Covid-19 Information: Reside Updates – The New York Occasions
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Credit…David Walter Banks for The New York Times
With an outside panel of vaccine experts voting in favor of granting emergency authorization to Pfizer’s coronavirus vaccine, American health officials are one critical step closer to a vast and complicated inoculation campaign.
What happens next?
Since the panel’s vote on Thursday was only advisory, the vaccine must now secure the authorization of the federal Food and Drug Administration. That’s ordinarily a long and laborious process.
But that is highly unlikely to be the case this time. Barring last-minute snags, the F.D.A. is expected to issue an emergency authorization on Saturday.
And that means the first Covid-19 vaccinations to be administered in the U.S. outside the confines of an experiment are likely to begin early next week. First in line to get it are health care workers and nursing home residents.
“We could see people getting vaccinated Monday, Tuesday of next week,” Alex Azar, the secretary of health and human services, said on ABC’s “Good Morning America” on Friday.
The new vaccine could not arrive at a better time — or, perhaps, a worse one.
The day before the panel endorsed it, the United States set another record for daily Covid-19 deaths, breaking the 3,000 mark. And on Thursday evening, reported deaths were again nearing 3,000, and the case count — at least 223,570 new infections reported — made it the second-worst day since the pandemic reached American shores.
The Pfizer vaccine, and another expected to join it in the near future, added to the few real tools American health officials have to combat the virus.
“With the high efficacy and good safety profile shown for our vaccine, and the pandemic essentially out of control, vaccine introduction is an urgent need,” Kathrin Jansen, head of vaccine research and development at Pfizer, said Thursday.
A vaccine, of course, is only one piece of the puzzle.
Enormous challenges remain on the economic front before a staggered country can get back onto its feet. And whatever term you want to use for the speed at which American lawmakers are arriving at a solution, it is not “warp.”
Efforts to reach a year-end agreement on a stimulus package faltered on Thursday as aides to Senator Mitch McConnell, the majority leader, signaled that most Republicans were unlikely to endorse an emerging bipartisan compromise.
There is another enormous challenge: Now that we have a vaccine, how does it get to everyone?
Pfizer and its German partner BioNTech began working on the vaccine just 11 months ago, shattering all speed records for vaccine development, which typically takes years.
But the initial allotment of vaccines will allow only a small slice of Americans to get one.
A shipment of 2.9 million doses will leave warehouses within 24 hours of being cleared by the F.D.A. and sent across the country, according to federal officials. That is only about half of the doses prepared. The other half will be reserved so that the initial recipients can have the second, required dose about three weeks later.
The U.S. authorization of the Pfizer vaccine is expected to be followed soon by one for the biotech company Moderna’s version.
It will all be the beginning of a complex, monthslong distribution plan coordinated by federal and local health authorities, as well as large hospitals and pharmacy chains.
If successful, the campaign will help return a grieving and economically depressed country back to some semblance of normal, perhaps by summer.
Credit…Oliver Contreras for The New York Times
President Trump lashed out anew at the Food and Drug Administration in a Friday morning tweet, attacking the agency’s commissioner, Dr. Stephen M. Hahn, by name for not approving a Covid-19 vaccine faster.
Continuing his practice of publicly upbraiding subordinates with whom he is displeased, Mr. Trump told Dr. Hahn to “stop playing games and start saving lives!!!” He called the F.D.A. “a big, old, slow turtle,” flush with funds but mired in bureaucracy.
The F.D.A. has been walking a thin line, trying to fast-track vaccine approval without undercutting public confidence in the process. Dr. Hahn has repeatedly said regulators will not approve a vaccine that has not been proven safe and effective.
The president’s tirade came the morning after an outside advisory panel of experts voted overwhelmingly to recommend that F.D.A. regulators approve a vaccine developed by Pfizer and its German partner, BioNTech, for emergency use.
The regulators are expected to issue the authorization as early as Saturday, and in a statement on Friday said it put the Centers for Disease Control and Prevention and those involved with Operation Warp Speed on notice “so they can execute their plans for timely vaccine distribution.”
