A Russian vaccine works ‘effectively enough,’ President Putin said. But it hasn’t completed Phase III tests.
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.”
Mr. Putin also said that one of his daughters had taken the vaccine.
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.
But 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.
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 III, 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 III trial can also pick up more subtle side effects of a vaccine that earlier trials could not.
Asked about the Russian announcement on Tuesday, Alex Azar, the U.S. secretary of health and human services, said on ABC’s “Good Morning America” that “the point is not to be first with a vaccine — the point is to have a vaccine that is safe and effective.”
“We need transparent data and it’s got to be Phase III data,” he added.
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. Mr. Azar said that the United States has two vaccine candidates in Phase III trials and was on track to have “tens of millions of doses by December of F.D.A. gold-standard vaccine.”
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.
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 lift for Mr. Putin, whose popularity ratings have fallen steadily under the weight of the pandemic and a faltering economy.
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 do not appear to detail how long a citizen or legal resident would be required to remain outside of the United States.
Even as President Trump promised relief for tens of millions of unemployed Americans who saw critical $600-a-week benefits lapse at the end of July, it was unclear how quickly states would be able to set up the new system required to distribute aid under Mr. Trump’s executive action.
Experts warn that because the administration can only divert existing aid without the congressional approval of new funds, the combination of aid siphoned from a disaster relief fund with state aid may only last for a few weeks.
Mr. Trump said on Monday that “a lot of money will be going to a lot of people very quickly.” He said he had instructed Steven Mnuchin, the Treasury secretary, to move as quickly as possible to make it happen. It was unclear whether the aid would materialize if lawsuits were filed challenging the legality of the president’s actions.
Gov. Andrew M. Cuomo of New York said Mr. Trump’s directive would cost his state about $4 billion by the end of the year, making it little more than a fantasy. Mr. Cuomo, a Democrat, said that no New Yorker would see enhanced unemployment benefits because of the president.
Even some Republican governors said the order could strain their budgets and worried it would take weeks for tens of millions of unemployed Americans to begin seeing the benefit.
Congress initially provided a $600-a-week supplement to unemployment benefits when the pandemic shut down much of the United States in March. But that benefit lapsed on July 31, after talks between the White House and Congress broke down. Republicans had pushed for a $400 supplemental benefit, which Democrats said was not enough. On Saturday, Mr. Trump ordered the $400 benefit — but said it was contingent on states coming up with $100 of that on their own.
Republicans largely praised the president for trying to act where Congress had failed, but they said they would need to pull funds from other pressing budgetary needs.
Gov. Asa Hutchinson of Arkansas, a Republican, said it was possible to comply with Mr. Trump’s executive order, but he would have to reallocate money from another part of the budget.
“We could do it,” Mr. Hutchinson said in an interview. “It would be a readjustment of priorities and take some time.” He added, “That’s not ideal.”
Gov. Brian Kemp of Georgia, a Republican and an ally of Mr. Trump, said his staff was still working through what to do about unemployment benefits. “We’re digging in on that issue,” he said.
And Gov. Jim Justice of West Virginia, a Republican, said the order would cost his state $26 million a week. He said he was hopeful that the federal government would decide to cover the whole cost of the program, and that lawmakers would strike a deal. “We hope Congress will quit being a bunch of political babies,” he said.
The onset of warm weather nearly always brings with it a spike in violent crime, but with much of the United States emerging from weeks of shutdown, the increase this year has been much steeper than usual.
Across 20 major cities, the murder rate at the end of June was on average 37 percent higher than it was at the end of May, according to Richard Rosenfeld, a criminologist at the University of Missouri-St. Louis. The increase over the same period a year ago was just 6 percent.
In few places has the bloodshed been more devastating than in Kansas City, Mo., which is on pace to shatter its record for homicides in a year. Much of it has involved incidents of random violence that have claimed the lives of a pregnant woman pushing a stroller, a 4-year-old boy asleep in his grandmother’s home and a teenage girl sitting in a car.
The crime in Kansas City has prompted a much-debated intervention from the federal government, an operation named after the boy killed at his grandmother’s home, LeGend Taliferro, which sent about 200 federal agents into the city in an effort to help stem the violence. The operation has been expanded and has sent federal law enforcement agents to at least six cities.
“We’re surrounded by murder, and it’s almost like your number is up,” said Erica Mosby, whose niece, Diamon Eichelburger, 20, was the pregnant victim pushing the stroller in Kansas City. “It’s terrible.”
Nationally, crime remains at or near a generational low, and experts caution against drawing conclusions from just a few months.
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.
The Namibian government will auction fishing rights in a bid to raise desperately needed funds to fight the pandemic. The southern African country has recorded only 3,101 cases of the coronavirus and 19 related deaths, but cases are expected to increase in the coming weeks, in line with much of the rest of Africa.
The highest foreign bidder will have a 60 percent annual fishing quota normally owned by Fishcor, a state-owned company facing allegations of corruption including kickbacks in exchange for fishing rights. Fishcor’s stake amounts to 72,000 tons of horse mackerel and 11,000 tons of hake, while the rights to net a further 392 tons of monkfish will also be up for grabs by October.
“Government is in need of financial resources on an emergency basis with a view to mitigate the effects of Covid-19,” Albert Kawana, the minister of Fisheries and Marine Resources, said in a statement. “We do not produce medicines in Namibia nor do we manufacture medical equipment. In order to obtain these items, we have to buy them with foreign currency.”
