AstraZeneca Releases Blueprints for Virus Vaccine Trial Amid Safety Scrutiny

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AstraZeneca revealed details of its large coronavirus vaccine trial on Saturday, the third in a wave of rare disclosures by drug companies under pressure to be more transparent about how they are testing products that are the world’s best hope for ending the pandemic.

Polls are finding Americans increasingly wary of accepting a virus vaccine. And scientists inside and outside the government are worried that regulators, pressured by President Trump for results before Election Day on Nov. 3, might release an unproven or unsafe vaccine.

“The release of these protocols seems to reflect some public pressure to do so,” said Natalie Dean, a biostatistician and expert in clinical trial design for vaccines at the University of Florida. “This is an unprecedented situation, and public confidence is such a huge part of the success of this endeavor.”

Pfizer and Moderna revealed details of their vaccine trials on Thursday.

Experts have been particularly concerned about AstraZeneca’s trials because of the company’s refusal to provide details about serious neurological illnesses in two participants, both women, who received its experimental vaccine in Britain, where the company’s trials began in April.

Those cases spurred the company to halt its trials twice, the second time earlier this month. The studies have resumed in Britain, Brazil, India and South Africa, but are still on pause in the United States. About 18,000 people worldwide have received AstraZeneca’s vaccine so far.

AstraZeneca’s 111-page trial blueprint, known as a protocol, states that its goal is a vaccine with 50 percent effectiveness — the same threshold that the Food and Drug Administration has set in its guidance for coronavirus vaccines.

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A motorcycle rally in a resort area of Missouri is raising fears that the thousands of people who are expected to flock to the event this weekend could spread the virus during the festivities, which include stops at bars and live concerts.

The 14th annual Bikefest Lake of the Ozarks, which began on Wednesday and runs through Sunday, comes a month after a larger motorcycle rally in Sturgis, S.D., led to a surge of cases in multiple states.

Much like Sturgis, organizers for Bikefest promised, on the event’s website, that motorcycle fans “from all over the United States will be rumbling their way” there. The rally reportedly drew 125,000 people to Central Missouri last year, and plenty of people arrived this week, too, few of whom seemed to be worried about spreading or contracting the virus.

“You can ask any biker, or whatever, anything going on in the world, it ain’t gonna stop us riding,” one attendee told a local television network, KYTV, at the rally.

But public health experts fear what could come from thousands of people descending on the scenic reservoir to chat, drink and — in a contest created by organizers — visit a group of 24 restaurants, bars and wineries for a chance to win a Harley-Davidson motorcycle.

“It’s almost an explosive petri dish to me,” Steve Edwards, the president of a hospital network in Missouri, told KOLR, a local television network.

The experts’ fears are not unfounded.

South Dakota saw a sharp increase in virus cases after the 10-day motorcycle rally in Sturgis ended Aug. 16 — and nearly 2,000 new cases in the past week. Cases linked to the rally have been reported in a number of other states; Minnesota alone has confirmed more than 50 cases traced back to the rally, officials said, and one man died.

Missouri, where the current motorcycle rally is being held, is reporting an average of more than 1,600 cases daily, its highest total of the pandemic. Much of that case growth has been driven by college towns and smaller cities. Though counties around the Lake of the Ozarks have seen some of their highest daily case totals recently, all are averaging fewer than 20 cases daily.

Another motorcycle festival, the Leesburg Bikefest held every year in Leesburg, Fla., outside Orlando, was canceled because of the virus. The festival had already been rescheduled to November, from April, because of the pandemic.

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An uptick in U.S. virus cases this week is being driven, in part, by a surge of infections in the Southwest and the Midwest, where many students have returned to classes in schools or on college campuses.

The cases are rising sharply in North Dakota, Colorado, Wyoming and particularly dramatically in Wisconsin, where the number of infections being reported each day is now more than double what it was two weeks ago, with more than 2,500 infections reported on Friday, the most ever in the state.

The number of new infections being reported daily nationwide remains down from the peak in mid-July, when, at one point, more than 75,000 cases were reported in a single day. Some places, like New York City, have seen drastic and consistent declines in infections since the city was the focus of the pandemic in April. But other areas have struggled to keep cases from returning as students arrived in college towns and some primary and secondary schools opened their doors.

The infections in Wisconsin appear to be driven in part by young people, including college students, testing positive in places like Madison and La Crosse.

In Boulder County, Colo., which had the state’s second-highest infection rate over the last week on average, five of the six active outbreaks were tied to fraternity and sorority houses at the University of Colorado Boulder, according to a state database.

About 87 percent of the record number of cases reported on Friday in La Crosse County, along the Mississippi River, were among people 10 to 29 years old, according to The La Crosse Tribune. Those numbers are driven in part by a rash of infections at the University of Wisconsin-La Crosse, where nearly 250 people have tested positive in the last nine days and where an entire freshman dorm was ordered to shelter in place last week.