Mr. Trump has said little about the pandemic in recent weeks, as cases and deaths have been mounting across the country. On Thursday, 2,923 people in the United States died from the virus, according to a Times database. More than 3,000 deaths were reported on Wednesday.
The president has repeatedly accused the F.D.A. and the vaccine-makers themselves of deliberately slowing the approval process in order to harm him politically. Allies of Dr. Hahn have been on tenterhooks for weeks, expecting him to be fired any day.
The president wrote that with “my pushing,” the administration had shaved years off the development of vaccines. “Get the dam vaccines out NOW, Dr. Hahn,” he wrote, misspelling the expletive.
One minute after the president’s tweet posted, Alex M. Azar, the Secretary of Health and Human Services, posted a “BREAKING” message on his official Twitter account, saying the F.D.A. had informed Pfizer that it was moving “rapidly” toward authorizing its vaccine. He was echoing a statement from Dr. Hahn and Dr. Peter Marks, the agency’s top vaccine regulator that officials say was posted before the president’s tweet.
Eileen Sullivan contributed reporting.
Credit…Martin Joppen/Sanofi, via EPA, via Shutterstock
The pharmaceutical companies Sanofi and GlaxoSmithKline said Friday that their experimental Covid-19 vaccine did not appear to work well in older adults, a significant setback to their late-stage clinical trial that was previously expected to begin in the United States in December.
Instead, the companies said they planned to test a modified version of their vaccine in a smaller trial beginning in February. Rather than compare their candidate with a placebo, they said, it could be tested against a vaccine expected to be authorized by regulators for emergency use soon.
The Sanofi vaccine is one of six that were selected by Operation Warp Speed, the federal government’s effort to quickly bring a vaccine to market. The companies negotiated a $2.1 billion agreement with the United States to provide 100 million doses.
A vaccine developed by Pfizer and the German company BioNTech was authorized for emergency use in the United Kingdom and approved in Canada. In the United States, an expert panel voted on Thursday to recommend that the Food and Drug Administration authorize that vaccine. A decision could come as early as Saturday. Another vaccine developed by Moderna could also be authorized within weeks.
Sanofi and GSK now face a more difficult path because they may have to show their vaccine is at least as good as one already authorized by regulators. The Pfizer and Moderna vaccines have each shown that they are more than 90 percent effective against Covid-19.
The companies said they now expect their vaccine will not be available until the end of next year.
“We care greatly about public health which is why we are disappointed by the delay announced today, but all our decisions are and will always be driven by science and data,” said Thomas Triomphe, executive vice president and head of Sanofi Pasteur, the company’s vaccine division. “No single pharma company can make it alone; the world needs more than one vaccine to fight the pandemic.”
The companies said Friday that interim results of their early-stage clinical trials showed that, among adults 18 to 49 years old, the vaccine stimulated an immune response that was comparable to patients who had recovered from Covid-19. But older adults showed a low immune response, likely because of an insufficient concentration of the antigen, the protein that stimulates the body’s immune reaction.
The Sanofi vaccine is based on viral proteins that are produced with engineered viruses that grow inside insect cells. GSK supplements the proteins with adjuvants that stimulate the immune system. The vaccine is based on the same design Sanofi used to create Flublok, an approved vaccine for influenza.
If the vaccine does not succeed, or if it takes longer to develop, that could limit the available supply of vaccines, both in the United States and around the world.
In addition to the U.S. deal, Sanofi and GlaxoSmithKline also reached a deal in September with the European Union for 300 million doses, and with Canada for up to 72 million doses. Sanofi also agreed to provide 200 million doses to COVAX, an international collaboration to deliver the vaccine equitably across the world. They had previously announced plans to make up to one billion doses in 2021.
Credit…Paul Ratje/Agence France-Presse — Getty Images
The new daily record of coronavirus deaths is a stunning number in and of itself.
