The F.D.A. chief confirms his agency’s willingness to approve a vaccine before human trials are complete.
Dr. Stephen M. Hahn, the commissioner of the Food and Drug Administration, who has been under pressure from the White House to speed coronavirus treatments, said in a newspaper interview that his agency would be willing to approve a coronavirus vaccine before Phase 3 clinical trials were complete if the agency found it “appropriate” to do so.
Dr. Hahn told the newspaper that a vaccine developer could apply for approval before the end of Phase 3 clinical trials, which are the largest and most rigorous, but that the agency would make “a science, medicine, data decision” and might issue emergency authorization for use for particularly vulnerable groups rather than a blanket approval.
“This is not going to be a political decision,” he said.
Dr. Hahn’s comments, published online on Sunday by The Financial Times, were not his first indication that the agency could fast-track a vaccine under the right circumstances, which would not be out of line with the agency’s standard protocols. But the interview came at the end of a particularly turbulent week for the F.D.A.
Last weekend, after President Trump criticized the agency for moving too slowly to develop vaccines and treatments and accused it of being part of the “deep state,” Dr. Hahn appeared with Mr. Trump at a news conference where they made erroneous claims that overstated the benefits of plasma treatments for Covid-19, prompting a wave of scientific disbelief and criticism.
Dr. Hahn later corrected the misleading claims. On Thursday, the Department of Health and Human Services, the parent agency of the F.D.A., terminated the contract of a public relations consultant who had advised Dr. Hahn to issue the correction, and the F.D.A.’s chief spokeswoman, who had been on the job for just 11 days, was removed from her position.
Last week, The Times reported that, on July 30, Treasury Secretary Steven Mnuchin and the White House chief of staff, Mark Meadows told House Speaker Nancy Pelosi and Senator Chuck Schumer, the Democratic leader, that a vaccine would probably be given emergency approval before the end of Phase 3 clinical trials in the United States, perhaps as early as late September.
The account was based on information from two people briefed on the discussion, who said that Mr. Meadows indicated would likely be the one being developed by AstraZeneca and Oxford University, which is now undergoing Phase 2 and Phase 3 trials in Britain, Brazil and South Africa. However, senior administration officials disputed the account, saying Mr. Meadows and Mr. Mnuchin were either being misrepresented or had been misunderstood.
Last week, Dr. Anthony S. Fauci, the nation’s leading expert on infectious diseases, told The Times of London that three vaccines candidates focused on by Operation Warp Speed, the White House’s effort speed vaccine development, were lined up for testing and that getting results by November or December was “a safe bet.” He also said that “It is conceivable that we would get an answer before that.”
An independent advisory committee is scheduled to meet on Oct. 22 to discuss vaccines in development, but Dr. Hahn has said the agency was prepared to “rapidly” schedule additional meetings once a vaccine application is submitted.
China and Russia have both approved vaccines without waiting for the end of Phase 3 trials, drawing criticism from global health experts.
Some aspects of vaccine development cannot be rushed. There is no way to hasten the production of antibodies in the human body, and researchers must be on guard for “antibody-dependent enhancement,” in which a vaccine makes recipients more susceptible to infection rather than less. In the past, vaccines against H.I.V. and dengue have unexpectedly triggered enhancement.
The former F.D.A. commissioner Dr. Scott Gottlieb said in an interview on CBS’s Face the Nation that the agency leadership could not “obviate” the process of approval. But he also said that the trials could “read out early” if the data shows a particular vaccine to be “very effective” and such results might allow emergency authorization for vulnerable populations.
Some experts fear that rapid approval could have unintended consequences. In a letter to Dr. Hahn dated Aug. 26, the Infectious Disease Society of America, an association of infectious disease doctors, warned that approval before the completion of a Phase 3 trial “could significantly undermine COVID-19 vaccination efforts and seriously erode confidence in all vaccines in the current atmosphere of vaccine hesitancy.”
President Trump retweets a barrage of false claims, including some about the pandemic.
More than 180,000 people in the United States have died of Covid-19, the illness caused by the coronavirus. But President Trump retweeted multiple messages overnight and Sunday morning by people embracing fringe conspiracy theories claiming the death toll has been grossly exaggerated.
The reposted messages, decidedly at odds with government and other tallies, assert that the virus’s real death toll is only around 9,000 — not 182,000 — because many of those who died also had other health issues and most were of an advanced age.
“So get this straight — based on the recommendation of doctors Fauci and Birx the US shut down the entire economy based on 9,000 American deaths to the China coronavirus,” said the summary of a story by the hard-line conservative website Gateway Pundit that was retweeted by the president, assailing his own health advisers, Dr. Anthony S. Fauci and Dr. Deborah L. Birx.
In fact, experts say, the official estimate of deaths may actually undercount mortality attributable to Covid-19. The more accurate figure may well exceed 200,000, according to an analysis by The Times earlier this month.
There were at least 871 new coronavirus deaths and 44,639 new cases reported in the United States on Aug. 29, according to a database maintained by the The Times. Over the past week, there have been an average of 41,924 cases per day, a decrease of 4 percent from the average two weeks earlier.