After mining and agriculture, fishing is the biggest foreign currency earner for Namibia, bringing in some $10 billion Namibian dollars ($565 million U.S.) annually.
Last month, the government ordered the closure of schools for 28 days as part of a new set of restrictions aimed at curbing rising virus cases.
New Zealand breaks a 102-day streak without any locally transmitted cases of the virus.
New Zealand on Tuesday confirmed its first locally transmitted cases of the coronavirus in months, shortly after its 100-day milestone without any new such infections.
Four people from the same family were found to be infected from an unknown source, said Dr. Ashley Bloomfield, the country’s top health official. The first case in the new cluster was a person living in South Auckland who had no history of traveling abroad, he said.
The new cases immediately triggered “level three” restrictions in Auckland for three days, which means residents are instructed to stay home other than for essential personal movements, while the rest of the country will follow social-distancing measures.
“We are asking people in Auckland to stay home to stop the spread,” Prime Minister Jacinda Ardern said Tuesday. “Act as if you have Covid, and as if the people around you have Covid.”
The nation of five million people was able to declare itself free from the coronavirus in June after strict lockdown measures were implemented, and had been hailed as a model of successfully fighting the virus. But imported cases were later confirmed.
NEW YORK ROUNDUP
Some wedding gatherings won’t be subjected to the 50-person cap, a New York State judge rules.
Wedding receptions at restaurants in New York State where indoor dining is allowed are not subject to the 50-person cap on gatherings that the governor imposed as part of the state’s virus restrictions, a federal judge has ruled.
The ruling, by Judge Glenn Suddaby of Federal District Court for the Northern District of New York, would allow wedding venues to host parties of more than 50 people under the same rules that apply to restaurants. The rules now limit indoor service to half a restaurant’s typical capacity.
Because indoor dining has not yet been allowed in New York City, the ruling would not appear to apply to wedding venues there.
The decision, which was issued on Friday, came in response to a lawsuit filed by two couples who had booked weddings at the Arrowhead Golf Club in Akron, N.Y., about a half-hour’s drive northeast of Buffalo.
Lawyers for the state argued in legal filings that “the court should not second-guess the state’s response to a health crisis.”
But the plaintiffs argued in their complaint that their wedding parties should be allowed to proceed because the Arrowhead rooms that are used for receptions were large enough to legally seat well over 50 people when operating as restaurants.
Judge Suddaby agreed.
“The court can find no rational basis for this state’s difference in treatment between use of the venues in question for ordinary dining and use of those venues for weddings,” he wrote, noting that the plaintiffs and the Arrowhead’s owners had pledged to abide by social distancing, mask wearing and all other public-health rules adopted amid the pandemic.
Anthony Rupp, a lawyer for the plaintiffs, said he was “extraordinarily pleased” with the ruling.
Caitlin Girouard, the governor’s press secretary, described Judge Suddaby’s ruling as “irresponsible at best as it would allow for large, non-essential gatherings that endanger public health” and said the administration would “pursue all available legal remedies immediately.”
Elsewhere in the New York area:
New Yorkers may have paid quadruple what they should have for eggs at a time when virus cases were surging, according to a lawsuit by the state attorney general’s office.
Many Americans won’t set foot in a hospital during the pandemic, but their pets are seeing vets.
The human health care system has struggled financially through the pandemic, losing billions from the cancellations of lucrative elective operations as patients were first told to stay away from hospitals and then were leery of setting foot in one.
“It’s crazy, in a good way,” said Dr. Margot Vahrenwald, a veterinarian in Denver. “We’re probably seeing 25 percent more new pets than what we would normally. It feels busier, and we’re seeing increased revenue.”
While hospitals were furloughing workers, Dr. Vahrenwald, an owner of Park Hill Veterinary Medical Center, added five employees, and still has job listings for more. Her clinic has had to buy two phone lines to handle a deluge of calls from pet owners.
Animal hospitals appear to have pulled off something human hospitals have struggled to do: make patients feel comfortable seeking routine care.
Most veterinarians are now requiring curbside service — owners drop their pet at the door, and wait outside during the appointment — lessening the risk of being infected.
Their animal patients tend to be less susceptible to the coronavirus, although not completely immune. Some pets have become infected, and last month the first dog in the United States to test positive for the virus died.
Pet owners have, collectively, decided there is enough value in maintaining the health of their cats and dogs to brave the outside world at least a little more. Much of the increase in veterinary care seems to be for wellness visits and vaccinations. By contrast, primary care spending for humans is estimated to have dropped by $15 billion over the course of the pandemic.
The veterinary industry provides something else important that the human health system doesn’t: transparent prices. Veterinarians can typically provide reliable price estimates, in part because they have standard charges that don’t vary by type of insurance.
Patients may be reluctant to return to the human health system in part because they’ve lost coverage, or have less income, and are worried about the possibility of a surprise bill.
Reporting was contributed by Nicholas Bogel-Burroughs, Luke Broadwater, Nick Bruce, Emily Cochrane, Shaila Dewan, Caitlin Dickerson, John Eligon, Sarah Kliff, Andrew E. Kramer, Mark Landler, Sarah Mervosh, Alan Rappeport, Ed Shanahan, Michael D. Shear, Mitch Smith, Kaly Soto, Will Wright, Jin Wu and Elaine Yu.