F.D.A. Panel Recommends Pfizer Boosters for People 65 and Older

WASHINGTON — A scientific advisory committee to the Food and Drug Administration on Friday recommended authorizing a booster shot for recipients of the Pfizer-BioNTech coronavirus vaccine who are 65 or older or are at high risk of severe Covid-19.

The move came after the panel overwhelmingly recommended against approving a Pfizer booster for people 16 and older.

The committee voted 16 to 2 against a broader recommendation after an intense daylong public discussion on whether booster shots are necessary and if so, for whom. The Biden administration had been hoping the F.D.A. and the Centers for Disease Control and Prevention would approve a third shot of the Pfizer vaccine in time to begin rolling out boosters for Pfizer recipients next week.

Although the F.D.A. is not obliged to follow its advisory committee’s recommendations, it typically does. The agency will likely make a decision by early next week.

The votes came after a sharp debate in which many of the panel’s independent experts, including infectious disease doctors and statisticians, challenged whether the data justified extra shots for so much of the population when the vaccines appear to still offer robust protection against severe Covid-19 disease and hospitalization, at least in the United States.

“It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” said Dr. Michael G. Kurilla, a committee member and official at the National Institutes of Health.

The negative vote was the latest in a series of setbacks for President Biden’s booster plan since he first announced it a month ago. Mr. Biden said at the time that he wanted most adults who had gotten a second Pfizer or Moderna vaccine at least eight months ago to start receiving booster shots the week of Sept. 20.

But two weeks after his announcement, leaders of the F.D.A. and the C.D.C. told the White House that it would be impossible to authorize booster shots for recipients of the Moderna vaccine that soon. It is now unclear whether extra injections will be offered to Pfizer recipients, and if so, to how many.

In a remarkable public display of internal dissension, two F.D.A. scientists co-authored a medical journal article earlier this week arguing that there was no credible evidence yet in support of booster shots for the general population. Those officials, who are leaving the agency this fall, joined outside experts and other federal health officials who cast doubt at the meeting on whether Pfizer’s request should be approved.

On the other hand, Dr. Peter Marks, their superior and the official who oversees the F.D.A.’s vaccine division, noted that many well-known vaccines require booster shots and urged the committee to consider the importance of not just of preventing severe disease but of curbing the spread of infection.

After the F.D.A. rules on Pfizer’s request, an advisory committee to the C.D.C. will meet to recommend how exactly the extra doses should be used. Earlier public discussions suggest the C.D.C. committee may be leaning toward tailoring booster shots toward the elderly and others particularly vulnerable to worse outcomes from Covid-19, instead of to all those who received their second injection eight months earlier.

The F.D.A. committee’s vote followed hours of presentations by officials from Pfizer, the C.D.C., the Israeli government and independent experts on the complex array of data they have collected up until now about the waning effectiveness of Pfizer and other vaccines over time.

Dr. Sara Oliver of the C.D.C. presented data showing that vaccines continue to strongly protect against severe forms of Covid-19 in the United States, even in people 75 and older.

Jonathan Sterne, a professor of medical statistics and epidemiology in the United Kingdom, said he had analyzed 76 different studies on the vaccines’ real world effectiveness and found that multiple factors can skew the results, including how many unvaccinated people in a study have natural immunity from prior Covid-19 disease. He also warned against drawing conclusions from short-term results from booster shots; data from Israel, for example, only included a follow-up period of several weeks for older adults.

Israeli experts made a different argument, telling the committee that they believed third Pfizer shots helped dampen a fourth wave of transmission as the Delta variant swept the nation this summer. The Israeli government, which has relied almost entirely on the Pfizer vaccine, began offering booster shots in late July, starting with the elderly.

Dr. Sharon Alroy-Preis, Israel’s head of public health services said the summer’s rise in the number of hospitalized patients who had been fully vaccinated with Pfizer’s vaccine was “scary.” She said 60 percent of severely or critically ill patients and 45 percent of those who died during what she called the fourth surge had received two injections of Pfizer’s vaccine.

After offering boosters to the general population, she said, Israel is now averaging about half as many severe or critically ill patients as anticipated. She said boosters not only helped curb the spread of infection, but “actually saved lives.”

Another Israeli scientist walked the panel through a new study of health records of more than 1.1. million people over age 60. It found that at least 12 days after the booster, the rates of severe disease were nearly twenty-fold lower among those who received a third Pfizer shot compared to those who did not.

