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F.D.A. Vaccine Panel Considers Conflicting Data on Pfizer Booster Shots - The New York Times

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A vaccination event last month in Miami.
Saul Martinez for The New York Times

Government and outside experts presented conflicting data Friday morning on whether Pfizer-BioNTech coronavirus booster shots are needed in the United States to an independent panel that advises the Food and Drug Administration.

The advisory committee is weighing that request for approval of a booster shot for people 16 and older at least six months after their second shot.

The vote, which could significantly influence federal booster policy, comes amid a fraught debate within the Biden administration about whether the shots are needed now, and for whom. If the discussion mirrors the acrimony in the administration, the expert committee may end up divided, complicating the F.D.A.’s decision.

The F.D.A. is not obligated to follow the advice of the committee, but often does. The panel’s meetings earlier in the pandemic to consider vaccine authorizations were mostly agreeable, ending in decisive votes in favor of the F.D.A.’s presumed position.

But this time around there is more division in the scientific community about the question at hand. And the White House has already been forced to delay offering boosters to recipients of the Moderna vaccine, and for now it is planning third shots only for those who received the Pfizer-BioNTech vaccine if the F.D.A. signs off.

Vaccination remains powerfully protective against severe illness and hospitalization in the United States in the vast majority of people in all of the studies published so far, experts say. Regulators have said those metrics are key in deciding on whether extra shots are needed now. Vaccines do seem less potent against infection in people of all ages, particularly those exposed to the highly contagious Delta variant.

Committee members seemed particularly interested in whether the data was strong enough to justify additional shots for older Americans but not younger ones. Some expressed concern that the long-term benefit of additional shots remains unclear, and that it is not feasible to repeatedly boost the general population.

The morning’s presentations underscored the complex array of data from disparate sources on whether waning potency of the vaccines might lead to an increase in severe Covid-19 cases among vaccinated people over time. Dr. Sara Oliver, an official with the Centers for Disease Control and Prevention, presented data showing vaccine effectiveness against severe forms of Covid-19 holding strong, 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 that multiple factors may have skewed the results.

“You’re making incredibly important policy, policy decisions, very rapidly in a situation of uncertainty,” he said, “and there are very good reasons those decisions have to be made.” But he warned that it was difficult for scientists to reach sound conclusions based on studies of a rapid rollout of vaccines. Those evaluating the case for boosters should be “cautious” of any apparent short-term effects of a booster dose, he said.

Israeli experts told the committee that they believed a third shot of the Pfizer-BioNTech helped dampen a fourth wave of infection due to the Delta variant, which swept the nation this summer. The nation started offering boosters in late July.

Dr. Sharon Alroy-Preis, Israel’s head of public health services, described the rise in the number of hospitalized patients who had been fully vaccinated with two shots of Pfizer’s vaccine as “scary.” After offering boosters to the general population, she said, the nation is now averaging about half as many severe or critically ill patients as the Ministry of Health had anticipated.

Top federal health officials, including Dr. Anthony S. Fauci, President Biden’s chief medical adviser, have argued for weeks that immunity against infection is waning in fully vaccinated people, and that there are hints of diminished protection against more severe forms of Covid-19. Their concern, in other words, is that vaccinated people are becoming more at risk not only of getting asymptomatic or mild cases over time, but of getting sick enough to be hospitalized.

Eight of those officials in August signed a policy statement saying that boosters would be needed and that the administration was prepared to deliver them for adults as early as the week of Sept. 20, a decision some public health experts said was premature. On Friday, Dr. Vivek Murthy, the surgeon general, defended the administration’s decision to publicly announce plans for a late September rollout, emphasizing it has always been contingent on F.D.A. clearance.

“​If you want to roll out booster shots to the population, you can​’t​ flip a switch and make that happen overnight​,” Dr. Murthy said at a White House briefing. “It’s important planning that has to take place with localities,​ with state governments​,​ with community organizations​. And so we laid out an initial plan for that purpose​.”

In its application to the F.D.A., Pfizer is asking for boosters to be given six months after the second dose, not eight months after, as President Biden called for in his booster plan last month.

There has been fierce resistance to boosters from some federal career scientists and many vaccine experts outside the government. Two key F.D.A. regulators wrote in The Lancet this week that there is no evidence additional shots are needed yet for the general population, assessing data from dozens of studies. One of them, Marion Gruber, who directs the F.D.A.’s vaccines office, suggested at the Friday meeting that the evaluation the F.D.A. makes depends on strong clinical studies, and on how boosters doses are performing against currently circulating virus variants, something the agency said in an analysis this week it had little of in Pfizer’s application.

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. But some high-income countries have already begun offering boosters to their residents, and others may follow their lead. A number of American scientists have also made the case that more of the world should get initial vaccinations before the United States turns to boosters; even two top vaccine scientists at the F.D.A. did so in the Lancet article, saying there was no credible evidence supporting boosters for the general population yet.

But Dr. Peter Marks, the agency’s top vaccine regulator, warned at the beginning of the meeting Friday against discussing “issues related to global vaccine equity.” Instead, he said, the committee should focus on the scientific questions before them.

The F.D.A. panel — the Vaccines and Related Biological Products Advisory Committee — is composed of independent scientific experts, infectious disease doctors and statisticians, many of whom participated in earlier meetings about coronavirus vaccines.

