The federal government is expected to take a significant step this week toward offering booster doses to a much wider range of Americans as advisers to the Food and Drug Administration meet on Thursday and Friday to discuss recipients of the Johnson & Johnson and Moderna coronavirus vaccines.
So far, regulators have authorized booster shots only for certain adults who received the Pfizer-BioNTech vaccine — a source of some frustration to the government’s medical advisers, who questioned at a meeting last month whether recipients of the other shots were being left out.
But the Biden administration is eager to shore up the protection provided by all three vaccines. And federal officials have become increasingly worried in particular about the more than 15 million Americans who received the Johnson & Johnson vaccine, which is less effective than the others.
On Thursday, the F.D.A.’s advisory panel of vaccine experts will discuss safety and efficacy data regarding booster shots for Moderna recipients. On Friday, the group will discuss Johnson & Johnson boosters. The agency typically issues decisions within a few days of advisory committee meetings.
The expert committee will also hear an eagerly awaited presentation on Friday from scientists at the National Institutes of Health on the effectiveness of mixing different brands of vaccines.
Dr. Peter Marks, the F.D.A.’s top vaccine regulator, suggested last week that federal officials favor extra shots for all three vaccines. “The data seem to demonstrate that booster shots seem necessary,” he said.
The deliberations come as coronavirus cases across the United States are falling, with the seven-day average of daily new cases slipping below 100,000 for the first time since early August. Hospitalizations and deaths are also declining.
The meetings also come as the drug maker Merck said it had applied for federal authorization of what would be the first antiviral pill to treat Covid. The drug, molnupiravir, would be a less expensive treatment for high-risk people sick with Covid than the antibody treatments currently in use. But at least at first, many more Americans would be eligible than the supply could cover. So far, the federal government has placed an advance order for enough pills for 1.7 million Americans.
On Sunday, Dr. Anthony S. Fauci, the nation’s top infectious disease doctor, said in a CNN interview that “we have to be careful that we don’t prematurely declare victory,” citing the potential for the virus to rebound among unvaccinated Americans.
Dr. Fauci said that vaccinating younger children could offer another crucial line of defense. As early as Halloween, the F.D.A. could authorize the Pfizer-BioNTech vaccine for children ages 5 to 11, a move that could help protect more than 28 million people in the United States.
Although the federal government has emphasized for months that all three vaccines are highly effective, a recent study by the Centers for Disease Control and Prevention found that Johnson & Johnson’s single-dose vaccine was only 71 percent effective against hospitalization from Covid-19, compared with 88 percent for the two-dose Pfizer-BioNTech vaccine and 93 percent for Moderna’s two-shot regimen.
Last month, Johnson & Johnson announced that a second dose, given two months after the first, bolstered the vaccine’s effectiveness against symptomatic Covid-19 to 94 percent. The firm also said two shots were 100 percent effective against severe disease, although that estimate was less conclusive.
People eligible for Pfizer’s booster include those 65 and older and those who live in long-term care facilities, have underlying medical conditions or are at higher risk of exposure to the virus because of their jobs or institutional settings, a group that includes health care workers, teachers and prisoners.
The F.D.A. and C.D.C. are expected to propose essentially the same criteria for booster shots of Moderna and Johnson & Johnson, although they could also discuss whether to broaden eligibility to include more middle-aged people.
Rebecca Robbins contributed reporting.
Merck said on Monday that it had submitted an application to the Food and Drug Administration to authorize what would be the first antiviral pill to treat Covid.
Clearance for the drug, molnupiravir, would be a milestone in the fight against the coronavirus, experts said, because a convenient, relatively inexpensive treatment could reach many more high-risk people sick with Covid than the cumbersome antibody treatments currently being used.
The Biden administration is preparing for an authorization that could come within weeks; the pill would likely to be allocated to states, as was the case with the vaccines. States could then distribute the pills how they wish, such as through pharmacies or doctors’ practices, senior administration officials said.
