Covid-19 Live Updates: Trump Administration Vaccine Chief Casts Doubt on Vaccine by Election Day

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Credit…Agence France-Presse, via Henry Ford Health System

President Trump’s vaccine chief sees a ‘very, very low chance’ of a vaccine by Election Day.

Moncef Slaoui, the chief adviser for the White House vaccine program, said on Thursday that it was “extremely unlikely but not impossible” that a vaccine could be available by the end of October.

In an interview with National Public Radio, Dr. Slaoui, the chief scientific adviser of the Trump administration’s coronavirus vaccine and treatment initiative, called Operation Warp Speed, explained that the Centers for Disease Control and Prevention’s guidance to states to prepare for a vaccine as early as late October — a notification Dr. Slaoui said he had learned of through the news media — was “the right thing to do” in case a vaccine was ready by that time. “It would be irresponsible not to be ready if that was the case,” he said.

However, he described that as a “very, very low chance.”

That message ran counter to the optimistic assertions in recent days from the White House that a vaccine could be ready for distribution before Election Day in November. President Trump, during the Republican National Convention, said a vaccine could be ready “before the end of the year or maybe even sooner.” And he and others have tried to project confidence in a quick victory.

Dr. Slaoui confirmed that the two main candidates, referred to as Vaccine A and Vaccine B, were being developed by Pfizer and Moderna. He said that there was “no intent” to introduce a vaccine before clinical trials were completed, and that trials would only be completed when an independent safety monitoring board, separate from the government, affirmed the effectiveness of the vaccine.

The interviewer, Mary Louise Kelly, raised the timing of a possible vaccine given in the documents the C.D.C. recently sent to public health officials, and asked directly whether the delivery of the vaccine was being motivated by political concerns.

“For us there is absolutely nothing to do with politics,” Dr. Slaoui responded, saying that those involved were working as hard as they could because so many people were dying every day. “Many of us may or may not be supportive of this administration. It’s irrelevant, frankly.”

Though he continued to express doubt that a vaccine would be ready by the end of October, Dr. Slaoui said, “I firmly believe that we will have a vaccine available before the end of the year and it will be available in quantities that can immunize patients, subjects at the highest risk,” including the elderly and those who are working in jobs with high exposure to the virus.

He estimated that there would be enough vaccine by the end of the year to immunize “probably between 20 and 25 million people.” He said that manufacturingwould be ramped up so that there would be enough vaccine doses to immunize the U.S. population “by the middle of 2021.”

Hydroxychloroquine prescriptions soar on President Trump’s say-so.

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Credit…Anna Moneymaker for The New York Times

Prescriptions for hydroxychloroquine, the anti-malaria drug promoted by President Trump as a treatment for the virus, skyrocketed in March and April after the Food and Drug Administration issued an emergency waiver for its use against Covid-19, but tapered off to more normal levels in May and June, the Centers for Disease Control and Prevention reported on Thursday.

The F.D.A. withdrew its emergency use authorization for hydroxychloroquine (and its less-prescribed sister drug, chloroquine) in June after scientists concluded that its benefits did not outweigh its risks for Covid-19; the review that led to the revocation found more than 100 cases — including 25 deaths — of serious heart disorders in Covid-19 patients taking the drug. Clinical trials also showed it was of little benefit in treating the disease.

Even so, the C.D.C. reported that more than 1.3 million prescriptions — new and refills — were written in March and April, up from about 819,000 during the same period last year. The strong spike in usage suggests the influence that Mr. Trump and emergency waivers from the F.D.A. can have in driving medical decision-making — even in the absence of limited evidence of a drug’s effectiveness.

But perhaps the most striking finding was that “nonroutine prescribers” — specialists who would not typically have a reason to prescribe the drug — wrote more than 75,000 hydroxychloroquine or chloroquine prescriptions in the month of March alone. That is 80 times the number written during March 2019.

Hydroxychloroquine and chloroquine are approved to treat autoimmune diseases like lupus as well as malaria. Mr. Trump, who said he took hydroxychloroquine himself, called it a possible “game changer” and repeatedly promoted it during his daily briefings this spring.