But it’s not just that at least 3,055 deaths were reported on Wednesday for the first time since the pandemic began, far surpassing the spring peak of 2,752 deaths. It’s that the nation lost 3,055 people who once blew out birthday candles, had triumphs and stumbles, and laughed and cried — before succumbing to the virus.
In a single day, the country, numbed and divided, lost more Americans to the coronavirus than were killed in the Sept. 11 attacks or the attack on Pearl Harbor.
And it appears far from over.
“The worst is yet to come in the next week or two or three,” said Catherine Troisi, an infectious-disease epidemiologist at the UTHealth School of Public Health in Houston. “What happens after that is going to depend on our behavior today.”
Dr. Troisi, said she expected the death toll to accelerate in part because current numbers most likely do not reflect infections from Thanksgiving gatherings.
During yet another week of loss, the virus took the lives of the young and the old, the healthy and the sick, the prominent and the ordinary people known best by those who loved them.
They include Lillian Blancas, a proud daughter of immigrants, part of the first generation in her family to attend college and a lawyer in El Paso who was on the brink of fulfilling her dream of becoming a judge.
Ms. Blancas, 47, died alone in her hospital room this week, just before a runoff election on Saturday in which she was the favorite.
In Ms. Blancas’ hometown of El Paso, Linda Azani, the assistant manager of Perches Funeral Homes, said the virus toll was so steep that “there’s not enough of us to go around.”
“Not enough directors to see families,” she said. “Not enough facilities to have funerals. Not enough chapels.”
But the virus surge is no longer isolated to any one place. Across the country, officials and funeral homes are sounding the alarm.
Barbara Ferrer, a seasoned public health director in Los Angeles County, choked up this week while recounting the cumulative death toll in her area: over 8,000 people. So many people are dying in Amarillo, Texas, that there is a two-week wait to be cremated.
Almost every call coming into the Bauer Funeral Home in Effingham, Ill., involves a request for a service for a Covid-19 victim. In the last week, nine of the 13 deaths were from the virus.
“It seemed like every time I answered the phone it was somebody passing at a nursing home or a hospital from Covid,” said Mr. Young. Sometimes there were two or three a day. With cases rises after Thanksgiving, he is bracing for even more.
Credit…James Ross/AAP, via Reuters
Australia on Friday canceled a roughly $750 million plan for a large order of a locally developed coronavirus vaccine after the inoculation produced false positive test results for H.I.V. in some volunteers participating in a trial study.
Of the dozens of coronavirus vaccines being tested worldwide, the Australian one was the first to be abandoned. While its developers said the experimental vaccine had appeared to be safe and effective, the false positives risked undermining trust in the effort to vaccinate the public.
Prime Minister Scott Morrison on Friday said that his government would compensate for the loss of 51 million doses it had planned to buy from the Australian consortium in part by increasing orders of vaccines made by AstraZeneca and Novavax. The government has said it plans to begin inoculating citizens by March.
“We can’t have any issues with confidence,” he told reporters, “and we are as a nation now, with a good portfolio of vaccines, able to make these decisions to best protect the Australian people.”
Australia’s health minister, Greg Hunt, told reporters that the country still had access to 140 million units of coronavirus vaccines — more than enough to cover its population of about 25 million people.
The Australian setback showed the missteps that can inevitably occur when scientists, during a pandemic that has killed more than 1.5 million people, rush to condense the usual yearslong process to develop vaccines into a matter of months.
The mistake, said John P. Moore, an immunologist at Weill Cornell Medical College in New York, was an “honest error” that cost money, not human lives.
“I’m sure a lot of people are very embarrassed by it,” Professor Moore said. “It’s not great to be associated with a mistake like this. But when you’re running at 90 miles an hour, sometimes you trip.”
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More than 6,600 college athletes, coaches and staff members have tested positive for the coronavirus this year, a dispiriting measure of the pathogen’s reach across the United States and its spread among some of the country’s most closely monitored people.
At least 6,629 people who play and work in athletic departments that compete in college football’s premier leagues have contracted the virus, according to a New York Times analysis. The vast majority of those infections have been reported since Aug. 15, as players, coaches and the staff members around them began preparing for the fall semester, including football season.
