Russian vaccine has yet to complete clinical trials but works ‘effectively enough,’ President Putin said.
A Russian health care regulator has become the first in the world to approve a vaccine against 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 the country is rushing approval for political or propaganda purposes in the global race to inoculate the public, while cutting corners on testing.
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 despite the absence of published information about any late-phase testing.
The announcement came despite a warning last week from the World Health Organization that Russia should not stray from the usual methods of testing a vaccine for safety and effectiveness.
“It works effectively enough, forms a stable immunity and I repeat, it has gone through all necessary tests,” Mr. Putin told a Cabinet meeting on Tuesday. Mr. Putin also said that one of his daughters had taken the vaccine.
The Russian vaccine sped through early monkey and human trials with apparent success, but the scientific organization that developed the vaccine, the Gamaleya Institute, has yet to test it broadly in highly controlled trials, a process seen as the only method of ensuring a vaccine is actually safe and effective.
Russia’s minister of health, Mikhail Murashko, has said the country will begin a mass vaccination campaign in October, starting with teachers and medical workers.
The World Health Organization maintains a comprehensive list of worldwide vaccine trials. In the latest version of the W.H.O.’s list, there is no Russian Phase.
The Russian ministry of health did not respond to detailed written questions sent last week about human trials and research into possible side effects. Those include the possibility that inoculation might render those vaccinated more, not less, vulnerable to severe forms of Covid-19, the disease caused by the coronavirus, a possibility that researchers outside Russia say they have yet to rule out.
Regulatory approval in Russia, which came well ahead of the timeline that Western countries say they are expecting for their vaccine candidates, could become a symbol of national pride. Western regulators say a vaccine will not become available sooner than the end of this year.
The governments of the United States, Canada and Britain have all accused Russian state hackers of attempting 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 leading 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 that 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.
The Russian vaccine was developed by the Gamaleya Institute in Moscow. It uses two strains of adenovirus that typically cause mild colds in humans. Adenovirus vaccines are in trials in various countries. 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.
The coronavirus has now sickened more than 20 million people worldwide, a number that has doubled in about six weeks, according to a New York Times database. The global death toll has reached nearly 735,000.
More than 200,000 cases are being reported each day on average, according to the database.
The United States leads all countries in cases, with 5.1 million. More than 47,000 cases and more than 530 deaths were announced across the nation Monday. The next highest caseloads are Brazil, with three million confirmed cases, and India, with 2.3 million.
After lockdowns went into effect across the world in March, cases leveled off in April. But as countries began to reopen again, cases started to rise. The virus is resurgent in Europe at the moment, with Belgium, Britain, France, Germany, the Netherlands and Spain among the countries seeing cases rise.
Africa reached 1 million cases last week, although the spread there happened more slowly than anticipated.
Latin America is also dealing with high numbers. Brazil’s case count has remained stubbornly high. And Mexico passed 50,000 deaths from the virus last week.
President Trump is considering new immigration regulations that would allow border officials to temporarily block American citizens and legal permanent residents from returning to the United States from abroad if authorities believe they may be infected with the coronavirus.
In recent months, Mr. Trump has imposed sweeping rules that ban entry by foreigners into the United States, citing the risk of allowing the virus to spread from hot spots abroad. But those rules have exempted two categories of people attempting to return: American citizens and noncitizens who have already established legal residence.
Now, a draft regulation would expand the government’s power to prevent entry by citizens and legal residents in individual, limited circumstances. Federal agencies have been asked to submit feedback on the proposal to the White House by Tuesday, though it is unclear when it might be approved or announced.
Under the proposal, which relies on existing legal authorities of the Centers for Disease Control and Prevention, the government could block a citizen or legal resident from crossing the border into the United States if an official “reasonably believes that the individual either may have been exposed to or is infected with the communicable disease.”
The draft, parts of which were obtained by The New York Times, explicitly says that any order blocking citizens and legal permanent residents must “include appropriate protections to ensure that no Constitutional rights are infringed.” And it says that citizens and legal residents cannot be blocked as an entire class of people.
The documents appear not to detail how long a citizen or legal resident would be required to remain outside of the United States.
Prime Minister Boris Johnson says that opening Britain’s schools next month is a “moral duty,” and that in the event of a resurgence of the virus, “the last thing we want to do is to close schools.”
To avoid the scenario that Mr. Johnson described on Monday, medical experts said, the government will have to be ready to sacrifice a hallowed British institution — pubs, as well as restaurants, which reopened a few weeks ago but are increasingly viewed as among the greatest risks for spreading the virus.
Mr. Johnson’s drive to reopen schools has put him at odds with teachers’ unions and local governments, which generally accept that schools should reopen but argue that Britain’s system for testing and contact tracing is not robust enough to cope with the outbreaks that may follow.
The government, they said, had not developed plans for how teachers should handle sick students or communicate with parents if there is an outbreak. Mr. Johnson’s back-to-school campaign, some said, smacked of a government that had emphasized other priorities, like eating out in restaurants, and was playing catch-up.
“The big question is, if you open schools, how long can you keep them open?” said Devi Sridhar, the director of the global health governance program at Edinburgh University. “If there’s spreading, do you shut down the whole school? Do you shut down a single class?”
Professor Sridhar said the safest way to open schools was to drive down the transmission rate — and the way to do that, she said, was to close “the nighttime economy.” In the Scottish city of Aberdeen, she noted, nearly 800 people were forced into quarantine because of an outbreak that authorities traced to a handful of pubs.
“My message is, you have to choose,” she said. “Which part of the economy do you have to sacrifice? Something’s got to give.”
Mr. Johnson cannot order schools to open or close; those decisions are made by the local health authorities. But some teachers say they are eager to return to the classroom, viewing the health risks as manageable. Schools in Scotland plan to reopen this week, with England’s opening on Sept. 1.
In other news from around the world:
Vietnam, which did not record its first Covid-19 death until July 31, reported four on Tuesday, its highest daily number since the start of the pandemic. All 15 of the country’s fatalities so far were linked to an outbreak that began last month in the central city of Danang and infected nearly 400 people. The country now has a total of 847 confirmed cases.
Reporting was contributed by Caitlin Dickerson, Andrew E. Kramer, Mark Landler, Michael D. Shear and Kaly Soto.