• Mon. Oct 26th, 2020

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Top U.S. health officials update Congress on vaccine development and distribution plans.

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N.I.H. Director Has ‘Cautious Optimism’ for Covid-19 Vaccine by End of 2020

Dr. Francis Collins, the director of the National Institutes of Health, emphasized to senators that coronavirus vaccine development and distribution would be determined based on science and not politics.

I can’t say strongly enough that the decisions about how this vaccine is going to be evaluated and assessed is going to be based on science. And I know I speak for my colleagues in the government, and certainly for the scientific community broadly, that that can be the only basis upon which this decision is made. Otherwise, the public would not be expected to trust us. So that will be the only measure. Will it be done by a certain date? I could not possibly tell you right now because I don’t know what’s going to happen in the coming months. I do have cautious optimism that by the end of 2020 at least one of these vaccines will have emerged, and turned out to be safe and effective. But even that is a guess, and certainly to try to predict whether it happens on a particular week before or after a particular date in early November is well beyond anything that any scientist right now could tell you, and be confident that they know what they’re saying. So yes, science, and science alone will be the way in which this decision is made. Otherwise, I’ll have no part of it.

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Dr. Francis Collins, the director of the National Institutes of Health, emphasized to senators that coronavirus vaccine development and distribution would be determined based on science and not politics.CreditCredit…Pool photo by Greg Nash

Dr. Francis Collins, the director of the National Institutes of Health, took issue on Wednesday with President Trump’s suggestion that a coronavirus vaccine would be available by Election Day, as he repeatedly sought to reassure senators and the public that a vaccine would not be made available to the public unless it was safe and effective.

“Certainly, to try to predict whether it happens on a particular week before or after a particular date in early November is well beyond anything that any scientist right now could tell you and be confident they know what they are saying,” Dr. Collins told a Senate panel at a hearing on the effort to find a vaccine.

Wednesday’s hearing, before the Senate Health, Education, Labor and Pensions Committee, came amid growing concern over whether people would be reluctant to take a coronavirus vaccine, and whether Mr. Trump would apply political pressure on his administration to quickly approve one to give him a lift in his re-election bid against former Vice President Joseph R. Biden Jr.

On Tuesday, a group of drug companies all in the race to develop vaccines pledged that they would not release any vaccines that did not follow rigorous efficacy and safety standards. Hours later, a leading vaccine developer, AstraZeneca, announced that it had suspended a large-scale clinical trial of a vaccine candidate after a patient experienced what may be a severe adverse reaction. Dr. Collins pointed to that development as “a concrete example of how even a single case of unexpected illness is sufficient to hold a clinical trial in multiple countries” — and evidence that “we cannot compromise” on safety.

In an interview on “CBS This Morning,” Dr. Anthony S. Fauci, the government’s top infectious disease expert, echoed that sentiment.

“That’s the reason why you have various phases of trials, to determine if in fact these candidates are safe,” Dr. Fauci said, adding that such a halt was “not uncommon at all.”

At the hearing, Democrats on the panel grilled both Dr. Collins and Surgeon General Jerome Adams on the effect of Mr. Trump’s false statements about the vaccine, and whether they would erode trust in the development process. Dr. Collins demurred, however, as Senator Elizabeth Warren, Democrat of Massachusetts, asked him point blank whether Mr. Trump’s misinformation would discourage people from taking the vaccine and hurt the effort to distribute it.

“I’m not sure I know the answer to that question,” Dr. Collins said. When Ms. Warren pressed him again, he added, “I just hope Americans will choose to take the information they need from scientists and not from politicians.”

Three companies are in late-stage, Phase 3 clinical trials that seek to enroll 30,000 Americans, half of whom will be injected with the vaccine candidate and half of whom will get a placebo.

Dr. Collins said he had “cautious optimism” that a safe and effective vaccine would emerge by the end of the year, though he added, “but even that is a guess.”

Even as the trials proceed, there are huge questions about who will get a vaccine first and how it will be distributed. Dr. Adams told the panel that the administration intended to release guidelines later Wednesday that would allow state-licensed pharmacists to vaccinate anyone older than age 3.