The actual tally of cases during the pandemic is assuredly far larger than what is shown by The Times’s count, the most comprehensive public measure of the virus in college sports. The Times was able to gather complete data for just 78 of the 130 universities in the National Collegiate Athletic Association’s Football Bowl Subdivision, the top level of college football. Some of those schools released the statistics only in response to requests filed under public records laws.
The remaining schools, many of them public institutions, released no statistics or limited information about their athletic departments, or they stopped providing data just ahead of football season, drawing a curtain of secrecy around college sports during the gravest public health crisis in the United States in a century.
No athletic department that shared data reported any deaths associated with the virus, the spread of which the N.C.A.A. did not track at its member schools.
Most members of the Southeastern Conference, the college football league that many people fear, respect and revile in equal measure, for example, refused to provide complete data. The Times found at least 587 cases in its athletic departments.
Experts believe that few, if any, of the infections in college sports are linked to the games themselves and are far more often traceable to meetings, meals, travel or nonathletic activities that then seed cases. The data gathered by The Times, though, shows at least some of the consequences and risks of a porous, multibillion-dollar athletic network centered on college campuses.
Credit…Kin Cheung/Associated Press
Hong Kong and Japan announced on Friday that they had secured vaccines for their citizens, while Saudi Arabia said on Thursday it had approved one for use, as governments worldwide line up for vaccines rapidly becoming available.
The chief executive of Hong Kong, Carrie Lam, said on Friday that the Chinese territory had struck an agreement to buy 15 million doses of coronavirus vaccines. Half will come from Sinovac — whose unproven vaccine has already been given to tens of thousands on the Chinese mainland — and the other half from Pfizer-BioNTech.
Each of Hong Kong’s 7.5 million residents will be vaccinated free, Mrs. Lam said, and the first million doses from Sinovac will arrive in January.
Japan’s Health Ministry said on Friday that it had formalized a deal to buy 120 million doses of the AstraZeneca coronavirus vaccine, enough for 60 million people, and that it expected to receive the first quarter of those doses by March.
Japan has also agreed to buy 120 million doses of the Pfizer-BioNTech vaccine and 50 million doses of the Moderna vaccine.
While Saudi Arabia has not announced the number of vaccines it plans to purchase, government officials said on Thursday that it had approved the Pfizer-BioNTech vaccine as the first to be used in the country. Officials did not say when the vaccine would arrive or when it would be distributed.
In other developments across the world:
As Germany sees record levels of coronavirus infections and deaths, several states are planning tight lockdowns even before nationwide measures can be announced. On Friday, the Eastern state of Thuringia announced it would close shops and move classes to online lessons by the end of next week. A meeting between Chancellor Angela Merkel and state governors to agree on a countrywide lockdown is expected to take place on Sunday, and the mayor of Berlin told reporters he expected a three-week lockdown starting at the end of next week. German health authorities registered 29,875 new infections on Thursday, beating the previous record, set on Wednesday, by 6,196. Hospitals also recorded a record 598 deaths in one day on Thursday.
Bahrain said on Thursday that it would provide a free vaccine to all citizens and residents. The plan is to vaccinate as many as 10,000 people per day through 27 medical centers, officials said without naming which vaccine it would offer.
Credit…Florida Department of Law Enforcement, via Reuters
MIAMI — The complicated story of how a Florida data scientist responsible for managing the state’s coronavirus numbers wound up with state police agents brandishing guns in her house this week began seven long months ago, when the scientist, Rebekah D. Jones, was removed from her post at the Florida Department of Health.
Ms. Jones had helped build the statistics dashboard that showed how the virus was rapidly spreading in a state that had been hesitant to mandate broad restrictions.
Two months in, Ms. Jones was sidelined and then fired for insubordination, a conflict that she said came to a head when she refused to manipulate data to show that rural counties were ready to reopen from coronavirus lockdowns. The specter of possible censorship by the administration of Gov. Ron DeSantis, a Republican allied with President Trump, exploded into the frenetic pandemic news cycle, and Ms. Jones’s defiance came to symbolize the growing questions over Florida’s handling of the pandemic.