Dr. William C. Gruber, a senior Pfizer vice president in charge of vaccine development, suggested that if the United States does not follow Israel’s lead, it could potentially face more than five million more infections a year among people who received their second dose 10 months earlier, compared to those who got the second shot five months earlier.

“Israel could portend the U.S. Covid-19 future, and soon,” he said.

He said Pfizer’s data shows a third shot elicits a robust antibody immune response that equals or greatly exceeds the response after the second dose. Data also show, he argued, that breakthrough infections among vaccinated Americans are linked more to the ebbing power of the vaccine over time instead than to the Delta variant.

But committee members, including some government officials, appeared deeply skeptical of the Pfizer’s data and Israel’s analyses. Dr. Philip Krause, one of the F.D.A. vaccine experts who authored the medical journal review, criticized Pfizer’s presentation of data that had not been peer-reviewed or evaluated by the F.D.A., arguing that possible problems in the modeling within could understate the vaccine’s efficacy.

Dr. Oliver, the C.D.C. official, questioned attempts to draw a parallel between the United States and Israel, noting that Israel has only nine million residents and is less diverse than the United States. Notably, she also said that Israel defines a severe case of Covid-19 more broadly than the United States does, which might help explain why Israel reports more serious breakthrough infections among its vaccinated.

Another C.D.C. official, Dr. Amanda Cohn, asked Israeli officials why the spread of the virus there had recently intensified, despite a broad rollout of boosters. Dr. Alroy-Preis said that the Jewish holidays, together with the start of the school year, had contributed to what she suggested would be a temporary surge in cases.

Committee members also said they were concerned about a paucity of safety data in younger recipients of a booster dose, since studies have shown a higher risk of the heart condition myocarditis in young men who received Pfizer-BioNTech’s vaccine. Several of them asked whether it would be better to wait for a booster vaccine designed specifically to fend off the Delta variant of the virus.

Apoorva Mandavilli and Sheryl Gay Stolberg contributed reporting.

Advisers to the Food and Drug Administration on Friday questioned an assertion by researchers in Israel and by the drug company Pfizer that the protection from its coronavirus vaccines wanes over time not just against infection, but against severe illness and hospitalization.

The advisers were meeting officially to evaluate the application for booster doses of Pfizer-BioNTech vaccine, and they ended up voting to recommend authorizing booster shots for those who are 65 or older or are at high risk of severe Covid-19, after overwhelmingly voting against recommending them broadly for those over 16.

Among the details that surfaced during the lively debate: Israel defines anyone with an accelerated respiratory rate and an oxygen level of below 94 percent as being severely ill. By contrast, the Centers for Disease Control and Prevention considers people who are sick enough to be hospitalized as having severe disease, according to Dr. Sara Oliver, a C.D.C. scientist who presented data on the trajectory of the pandemic in the United States.

The discrepancy might explain why the two countries have reported vastly different outcomes in people who are fully immunized. Israeli researchers said they have seen large numbers of hospitalized patients who had received two doses months earlier, but in the United States, the C.D.C. has reported that vaccinated patients make up about 2 percent of people hospitalized for Covid-19.

Other advisers noted that antibodies are expected to wane over time, but studies so far — including from Pfizer — have indicated that immune cells, which would prevent severe illness, remain stable. One study published this week showed steady levels of immune cells seven months after the second dose.

Some advisers seemed more inclined to OK the booster shots, noting that the boosters appear to have eased Israel’s surge.

Three other important pieces of research landed just this week. On Monday, in the journal The Lancet, an international team of scientists analyzed dozens of studies and concluded that boosters are not yet needed by the general population, and that the world would be better served by using vaccine doses to protect the billions of people who remain unvaccinated.

Two of the authors are vaccine experts at the F.D.A. itself, and both had already announced plans to resign over what they felt was undue pressure from the Biden administration to clear booster shots.

On Wednesday, scientists at the agency posted an assessment online hinting that they, too, are unconvinced that there’s enough evidence that boosters are needed. “Overall, data indicate that currently U.S.-licensed or authorized Covid-19 vaccines still afford protection against severe Covid-19 disease and death in the United States,” according to their executive summary.

But some F.D.A. leaders had publicly endorsed booster shots. “The need for an additional dose at six months to provide longer term protection should not come as a surprise, as it’s likely necessary for the generation of a mature for immune response,” Dr. Peter Marks, one of the agency’s top officials, said in the meeting on Friday.