If the pill wins authorization, tens of millions of Americans will most likely be eligible to take it if they get sick with Covid — many more than the supply could cover, at least initially. The federal government has placed an advance order for enough pills for 1.7 million Americans, at a price of about $700 per patient. That is about one-third the price that the government is paying for the monoclonal antibody treatments, which are generally given via intravenous infusion.
Merck, which is developing the pill with Ridgeback Biotherapeutics of Miami, expects to be able to produce enough pills for 10 million people by the end of this year. Governments have raced to lock up supplies since the strong clinical trial results were released this month; Australia, Malaysia, Singapore and South Korea have all announced agreements.
An antiviral pill being developed by Pfizer and one from Atea Pharmaceuticals-Roche will report study results in the next months and, if effective, could expand supply.
Merck’s pill is meant to be taken at home as four capsules twice a day for five days, for a total of 40 pills. It halved hospitalizations and deaths in a clinical trial that enrolled unvaccinated adults who had begun showing Covid symptoms within the previous five days and were at high risk for bad outcomes from the disease.
Merck said it was seeking authorization for its pill to be given only to high-risk adults, which in the clinical trial was most commonly people over 60 or younger people with obesity, diabetes or heart disease.
It was not clear whether the treatment would be available to vaccinated people, who were not eligible for the clinical trial. A company spokeswoman said it would be up to the F.D.A. to decide.
Originally tested for influenza, the drug works by stopping the coronavirus from replicating by inserting errors into its genetic code.
That mechanism is likely to make one high-risk group, people who are pregnant, ineligible to receive the pills if they are authorized, because of fears that the drug might cause mutations that could result in birth defects. In the clinical trial, volunteers had to agree to abstain from unprotected sexual intercourse for four days after they finished taking the pills, and some women of childbearing age had to have a negative pregnancy test to enroll in the study.
Sheryl Gay Stolberg contributed reporting.
Unvaccinated pregnant women make up nearly 20 percent of the most critically ill Covid-19 patients in England, according to data released by the National Health Service on Monday.
Since July, approximately one in five coronavirus patients who received an intensive lung-bypass treatment, or Extracorporeal Membrane Oxygenation (ECMO), were unvaccinated and pregnant.
“The disproportionate number of unvaccinated pregnant women in intensive care demonstrates that there is a significant risk of severe illness from Covid-19 in pregnancy,” said Dr. Edward Morris, president of the Royal College of Obstetricians and Gynecologists, in a statement on the N.H.S. website.
The N.H.S. is now pleading with pregnant women to get vaccinated as soon as possible, pointing to mounting safety data that counters unfounded fears that the vaccine poses severe risks to their health.
The N.H.S. reports that “over 100,000 Covid vaccinations in England and Scotland, and a further 160,000 in the U.S., show there has been no subsequent harm to the fetus or infant.”
Jacqueline Dunkley-Bent, the chief midwifery officer for England, called the announcement “another stark reminder that the Covid-19 jab can keep you, your baby and your loved ones safe and out of hospital.”
The vaccine was made available in December of last year and access was given to pregnant women at high risk of serious complications from Covid-19. But other pregnant women were advised against the vaccine while data surrounding its side effects was gathered.
British health regulators finally advised in April that pregnant women should receive the vaccine, citing data from the Centers for Disease Control and Prevention that showed about 90,000 pregnant vaccinated women in the United States had no emerging health issues. Now, more than 81,000 pregnant women have received their first dose of the vaccine, according to Public Health England.
“But there is still more to be done,” Britain’s health secretary, Sajid Javid, said in a statement Monday, adding that the Covid vaccine is generally considered safe for pregnant women. It is now recommended by the Royal College of Obstetricians, Royal College of Midwives and the U.K. Tetralogy Service.
Covid-19 poses a significantly higher risk to women who are pregnant, and outweighs the risks of women getting vaccinated, according to safety data released by the C.D.C. in August. In the United States, vaccination rates among pregnant individuals are far lower than the rest of the population, the C.D.C. reported last month, with only 31 percent of pregnant women having received both shots before or during pregnancy, as of Sept. 18.