Total cases in the United States are nearing 6 million. Worldwide, the caseload has passed 25 million.
In an apparent contradiction, Mr. Trump also retweeted a message calling for New York’s governor, Andrew M. Cuomo, to be imprisoned because of the high death toll from the virus in nursing homes in the state. “#KillerCuomo should be in jail,” said the message by the actor James Woods, a strong supporter of the president.
The tweets were part of more than 80 presidential tweets and retweets, many of them inflammatory comments or assertions about violent clashes in Portland, Ore., where a man wearing the hat of a far-right, pro-Trump group was shot and killed Saturday after a large group of Mr. Trump’s supporters gathered in the streets.
Five months after shutting down the subway in New Delhi, India is reopening the city’s underground rail network, even as the country continues to set global records for the greatest number of new daily confirmed cases.
India, a nation of 1.3 billion people, is loosening some restrictions in parts of the country while adding others aimed at thwarting the virus.
“This is good news,” said Anuradha Raman, a college student in New Delhi. “But people are also scared, because we don’t follow social distance guidelines here.”
The country reported 78,761 new coronavirus infections on Sunday, setting a global record for the third time in recent days. Until this past week, the United States had held the record for a single-day increase in cases, 75,682 on July 16.
Indian officials say the steep rise in confirmed infections is partly explained by an increase in testing. More than 60,000 Indians have died from Covid-19.
Arvind Kejriwal, New Delhi’s chief minister, said he was glad the subway, which is used by 2.6 million commuters a day, was resuming service. But the capital also reported 1,954 new cases on Saturday, its largest daily tally in 50 days.
It was not clear whether subways in other cities will also resume service.
While sports events and religious festivals have been allowed with restrictions on attendance, the country’s schools will remain closed until the end of September.
Other coronavirus developments around the world:
Global confirmed cases have surpassed 25 million, reaching 25,020,700, according to a Times database, and at least 842,700 people have died. The 10 countries reporting the highest per capita infections in the last week are largely clustered in the Caribbean (Aruba, Turks and Caicos, Sint Marten) and in Central and South America (Peru, Colombia, Argentina, Costa Rica). The Maldives and Bahrain are in that category.
Prime Minister Jacinda Ardern of New Zealand thanked residents of Auckland, the country’s largest city, as they prepared to come out of lockdown at 11:59 p.m. on Sunday. She also encouraged residents to wear masks in public and remain vigilant. “Our system is only as good as our people, and our people are amazing,” she said. The city had been on lockdown since Aug. 12 as it tries to contain a cluster that has grown to 135 cases, including two reported on Sunday.
SUNY Oneonta, a public college in central New York, is the latest campus to close down in-person classes within a few days of reopening. The college took the step after learning of more than 100 coronavirus cases connected with the campus.
SUNY Oneonta, part of the State University of New York system, learned of the outbreak after it began testing 3,000 students and faculty members, following “several large parties” and positive tests for 20 people on campus. Fall classes at the school began on Monday.
Around the country, many colleges are finding outbreaks in their student dormitories.
After several cases were discovered at Baylor University in Texas, students living on two floors of one residence, Martin Hall, were ordered not to leave their floors for four days while the university carried out coronavirus testing and contact tracing.
“Since Thursday, we have seen an increase from five positive Covid-19 cases to 21 positives on these two floors as of Saturday,” the university said in a letter to students and parents. “We will evaluate the need for stricter quarantine if evidence suggests that such action is necessary.”
Concern over the potential for campus outbreaks has some colleges turning to innovative approaches to detecting and preventing infections. The schools are testing wastewater, deploying health-check apps and developing versions of homegrown contact technologies that log students’ movements and exposure risks. They are experimenting with test methods that might yield faster results and be easier to administer than those now in widest use.
At more than 15 dormitories and on-campus apartment buildings at the Rochester Institute of Technology in New York, sewage is being tested twice weekly for genetic evidence of virus shed in feces.
This provides a kind of early-warning system for an outbreak, limiting the need to test every student for the coronavirus. If the virus is found in the sewage, individual tests can be administered to identify the source.
“It’s noninvasive,” said Enid Cardinal, a senior adviser to R.I.T.’s president. The school is among a half-dozen colleges in upstate New York adopting similar technology, which was first introduced by Syracuse University. At the University of Arizona, officials said such tests had led to the discovery that several students in a dorm were infected.
“Wastewater,” Ms. Cardinal quipped. “My new favorite topic.”
In the spring, teenagers started showing up at U.S. doctors’ offices with angry red and purple blisters on their fingers and toes — the latest unexpected feature of the coronavirus. Suddenly photographs of so-called Covid toes were everywhere on social media.
But almost all of the images depicted glossy pink lesions on white skin. Though people of color have been affected disproportionately by the pandemic, pictures of Covid toes on dark skin were curiously hard to find.
The problem isn’t unique to Covid toes or social media. Although progress has been made in recent years, most textbooks that serve as road maps for diagnosing skin disorders often don’t include images of skin conditions as they appear on people of color.
