The Food and Drug Administration’s independent panel of vaccine advisers is set to meet Friday to discuss the case for booster shots of the Pfizer-BioNTech coronavirus vaccine, and to vote on whether the agency should approve additional doses for people 16 and older.
The meeting and vote, which could significantly influence federal booster policy, come amid a fraught debate within the Biden administration about whether booster 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.
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.
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. But 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.
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, is scheduled to speak at the Friday meeting.
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. But the vaccines do seem less potent against infection in people of all ages, particularly those exposed to the highly contagious Delta variant.
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.
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.
The meeting is scheduled to begin at 8:30 a.m. Eastern time and conclude in the late afternoon. (You can watch it here.) 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 the extra doses, if cleared by the F.D.A., should be used.
Dr. Sara Oliver, a C.D.C. official, is set to present to the F.D.A. committee on Friday, as is Jonathan Sterne, a British statistician who was one of the authors of the Lancet article. Afterward, Israeli officials will present 42 slides on what they describe as clear signs that protection against Covid-19 is declining markedly in fully vaccinated people. Officials from Pfizer will also present their case for booster shots.
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.
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 will publicly discuss and 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.
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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Vaccination Is Required at U.N. Meeting, N.Y.C. Mayor Says
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.
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I spoke to Secretary General Guterres two weeks ago, and we had a very good conversation. He’s been outstanding in trying to push the highest health standards for the General Assembly. We’ll have vaccination sites available. Anyone who is not yet vaccinated can get vaccinated. Anyone who’s had a non-approved vaccine can get one of the ones that we’re using here that are effective. So I reached out to him proactively to say, “Hey, here are our standards in the city, and we understand the United Nations is a particular organization, has its own rules and its own jurisdiction.” But we, you know, I expressed to him how important it was to have continuity with what we’re doing in the city, just for the health and welfare of everyone. I don’t know what else was happening with the federal government, for example, but I do want to give the secretary general credit. I think he very much is trying to find every way to work cooperatively with his member states to maximize vaccination and to create the most protected environment for the General Assembly.
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 he does not intend to be vaccinated.
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 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.”