The world’s biggest marathons were some of the first events canceled because of the coronavirus pandemic, and they were some of the last vestiges of prepandemic life to return.
In the last 15 days, however, they have come back in force. Berlin in late September, London last weekend, Chicago on Sunday. Tens of thousands of runners trotted through the streets and thousands more cheered them on, celebrating a return to something approaching normalcy.
Now comes the oldest and grandest marathon of all: Boston, which until the pandemic had been run in April of every year since 1897. Organizers last year first postponed the race to the fall, then canceled the in-person event altogether for the first time in its 124-year history.
Monday’s version will be smaller, and have some different details, but once more Boston is set to hold a 26.2-mile celebration of running and itself like no other city does, beginning early Monday morning and running right into the start of the Red Sox playoff game at a packed Fenway Park, a little more than a mile from the finish line, Monday night.
It doesn’t get much more Boston than that. For one day at least, and especially for 20,000 marathoners, life might actually feel almost normal.
Southwest Airlines canceled several hundred flights on Monday as it worked to resolve the problems that led it to strike more than a quarter of its scheduled flights last weekend.
Over 1,800 Southwest flights were canceled on Saturday and Sunday, accounting for more than 28 percent of its flights over the weekend, according to FlightAware, a tracking service. By noon on Monday, Southwest had canceled about 10 percent of the flights scheduled for the day, just over 360 flights.
The cancellations wreaked havoc on travel plans for thousands of passengers, many of whom vented their frustrations on social media. At least some were trying to make it to the Boston Marathon, which was canceled last year and delayed by six months this year.
Southwest blamed the cancellations on several causes, including problems with the weather, air traffic control and an inability to get flight crews and planes to where they were needed.
The airline and the union that represents its pilots took pains to say that the disruption was not caused by protests over the airline’s recently announced vaccination mandate, denying an idea that had gained traction online among conservatives and anti-vaccination activists. Conservative lawmakers pointed to Southwest’s cancellations as evidence that vaccine requirements could harm the economy.
“Joe Biden’s illegal vaccine mandate at work!” Senator Ted Cruz, Republican of Texas, said Sunday night on Twitter. “Suddenly, we’re short on pilots & air traffic controllers.” Senator Ron Johnson, Republican of Wisconsin, echoed those comments on Monday.
In a statement, Southwest said its problems began in Florida over the weekend.
“We experienced weather challenges in our Florida airports at the beginning of the weekend, challenges that were compounded by unexpected air traffic control issues in the same region, triggering delays and prompting significant cancellations for us beginning Friday evening,” the airline said. “We’ve continued diligent work throughout the weekend to reset our operation with a focus on getting aircraft and crews repositioned to take care of our customers.”
The Federal Aviation Administration acknowledged that some flights were delayed or canceled on Friday because of severe weather, military training exercises and a brief staffing shortage at one air traffic control center, but it said the disruption only lasted a few hours.
“Some airlines continue to experience scheduling challenges due to aircraft and crews being out of place,” the agency said in a statement.
Casey Murray, the president of the Southwest Airlines Pilots Association, said pilots called in sick at a normal rate this weekend.
The widespread cancellations, he said, were instead caused by technological issues and problems with how pilots are reassigned and rerouted during disruptions, a process complicated by Southwest’s uniquely large, point-to-point network. In a typical day, about 10 percent of pilots are reassigned from the flights they were scheduled to operate. That figure was 71 percent on Saturday and 85 percent on Sunday, according to Mr. Murray.
“That is unsustainable,” he said. “The domino effect continues, and what we see, due to some internal failures, is it’s happening so many times that they just can’t move everyone.”
The union also said in a statement on Sunday that its members are barred by federal law from using a strike to resolve a labor dispute without exhausting other options first.
While the union, which says it does not oppose vaccination, denied that its members were calling in sick to protest the mandate, it did ask a judge on Friday to stop the airline from enacting the vaccine mandate and other policies. The request is part of a broader lawsuit that predates the mandate and centers on the union’s assertion that Southwest has taken a number of “unilateral actions” in violation of labor law.
