A test of a late-stage vaccine will enroll people at 89 sites around the United States.
One of the first large studies of safety and effectiveness of a coronavirus vaccine in the United States began on Monday morning, according to the National Institutes of Health and the biotech company Moderna, which collaborated to develop the vaccine.
The study, a Phase 3 clinical trial, is to enroll 30,000 healthy people at about 89 sites around the country. Half will receive two shots of the vaccine, 28 days apart, and half will receive two shots of a saltwater placebo. Neither the volunteers nor the medical staff giving the injections will know who is getting the real vaccine.
Researchers will then monitor the subjects, looking for side effects and waiting to see if significantly fewer vaccinated people get Covid-19, indicating that the vaccine works. The main goal is to determine whether the vaccine can prevent the illness. The study will also try to find out if it can prevent severe Covid-19 and death; if it can prevent infection entirely, based on lab tests; and if just one shot can prevent the illness.
Earlier tests of the vaccine showed that it stimulated a strong immune response, with minor and transient side effects like sore arms, fatigue, achiness and fever. But exactly what type of immune response is needed to prevent the illness is not known, so Phase 3 studies are essential to determine whether a vaccine really works.
In a statement, Dr. Francis Collins, the director of the N.I.H., said, “Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people.” He said that despite the unprecedented speed in bringing this experimental vaccine to human testing, “the most stringent safety measures” were being maintained.
Moderna said in a statement that it would be able to deliver about 500 million doses per year, and possibly up to a billion doses per year, starting in 2021. The company says it will not sell the vaccine at cost, but for profit.
The vaccine uses a synthetic version of genetic material from part of the coronavirus, encased in tiny particles made of fat that help it get into human cells. The genetic material, called messenger RNA or mRNA, then prompts the cells to churn out a tiny piece of the virus, which the immune system sees as foreign, and learns to recognize. If the person is later exposed to the real virus, the immune system will attack.
Messenger RNA has not produced any approved vaccines, but other companies have also invested in the approach because of its potential to produce vaccine quickly. The government announced last week that it had made a $1.95 billion deal to buy 100 million doses of an mRNA vaccine made by Pfizer, in partnership with a German company, BioNTech. That vaccine is also expected to begin Phase 3 trials this month, and the government will buy it only if the trial proves it safe and effective. Curevac and Sanofi are also working on mRNA vaccines.
Moderna said on Sunday that it would receive up to $472 million in additional funding from the federal government to help pay for the late-stage clinical trial. Hundreds of vaccines are being tested for the coronavirus, and 27 are in human trials. The federal government has been promising billions of dollars to companies to quickly develop and manufacture vaccines as part of Operation Warp Speed. In addition to Pfizer and Moderna, Novavax has entered a $1.6 billion deal. Other companies that have received significant federal money include AstraZeneca and Johnson & Johnson. The total value of Moderna’s award is now $955 million, the company said.
With Kentucky officials set to announce stricter measures on Monday to contain the coronavirus, a top federal health official suggested that the leaders of nearby states should take a hard look at doing the same.
On a visit to Kentucky on Sunday, Dr. Deborah L. Birx, the Trump administration’s coronavirus response coordinator, said several states in the region should reinstate bar closures and restrictions on public gatherings to quell the rise of infections.
“We do believe that there are states that do need to close their bars, to decrease indoor gatherings to less than 10 and to decrease social gatherings to less than 10 to really make it possible to control the pandemic before it gets worse,” Dr. Birx said at a news conference.
Several states in the South and Midwest are facing the prospect of shutting down parts of their economy again to try to stem the virus, which the Trump administration and many governors have increasingly been forced to recognize as unrelenting. As some states turn to new restrictions to try to stem the spread, Larry Kudlow, the president’s economic adviser, said Sunday on CNN that the administration would “lengthen” the eviction moratorium which was set to expire at the end of July.
Florida has surpassed New York, an early epicenter of the pandemic in the United States, in the number of cases, and four states have set single-day records for infections: Louisiana, Tennessee, Oklahoma and Alaska.
On her visit to Kentucky, Dr. Birx cited as worrisome not just that state but also Indiana, Ohio, Tennessee and Virginia. She said the federal health authorities were concerned about the percentage of people who were testing positive for the virus, as well as the total number of cases.