White House officials have said they are particularly worried by data from Israel, where officials have said that vaccinated people are seeing waning immune responses and higher rates of infection. Alarmed by the rise in cases, Israeli officials offered third doses of the vaccine to everyone older than 12.

Researchers from Israel published early results from that rollout on Wednesday in the New England Journal of Medicine — but few outside scientists found the findings convincing.

The team collected data on the effects of booster shots from the health records of more than 1.1 million people over age 60. At least 12 days after the booster, rates of infection were elevenfold lower — and rates of severe disease nearly twentyfold lower — in those who received a booster compared with those who had received only two doses, the researchers found.

The results are unsurprising, experts said, and do not indicate long-term benefit.

“We have known for some time that the vaccines elicit less robust immune responses in the elderly,” said Dr. Celine Gounder, an infectious disease specialist at Bellevue Hospital Center and a former adviser to the Biden administration. “Recommending additional doses of vaccine for the elderly isn’t controversial.”

Vaccination remains powerfully protective against severe illness and hospitalization in the vast majority of people in all of the studies published so far, experts said. But the vaccines do seem less potent against infections in people of all ages, particularly those exposed to the highly contagious Delta variant.

The cumulative data so far suggest that only older adults might need boosters — and maybe not even them. But White House officials had said that they did not want to wait for hospitalizations to begin rising — if they ever do — among the vaccinated before taking action.

The Biden administration has said that booster doses could be rolled out quickly if they were deemed necessary.

British scientists have recommended giving third doses to adults over 50 and other medically vulnerable people. France, Germany, Denmark and Spain are also considering boosters for older adults or have already begun administering them. Israel is already contemplating fourth doses for its population.

But recent history leaves many experts leery of adding the United States to the list.

The Biden administration is negotiating with Pfizer to buy another 500 million doses of coronavirus vaccine to donate overseas, which would bring the total number of planned donations to 1.15 billion doses — about a tenth of the world’s need — according to two people familiar with the plan. It was not immediately clear over what time period the donation would be.

The deal is not yet final, but the talks come just in time for a global Covid-19 summit that Mr. Biden will host on the sidelines of the United Nations General Assembly meeting next week. The president will use the summit to convince other nations to set aside domestic demands and instead focus on getting vaccine doses to poor countries dependent on donated shots.

Separately, White House officials, speaking on condition of anonymity to preview a formal announcement of the summit later on Friday, said that Mr. Biden’s message to other nations would be that the United States cannot and should not do it alone, and that all nations should honor exiting commitments.

The talks with Pfizer, which were reported without specifics earlier in The Washington Post, also come as Mr. Biden is under fire for proposing booster shots for already vaccinated Americans while citizens of poor nations have not even had their first doses. A scientific advisory committee to the Food and Drug Administration on Friday recommended authorizing a booster shot for recipients of the Pfizer-BioNTech coronavirus vaccine who are 65 or older or are at high risk of severe Covid-19.

Jeff Zients, Mr. Biden’s coronavirus response coordinator, declined to offer specifics on the talks, saying only that how to help the 100 countries that are most in need would be “a big topic of conversation” at the U.N. gathering.

The World Health Organization has asked world leaders to refrain from rolling out boosters at least until the end of the year, with the goal of immunizing 40 percent of the global population first. Its experts, and others, have said a much more aggressive — and comprehensive — approach to fighting the global pandemic is needed.

“A piecemeal approach favors those who can most easily pay,” Dr. Kate O’Brien, the W.H.O.’s top vaccines expert, told reporters earlier this week. Without naming the United States, she noted that some countries are “moving forward with booster programs for which we do not see evidence that would support a need for broad booster programs in the general population. And at the same time, others haven’t even started vaccinating health workers or high risk groups sufficiently.”

The summit, which Mr. Biden plans to convene on Wednesday, will be the largest gathering of heads of state dedicated to addressing the coronavirus crisis. Previous gatherings have included much smaller groups of leaders, like those from the Group of 7 nations.

White House officials said that Mr. Biden aimed to inject a fresh sense of urgency in the fight against the pandemic, as well as to “create a bigger tent” of people and groups committed to ending the pandemic. Pharmaceutical makers, philanthropists and nongovernmental organizations are being invited to participate.

The officials said that Mr. Biden wants to forge consensus around a broad framework for action, including specific targets for vaccination. The officials offered few specifics, saying that the precise goals were still under discussion.