The AstraZeneca vaccine trial was halted after a person enrolled in it developed a rare inflammatory condition.

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Credit…Pool photo by Siphiwe Sibeko

AstraZeneca, a front-runner company in the race to develop a coronavirus vaccine, on Tuesday announced a global pause in late-stage trials for its product because of a suspected adverse event.

Several individuals familiar with the event, who spoke on the condition of anonymity, said that an individual in Britain who was enrolled in a Phase 2/3 trial had experienced symptoms consistent with a condition called transverse myelitis, or inflammation of the spinal cord.

The trial’s suspension will allow an independent board of experts to determine whether the participant’s condition was linked to the vaccine or merely coincidental, said Saad Omer, a vaccine expert at Yale University.

Part of this process will include generating a timeline of the participant’s symptoms to see if they match up roughly with when the vaccine was administered. The committee will also investigate other potential causes of the symptoms, in a process of elimination. After determining whether AstraZeneca’s vaccine is a probable culprit, experts will advise the company on whether to resume their trials.

In the interim, no further doses of the vaccine will be administered. It remains unclear how long the evaluation process will take. AstraZeneca representatives did not respond to repeated requests for comment and clarification.

The suspension is the second time that AstraZeneca has halted coronavirus vaccine administration in Britain because of severe neurological symptoms, according to information sheets uploaded to a clinical trial registry that was first reported by Nature News. Another participant developed symptoms of transverse myelitis, researchers reported in July, and was later diagnosed with an “unrelated neurological illness.” After a safety review, trials resumed.

Transverse myelitis is relatively rare, prompting symptoms in roughly 1,400 people each year in the United States, according to the National Institutes of Health. Its root cause is often mysterious, although doctors believe that the syndrome generally results when inflammatory responses in the body go awry, sometimes in response to an ongoing or past infection, said Dr. Felicia Chow, a neurologist at the University of California, San Francisco. “It’s not uncommon that we never figure out the cause,” Dr. Chow said.

There has been some past speculation that vaccines might be able to cause transverse myelitis, she added, but “there’s never been really any clear-cut, definitive proof.”

Should other participants in the AstraZeneca trials develop symptoms consistent with transverse myelitis, “that would raise these questions again,” Dr. Chow said.

Indoor dining in N.Y.C. will return with limits on Sept. 30, Cuomo says.

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‘We Can Now Take the Next Step,’ Cuomo Says of Indoor Dining

The governor of New York, Andrew M. Cuomo, announced that indoor dining will open in New York City on Sept. 30 with restrictions.

We want to thank New Yorkers for the increasing compliance, and because the compliance has gotten better, we can now take the next step. That takes us to restaurants. Opening restaurants, I understand the economic benefit, and I understand the economic pressure that they’ve been under. A restaurant is not just the restaurant owner, a restaurant is the kitchen staff, the wait staff. There’s a whole industry around restaurants, and restaurants also pose a possible risk, right, concentrations of people inside indoor dining. But there’s also a great economic loss when they don’t operate. We’ve been speaking with stakeholders. We’ve been working on this issue every day. And we’re now announcing today that we can go to 25 percent of indoor dining with certain restrictions that will be enacted on Sept. 30. Indoor dining, the rules will be temperature checks for anyone who comes in at the door. One member of each party has to leave information — phone number, email so that there’s contact tracing information if there is an outbreak.

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The governor of New York, Andrew M. Cuomo, announced that indoor dining will open in New York City on Sept. 30 with restrictions.CreditCredit…Chang W. Lee/The New York Times

Gov. Andrew M. Cuomo announced on Wednesday that the ban on indoor dining in New York City would be lifted on Sept. 30, a boost to the city’s recovery from the pandemic that would end its status as one of the few places in the nation with a complete ban.

The governor’s announcement, which would allow restaurants to open indoor tables at 25 percent capacity, could be a major milestone in the coronavirus crisis in New York City, where restaurants form a critical part of the city’s economy and its currently moribund tourist trade, and are a vital part of its usually vibrant social fabric.