Dr. Birx appeared with Gov. Andy Beshear of Kentucky, a Democrat, who said that the state would announce new guidelines on Monday to address the rise in cases.
“I want you to know that the White House and Kentucky state government are in complete agreement that the escalation of cases is going to require us to take some new steps,” Mr. Beshear said.
In Florida, cases have surged this month. Over the past week, there have been an average of about 10,500 cases per day, an increase of about 19 percent from the average two weeks earlier, according to a New York Times database. There have been at least 5,853 deaths in Florida since the beginning of the pandemic.
And despite increased testing capacity across the nation, there is a consensus among federal state and local officials that test results are taking too long.
The federal government said Sunday that it would pay the testing company Hologic up to $7.6 million to expand the number of tests its machines can run by two million a month. The expanded capacity won’t be available until next January.
Testing is considered crucial to understanding — and slowing — the spread of the virus. When turnaround times extend beyond several days, it can render the information useless, since those tested may have spread the virus to other people by the time their results are back.
Top Trump administration officials proposed on Sunday potentially short-circuiting free-ranging stimulus talks with Democrats to rush through a much narrower bill prioritizing an extension of federal unemployment benefits that are set to expire this week for millions of Americans.
Mark Meadows, the White House chief of staff, said he would now like to see lawmakers act this week to extend and alter the unemployment program, give tax credits to businesses to help ease reopening costs and grant employers new liability protections — while setting aside a long list of other objectives, including Democrats’ priorities.
“Perhaps we put that forward, get that passed, as we can negotiate on the rest of the bill in the weeks to come,” Mr. Meadows said on ABC’s “This Week.”
The proposal, echoed by Treasury Secretary Steven Mnuchin in his own Sunday morning interview, was a last-ditch effort by Republicans to prevent the program from lapsing as signs mounted that the nation’s economy was once again weakening amid a resurgence of coronavirus cases.
With Democrats already on record in opposition to a piecemeal approach, a narrow fix is almost certainly dead on arrival. Republicans know that, suggesting their Sunday proposal may in part be a negotiating tactic laying the groundwork to blame the opposition party when the funds ultimately expire.
Democrats passed their own $3 trillion proposal — which also includes money to bail out states and cities, fully fund the $600 additional federal jobless benefit and infuse billions more into the nation’s health care system — in May and view the time pinch now as a problem of Republicans’ making that only gives them more leverage in shaping a final bill.
“We’ve been anxious to negotiate for two months and 10 days,” Speaker Nancy Pelosi said on Sunday on the CBS program “Face the Nation.” She said Congress could not leave town for its annual August recess until a deal was
How do you keep people safe from a pandemic when a hurricane is bearing down?
As Hurricane Hanna began to slam the coast of Texas coast over the weekend, some Texans were forced to balance one threat against another. To avoid possible injury or death in the storm, they had to risk infection from the coronavirus.
In ordinary times, if a big storm is approaching, city officials will ask people in seaside and flood-prone areas to evacuate and seek shelter with relatives or in emergency shelters — places where people share bathrooms and tight quarters.
But fear of contagion has thrown old protocols out the window.
“When I saw that the hurricane was headed our way, I thought, ‘We have enough problems,’” said the mayor of Corpus Christi, Joe McComb.
Hanna has not displaced many people, as hurricanes go, and that made things a little easier. The relatively low-stakes storm allowed officials to assess how to help people evacuate safely while diminishing the spread of the virus.
But some still faced tough decisions, among them Bartt Howe, a 49-year-old Texan whose boat was his refuge from the pandemic.
Battling diabetes and H.I.V., he knew that catching the virus could kill him, so he had been living alone on the docked boat for three months.
“I had managed to stay safe all this time, but the storm kicked me out of my boat,” Mr. Howe said. “Now here I am, back on land, on borrowed time.”
Here’s what else is happening with the coronavirus response in the United States:
Everyone who is evacuated will be required to go isolation for 14 days, and their health will be closely monitored, officials said Monday.
The strain of the virus found in Danang is different from five strains detected earlier in the county and spreads more rapidly than the others, they said.