“Pattern recognition is central to dermatology, and a lot of the pattern recognition is training your eye to recognize certain colors that trigger you to think of certain diseases,” said Dr. Jenna Lester, the director of the skin of color program at the University of California, San Francisco.
As the coronavirus spread, dermatologists started an international registry to catalog examples of skin manifestations of Covid-19. It included more than 700 images, but only 34 of disorders in Hispanic patients and 13 in Black patients were submitted.
It wasn’t until July that Dr. Roxana Daneshjou and her colleagues at Stanford University published some of the first pictures of Covid toes in nonwhite patients in the Journal of the American Academy of Dermatology.
“We know for certain that if dark skin images are not well represented, skin doctors — but also other doctors who are not skin experts — are at a disadvantage for making a proper diagnosis,” said Dr. Hao Feng, an assistant professor of dermatology at the University of Connecticut.
A worldwide virus-hunting program allowed to expire last year by the Trump administration, just before the coronavirus pandemic broke out, will have a second life — whatever the outcome of the presidential election.
The Obama-era program, called Predict, searched for dangerous new animal viruses in bat caves, camel pens, wet markets and wildlife-smuggling routes around the globe.
USAID, the government agency that let Predict lapse last October, has quietly created a $100 million program with a similar purpose set to begin in October. It will be called Stop Spillover.
And Joseph R. Biden Jr. has promised that, if elected, he will restore Predict.
The program’s expiration came just weeks before the advent of the pandemic, and its termination prompted wide criticism among scientists, who noted that the coronavirus is exactly the sort of catastrophic animal virus the program was designed to head off.
In a speech on Thursday, ahead of the last night of the Republican National Convention, Kamala Harris, the Democratic vice-presidential candidate, briefly alluded to the controversy.
“Barack Obama and Joe Biden had a program, called Predict, that tracked emerging diseases in places like China,” she said. “Trump cut it.”
Dennis Carroll, Predict’s creator and director, retired from government service when the program shut down. In an interview on Friday, he said Predict was closed by “risk-averse bureaucrats who were trying to divine what the Trump administration did and didn’t want.”
Dr. Carroll is now a fellow at the Bush School of Government and Public Service at Texas A&M in College Station and an informal adviser on global health to the Biden campaign.
On Friday, a USAID spokeswoman, Pooja Jhunjhunwala, denied that Predict was canceled and said it simply came to the end of its 10-year “life cycle.”
Ms. Jhunjhunwala said that Stop Spillover “is not a revival of Predict, nor a follow-on project,” but that it was designed to “implement the scientific gains of Predict to reduce the risk of viral spillover.”
Also, on Thursday, the National Institute of Allergy and Infectious Diseases announced that it would spend $82 million over five years to create 11 centers in which American and foreign scientists would collaborate to hunt emerging diseases.
“Yes, it’s like Predict, but it wasn’t the cancellation of Predict that inspired it,” said Dr. Anthony S. Fauci, the N.I.A.I.D.’s director.
The Times’s Jeré Longman talked to five elite athletes — a shot-putter, a long-distance runner, a swimmer, a discus thrower and a major outfielder — who have found ways to turn the limitations of the pandemic into benefits.
Ryan Crouser, the 2016 Olympic shot-put champion, had expected to defend his gold medal in Tokyo this summer. He did not expect to enter bass-fishing tournaments as a way to feed his competitive bend that was being stifled by a pandemic.
“Finished in the money three of the last four tournaments,” Crouser, 27, who lives in Fayetteville, Ark., said in a telephone interview.
Many Olympic sports lost their primary showcase with the postponement of this year’s Tokyo Games. The annual international circuit for dozens of sports were also disrupted. Some athletes, their motivation sagging, decided to throw in the towel and resume serious training in the fall.
But not everyone.
On July 18, after driving 10 hours to compete in one of the rare track meets held this summer, Crouser unleashed the best throw of his life — 75 feet 2 inches, or 22.91 meters — which tied for the fourth-best throw of all time.
He is one of many athletes who have performed as well as or better than ever despite the complications of the last several months. They say they feel refreshed by increased rest, less exhaustive travel, enhanced focus on training, healed injuries, creative improvisation and a less stressful perspective.
Claire Curzan, 16, an Olympic swimming hopeful from Raleigh, N.C., said it had been “almost a relief” when the Tokyo Games were postponed. After posting a top-20 time in the world last year in the 100-meter butterfly and reaching the medal podium at the world junior championships, she said she felt pressure to make the Olympic team “to make everyone proud.”
Yet when her club pool shut down in March, Curzan was forced to rethink her approach. She improvised her workouts, ran to maintain her stamina, and began focusing on improvement instead of international rankings. And perhaps most important, she slept at least nine hours per night instead of six or seven.
After resuming her usual workouts, Curzan posted four personal-best times at an intrasquad meet.
Reporting was contributed by Peter Baker, Tess Felder, Abby Goodnough, Matthew Haag, Thomas Kaplan, Sharon Lafraniere, Jeré Longman, Donald G. McNeil Jr., Roni Caryn Rabin, Alan Rappeport, Matt Richtel, James B. Stewart, Abby Goodnough, Sameer Yasir and Mihir Zaveri.