The announcement came more than two months after the governor and Mayor Bill de Blasio halted a plan to reopen indoor dining at restaurants, citing ongoing concerns about the coronavirus, which has killed more than 30,000 people in New York. But the infection rate in the state has been kept below 1 percent for weeks, allowing for the easing of some restrictions. Indoor dining resumed in neighboring New Jersey at 25 percent capacity last week.

“Because compliance is better, we can now take the next step,” the governor said.

The timing coincided with a date, still three weeks away, that is around when fall weather is likely to put a chill on outdoor tables. Additional restrictions would also be placed on restaurants and their patrons, including temperature checks and a requirement to wear face coverings when not seated. Bars will be used to make drinks to serve tableside and restaurants must close at midnight.

Even with the reopening plan, the restrictions in New York City will still be more stringent than other parts of the state, where restaurants are operating with half their indoor tables in use.

“This may not look like the indoor dining that we all know and love,” Mr. de Blasio said in a statement after the governor’s announcement, “but it is progress for restaurant workers and all New Yorkers.”

The virus can stealthily attack the brain, according to a new study.

Credit…Ross W. Paterson, Rachel L. Brown, et al./Brain, Oxford University Press

The lungs are the coronavirus’s foremost target in the body, and it has been clear for some time that the virus can attack the kidneys, liver and blood vessels as well. About half of Covid-19 patients also report neurological symptoms, including headaches, confusion and delirium — suggesting that the virus might attack the brain.

A new study offers the first clear evidence that in some people, it does just that, in two ways: The virus invades brain cells, hijacking them to make copies of itself, and it appears to suck up all the oxygen near the host cells, starving other cells to death.

It’s unclear exactly how the virus gets into the brain or how often it touches off this trail of destruction. Infection of the brain is likely to be rare, but some people may be susceptible because of their genetic backgrounds, because of a high viral load or for other reasons.

“If the brain does become infected, it could have a lethal consequence,” said Akiko Iwasaki, an immunologist at Yale University who led the work.

The study was posted online on Wednesday and has not yet been vetted by experts for publication. But several researchers said it was careful and elegant, showing in multiple ways that the virus can infect brain cells.

In the new study, Dr. Iwasaki and her colleagues documented brain infection in three contexts: in brain tissue from a person who died of Covid-19, in a mouse model, and in organoids — clusters of brain cells in a lab dish meant to mimic the brain’s three-dimensional structure.

Other pathogens, including the Zika virus, are known to infect brain cells. Immune cells then flood the damaged sites, trying to cleanse the brain by destroying infected cells.

The coronavirus is much stealthier than some other pathogens: It exploits the brain cells’ machinery to multiply, but doesn’t destroy the cells. Instead, it chokes off oxygen to adjacent cells, causing them to wither and die.

The researchers didn’t find any evidence of an immune response to remedy this problem. “It’s kind of a silent infection,” Dr. Iwasaki said. “This virus has a lot of evasion mechanisms.”

global roundup

Britain bans gatherings of more than six people.

Credit…Oli Scarff/Agence France-Presse — Getty Images

Britain, undergoing a spike in new coronavirus cases, will ban most gatherings of more than six people beginning next week, Prime Minister Boris Johnson said Wednesday.

“I wish we did not have to take this step,” Mr. Johnson said. “As your prime minister, I must do what is necessary to stop the spread of the virus.”

He stressed hand washing and wearing face coverings, and said the new rule would be in place only “as long as necessary.”

He said the order, which he referred to as the “Rule of Six,” superseded old guidelines and would apply to public and private gatherings.

The government’s chief medical officer, Professor Chris Whitty, said the uptick the country is seeing is not just a matter of testing more people and compared the situation Britain is facing to the one in France, where cases are surging.

Restaurants and other hospitality venues will also now be required by law to take customers’ personal details for contact-tracing purposes. And Mr. Johnson said there would be stronger enforcement of quarantine rules for those entering the country.

