too dire a risk for students and teachers. Together, the two districts enroll some 825,000 students. They are the largest in the country so far to abandon plans for even a partial physical return to classrooms when they reopen in August. For other districts, the solution won’t be an all-or-nothing approach. Many systems, including the nation’s largest, New York City, are devising hybrid plans that involve spending some days in classrooms and other days online. There’s no national policy on this yet, so check with your municipal school system regularly to see what is happening in your community.
The Russian Ministry of Health did not respond to detailed written questions sent last week about human trials and research into potentially harmful side effects.
Russia has already used the vaccine race as a propaganda tool, even in the absence of published scientific evidence to support its claims as the front-runner.
For the last several months, state television has promoted the idea that Russia is leading the competition. In May, it reported that the first person in the world to be vaccinated against the virus was a Russian researcher who had injected himself even before monkey trials had been completed.
Russia tested the vaccine on soldiers, raising concerns about consent, though the Ministry of Defense said that all the soldiers had volunteered.
The United States, Canadian and British governments have all accused Russian state hackers of trying to steal vaccine research, casting a shadow over Russia’s claim to have achieved a medical breakthrough. Russian officials have denied the accusation and say their vaccine is based on a design developed by Russian scientists to counter Ebola years ago.
Kirill Dmitriev, the head of a government-controlled fund that invested in the vaccine, denied Russia had cut corners on testing or stolen intellectual property to get ahead.
In an interview last month, Mr. Dmitriev said Russia relied on a legacy of once formidable research into viruses and vaccines in the Soviet Union and focused on established technologies, like the approach already used for the Ebola vaccine.
He contrasted that history with Trump administration’s Operation Warp Speed program, which is financing research by Pfizer and Moderna for a genetic vaccine and supporting a variety of other experimental technologies.
If Russian scientists have taken an unorthodox route to the coronavirus vaccine, it would not be the first time. Back in the 1950s, a team of researchers tested a promising, and ultimately successful, polio vaccine on their own children.
Nick Cumming-Bruce contributed reporting from Geneva.