Dozens of flights have been added, but the evacuation is expected to take at least four days. The evacuees are mostly local tourists; Vietnam remains closed to incoming foreign tourists.
Health officials began expanded screening and testing in Danang, a popular tourist destination, after a 57-year-old man tested positive for the fourth time on Saturday, the government said. The infections of three additional people on Sunday, including a 61-year-old man requiring a ventilator, prompted the evacuation. Officials said it was unclear whether all four patients had the same source of infection.
Vietnam said late Monday that it had found an additional 11 cases linked to a Danang hospital, Reuters reported.
Vietnam has been among the world’s most successful countries in containing the virus. It closed down international borders early in the crisis, called for widespread use of masks, and rapidly began strict quarantine and contact-tracing measures. There have been 420 cases and no deaths, according to a New York Times database.
But the case of the 57-year-old-man, who had not traveled outside Danang and rarely left home in the previous month, alarmed Vietnam’s residents, who are being asked to wear masks again after becoming more lax in recent months.
Several countries that had the virus under control have had to sharpen their response after a sudden uptick in cases. In June, China reimposed restrictions in Beijing after a flare-up ended a 56-day run of no locally transmitted cases. Officials in Australia locked down much of Melbourne in early July after restrictions had been eased for months. But Japan has shied away from new restrictions even as cases broke records last week.
In other news from around the world:
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Often criticized for a slow response to the coronavirus, the government in Britain moved quickly this weekend to impose a 14-day quarantine on anyone arriving from Spain, after a spike in coronavirus cases there. The rapid move brought disarray to thousands of Britons, blindsiding those already traveling and embarrassing Britain’s transportation secretary, Grant Shapps, who is responsible for aviation policy but learned of the quarantine while on vacation. In Spain.
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Officials in Hong Kong, which reported a record 145 new cases on Monday and has had more than 100 new cases for six days in a row, said on Monday that they would shut down all dine-in restaurant service, limit public gatherings to two people and require masks in public at all times. Hong Kong is coping with its worst outbreak yet after having the virus largely under control from mid-April to July.
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The government of Morocco locked down eight cities on Sunday before the Eid al-Adha holiday. People are prohibited from leaving or entering Berrechid, Casablanca, Fez, Marrakesh, Meknes, Settat, Tangier and Tetouan, except under specific conditions. The lockdown is open-ended. The decision comes after a week of rising coronavirus cases in the North African kingdom and is aimed at containing the virus during a holiday when Moroccans travel across the country to visit family. Over the weekend, the authorities also tightened the control of the mask mandate and fined and even arrested people who didn’t wear their masks outside of their homes. Morocco has had 20,278 cases and 313 deaths from the virus.
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The health minister of the Mexican state of Chihuahua, Dr. Jesus Grajeda, died nearly two weeks after being hospitalized with Covid-19, Reuters reported. Announcing the death on Sunday on Facebook, Chihuahua’s governor, Javier Corral, expressed “profound sadness.”
In Zambia, 15 lawmakers tested positive for the virus.
The coronavirus pandemic has been surging across Zambia, with the government announcing a record number of cases. Last week, the authorities also said that 15 lawmakers and 11 members of staff had tested positive for the coronavirus.
One of those is the lawmaker Princess Kasune Zulu, 44, prominently known for being the first Zambian legislator to declare that she had H.I.V. Elected in 2016, she has worked with global organizations and traveled the world talking about living with H.I.V. and advocating on behalf of others with it. Ms. Zulu announced that she had tested positive for coronavirus on Facebook, saying she was going into quarantine.
“Covid-19 is moving rapidly and so many lives at stake,” she wrote on Facebook, urging Zambians to stay at home, wear masks and avoid gatherings, including church. “Let’s do our part so that God can do his,” she said. As of Sunday, Zambia’s ministry of health had reported cumulative 4,481 cases and 139 deaths.
Hoping to understand the virus, everyone is parsing a mountain of data.
The latest count of new coronavirus cases was jarring: Some 1,500 virus cases were identified three consecutive days last week in Illinois, and fears of a resurgence in the state even led the mayor of Chicago to shut down bars all over town on Friday.