Southwest isn’t alone in seeing pushback from employees over a vaccine mandate. Last week, hundreds of American Airlines workers and supporters protested its new mandate outside that airline’s Fort Worth, Texas, headquarters, according to The Dallas Morning News.
But many others have voiced support for such requirements. United Airlines, the first large U.S. airline to impose a mandate, has said that nearly all of its 67,000 employees had been vaccinated, with the exception of about 2,000 who had applied for religious or medical exemptions. United said it expects to have to fire fewer than 250 employees for failing to comply. The airline’s executives had expected some blowback but were surprised by the positive reaction, noting that it had received many more applicants for open flight attendant positions than it used to before the pandemic.
“I did not appreciate the intensity of support for a vaccine mandate that existed, because you hear that loud anti-vax voice a lot more than you hear the people that want it,” United’s chief executive, Scott Kirby, told The New York Times this month. “But there are more of them. And they’re just as intense.”
Delta Air Lines has not imposed a vaccination requirement, but it said it will charge unvaccinated employees $200 more a month for health insurance.
Almost all the eligible adults who remain unvaccinated in the United States are hard-core refusers, and the arrival of boosters is making efforts to coax them even more difficult. In the September vaccine monitor survey from the Kaiser Family Foundation, 71 percent of unvaccinated respondents said the need for boosters indicated that the vaccines were not working.
In some ways, the Covid vaccine landscape reflects great progress: Millions of holdouts have decided to get vaccinated over the past couple months, many prodded at the last minute by mandates or anxiety over the highly transmissible Delta variant.
But experts in vaccine behavior fear that the country is bumping up against the ceiling of persuadable people, one that is significantly lower than the threshold needed for broad immunity from Delta and, possibly, future variants.
Christopher Poe, 47, who works in a manufacturing plant in Lima, Ohio, hasn’t gotten the shot, despite haranguing and wheedling from worried relatives. He said the need for a booster had deepened his skepticism.
“It seems like such a short time and people are already having to get boosters,” Mr. Poe said. “And the fact that they didn’t realize that earlier in the rollout shows me that there could be other questions that could be out there, like the long-term effects.”
SYDNEY, Australia — With excitement and caution, Sydney stepped out of lockdown Monday after more than 100 days of Delta-diminished existence.
It was “Freedom Day,” with rules. Across the state of New South Wales, home to Sydney, as many as 10 vaccinated people could gather at home, with the number rising to 100 people for weddings, and 500 for outdoor events. Bars and restaurants also opened with masks required indoors when people are not eating and drinking.
But with more than 70 percent of the state’s adult population fully vaccinated, the first few sips of normalcy were more than enough to celebrate.
“People can call it whatever day they want to call it,” said Dominic Perrottet, the state premier, who accidentally sprayed himself with beer as he tapped a keg to commemorate the occasion. “I just think it’s a great day for the people of our state based on the efforts and sacrifices that everyone has made.”
For a country that was a capital of the “Covid zero” strategy to fully eliminate the virus, it’s been a wrenching metamorphosis. When the outbreak started in June, Australia lacked both urgency and supplies of the vaccine. New cases exploded to 1,500 a day. Now, after months of public compliance, case numbers have fallen to about 500 daily and many epidemiologists believe the country is on track to fully vaccinate 90 percent of its population if not more.
Given the promising numbers, Mr. Perrottet has been rapidly accelerating the move away from restrictions. He recently granted an exemption that will allow 10,000 vaccinated fans to attend Sydney’s The Everest horse race. He has also pushed to reopen international travel as early as next month.
The progress is still uneven. Some regional communities have much lower vaccination rates. Melbourne, Australia’s second-largest city, is still locked down, with case numbers hovering at around 1,500 per day. And in Western Australia, which has enjoyed life without Covid for most of the pandemic, only around half of adults are fully vaccinated, which means that Sydney residents may be able to reach New York before they can visit Perth because of state border restrictions.