The new rules will take effect Monday and people who break them can be fined and possibly arrested.

“You must not meet socially in groups of more than six,” Mr. Johnson said. “If you do you will be breaking the law.”

About 3,000 new cases were reported on both Sunday and Monday of this week, the highest daily figures in Britain since May. And about 2,500 more new cases and 32 deaths were reported on Tuesday.

In other developments around the world:

  • A fast-moving fire destroyed most of Europe’s largest refugee camp on the Greek island of Lesbos, leaving its 12,000 residents homeless just days after they were collectively quarantined because of a coronavirus outbreak there.

  • France’s prime minister, Jean Castex, is self-isolating after he came into contact with the director of the Tour de France, who has tested positive. Mr. Castex tested negative on Tuesday, but he will isolate until being retested seven days after the contact took place. France is facing a resurgence, with a daily average of 7,000 cases for the last seven days and an increase in the number of patients in intensive care after months of decline.

  • India’s Health Ministry said Tuesday that it planned to open classrooms for high school students on a voluntary basis, and only with their parents’ approval, starting Sept. 21. The vast majority of schoolchildren will continue to study online. The Taj Mahal will also open for tourism on Sept. 21, with access restricted to 5,000 people per day. India has recorded more than 4.3 million cases, second only to the United States, with nearly 90,000 new infections reported on Tuesday.

  • China’s biggest air show will go ahead in November, the organizer said on Wednesday, backtracking on an earlier announcement that the event had been canceled because of the pandemic. The biennial International Aviation and Aerospace Exhibition comes amid a steep downturn in the industry.

  • Germany extended a travel advisory to include all countries outside Europe through Sept. 30. But the foreign ministry said that starting in October, it would evaluate individual non-European destinations case by case, rather than issue another blanket warning.

  • A photo of an older man having a meal in a pub in Galway, Ireland, started a national conversation about virus regulations and life’s simple pleasures.

Schools in Iowa’s big cities are fighting orders from the governor to open their classrooms.

Credit…Olivia Sun/The Des Moines Register, via Associated Press

Like millions of schoolchildren across the country, students in Des Moines’s public schools started classes remotely on Tuesday, despite orders from the governor and a ruling by a state judge requiring the district to hold at least half of its classes in person.

The litigation in Iowa is one of numerous legal battles that have emerged across the country as school districts, elected officials, educators and parents wrangle over balancing educational needs with public health concerns. In North Carolina, a group of parents filed a lawsuit earlier this month against the Charlotte-Mecklenburg school board demanding in-person classes.

In Des Moines, District Judge Jeffrey Farrell on Tuesday denied the school district’s request for an injunction that would allow it to continue holding all of its classes remotely amid rising coronavirus caseloads, which school officials said make their classrooms unsafe.

Despite the ruling, the district again held remote classes on Wednesday, although the school board was meeting with lawyers to discuss options. Another judge made a similar ruling Tuesday against schools in Iowa City, which also started remotely under a two-week waiver from the state that Des Moines did not receive.

Des Moines schools sued the Iowa Department of Education and Gov. Kim Reynolds, a Republican, in August after the governor issued an order requiring schools in the state to offer in-person instruction for at least 50 percent of their classes if the coronavirus positivity rate in their communities is less than 15 percent — triple the rate recommended by the Centers for Disease Control and Prevention. Polk and Warren Counties, home to Des Moines’s public schools, both exceed that federal threshold. Tuesday’s ruling denied the district a temporary injunction while the lawsuit proceeds.

Despite the denial, Des Moines schools will remain closed “until further notice” in order to protect public health, even if that puts the district at risk of losing state funding, the Des Moines superintendent, Thomas Ahart, said in a statement.

Mr. Arhart later said by telephone: “There’s not a way for us to tell our community that we are genuinely protecting their students, or for us to tell our staff that we’re not putting them in harm’s way and to meet the return-to-learn requirements of the state. Those two are incompatible actions.”

Trump admitted to the journalist Bob Woodward that he played down the threat of the virus.