However, the White House sent a draft document to summit invitees earlier this week that called for 70 percent of the world’s population to be vaccinated by the time the U.N. gathers again in September of next year.

Experts have estimated that 11 billion doses are necessary to achieve broad global immunity to the coronavirus. The United States has already committed to sending more than 600 million doses abroad, and is working to scale up manufacturing in this country and overseas, particularly in India.

But global health advocates say donating doses is not enough. They want Mr. Biden to work to create manufacturing hubs in many other countries and to press vaccine makers to share their technology as part of a far-reaching plan similar to the one former President George W. Bush created to address the global AIDS epidemic.

The White House officials who discussed Mr. Biden’s summit plan insisted the United States can do both. In an interview earlier this week, Dr. Anthony S. Fauci, Mr. Biden’s top adviser for the coronavirus — and a driving force behind Mr. Bush’s Emergency Plan for AIDS Relief — said the administration was committed to doing more.

“We’re trying to figure out what is the best way to get a really fully impactful program going,” Dr. Fauci said, noting that building manufacturing plants overseas might be a reasonable step to prepare for any future pandemics, but could not happen quickly enough to end this one. “We want to do more, but we’re trying to figure out what the proper and best approach is.”

Reaching specific global vaccination targets has so far proven difficult. Covax, the U.N.-backed vaccine distribution program, announced this month that it would not be able to meet its forecast for doses available in 2021. So far, only 20 percent of people in poor and middle-income nations have received at least one dose of a Covid vaccine.

The Centers for Disease Control and Prevention released data on Friday indicating that the level of protection against Covid hospitalizations afforded by the Pfizer-BioNTech vaccine dropped significantly in the four months after full inoculation.

The data was released hours before a scientific advisory committee to the Food and Drug Administration overwhelmingly recommended against approving a booster shot of the Pfizer-BioNTech vaccine for people 16 and older. However, the debate over booster shots will continue as time passes and more data accumulates.

The new study found that from two weeks after recipients got their second dose — a point at which they are normally considered fully vaccinated — to four months later, the Pfizer vaccine was 91 percent effective in preventing hospitalization. Beyond 120 days, though, its effectiveness fell to 77 percent.

The Moderna vaccine showed no comparable decrease in protection over the same time frame: It was 92 percent effective against hospitalizations four months after recipients’ vaccination, a level virtually identical to its 93 percent effectiveness before then.

The study said that not enough participants had received the one-shot Johnson & Johnson vaccine to compare its performance. Overall, though, the Johnson & Johnson shot has been 71 percent effective in preventing hospitalizations.

The C.D.C. study released on Friday supported some others that suggested the Pfizer vaccine may offer less protection from hospitalization over time. But the available data is far from unanimous.

Other studies have shown that Pfizer’s effectiveness against hospitalization has remained above 90 percent, despite the spread of the Delta variant and the lengthening time since people received their second shots. Pfizer has said that data from Israel suggest a falling effectiveness against severe disease, though it appears that Israel and the United States define “severe disease” differently.

The latest C.D.C. study was based on an analysis of roughly 3,700 adults hospitalized across the United States from March to August.

People with compromised immune systems, who typically don’t respond as well to vaccines, were excluded from the study. Nevertheless, the vaccinated patients tended to be older people — the Pfizer cohort had a median age of 68 — and it was unclear whether vaccine effectiveness had changed much in younger age groups. Previous studies have shown lower levels of protection in older people.

The authors of the study said that the gap in the performance of the Moderna and Pfizer vaccines could stem from higher dose of mRNA in the Moderna shots or the four-week space between doses of the Moderna vaccine. (Pfizer vaccines were given three weeks apart.) It’s also possible, they said, that other, unnoticed differences in the study participants receiving either shot could have also influenced the results.

A scientific advisory committee to the Food and Drug Administration on Friday voted to recommend authorizing booster shots for Pfizer-BioNTech recipients who are 65 or older or are at high risk of severe Covid-19, after overwhelmingly voting against recommending them broadly for those over 16.

There is no clear timeline for when the F.D.A. might put the possibility of booster shots for the two other vaccines available for use in the United States through the same process.

Covid vaccines made by Moderna and Johnson & Johnson are the other shots the F.D.A. has authorized for emergency use for those 18 and older. (Pfizer’s vaccine is the only one that has been fully approved for use in people 16 and older; it has emergency authorization for 12- to 15-year-olds.)