Cases have also risen sharply in Utah, which reported more than 1,000 infections on Friday for the first time.

Utah has recently come under fire from schoolteachers, who said this week that the governor and school officials were failing to protect them after several schools remained open despite registering more than 15 positive cases among staff members and students, The Salt Lake Tribune reported.

Hot spots are forming at colleges there, too, with more than 762 people at Brigham Young University becoming infected since late August, more than 60 percent of whom tested positive this past week.

And Montana reported more than 250 new cases on Saturday, a single-day record. More cases have been announced in the state over the last week than in any other seven-day period. Montana’s total cases per capita, however, remain among the lowest in the country.

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In a stunning declaration of authority, Alex M. Azar II, the secretary of health and human services, this week barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.

Going forward, Mr. Azar wrote in a memorandum dated Sept. 15, such power “is reserved to the Secretary.” The bulletin was sent to heads of operating and staff divisions within H.H.S.

It’s unclear if or how the memo would change the vetting and approval process for coronavirus vaccines, three of which are in advanced clinical trials in the United States.

Outside observers were alarmed by the new memo and worried that it could contribute to a public perception of political meddling in science-based regulatory decisions. Dr. Mark McClellan, who formerly headed the F.D.A. and now runs Duke University’s health policy center, praised the agency’s work on vaccine development but said the policy change was ill timed.

“We’re in the midst of a pandemic, when trust in the public health agency is needed more than ever,” he said. “So I’m not sure what is to be gained with a management change with respect to F.D.A. when they are doing such critical work.”

Dr. Peter Lurie, president of the Center for Science in the Public Interest and a former associate commissioner of the F.D.A., called the new policy “a power grab.” Many rules issued by federal health agencies are signed by lawyers or by the heads of agencies, including the F.D.A., under the umbrella of H.H.S. The new memo requires the secretary to sign them, which Dr. Lurie said could lead to delays in the regulatory process.

“It will introduce an element of inefficiency within government operations that is wholly unnecessary and likely to gum things up,” he said.

Political appointees, under pressure from the president, have taken a rash of steps over the past few months to interfere with the standard scientific and regulatory processes at the health agencies. For example, a much criticized guideline on testing for the virus was not written by C.D.C. scientists, and was posted on the agency’s public website over their objections. It was reversed on Friday.

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Two days before Justice Ruth Bader Ginsburg’s death on Friday, the Supreme Court announced that it would again hear arguments by telephone when the justices return from their summer break on Oct. 5.

“The court building remains open for official business only and closed to the public until further notice,” a spokeswoman, Kathleen Arberg, said in a news release.

It has been more than six months since the justices met in person. The court had postponed arguments scheduled for March and April in light of the coronavirus pandemic. In May, it embarked on an experiment, hearing arguments by telephone and letting the public listen in.

There were bumps along the way: the stilted quality of the questioning, with the justices speaking in order of seniority; questions about whether Chief Justice John G. Roberts Jr. acted fairly as a timekeeper; the sound of a flushing toilet.

But the arguments were generally viewed as a success. One unexpected development was vigorous questioning from Justice Clarence Thomas, who is ordinarily silent when the court hears cases in person. The telephone arguments also allowed Justice Ginsburg to participate from the hospital, where she was undergoing a gallbladder procedure.

On Wednesday, Ms. Arberg announced that the court would hear five more days of arguments by telephone.

Her statement said that the situation remained fluid. “The court will continue to closely monitor public health guidance in determining plans for the November and December argument sessions.”

The justices last appeared on the Supreme Court bench on March 4, when they heard arguments in an abortion case from Louisiana. In June, the court struck down the law at issue in the case, with Chief Justice Roberts voting with the court’s four-member liberal wing. Without Justice Ginsburg’s vote, the case would have ended in a tie, which would have left the law intact.

The arguments in October will explore cases on gay rights and foster care, a $9 billion copyright dispute between Google and Oracle, whether Delaware can take account of its judges’ partisan affiliations, police violence and abuses of the no-fly list.

The cases will be heard by an eight-member court, leaving open the possibility of a deadlock. In such cases, the lower court’s ruling stands.

GLOBAL ROUNDUP

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Despite imposing one of the world’s longest lockdowns, Argentina has one of the worst current rates of infection and death, and has not been able to bend the curve on the virus even as outbreaks ease in some of its hardest-hit neighbors.

While the virus appears to be slowing in Brazil and Peru, where death rates have been high, Argentina’s outbreak is accelerating. Daily cases have stabilized in the Buenos Aires metropolitan area but are growing beyond it and beginning to spread to more remote, and often poorer, provinces. Those areas have fewer medical resources, and some have seen their medical facilities overwhelmed, like the northern province of Jujuy.