The disease control centers analyzed prescriptions of the drug to gauge the effects of the F.D.A.’s emergency waiver, which was issued March 28 to allow the drugs to be distributed from the national stockpile. “During March and April 2020, nonroutine prescribers accounted for the largest percentage increase in new prescriptions compared with the same period in 2019,” the agency wrote, adding, “The nonroutine prescribing specialties with the highest prescribing volume and growth in March 2020 were ophthalmology, anesthesiology, and cardiology.”

But new prescriptions written by such prescribers have tapered off considerably. In June, roughly 1,900 were written.

The virus is surging at U.S. colleges, where more than 51,000 cases have been identified so far.

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More than 51,000 cases of the coronavirus have been identified at American colleges and universities over the course of the pandemic, including thousands that have emerged in recent days as students returned to campus for the fall.

The New York Times surveyed more than 1,500 colleges, and found that over two-thirds have reported at least one case. More than 100 of the institutions have reported at least 100 cases, including several large public universities in the Midwest and South that have tested aggressively but struggled to contain the spread. Auburn, Illinois State and South Carolina are among at least six universities with more than 1,000 known cases.

Direct campus-to-campus comparisons are not meaningful because of differences in colleges’ size, mission and reporting practices. But it is clear that the pandemic has affected every segment of higher education. Small religious colleges, stand-alone medical schools, Ivy League universities, community colleges and public research institutions have all had significant outbreaks.

The reopening of campuses has led to case surges in several college towns, quarantines at fraternity and sorority houses, and pleas for students to avoid large gatherings. Iowa State scrapped plans to allow fans at its first football game. Virginia Commonwealth had to find more isolation space after a large cluster emerged. And California State University, Chico, sent its students home after dozens of cases emerged in the first days of the fall term.

“I, like you, wish the story of this semester had been much different,” Gayle Hutchinson, the university’s president, wrote in a letter announcing the decision.

Education Roundup

A small college in Pennsylvania has locked down every single student. It may be a first.

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Gettysburg College in Pennsylvania has ordered its entire student body to quarantine in their dorm rooms, becoming possibly the first American campus to lock down all its students because of coronavirus cases.

The small liberal arts school reported on Tuesday that 24 students had tested positive in the previous two days, a positivity rate of about 7 percent. (The World Health Organization recommends that the positivity rate be 5 percent or lower for 14 days before schools and businesses reopen.)

It then directed all its full-time students — its enrollment is generally about 2,500 — to remain in their rooms except to get takeout meals at campus dining facilities, use the bathroom, go for a coronavirus test or speak with a counselor. The lockdown could last through the end of the week, officials said.

In a letter to students, Julie Ramsey, the college’s dean of students, said that many of the infections “were connected to certain affinity groups or social gatherings.” Some students assert that Greek life organizations holding gatherings for rush week were responsible for the campus’s uptick in positive cases.

Many larger universities have created special isolation housing for students who test positive, or have ordered individual dormitories or fraternity houses to quarantine after outbreaks. But Jo Ellen Parker, a spokeswoman for the Council of Independent Colleges, said she knew of no other college that had asked an entire student body to quarantine in their rooms.

One Gettysburg student, Alexander Bove, a freshman, summed it up starkly: “It’s essentially a prison situation.”

“Our administration goes home to their families,” he said. “They can buy things. They can go to events. And they’re not being held to the same standard as we are.”

Thousands of coronavirus cases have been reported at American colleges and universities in recent day as more students return to campuses.

In other education news:

  • Temple University, which had planned to be online-only for just the first two weeks of classes, said Thursday that it would remain virtual for the rest of the fall term because of the continued spread of the virus. . As of Tuesday, the university had reported 212 active cases among students on and off campus, and none of them had more than moderate symptoms.

  • After testing found “uncontrolled spread” in its fraternity and sorority houses, the Indiana University has told the 2,600 students who live in them to move out and go home if possible. Thirty of the 42 Greek houses and communal living facilities connected with the campus in Bloomington, Ind., were already under quarantine orders, and five have had more than half their residents test positive. The houses were required to have safe living plans in place before opening for the fall, “but many of those plans are proving to be ineffective in adequately providing for the health and safety of the students living in the houses,” the college said in a statement Thursday.