You can watch the meeting here, which is scheduled to conclude in the late afternoon. A “no” vote on Pfizer’s application could lengthen the discussion and possibly prompt a different vote, such as on whether to recommend clearing the booster for a more limited group.

The Centers for Disease Control and Prevention’s own vaccine advisory panel is set to meet next week, and could make recommendations on how boosters, if cleared by the F.D.A., should be used.

As administration officials argue about the need for the shots, many Americans are taking the matter into their own hands, seeking out booster doses before federal clearance.

Joseph Prezioso/Agence France-Presse — Getty Images

Advisers to the Food and Drug Administration on Friday must confront a range of bewildering scientific questions before deciding whether to sign off on Pfizer-BioNTech coronavirus vaccine booster shots — and if so, for whom.

Three 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.

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.

Amr Alfiky/The New York Times

“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 will need boosters — and maybe not even them. But White House officials have said that they do 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, should the F.D.A. and the Centers for Disease Control and Prevention deem them necessary. An advisory committee to the C.D.C. is scheduled to meet next week to take up the question.

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.

Dr. Luciana Borio, a former acting chief scientist at the F.D.A., criticized the Biden administration for announcing a plan for boosters before federal scientists could review the evidence.

The Trump administration pressured scientists at the F.D.A. to authorize hydroxychloroquine and convalescent plasma, for example, without enough evidence to support either treatment. “It seems to me that there’s been a process foul in how we go about making those decisions,” Dr. Borio said.

“We need an F.D.A. that has people making these decisions and retaining that ability to make those decisions independently and based on science alone. If this changes, we all lose.”

Elizabeth D. Herman for The New York Times

President Biden, under pressure to assert more leadership in ending the global coronavirus pandemic, intends to use a summit next week on the sidelines of the United Nations General Assembly meeting to convince other nations to set aside domestic demands and instead focus on getting vaccine doses to poor countries dependent on donated shots.

A senior administration official said that Mr. Biden’s message to other nations would be: “The United States cannot and should not do this alone. Everyone has to hold themselves accountable to fulfilling the commitments we’ve all made.”

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, speaking on condition of anonymity to preview a formal announcement of the summit later on Friday, 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.

The United States has already committed to sending more than 600 million doses abroad, and is working to scale up manufacturing overseas, particularly in India.

Mr. Biden has been under fire from global health advocates over his decision to promote booster shots for already vaccinated Americans while much of the world remains entirely unvaccinated and at risk. They want him 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.

Part of the global vaccine shortage stems from potential donor countries’ domestic needs. Some nations in Asia have imposed tariffs and other trade restrictions on Covid vaccines that slow their delivery overseas. India has banned exports of Covid vaccines, preventing distributions of doses from the Serum Institute of India, the world’s largest vaccine maker.

At a briefing with reporters earlier this week, Loyce Pace, who heads the office of global affairs at the federal Department of Health and Human Services, made particular note of the administration’s work with India to lift the export ban.

“We continue to work with the government of India in particular, on their trajectory of helping produce the world vaccines,” Ms. Pace said.

Arnd Wiegmann/Reuters

An advisory committee to the Food and Drug Administration is weighing the merits of Pfizer-BioNTech’s application on Friday to provide third shots of its coronavirus vaccine to people 16 and older. But there is still no clear timeline for when the F.D.A. might consider signing off on booster shots for the two other vaccines available for use in the United States.

Moderna and Johnson & Johnson make those vaccines, which have both been authorized for emergency use by the F.D.A. 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 is available under emergency use authorization for those 12 to 15.)

The question of whether booster shots are necessary has become the subject of intense debate and multiple studies since President Biden announced in August his plan to make booster shots available to adult recipients of the Pfizer-BioNTech and Moderna vaccines in September. The White House has already been forced to delay offering boosters to Moderna recipients, and for now, it is planning third shots only for those who received the Pfizer vaccine if the F.D.A. signs off. In its application to the F.D.A., Pfizer is asking for boosters to be given six months after the second dose, not eight months after, as Mr. Biden called for.

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 a booster might be cleared.

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 approval for the vaccine by the end of the year, but did not provide a timeline for when the company might submit a booster application.

Sharon LaFraniere and Noah Weiland contributed reporting.

Mahesh Kumar A/Associated Press

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 20 million shots had been administered in nine hours, a special push to mark the birthday of Prime Minister Narendra Modi and celebrate his 20 years in public office.

That is more than double its previous daily record — 9.3 million shots, reached on Sept. 2 — and more than six 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 784 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 1.8 million shots, more than any other state, officials said.

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.

Jon Cherry/Getty Images

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 sett 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.

For those who are vaccinated, an advisory committee to the Food and Drug Administration is meeting Friday regarding a vote on Pfizer-BioNTech’s application to offer third shots to people 16 and older who received its vaccine. Last month, the Biden administration proposed a booster plan that has become the subject of heated debate. And last week, President Biden imposed vaccination requirements on tens of millions of workers, aiming to put pressure on people who have not received the shots.

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.

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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.

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Mayor Bill de Blasio of New York said he had told António Guterres, the United Nations secretary general, that the city’s vaccination requirement for entering convention centers would apply to participants in the annual General Assembly.Angela Weiss/Agence France-Presse — Getty Images

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.

Elaine Thompson/Associated Press

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.”

Todd Heisler/The New York Times

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:

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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 ongoing 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.

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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.”

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