“This spill to the interior of the country is potentially very dangerous,” said Tomás Orduna, an infectious disease specialist who is one of the doctors advising the government on its virus response. “Now that the virus is spreading to areas where the health systems could easily collapse, we run the risk of the death rate quickly increasing.”

The country’s test positivity rate has hovered around 50 percent for weeks, meaning that almost one out of every two tests for the virus is positive.

On Thursday, Argentina reported a single-day high of 12,701 new cases.

Argentina imposed a strict national lockdown in mid-March and closed its borders. Most commercial air travel was grounded, and movement among provinces was severely restricted, which helped keep most cases concentrated in the Buenos Aires metropolitan area, home to almost one-third of the country’s population. However, measures have been relaxed and tightened as cases ebbed and flowed.

Elsewhere in the world:

  • New Zealand on Sunday reported four new coronavirus cases, including two imported cases and two cases of community transmission in Auckland, the country’s largest city, that are not related to the outbreak there last month. A man who traveled to New Zealand from India last month developed symptoms after his two-week quarantine and infected two household members, officials said; his case had been reported a day earlier. Prime Minister Jacinda Ardern is set to announce on Monday whether restrictions will be further eased in Auckland and lifted entirely in the rest of the country.

  • France on Saturday reported 13,498 new coronavirus cases, its highest daily increase. The French finance minister, Bruno Le Maire, said on Twitter on Friday that he was self-isolating at home after testing positive for the virus. He is at least the fourth French minister to be infected.

  • At least three countries in Eastern Europe reported their highest daily increases on Saturday: Poland (1,002), Slovakia (290) and Lithuania (99).

  • Indonesia on Saturday reported 4,168 new coronavirus cases, its highest daily increase.

  • Italy will allow as many as 1,000 spectators to attend Serie A soccer matches nationwide starting on Sunday, the sports minister, Vincenzo Spadafora, said Saturday on his Facebook page. Officials reported more than 1,600 new infections on Saturday, compared with daily increases of more than 6,000 during the peak of Italy’s outbreak in March, when public attendance was suspended at matches for Serie A, the country’s top soccer league.

  • Ontario, Canada’s most populous province, tightened restrictions on private gatherings throughout the province on Saturday amid a spike in cases. Indoor gatherings will be limited to 10 people, down from 50, and outdoor gatherings to 25 people, rather than 100.

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As governments around the world have grappled with misinformation and outright lies about the virus, in South Korea that struggle has become singularly personal.

The country owed much of its relative success in finding those infected with the virus to its aggressive use of surveillance camera footage, smartphone data and credit card transaction records. The government, which did not reveal patients’ names, sometimes released revealing data such as their addresses and employers.

The information has empowered trolls, harassers and other 21st-century scourges. The authorities have since pulled back on some of their more obtrusive tactics, though South Koreans still have raised relatively few outcries over privacy.

“I don’t think this reflects a lack of respect for privacy in South Korea,” said Park Kyung-sin, a professor at Korea University School of Law and an expert on privacy. “Rather, people seem to think that at a time of a pandemic, privacy can be sacrificed for the sake of public health.”

Doxxing — digging up and publishing malicious personal information — had already been a growing problem in the country, often cited in the recent suicides of K-pop stars.

In the initial desperate months of the pandemic, restaurants visited by patients were sometimes treated as if they were cursed. Citing one patient’s frequent visits to karaoke parlors, online trolls claimed that she must be a prostitute. Gay South Koreans began to fear being outed, prompting the government to promise them anonymity in testing after an outbreak erupted at a gay club in Seoul in May.

Other than China, South Korea is virtually the only country in the world whose government has the power to collect such data at will during an epidemic, Professor Park said.

On Sunday, South Korea reported 82 new coronavirus cases, the lowest daily increase since mid-August. The country of about 50 million has had a total of 22,975 cases and 383 deaths, according to a New York Times database.

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Baylor University abruptly canceled a game on Saturday against the University of Houston after its team failed to meet the Big 12 conference requirements for play, the university announced on Friday.

The Big 12 conference requires that each team have a minimum of 53 players ready to play, including at least seven offensive linemen, four interior defensive linemen and one quarterback. It was not clear whether Baylor failed to meet the threshold because of players testing positive for the virus, players quarantining because of possible exposure to the virus or a combination of those and other factors.

The college football season has been chaotic: last-minute game cancellations, frantic scheduling and fluctuating guidelines. The Baylor-Houston matchup was finalized only a week ago, an increasingly common timeline during the pandemic.

The scheduled game — which would have been the first between the Texas teams in 25 years — was possible only after sudden cancellations in both teams’ schedules because of virus outbreaks at both of their previously scheduled opponents. The matchup was Baylor’s second scheduled season opener that had been canceled because of the virus, and the fourth game to be postponed or canceled for Houston, according to a university spokesman.