Filming on ‘The Batman’ shuts down after its star, Robert Pattinson, tests positive.

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Just days after filming resumed on “The Batman” at studios outside London, it shut down again after its lead actor, Robert Pattinson, tested positive for the virus.

In a statement Thursday, Warner Bros. confirmed that filming was “temporarily paused” and that “a member of ‘The Batman’ production has tested positive for Covid-19, and is isolating in accordance with established protocols.”

Work on the film first shut down in March because of the pandemic, which has staggered the entertainment industry. Filming began last September.

In the title role, Mr. Pattinson, 34, plays a young Bruce Wayne early in his career as the DC comic-book vigilante.

Backed by U.S. federal funds, new virus tests are hitting the market.

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With the pandemic still raging as fall approaches, the government’s efforts to support development and deployment of a variety of testing methods are a rare if belated bright spot amid widespread failures to contain the coronavirus.

In the latest round of U.S. government backing, the National Institutes of Health said on Wednesday that it was providing nine more companies with $123.3 million from a $2.5 billion pot of money allocated last spring by the stimulus bill to support testing. That will bring the total amount disbursed so far by the N.I.H. to $372 million across 16 companies.

The goal is to support production of a broad spectrum of tests, making them more widely available and perhaps ultimately as easy to use as a home pregnancy test. Tests must show that they meet the Food and Drug Administration’s standards for safety and accuracy before they can be sold.

“It’s going to be a wonderful competition,” Dr. Francis S. Collins, the N.I.H. director, said in an interview on Tuesday evening.

Yet even as the government helps rush new tests to market, the administration continues to issue conflicting — and sometimes flatly contradictory — messages about how many and what types of tests are needed, when they should be administered and to whom.

President Trump has long derided testing, complaining that it drives up the number of confirmed cases. The lack of a clear national strategy has confused the public, deeply frustrated public health officials and befuddled pharmaceutical executives.

But as testing options have multiplied, easing some of the shortages and laboratory bottlenecks that hampered the early response to the pandemic, universities, employers, state and local governments and other institutions have been increasingly filling in some of the vacuum left by the administration with their own testing plans.

In a recent interview, Dr. Bruce J. Tromberg, who directs the N.I.H.’s test development program, estimated that the United States needed to test about six million people a day, citing reports by experts at the Rockefeller Foundation and other organizations. Without federal assistance, he said, companies would at best produce only half that number by the end of the year.

Trump administration officials like Adm. Brett P. Giroir, the testing czar and an assistant secretary of health, say they want states and localities to create their own testing plans that fit their specific needs rather than to be forced to follow federal dictates. But many experts complain that the lack of federal decision-making — including how many tests a day the United States should aim for — is an impediment in the nation’s battle against the virus, which so far has killed more than 184,000 people and infected more than six million.

“Let’s not just say we are ramping up and hope we get there. Let’s have a goal in mind,” said Dr. Mark McClellan, the director of the Duke-Margolis Center for Health Policy and the commissioner of the Food and Drug Administration under former President George W. Bush. “It’s not just a matter of getting the tests to market.”

Pfizer may know if its vaccine is effective by next month, its chief executive says.

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Pfizer Expects Vaccine Results by End of October

Pfizer’s chief executive, Dr. Albert Bourla, said the drug-making company is in a “very advanced stage” and should know by the end of October whether the coronavirus vaccine they are developing is safe and effective.

We are in a very advanced stage. We started end of July — the big, big trial. But it is the only trial that will tell us if we have an effective and safe vaccine or not. And this is a trial that will completed — we will have to enroll at least 30,000 participants to be able to come to conclusion. Right now, we have enrolled yesterday 23,000 patients were already enrolled in this study, and a significant number of them already started getting the second dose of the vaccine. We expect to, by the end of October, normal group should be able to have enough events to say if the product works or not. And we have already worked on the rest of the file. So, which means that help make the vaccine, if the vaccine is safe. And we are going to start submitting to the F.D.A. on their own and to other regulatory agencies. So what I want to say is that if we have enough events we may be able to say the product is safe and efficacious in the October timeframe, and submit immediately for approval.