Credit…Doug Mills/The New York Times

Mr. Trump acknowledged to the journalist Bob Woodward that he had knowingly played down the coronavirus earlier this year even though he was aware it was “deadly” and vastly more serious than the seasonal flu.

“This is deadly stuff,” Mr. Trump told Mr. Woodward on Feb. 7 in one of a series of interviews he conducted with the president for his coming book, “Rage.” The Washington Post and CNN were given advance copies of the book and published details on Wednesday.

“You just breathe the air and that’s how it’s passed,” the president said. “And so that’s a very tricky one. That’s a very delicate one. It’s also more deadly than even your strenuous flu.”

That was a vastly different story than Mr. Trump was telling the public.

“I wanted to always play it down,” Mr. Trump told Mr. Woodward on March 19. “I still like playing it down, because I don’t want to create a panic.”

In public, Mr. Trump claimed early on that the virus would disappear, predicting in February that by April, “when it gets a little warmer, it miraculously goes away.”

The national security adviser, Robert O’Brien, warned Mr. Trump on Jan. 28 that the coronavirus represented the “biggest national security threat” of his presidency, according to CNN’s account of the book, but Mr. Trump later said he did not remember the warning.

Former Vice President Joseph R. Biden Jr. took aim at Mr. Trump over the revelations during an appearance in Michigan on Wednesday

“He had the information,” Mr. Biden said, accusing Mr. Trump of lying to the public. “He knew how dangerous it was. And while this deadly disease ripped through our nation, he failed to do his job on purpose. It was a life-and-death betrayal of the American people.”

At the White House press briefing on Wednesday, shortly after the book’s contents were reported in the news media, the press secretary, Kayleigh McEnany, claimed that the president had not lied.

“This president does what leaders do, good leaders,” she said, saying “The president has never lied to the American public on Covid.”

U.S. roundup

Arizona’s new cases fall to their lowest level since March.

Credit…Adriana Zehbrauskas for The New York Times

Arizona reported its lowest number of new cases since late March, reflecting the progress made in curbing the spread of the virus after harrowing outbreaks over parts of the summer.

Though Arizona had only 77 new cases on Tuesday, a sharp decline from July, when new cases were reaching 3,800 a day, the seven-day average is more than 500 daily cases, according to a Times database. In total, there have been more than 200,000 cases and more than 5,200 deaths in Arizona, including two new deaths on Tuesday. Tuesday was the first business day since the Labor Day holiday, and case reports across much of the country were lower than usual.

The state led the nation in coronavirus infections per capita after Gov. Doug Ducey reopened the economy quickly in late spring. Mr. Ducey then reversed himself by allowing cities and counties to issue mask mandates and ordering some businesses to close once again.

The Navajo Nation, which spreads over parts of Arizona, New Mexico and Utah, is also making strides against Covid-19. For the first time in nearly six months, Navajo authorities on Tuesday reported no new cases of the virus.

Still, epidemiologists warn that cases in Arizona could spike again, citing the potential for outbreaks from school reopenings and Labor Day gatherings.

Elsewhere in the United States:

  • Colleges that have reopened for in-person instruction are struggling to contain the spread of the virus among tens of thousands of students. Many have set aside special dormitories to provide isolation beds for infected students and separate quarantine units for the possibly sick. But some undergraduates and epidemiologists say the policies have broken down, often in ways that may put students and college staff members at risk.

  • In Los Angeles County, Halloween will still be scary this year; it will just have to be scary from inside the safety of one’s own car. According to guidelines published by the Los Angeles County Department of Public Health, door-to-door trick-or-treating is not recommended and haunted house attractions are not allowed during a pandemic. Instead, the guidelines suggest, trick-or-treaters can celebrate in other ways, such as going to watch a scary movie at a drive-in movie theater or eating a Halloween-themed meal at a restaurant outdoors.