“The loss of this game is a devastating blow, but in the interest of the health and safety of our student-athletes, we believe we made the necessary decision,” said Mack B. Rhoades, director of athletics for Baylor. He added that the teams would work to reschedule the game, but that there may be little room for it in the calendar this fall.

The Big 12 is scheduled to play nine conference games and one nonconference game. The conference schedule begins the weekend of Sept. 26. Under conference guidelines, players are tested three times a week.

Florida Atlantic University, a member of Conference USA, also announced it would postpone its scheduled season opener on Saturday, at Georgia Southern. The university said it made the decision after receiving the results of its latest round of virus testing on Thursday.

Mike Norvell, head football coach at Florida State University, announced Saturday that he had tested positive for the virus and was isolating himself, according to The Tampa Bay Times. Florida State does not play this weekend, and Mr. Norvell said he would not travel next week when the team plays the University of Miami.

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After a laundromat in Manhattan said it couldn’t pay its monthly rent in April and May, the property’s manager asked for half of the $7,200 bill, while also allowing another struggling tenant, an electronics repair store, to pay a third of its $12,500 monthly rent. A nearby clothing store in the Chelsea neighborhood had its $10,000 rent cut 50 percent.

The drastic reductions are part of a desperate effort by landlords to stave off vacancies even as revenue plummets and taxes, utilities and other costs erode their own reserves.

“We kind of just take what we can get and work out a number,” said the laundromat property’s manager, Aaron Weber, whose company manages nearly 40 commercial properties in Manhattan. “As long as they are paying something, we’re happy.”

Yet with thousands of small businesses that are a staple of city life unable to pay basics like rent during the pandemic, that has set off an extraordinary crisis for landlords, who have lost tens of millions of dollars in income since New York City’s lockdown began in March, analysts said.

Landlords face an unpleasant choice: Forgive or lower rent payments even as their own bills pile up, or hold firm and risk losing a tenant who may not be replaced for months or even years.

Even as some landlords are cutting rents, others have not considered any compromise, going so far as to threaten tenants with lawsuits even if a business faces permanent closure.

“On the tenant side, the stakes are a massive wave of not temporary but permanent closures, which will mean damages to personal credit scores, many lost jobs and all the ripple effects,” said Ari Harkov, a broker who has worked with commercial landlords and tenants. “On the landlord side, you’re talking about potential foreclosure, you’re talking about people defaulting on their loans, not being able to pay their bills.”

He added: “That could be very, very painful for New York.”

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Corleone, the Sicilian town made infamous by its real and fictional Mafia connections, has gone into a broad but partial shutdown after 10 people linked to a large wedding last Saturday tested positive for the virus.

Officials ordered 250 people who attended the wedding to self-quarantine until they are tested. Because about 30 of them were local students, schools have been closed for two weeks. A 10 p.m. curfew was imposed on cafes, pubs and gaming halls, and gyms and other sports facilities must shut two hours earlier than usual. The town’s parks and museums closed indefinitely, and conferences were postponed. Masks were made mandatory in all indoor or public areas.

The wedding guests were told to contact their doctors as well as the city’s virus emergency authorities until they could be tested.

Mayor Nicolò Nicolosi told Corleone’s 11,000 residents in a video on Facebook on Friday that they should try to live their lives “as normally as possible,” while acting responsibly. “Corleone is not a red zone,” he reassured them, using the term that Italian officials had given to the hardest-hit areas at the beginning of the crisis in February.

Acknowledging that Corleone’s economy was already suffering in the pandemic, Mr. Nicolosi said he would try to limit the closures as much as possible while still “taking all the necessary precautions to contain the virus.”

The town, less than 25 miles south of the Sicilian capital, Palermo, became infamous as the hometown of some of the most prominent members of the Corleonesi clan, which in the 1980s ended up dominating the Mafia, or Cosa Nostra.

Corleone also gained notoriety through Mario Puzo’s “Godfather” books — whose protagonists were from and named after the town — and then through the film trilogy by Francis Ford Coppola. The first of the three, which won the 1973 best picture Oscar, began with a wedding in New York and later showed a second wedding set in Corleone.

Though Italy has fared better than Spain and France in containing cases after a widespread relaxation of social distancing rules, officials have been concerned by steadily growing numbers.

Reporting was contributed by Ian Austen, Nicholas Bogel-Burroughs, Marie Fazio, Denise Grady, Jennifer Jett, Andrea Kannapell, Sheila Kaplan, Sharon LaFraniere, Adam Liptak, Choe Sang-Hun, Mitch Smith, Apoorva Mandavilli, Bryan Pietsch, Daniel Politi, Elisabetta Povoledo, Katherine J. Wu and Mihir Zaveri.

Source: nytimes.com

Tags: health

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