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Pfizer’s chief executive, Dr. Albert Bourla, said the drug-making company is in a “very advanced stage” and should know by the end of October whether the coronavirus vaccine they are developing is safe and effective.CreditCredit…Chandan Khanna/Agence France-Presse — Getty Images

Pfizer’s chief executive, Dr. Albert Bourla, said Thursday that the company expects to know whether its vaccine is effective by the end of October, and that it would apply immediately for approval if that was the case.

His remarks, made to the International Federation of Pharmaceutical Manufacturers and Associations, a global trade group, come as a handful of companies are racing to finish a vaccine that could help end the pandemic, and as scientists have increasingly worried that the Trump administration is pushing prematurely for a vaccine approval before the Nov. 3 presidential election.

Dr. Bourla said that about 23,000 people have enrolled in the company’s late-stage clinical trial, out of a goal of about 30,000, and that “a significant number” of them have received the second booster shot. Half of the participants receive the vaccine, half receive a placebo, and then researchers wait to see how many people in each group develop Covid-19.

If significantly more people get Covid-19 on the placebo than the vaccine, that is evidence that the vaccine is effective. The F.D.A. has indicated that vaccine makers should aim for 50 percent protection in order to be considered effective.

“If we have enough events, we may be able to say the product is safe and efficacious in the October time frame and submit it immediate for approval or authorization,” Dr. Bourla said.

Two other companies, Moderna and AstraZeneca, are in late-stage trials in the United States, but neither has laid out a similarly aggressive timeline, instead saying they expect to have a vaccine by the end of the year.

In planning documents sent last week to public health agencies around the country, the Centers for Disease Control and Prevention described preparations for two coronavirus vaccines they refer to simply as Vaccine A and Vaccine B. The technical details of the vaccines, including the time between doses and their storage temperatures, match well with the two vaccines furthest along in clinical tests in the United States, made by Moderna and Pfizer.

Here’s what you need to know about how the vaccines work, how they’re being tested and how they might be rolled out to the public — if, and it’s still a big if, they are proven to work.

Michigan will reopen exercise and sports facilities.

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Credit…Michigan Governors Office, via Associated Press

Michigan gyms, fitness centers, pools and other sports facilities that have been closed since March can reopen on Sept. 9.

Gov. Gretchen Whitmer signed an executive order opening the facilities on Thursday. The order also allows organized sports to resume, although the state recommends against contact sports like football, soccer and basketball.

Dr. Joneigh S. Khaldun, the state’s chief medical officer, said 30 Covid outbreaks in August were connected to athletic teams. “We are not out of the woods yet,” Dr. Khaldun said. “Covid-19 is still a very real threat to our families.”

Gyms and fitness centers will have to maintain social distancing of at least six feet, require all members to wear masks while working out and keep a database of when members use the facilities.

Sporting events will be limited to two guests for each of the players.

Shortly after the announcement, the Michigan High School Athletic Association, which had postponed the fall sports season last month, reinstated it for high schools across the state.

Left off the list of businesses that can reopen were movie theaters, which will remain closed except for theaters in northern Michigan and the Upper Peninsula, which have had a lower number of coronavirus cases and were able to reopen in July.

Ms. Whitmer shut down much the state on March 23 to prevent the spread of coronavirus. As of Wednesday, 104,395 cases of Covid-19 have been reported in Michigan, along with 6,519 deaths, according to the Michigan Department of Health and Human Services.

Several business organizations have filed lawsuits to try to reverse Ms. Whitmer’s executive order, but none have been successful. In May, heavily armed agitators — cheered on by President Trump on Twitter — stormed the Michigan statehouse demanding the state reopen.

A Republican-led petition drive to repeal a state law that gives the governor emergency powers during a public health crisis is underway and could be considered by the legislature later this year.

A day after record highs, a tech-led tumble drives the worst market close in months.

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Credit…Andrew Kelly/Reuters

Tech stocks stumbled sharply on Thursday, causing the S&P 500 to close with its worst drop since June.

