Pfizer Gives F.D.A. Its Data on Vaccine for Children Ages 5-11

Pfizer and BioNTech announced on Tuesday that they had submitted data to the Food and Drug Administration showing that their coronavirus vaccine is safe and effective in children ages 5 to 11.

The companies said that they would submit a formal request to regulators to allow a pediatric dose of their vaccine to be administered in the United States in the coming weeks. Similar requests will be filed with European regulators and in other countries.

Pfizer and BioNTech announced favorable results from their clinical trial with more than 2,200 participants in that age group just over a week ago. The F.D.A. has said that it will analyze the data as soon as possible.

The companies said last week that their vaccine had been shown to be safe and effective in low doses in children ages 5 to 11, offering hope to parents in the United States who are worried that a return to in-person schooling has put youngsters at risk of infection.

About 28 million children ages 5 to 11 would be eligible for the vaccine in the United States, far more than the 17 million of ages 12 to 15 who became eligible for the vaccine in May.

But it is not clear how many in the younger cohort will be vaccinated. Inoculations among older children have lagged: Only about 42 percent of children ages 12 to 15 have been fully vaccinated in the United States, compared with 66 percent of adults, according to federal data.

Although many remain eager to inoculate their children, opinion polls suggest that some parents have reservations. A survey published last month by the Kaiser Family Foundation found that 26 percent of parents of children ages 5 to 11 would vaccinate their children “right away” once doses were authorized for their age group, 40 percent said they would “wait and see” how the vaccine worked before doing so and 25 percent said they would not have their child vaccinated at all.

Studies have shown that unvaccinated children who contract the coronavirus tend not to get seriously ill, leading some parents to wonder whether the potential risks of a new vaccine outweigh the benefits.

And some parents who are themselves vaccinated have expressed concerns about the relatively small size of children’s trials and about a lack of data on the long-term safety of the shots.

Thousands of health care workers in New York got inoculated against Covid-19 ahead of Monday’s deadline, helping the state avoid a worst-case scenario of staffing shortages at hospitals and nursing homes.

Health officials across the state reported that employees had rushed to get vaccinated before Monday, avoiding being suspended or getting fired. New York has 600,000 health care workers.

Statewide, the vaccination rate for hospital employees rose by Monday night to 92 percent of workers having received at least one dose, according to preliminary data from the governor’s office. The rate for nursing homes also jumped to 92 percent on Monday, from 84 percent five days earlier.

Many nursing homes were facing serious staffing shortages before the mandate, making any new staff reductions potentially dangerous.

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New York Readies to Enforce Vaccine Mandate for Health Care Workers

Gov. Kathy C. Hochul said New York would work with hospitals to address potential staffing shortages as a mandate requiring health care workers to have received at least one dose of a coronavirus vaccine goes into effect.

Can’t we just say that that is a basic right that everyone has, to know that they’ll be safe when they enter a health care facility, or you have your elderly parents or grandparents in a nursing home, that they will not get sick because of someone who’s charged with their care? I need to keep people in this state safe, and we’ll be nation-leading with our mandate, which strikes at midnight tonight when everyone is expected in a hospital in the State of New York or a health care facility to have been vaccinated. And so I’m calling on all the health care workers. First of all, those of you who’ve been vaccinated, I thank you from the bottom of my heart for doing what was right and helping lead the way so we do have the confidence we need. And to those who’ve not yet made that decision, please do the right thing. I will be signing an executive order to give me the emergency powers necessary to address these shortages where they occur. That’s going to allow me to deploy the National Guard, who are medically trained, deploy people who’ve been retired, who may have had a license lapse, bring in people from elsewhere. It’s not a role I relish. My default position is to ask people, please do this. This is why it’s been proven to be safe. The vaccine’s been out there a long time now. There are not legitimate religious exemptions because the leaders of all the organized religions have said there’s no legitimate reason, and we’re going to win that in court in a matter of days. And so this is so unnecessary. We’re taking all the steps preemptively in anticipation of what I call a preventable staffing shortage. Still preventable — enough hours in a day. Come on down. Go to this place. There’s plenty of places that can make this be a preventable — something that we just went through an exercise for but didn’t need to. But I also am realistic to know that there are people who will not come back to their jobs.

In the New York City public hospital system, more than 8,000 workers were unvaccinated a week ago. But by Monday morning that number had dropped to 5,000 — just over 10 percent of the work force. Although those unvaccinated employees were not permitted to work, city officials said that they felt they could manage the gaps.