But at the same moment, there were other, hopeful data points that seemed to tell a different story entirely. Deaths from the virus statewide are one-tenth what they were at their peak in May. And the positivity rate of new coronavirus tests in Illinois is about half that of neighboring states.
“There are so many numbers flying around,” said Dr. Allison Arwady, the commissioner of the Chicago health department. “It’s hard for people to know what’s the most important thing to follow.”
Six months since the first cases were detected in the United States, more people have been infected by far than in any other country, and the daily rundown of national numbers on Friday was a reminder of a mounting emergency: more than 73,500 new cases, 1,100 deaths and 939,838 tests, as well as 59,670 people currently hospitalized for the virus.
Americans now have access to an expanding set of data to help them interpret the coronavirus pandemic. Sophisticated data-gathering operations by newspapers, research universities and volunteers have sprung up in response to the pandemic, monitoring and collecting coronavirus metrics around the clock.
“Everybody’s tracking this virus in a way that they’ve never done with any other infectious disease,” said Dr. Amesh A. Adalja, a physician and senior scholar at the Johns Hopkins Center for Health Security who has treated coronavirus patients. “For some people, it’s helped them understand what is happening. For other people, it’s been misinterpreted and not very helpful.”
After North Korea on Sunday accused a man of secretly crossing into the country from South Korea and bringing the coronavirus with him, Seoul went in search of any defectors in the South who were missing.
By Monday, South Korean officials had zeroed in on a 24-year-old man, identified only by his family name, Kim, who in 2017 swam across the western inter-Korea border to defect to the South. On July 19, he swam back across the border into Kaesong in the North, they said.
It was not immediately clear why the defector had crossed. The South Korean news agency Yonhap reported that the man had been wanted by the South Korean police for questioning after a rape accusation.
North Korea said on Sunday that the North Korean man was “suspected to have been infected with the vicious virus” and could be the country’s first virus case. And the reverse defection prompted the North’s leader, Kim Jong-un, to order a total lockdown of Kaesong, a border city of 300,000, and declare a “maximum” national emergency.
Until Sunday, North Korea had repeatedly said that it had no Covid-19 cases. The claim was questioned by outside experts.
South Korea officials could not say whether the man might have carried the coronavirus across the border.
Nearly 3,000 small businesses in New York City have closed for good in the past four months, blaming falling revenue, vanished tourism and ballooning debt, especially for overdue rent.
Before the pandemic, Record Mart was a fixture of the Times Square subway station for more than 60 years, known for carrying vinyl recordings of Latin and jazz music.
Lou Moskowitz left his job in real estate in 2006 to work full time at the shop, which was owned by his father. Sales at independent record stores were on the decline nationwide, and many were shutting down throughout New York. Mr. Moskowitz’s friends questioned his move.
After his father died in 2012, Mr. Moskowitz took over the business. For years, Record Mart survived by selling electronics and headphones and drawing in passers-by to explore its extensive vinyl collection. The shop was not thriving, but revenue trickled in.
Then coronavirus cases and hospitalizations rose in New York, and more than 90 percent of the city’s subway ridership disappeared. That was “the final nail in the coffin,” Mr. Moskowitz said. He weighed the shop’s future for two months before closing it permanently in June.
Restaurants, barbershops and small shops have closed across the city, and for some New Yorkers, the near-weekly closures of neighborhood mainstays have ushered in a type of mourning.
“It’s been this long, drawn-out loss, and it’s a lot to take in emotionally,” said Jeremiah Moss, the author of “Vanishing New York: How a Great City Lost Its Soul,” a book about gentrification.
Mr. Moss said he recently rode by a Manhattan theater and suddenly began wondering if it, too, would disappear soon. “And then I pushed it aside,’ he said, ”because it’s just too much right now. It’s overwhelming.”
Reporting was contributed by Stephen Castle, Emily Cochrane, Nicholas Fandos, Julie Bosman, Troy Closson, Denise Grady, Choe Sang-Hun, Tiffany May, Raphael Minder, Richard C. Paddock, Edgar Sandoval, Eileen Sullivan, Neil Vigdor and Daniel Victor.
Source : Nytimes