The S&P 500 dropped 3.5 percent, while the tech-heavy Nasdaq composite was down nearly 5 percent. The Dow Jones industrial average briefly lost 1,000 points and ended the day down more than 800 points. Apple was down 8 percent. Amazon was down more than 4.5 percent, and Microsoft was down more than 6 percent.

As investors bet that the coronavirus crisis would amplify the dominance of the tech companies’ business models, share prices of large-cap technology companies have surged, generating the lion’s share of the stock market’s gains.

The rip-roaring race for tech shares has increasingly pulled in armchair investors, who have taken up speculating on stocks amid the work-from-home environment. Many of those traders have opted not to buy actual shares but instead to speculate in options trades, which are essentially leveraged bets on where share prices will go.

Analysts say dealers have rushed to boost their bets on falling shares in recent days in an attempt to hedge their risks, amplifying the sell-off in technology shares.

“I think today for tech stocks, you’re seeing that dynamic play out,” said Yousef Abbasi, director of U.S. institutional equities at StoneX, a brokerage firm.

Amid a turbulent market,the number of U.S. workers filing new state jobless claims remained at a historically high level last week, though it is gradually falling.

The government reported on Thursday that 833,000 workers filed new claims for state unemployment benefits last week. An additional 759,000 claims were filed by unemployed freelancers, part-time workers and others who are receiving federal relief under a separate emergency relief program.

Neither figure is seasonally adjusted. On that basis, both totals represented an increase from the previous week. The seasonally adjusted number of new state claims was 881,000.

Malls in N.Y.C. and casinos statewide can reopen on Sept. 9, the governor says.

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Credit…Chang W. Lee/The New York Times

Malls in New York City and casinos across the state will be allowed to reopen on Sept. 9 with certain limits, Gov. Andrew M. Cuomo announced on Thursday.

Casinos will be allowed to operate at 25 percent capacity and malls at 50 percent capacity. Both will need to be equipped with specialized air conditioning systems capable of filtering out virus particles.

The announcement is the latest effort to return some semblance of normalcy to New York, which has for weeks managed to keep positivity rates and hospitalizations low after the virus ravaged the state, killing more than 30,000 people.

The governor said he was eager to restart indoor dining in New York City, where it remains prohibited since mid-March even as he has permitted indoor dining to resume in the rest of the state. Dining will still not be permitted inside the city’s malls and casinos. This week, New Jersey announced indoor dining would restart with limits on Friday.

Mr. Cuomo said he was concerned about New York City’s ability to enforce social distancing and capacity rules inside restaurants, and suggested the New York Police Department be involved in enforcement efforts. But involving the police could prove a delicate issue in the wake of protests against police brutality and after the police’s uneven enforcement of social distancing rules in the spring led predominantly to arrests of Black people.

FEMA funds will no longer be available for disinfecting schools and public transit.

The Trump administration moved to eliminate millions in federal funding for states to disinfect schools, public transportation systems and government buildings this week, in an apparent escalation of President Trump’s efforts to cut support to cities controlled by Democrats. The move will most severely affect New York and California, which have each received around $1 billion of the funds, significantly more than any other state.

Since the pandemic’s onset, the Federal Emergency Management Agency has offered states billions in emergency aid for coronavirus-fighting efforts like disinfecting public buildings and purchasing personal protective equipment for public employees.

But this week, FEMA changed its rules for that funding to prevent the aid from being used to buy P.P.E. for nonmedical public employees or to disinfect public buildings. The shift will go into effect on Sept. 15 — a week before schools are set to reopen for in-person learning in New York.

“This is a downright dirty decision that nonsensically changes the rules in the middle of the game just when we need to keep sanitizing and PPE a federal priority,” said Senator Chuck Schumer, the minority leader and a New York Democrat.

More than 7,000 health workers have died in the pandemic, Amnesty International reports.

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Credit…Rebecca Blackwell/Associated Press

More than 7,000 health care workers have died from Covid-19 around the world, Amnesty International reported on Thursday, up from a July 3 tally of 3,000.

Mexico has suffered the highest toll, with 1,320 health worker deaths. After that comes the United States, with 1,077 dead. Britain, Brazil, Russia and India each have lost about 600 workers.

“For over 7,000 people to die while trying to save others is a crisis on a staggering scale,” said Steve Cockburn, head of economic and social justice at Amnesty International.