The question of whether booster shots are necessary has been the subject of intense debate and multiple studies since August, when President Biden announced that he planned to make booster shots available to adult recipients of the Pfizer-BioNTech and Moderna vaccines in September.

Dr. Janet Woodcock, the acting commissioner of the F.D.A., had hoped that booster shots could be offered this month not only for Pfizer and Moderna recipients, but for recipients of Johnson & Johnson’s one-dose vaccine as well, according to people familiar with the deliberations. But the administration had to limit its plan to Pfizer recipients, officials said, because neither Moderna nor Johnson & Johnson delivered the necessary data to the F.D.A. in time.

Moderna submitted an application for its booster dose to the F.D.A. earlier this month. A spokeswoman for the company said in an email on Thursday that she did not have an update on when the F.D.A. might act on its application.

Johnson & Johnson has not yet applied for booster clearance. A Johnson & Johnson spokesman said in an email on Thursday that the company planned to file for federal authorization for the vaccine by the end of the year, but did not provide a timeline.

Sharon LaFraniere and Noah Weiland contributed reporting.

Young students who recently endured a year of pandemic lockdowns may have suffered deteriorating eyesight, according to a study published Thursday in Jama Ophthalmology.

The study was conducted by the Sun Yat-sen University School of Public Health, based on data from annual eye exams given to more than 2,000 students in a dozen primary schools in Guangzhou, China, from 2018 to 2020.

About 13 percent of second-grade students who had eye exams in 2018 developed nearsightedness by 2019, according to the study. By comparison, more than 20 percent of those who had eye exams in 2019 became nearsighted by 2020, a statistically significant difference. Initial tests of both groups showed that about 7 percent of the students were nearsighted.

The effects on the eyesight of students ages 9 and older appeared to be negligible, the researchers said. The findings suggested that younger children were more susceptible to environmental effects on their vision.

The study did not explore the hours children spent in front of computer screens as part of remote learning, or the time spent reading books — avid young readers may develop nearsightedness as well — so it is not possible to draw conclusions about the effects of screen time on their eyesight.

But Dr. Carlos Emmanoel Chua, president of the Philippine Society of Pediatric Ophthalmology and Strabismus, said that studies in Hong Kong, Singapore and China had also concluded that the pandemic has had a negative impact on children’s vision for various reasons.

“Whether it’s due to being stuck indoors, doing more indoor activities and online schooling, or not being able to see their doctor for their annual appointments to check for progression, more students have developed nearsightedness during the pandemic than before,” he said.

A study of children in Australia and Singapore in 2018 found that outdoor activities, even for just a few hours a day, helped reduce the risk of nearsightedness. This was one of the findings that Dr. Chua said prompted pediatric ophthalmologists in the Philippines to start a pre-Covid campaign to encourage children to play outside.

The Philippines is one of only a few countries where schools still have not reopened and children continue to learn remotely. Dr. Chua said that during the pandemic his group had increased efforts to push for more frequent outdoor play and breaks from screens.

“A little bit of extra outdoor activity will help slow down the progression of myopia,” he said. “You have to take your breaks.”

New coronavirus cases and Covid hospitalizations across the United States have started to show signs of decline, although they remain far higher than they were earlier in the summer, and the number of new deaths is still increasing.

As the Delta variant has ripped through unvaccinated communities, reports of new deaths have reached an average of more than 1,900 a day, up nearly 30 percent in the past two weeks, according to a New York Times database. Approximately one in every 500 Americans has died from the disease.

The pace of vaccinations remains relatively sluggish, with 64 percent of eligible people in the United States fully vaccinated, according to federal data. (No shots have been federally authorized for children younger than 12.)

Vaccination remains powerfully protective against severe illness and hospitalization because of Covid-19 in the vast majority of people in all of the studies published so far, experts say. Health officials say that most of the patients who are being hospitalized and dying are not vaccinated, while areas with higher rates of vaccination have generally fared better. Over the summer, masks were recommended indoors for everyone, regardless of vaccination status, in virus hot spots and in schools across the country.

Some states have seen their hospital intensive-care wards become overwhelmed with Covid-19 patients, and have called in National Guard help or set up overflow units in parking lots. Idaho officials activated on Thursday “crisis standards of care,” meaning that hospitals can ration treatment if necessary.