But travel is only one of the joys that people are eager to experience. Salons have been popular — with some opening at 12:01 a.m., the moment they were allowed. Gyms also suddenly came back to life early Monday morning, and even the most mundane of activities seemed to be welcomed.
Alexis Phitidis, the owner of a mattress store in Eastern Sydney, sent text messages to suppliers and friends when there was just one minute to go until it reopened. Inside, a half-dozen customers lay on mattresses to test what they wanted to buy.
“It’s busy but calm,” Mr. Phitidis said. “People are just grateful for the opportunity — we’re all grateful for the opportunity to just engage.”
A customer suddenly rushed past. He offered three words that captured the mood: “It’s bloody awesome.”
Hong Kong’s chief executive said vaccination rates must rise before it considers loosening travel restrictions, putting the territory at odds with Asian countries that have started opening borders after almost two years of near isolation.
The government’s main priority is to resume normal travel with mainland China and to limit deaths from the virus, the chief executive, Carrie Lam, said on Monday in an interview with Bloomberg Television. Hong Kong remains firm on its cross-border policies, she said. Ms. Lam declined to say what percent would need to be inoculated to open up borders.
Hong Kong has vaccinated 61 percent of its population with at least one dose, according to a New York Times database, falling short of the government’s target of inoculating 70 percent by the end of September.
“I am duty bound to protect my people,” Ms. Lam said. “Any fatality or increase in fatality will cause a major concern in society.”
Governments across Asia are abandoning some of the strictest measures against the virus almost two years into a pandemic that has devastated their economies. Hong Kong has refused to ease these restrictions, including keeping in place a 21-day quarantine for travelers. The steps have helped the island have one of the lowest tallies of deaths and new cases in the world.
“I’m sorry to say that we are still lagging behind,” she said in the interview.
The policies have frustrated residents who have had to endure the quarantines on arrival. Over the weekend, a tropical storm caused a flight to Hong Kong from London’s Heathrow Airport to divert to Manila. The trip should have taken 12 hours, but passengers were onboard the plane for 36 hours. They will still have to self-quarantine for the full three weeks.
Despite the wide availability of Covid-19 vaccines, not all Halloween parades have been safe from virus-related cancellations this year.
In Westchester County, N.Y., for example, the Tarrytown Halloween Parade was canceled out of concern, the organizers said, for “our most precious attendees, our children,” many of whom are not yet eligible for vaccines. And in nearby Rockland County, Nyack’s Halloween parade was canceled, too. The National Zoo also canceled its popular Boo at the Zoo because it didn’t feel it could keep visitors or animals safe from the virus.
But Dr. Anthony S. Fauci, the nation’s top infectious disease doctor, came to the defense of the mask-friendly holiday during a CNN interview on Sunday, saying that outdoor trick-or-treating was perfectly safe.
“It’s a good time to reflect on why it’s important to get vaccinated,” he said, urging those who were eligible for coronavirus shots to get them before Halloween to protect themselves and their children. “But go out there and enjoy Halloween.”
He said that the ability for parents to get vaccinated, combined with the low risk of the virus spreading outdoors, offered some reassurance.
“This is a time that children love,” Dr. Fauci said. “It’s a very important part of the year for children.”
The F.D.A. authorized emergency use of the Pfizer-BioNTech vaccine for 12- to 15-year-olds in May. Since then, more than 8.2 million children in that age group have received at least one dose and more than 6.7 million have been fully vaccinated.
Pfizer and BioNTech asked federal regulators last week to authorize their vaccine for children ages 5 to 11, a move that could help protect more than 28 million people in the United States. Shots are not expected to be available to that group before the beginning of November.
Coronavirus cases, hospitalizations and deaths in the United States are currently falling, prompting hope that the wave caused by the Delta variant is ebbing. But Dr. Fauci warned on Sunday that enough people remained unvaccinated to allow the virus to rebound during the colder months.