The arrival of state agents at her home in Tallahassee on Monday to execute a search warrant in a criminal investigation marked a new, dramatic chapter in Ms. Jones’s saga, which at its core has always returned to the same basic question: Can Floridians, who are in the midst of another alarming rise in coronavirus infections and deaths, trust the state’s data?
“This isn’t really unexpected,” she said of this week’s raid. “You take down a governor, he’s going to come for you. Six months ago, I was just a scientist trying to do my job.”
Credit…David Zalubowski/Associated Press
After a spring semester in which most American universities adopted some form of pass/fail grading system, or even abolished grades entirely, the vast majority planned to bring back normal marks this fall. But as the pandemic has continued to disrupt campuses and uproot student lives, at least some are going back to the more lenient days of spring.
After many meetings and much deliberation, Colorado State announced this month that its 25,000 undergraduates could switch to a satisfactory or unsatisfactory grade after final exams if they were unhappy with their marks in a particular class.
Kelly Long, the school’s vice provost for undergraduate affairs, said it was clear that many students were struggling in classes, which are mostly online, often because of less-than-ideal home situations.
“Perhaps their home environment is not conducive to online learning, or they are having to work or caring for someone who is ill, or they themselves are falling ill,” Dr. Long said. “Those are parts of the generous thinking we’re trying to do.”
Dr. Long said Colorado State had consulted with other universities and found that many administrators were also considering whether they had underestimated the impact of the pandemic. “Our peer institutions were starting to revisit the question,” she said. But so far, few have made similar announcements.
“We believe that grades have meaning,” said Justin Anderson, a spokesman at Dartmouth, which adopted a pass/fail system in the spring but returned to letter grades this fall.
But at M.I.T., one of the most rigorous schools in the country, administrators have continued to be accommodating. Students who receive a letter grade worse than a C in a fall semester course will not have that class appear on their transcript, unless they choose to for credit. In a letter to students on Nov. 30, Rick Danheiser, the faculty chair, said that policy would continue into the spring, and the school might revert to a “pass” system if conditions deteriorate.
Credit…Ismail Ferdous for The New York Times
American officials warned Thursday that hackers are targeting K-12 schools in a new wave of cyberattacks that is disrupting distance learning even as coronavirus cases spike across the country.
The F.B.I. and the cybersecurity division of Homeland Security issued a joint advisory warning of a new wave of ransomware and so-called DDoS, or distributed denial of service, attacks on K-12 schools that are slowing or disrupting student and teacher access to distance learning.
Some of the hackers behind the ransomware, officials said, held school data hostage or threatened to leak confidential student data if a payment was not made.
Over the past month, the attacks have taken more than a hundred schools in Baltimore offline. They have also hit dozens of schools in Texas and Alabama, as well as a handful of schools in Georgia and Ohio, according to public reports collected by Emsisoft, a security firm.
More than half of all ransomware attacks reported to a multistate analysis center in August and September involved attacks on K-12 schools, officials said.
“Schools have always been targets because there is a high likelihood they’ll pay a modest ransom to get their data back,” said Alex Holden, the chief executive at Hold Security, which specializes in cybercrime.
The F.B.I. has advised ransomware victims not to pay, but some schools are ignoring that advice.
Officials in Yazoo County, Miss., recently revealed that they had paid $300,000 to recover data from a ransomware attack last October. In July, officials in Athens, Texas, paid $50,000 to keep their data from being published online.
Cybersecurity experts say K-12 schools are particularly vulnerable, given that younger children are not as well versed in password management and in not clicking on phishing emails.
Many school districts have worked with FireEye, the security firm, which has offered school districts in Texas and elsewhere access to their security tools through the end of 2020. But earlier this week, FireEye revealed that its systems had been penetrated by nation-state hackers that appeared to be Russian.