Across the country, one in four U.S. hospitals reported that more than 95 percent of intensive care beds were occupied as of the week ending Sept. 9, up from one in five in August. Experts say that hospitals could struggle to maintain standards of care for the sickest patients when all or nearly all I.C.U. beds are occupied.

Conditions are beginning to improve in some hard-hit regions. Southern states like Florida, Mississippi and Georgia are seeing some declines in new cases and hospitalizations.

But new outbreaks are spreading in the Mountain West and Upper Midwest. West Virginia, where a smaller percentage of residents are vaccinated than in any other state, now leads the country in new cases per capita.

The Delta variant has caused record numbers of pediatric infections and hospitalizations, although children are far less likely than adults to die or become very ill from the virus. Some schools that reopened for in-person instruction have closed temporarily because of outbreaks and staff shortages.

Asked on Tuesday on the MSNBC program “Morning Joe” whether he thought the struggle against the coronavirus would become a “forever war,” Dr. Anthony S. Fauci, the nation’s top infectious disease expert, said, “I don’t believe it needs to be.” But he said success in reining in the virus will depend on as many people as possible getting vaccinated.

To those who resist the shots, Dr. Fauci said: “You’re not in a vacuum, you’re part of society. And do you want to be part of the component that propagates the virus and propagates the outbreak, or do you want to be part of the solution?”

Mitch Smith and Sarah Cahalan contributed reporting.

India’s far-reaching effort to vaccinate its vast population against Covid-19 hit another milestone on Friday: Its health ministry said that a record 25 million shots had been administered over the course of the day, a special push to mark the birthday of Prime Minister Narendra Modi and celebrate his 20 years in public office.

That is more than two and a half times its previous daily record — 9.3 million shots, reached on Sept. 2 — and more than seven times the level reported three months ago, according to the Our World in Data Project at Oxford University.

Leaders of India’s governing Bharatiya Janata Party said that states under its control had long aimed to maximize a vaccination push as a birthday gift for Mr. Modi, who turned 71 on Friday.

“Good health is indeed wealth and a great way to celebrate PM @NarendraModi ji’s birthday,” India’s federal health minister, Mansukh Mandaviya, wrote on Twitter. Videos of the prime minister were circulated showing him distributing sweets to health workers.

India has administered over 793 million vaccine shots through a drive that had major setbacks in its early stages — although inoculating a population of 1.4 billion people, spread from the Himalayas to the coasts, was always going to be a challenge. The drive has gained considerable momentum in recent weeks.

The country is now recording over 30,000 new Covid-19 cases a day. With a total of more than 33 million total cases during the pandemic, its reported caseload is second only to that of the United States, and India was the third country to top 400,000 deaths. Scientists widely believe that the official figures vastly undercount the toll.

On Friday, the eastern state of Bihar, which is home to an estimated 127 million people and is one of the poorest regions in the country, gave 2.9 million shots, more than any other state, according to a government database.

In Mumbai, India’s financial capital, civic authorities organized a special vaccination drive for women, and many lined up for shots.

Health ministry officials say they plan to administer over a billion shots by mid-October. China, the only other country with a population of more than a billion people, has already far surpassed that number, reporting 2.16 billion shots, according to Our World in Data.

The Australian state of New South Wales will allow some returning international travelers to quarantine at home starting at the end of the month, possibly signaling the beginning of the end for the country’s strict hotel quarantine system.

The pilot program will allow 175 fully vaccinated people to isolate in their homes for seven days rather than spend two weeks in a government-appointed facility, Stuart Ayres, a New South Wales government official, announced on Friday. The police will employ location-based tracking and facial-recognition technology to monitor new arrivals’ movements, he added. Similar technology has been used in Western Australia since November.

The program will help the country plan next steps toward ending the current system, Mr. Ayres said at a news conference: “We’ve got to be able to learn what happens when we put people into home-based quarantine. Australia must reopen. We must get rid of lockdowns; we must re-engage with the world.”

Passengers arriving in Australia are currently required to spend two weeks in a hotel room. But spots in the country’s quarantine system are hard to come by. The border is closed to almost everyone other than returning citizens, many of whom have faced flight cancellations because of the country’s tight limit on the number of arrivals. In July, the cap was halved to 3,000 passengers a week, further complicating some Australians’ efforts to return home.