Mexico’s high death toll includes many hospital cleaners who were not given adequate protective equipment.

One cleaner at a state hospital, Don Alejandro, 70, told Amnesty in May that he had asked to be allowed to clean administrative areas instead of medical ones because he had a high risk of contracting the virus. His employer allowed him to move, but cut his income by 16 percent.

There were 97,632 cases of COVID-19 among the country’s health workers as of Aug. 25, the Mexican Ministry of Health said.

Medscape, a medical information site for clinicians, maintains a memorial page for health workers around the world who have died from COVID-19. Listed are more than 1,800 names of physicians, nurses, assistants, technicians, orderlies, administrators, volunteers, drivers, porters, EMTs and more from 64 countries. It includes people like Dr. Niloofar Esmail Beigi, 34, a physician in Iran, and Dr. Aleksey Aristov, 62, a deputy chief of surgery in Russia.

The youngest memorialized is 20, the oldest 99.

For its numbers, Amnesty used sources such as memorial pages, government figures, lists compiled by national medical associations, and lists and obituaries published in media globally. For the U.S. death count, researchers used a joint database from The Guardian and Kaiser Health News that specifically tracks deaths of the country’s health workers.

The Centers for Disease Control and Prevention, however, lists only 672 health worker deaths in the U.S. as of Thursday. The C.D.C. said that it was working with limited data.

roundup

Madrid leader issues dire warning on children as schools start reopening.

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Returning to school this fall has been fraught for parents everywhere. But in Spain, a message from the leader of the Madrid region that all schoolchildren would probably end up with the coronavirus was particularly alarming.

Speaking to a local radio station, Isabel Díaz Ayuso, who heads the Madrid region’s government, said Wednesday that it was “probable that all children would get infected, one way or another.”

But, she added, school was probably as safe as any place to be as a child was just as likely to catch Covid-19 at a family weekend gathering, or while out in the park.

“We don’t know, because the virus is everywhere,” she told esRadio. Ms. Díaz Ayuso did not say what scientific evidence she used to predict that the infection rate would be so high among children.

Madrid is once more the epicenter of Spain’s virus pandemic, accounting for almost one quarter of the 1,830 patients hospitalized in the country in the past week.

In response, Madrid is now requiring testing of all teachers returning to school, as is the case in other regions.

The result on Wednesday was chaotic: huge queues of school staff outside packed test centers forced the testing process to be suspended.

As the situation worsens in Madrid, some other regional leaders have been voicing their concerns about allowingresidents from the capital region into their towns.

But Salvador Illa, Spain’s health minister, on Thursday ruled out the idea of imposing a lockdown around the Madrid area.

In other developments from around the world:

  • Thailand has gone 100 days without a reported case of local transmission, but its success in halting the spread of the virus has come at a significant financial cost. Thailand’s last reported case of community transmission was confirmed on May 24. Hundreds of cases have been found since then among residents returning from abroad, but all were detected during the required 14-day quarantine periods. As of Thursday, Thailand had reported 3,425 cases and 58 deaths, according to a Times database.

  • India reported 83,883 new cases on Thursday, breaking its own global record. It has thethird-highest number of cases and deaths after the United States and Brazil.

  • The Czech Republic reported 650 new cases on Thursday, its highest single-day increase.

  • Turkey will impose restrictions on weddings and other social events amid a surge in new cases. The daily number of cases has reached almost 1,600 in the last week.

Reporting was contributed by Liz Alderman, Ilise S. Carter, Choe Sang-Hun, Patricia Cohen, Ben Casselman, Michael Gold, Christina Goldbaum, Kathleen Gray, Luis Ferré-Sadurní, Jacey Fortin, Ethan Hauser, Jennifer Jett, Juliana Kim, Sharon LaFraniere, Raphael Minder, Matt Phillips, Campbell Robertson, Eleanor Stanford, Isabella Kwai, Jim Tankersley, Katie Thomas, Lucy Tompkins, Neil Vigdor, Allyson Waller, Lauren Wolfe, Katherine J. Wu and Carl Zimmer.

Source: nytimes.com

Tags: health

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