  • A day after President Trump held a large rally in North Carolina without wearing a mask, Anthony S. Fauci, the nation’s leading official on infectious diseases, expressed concerns about the example this set. When asked on “CBS This Morning” on Wednesday about whether the sight of such rallies was frustrating, Dr. Fauci said: “Well, yes it is, and I’ve said that often. We want to set an example.”

  • Senate Democrats released a report on Wednesday that showed that the delivery of prescription drugs by mail slowed over the summer as Louis DeJoy, the postmaster general, enacted cost-cutting changes at the United States Postal Service. That corroborates reports of delayed packages from across the country. Delivery times lengthened by as much as 32 percent, and patients had to wait, on average, an extra day or two to receive their prescriptions, the report said.

Mnuchin expressed little optimism about another stimulus bill.

Treasury Secretary Steven Mnuchin raised doubts on Wednesday about the likelihood of another economic stimulus package being passed this year and said his current focus was on a measure to extend government funding this month.

The comments come as Republicans and Democrats in Congress remain far apart in their views about the scope and cost of another relief bill and as Mr. Trump has been largely disengaged from the negotiations.

Asked about the prospects of another bill, Mr. Mnuchin showed little optimism.

“I don’t know,” Mr. Mnuchin said outside the White House. “We’ll see. I hope there is. It’s important to a lot of people out there.”

He said that he had been having discussions with Speaker Nancy Pelosi about a “clean” bill to keep the government funded until after the election, avoiding a government shutdown.

Mr. Mnuchin has also been in touch with Senate Republicans about the scaled-back stimulus bill that they unveiled on Tuesday that would provide federal aid to unemployed workers, schools, farmers, the Postal Service and small businesses. The legislation, which cuts billions of dollars from the original $1 trillion Republican proposal unveiled in July, does not include another round of $1,200 stimulus checks or additional funding for state and local governments.

A vote on that bill that is scheduled for Thursday in the Senate is expected to fail to meet the necessary 60 vote threshold, as Democrats continue to push for a more robust and costly package.

A group of gym owners sue N.Y.C. over the prohibition against indoor fitness classes in the city.

Credit…Sarah Blesener for The New York Times

A group of gym and boutique fitness studio owners announced a class-action lawsuit on Wednesday against Mayor Bill de Blasio and New York City to allow indoor group fitness classes to reopen in the city.

New York City’s gyms were given the green light to reopen with new safety regulations a week ago; the governor allowed them to reopen statewide as early as Aug. 24 after a similar lawsuit was filed against the state. But indoor boutique studios and group classes, like Pilates, Zumba, yoga and many other flavors of fitness, are still prohibited by the city.

City and state officials have said that group fitness classes are more conducive to spreading the virus than a traditional gym setting, where people often have more space. Mr. Cuomo noted the potential dangers of such classes while announcing the return of indoor dining in the city on Wednesday.

“You’re exhaling deeply, you’re inhaling deeply, you’re perspiring, you’re touching other material,” Mr. Cuomo said. “That is a much riskier situation to be in than sitting at a table with four people.”

Fitness studio owners say that describing their classes as unsafe is inaccurate and unfair, and that if anything they are more carefully controlled than ordinary gyms, where activities are less coordinated.

Charles Cassara, a gym owner and leader of the New York Fitness Coalition, one of the groups behind the suit, called the mayor’s decision to keep studios closed a “sin” and a “disgrace” on Wednesday.

“If he does not open up in a timely fashion, we are all going to close,” Mr. Cassara said.

Reporting was contributed by Aurora Almendral, Troy Closson, Emily Cochrane, Katie Glueck, Michael Gold, Maggie Haberman, Jason Horowitz, Mike Ives, Thomas Kaplan, Patrick Kingsley, Dan Levin, Jesse McKinley, Constant Méheut, Claire Moses, Richard C. Paddock, Alan Rappeport, Simon Romero, Christopher F. Schuetze, Natasha Singer, Karan Deep Singh, Daniel E. Slotnik, Kaly Soto, Megan Specia, Sheryl Gay Stolberg, Muktita Suhartono, Katie Thomas, Katherine J. Wu and Elaine Yu.