The announcement of the pilot program comes as New South Wales reaches a key vaccination goal: Half of all residents over age 16 have now received two doses of a Covid vaccine, while more than 80 percent have had at least one. The state is battling one of the country’s most severe outbreaks, with 1,284 new cases and 12 deaths recorded on Friday.

Greg Hunt, the federal health minister, also announced that Australia has surpassed the goal of providing one dose of the vaccine to 70 percent of people over age 16. “It’s a significant and important milestone in protecting Australians and keeping Australians safe,” he said at a news conference on Friday.

Victoria, which neighbors New South Wales, has also administered a first Covid vaccine dose to at least 70 percent of the population over 16, and will ease some restrictions starting late Friday night. The vast majority of businesses remain closed, and a curfew is still in place in Melbourne, the largest city.

Australia will soon begin vaccinating people with the Moderna vaccine, in addition to vaccines produced by AstraZeneca and Pfizer-BioNTech. One million doses of the Moderna vaccine are expected to arrive by the end of the weekend, Mr. Hunt said.

Still, in response to Australia’s ongoing outbreak, New Zealand will not resume quarantine-free travel between the two countries for at least another eight weeks, Grant Robertson, the deputy prime minister, announced on Friday. The country suspended the so-called trans-Tasman bubble in July as cases began to rise in Australia.

The New Zealand city of Auckland, home to one-third of the country’s population, has been under a strict lockdown for one month, as the country attempts to eliminate the Delta variant. New Zealand has so far recorded more than 1,000 coronavirus cases and one death in the latest outbreak.

The United Nations is facing a potentially disruptive wrinkle over New York City’s Covid vaccination requirements that could derail attendance by at least some participants in the annual General Assembly gathering, just as many world leaders are about to arrive.

While the 193-member organization requires that all staff members at its New York headquarters have proof of vaccination, it has been imposing less stringent rules for visiting dignitaries and diplomats, relying on an honor system for all guests to declare they are vaccinated or have tested negative for the virus.

But New York City municipal officials said this week that the General Assembly meeting, even though scaled down from prepandemic years, qualified as a “convention center” event and that under the city’s current health rules, all those who attend must show proof of vaccination.

In a letter to the newly chosen president of this year’s General Assembly, Foreign Minister Abdulla Shadid of the Maldives, municipal officials also said that under the host city’s pandemic rules, visitors must show proof of vaccination before indoor dining, drinking or exercising within the 16-acre U.N. campus.

U.N. officials have said the organization is obliged to follow the city’s health rules. It remained unclear as of Thursday exactly how many visiting diplomats and others who had planned to attend lacked vaccination proof.

But word that all visitors would need to show such proof generated confusion and anger. Russia’s ambassador, Vassily Nebenzia, called the rules a violation of the United Nations Charter, arguing that they were discriminatory.

While President Vladimir V. Putin of Russia had no prior plans to attend — and has been in isolation anyway for possible exposure to Covid from infected aides — more than 100 leaders including President Biden, President Jair Bolsonaro of Brazil, President Recep Tayyip Erdogan of Turkey and Prime Minister Boris Johnson of Britain have planned to deliver their speeches in person.

Others have opted to deliver them via prerecorded video, as was done by all leaders last year when vaccines were still under development and each delegation in the General Assembly hall was limited to two people. Nearly all events at the 2020 event were conducted virtually.

Mr. Bolsonaro, an avowed vaccine skeptic whose popularity has fallen in Brazil partly over what critics call his disastrous handling of the pandemic, is scheduled to be among the first leaders to speak in person when the speeches begin on Tuesday. News reports from Brazil have said that Mr. Bolsonaro does not intend to be vaccinated. He was infected with Covid more than a year ago and then claimed to have cured himself by taking hydroxychloroquine, an antimalarial drug that has not been shown to be effective in Covid treatment.

Asked how the problem would be resolved with just days to go before the speeches begin, Stéphane Dujarric, the chief U.N. spokesman, told reporters on Thursday that discussions were underway to continue the honor system “in a way that is acceptable for all.”

The United Nations has been aiming for at least a partial restoration of the person-to-person diplomacy at this year’s General Assembly that its leaders regard as critical for the organization’s ability to function. Still, many of the meetings will remain virtual or a hybrid mix this year.

King County in Washington State — which includes Seattle and its suburbs — announced coronavirus vaccine and testing requirements on Thursday, falling in line with similar indoor vaccine mandates recently ordered in Los Angeles, New York and San Francisco.

Beginning Oct. 25, people attending recreational activities in most public places in the county will be required to show proof of vaccination against Covid-19. The health order extends to outdoor events with 500 or more people and indoor activities of any size, such as performances, movie theaters, conferences, gyms, restaurants and bars.

People who are unvaccinated or cannot prove vaccine status will be required to show proof of a negative test.

“We are at a critical point in this pandemic, with high levels of new Covid-19 cases and hospitalizations, and no certainty as to what will follow the Delta variant,” said King County Executive Dow Constantine at a news conference.

Health officials said Washington State is experiencing record levels of coronavirus cases and hospitalizations. As of Wednesday, daily deaths have jumped 74 percent, according to a New York Times database.

New York last month became the first U.S. city to require proof of at least one dose of a coronavirus vaccine for a variety of activities for workers and customers, and enforcement began on Monday. San Francisco is requiring proof of full vaccination for most indoor recreation, and Los Angeles will require proof of vaccination to enter bars, nightclubs and other drinking establishments beginning next month.

King County and the city of Seattle have already enacted mask requirements and vaccination mandates for city and county workers.

“With over 85 percent of King County residents having received at least their first vaccine dose, vaccine verification will help keep people safe and keep businesses open,” said Mr. Constantine. “Vaccination is our best shield against this deadly virus.”

The Empire State Building, like the city it inhabits, relies on a steady stream of tourists, thriving retail businesses and companies willing to lease its vast amount of office space. The coronavirus pandemic emptied out the attractions, shops and offices, in both the building and the city, for months.

Now, as a promised return to normal has once again been put on hold, the plans being made by the building’s occupants reveal a meaningful cultural shift.

Interviews with dozens of the building’s tenants and an analysis of public records suggest that the role of the office building in America has changed, perhaps permanently, and that local economies once centered on the traditional 9-to-5 workday face an uncertain future. Read the full article at the link below:

FORT MEADE, Md. — A military judge overseeing the Sept. 11, 2001 case abruptly canceled a hearing on Friday at Guantánamo Bay because of illness related to the coronavirus pandemic, ending this month’s pretrial session a day early.

Lawyers, the defendants and the judge, Col. Matthew N. McCall of the Air Force, were due in court Friday morning for the final day of arguments in a two-week hearing in the case when a clerk sent word, moments before it was to begin at 9 a.m., that the judge had canceled it “in light of recent developments” related to Covid-19 and “in an abundance of caution.”

At least one of the trial participants, a senior defense lawyer, was in quarantine Friday morning and was awaiting test results after developing a symptom of the virus. Separately, a journalist who returned to the United States from Guantánamo on Sunday discovered on Thursday that he had been infected with the virus. Both men were fully vaccinated, although their names were not released to the public.

The cancellation came on what was to be the final day of the first set of hearings amid the coronavirus pandemic in the long stalled death-penalty case that accuses Khalid Shaikh Mohammed and four other men of conspiring in the hijackings that killed nearly 3,000 people in New York, Pennsylvania and the Pentagon.

Mr. Mohammed and three of the defendants were already at the court compound on Friday when the judge decided to cancel the hearing. They were notified that they would not be returned to the general population at the prison until they were tested for the virus as well, according to people inside the court who overheard the advisory.

The Pentagon currently has 39 detainees at Guantánamo, spread across two prison facilities. A few have refused the vaccination.

The naval base in Cuba, with about 6,000 residents and a small hospital, has so far been able to avoid a major coronavirus outbreak through isolation, testing and quarantines. Residents have confirmed two known cases on base in September, including a fully vaccinated schoolteacher who tested positive on his return to Guantánamo the week of Sept. 6.

Some court observers and participants went to the base hospital Friday for testing and then self-quarantined in guest quarters at the base awaiting the results. In other instances, health officials in full protective gear knocked on doors at the quarters and tested some people at their rooms.

Colonel McCall, the judge, is new to the case. He said on Monday that the trial would not begin for at least a year. He had set aside Friday morning to hear arguments over continuing requests by defense lawyers for information about the defendants treatment in C.I.A. custody from 2002 to 2006.

In one request, lawyers for the defendant Ramzi bin al-Shibh were asking the judge to order the government to provide details about the prisoner’s forced shaving while held by the C.I.A. and later at Guantánamo in 2007. Prosecutors have acknowledged that “forced shaving occurred” in January 2007, but declined to name those who did it.