In Rochester, officials at Strong Memorial Hospital placed a two-week pause on scheduling elective procedures and warned patients to expect longer wait times for routine appointments as the deadline loomed last week. But on Monday they said that they had been able to bring up their staff vaccination rate to 95.5 percent, from 92 percent last week, meaning that fewer than 300 employees out of 16,000 will be fired if they don’t relent.

“Some are still very scared,” said Kathleen Parrinello, the hospital’s chief operating officer. “So they need hand-holding and reassurance.” Other employees, she said, had told her that they were not convinced that they should get vaccinated but also did not want to lose their jobs.

Opposition to the mandate remains strong, despite the 11th-hour vaccinations. At least eight lawsuits challenging it have been filed, some based on First Amendment grounds and others arguing that the state should recognize immunity from prior infection as equivalent protection. In one federal case, health care workers are demanding that the state allow religious exemptions.

The Delta variant of the coronavirus was the main reason that people decided to get vaccinated against Covid-19 this summer and why most say they will get boosters when eligible, according to the latest monthly survey on vaccine attitudes by the Kaiser Family Foundation, released on Tuesday morning. But the survey indicated that nearly three-quarters of unvaccinated Americans view boosters very differently, saying that the need for them shows that the vaccines are not working.

That divide suggests that while it may be relatively easy to persuade vaccinated people to line up for an additional shot, the need for boosters may complicate public health officials’ efforts to persuade the remaining unvaccinated people to get their initial one.

Another takeaway from the Kaiser Family Foundation survey: For all the carrots dangled to induce hesitant people to get Covid shots — cash, doughnuts, racetrack privileges — more credit for the recent rise in vaccination goes to the stick. Almost 40 percent of newly inoculated people said that they had sought the vaccines because of the increase in Covid cases, with more than a third saying that they had become alarmed by overcrowding in local hospitals and rising death rates.

“When a theoretical threat becomes a clear and present danger, people are more likely to act to protect themselves and their loved ones,” said Drew Altman, the Kaiser Family Foundation’s chief executive.

The nationally representative survey of 1,519 people was conducted from Sept. 13-22 — during a time of surging Covid deaths, but before the government authorized boosters for millions of high-risk people who had received the Pfizer-BioNTech shot, including those 65 and over and adults of any age whose job puts them at high risk of infection.

Sweeteners did have some role in getting shots in arms. One-third of respondents said that they had gotten vaccinated to travel or attend events where the shots were required.

Two reasons often cited as important for motivating those hesitant to get a vaccine — employer mandates (about 20 percent) and full federal approval for the Pfizer-BioNTech vaccine (15 percent) — carried less sway.

Seventy-two percent of adults in the survey said that they were at least partly vaccinated, up from 67 percent in late July. The latest numbers from the Centers for Disease Control and Prevention are even higher, reporting 77 percent of the adult population in the United States with at least one shot. The sharpest change in this month was in vaccination rates for Latinos: a jump of 12 percentage points since late July, to 73 percent, in the number of Latino adults who had received at least one shot.

With the vaccination racial gap narrowing, the political divide has, by far, become the widest, with 90 percent of Democrats saying that they have gotten at least one dose, compared with 58 percent of Republicans.

Perhaps reflecting pandemic fatigue, about eight in 10 adults said that they believed Covid was now a permanent fixture of the health landscape. Just 14 percent said that they thought “it will be largely eliminated in the U.S., like polio.”

Japan is ending its state-of-emergency measures on Thursday amid a fall in the number of new daily coronavirus cases and a vaccine rollout that has reached nearly 60 percent of the population, hoping that the move helps to revive the country’s economy.

It will be the first time since April 4 that no part of Japan is under a state of emergency.

The move was announced by Prime Minister Yoshihide Suga on Tuesday, a day before a Liberal Democratic Party vote that will select a leader to succeed him. Mr. Suga said that he would not be extending the emergency measures currently active in 19 prefectures and that they would instead expire at the end of the month, as scheduled.

“Moving forward, we will continue to put the highest priority on the lives and livelihoods of the people,” Mr. Suga said in Parliament on Tuesday afternoon.

He said that the government would “work to continue to achieve both infection control and the recovery of daily life.”

New daily coronavirus cases in Japan have decreased 73 percent over the past two weeks, to an average of 2,378 a day, according to the Our World in Data project at the University of Oxford. And there has been a sharp improvement in Japan’s vaccine rollout, with close to 60 percent of the population fully inoculated, a rate that exceeds that of the United States and of many other countries around the Pacific Rim.

Under the state of emergency, people were urged to refrain from nonessential outings, and restaurants were asked to close by 8 p.m. and to not serve alcohol. The government plans to ease those restrictions in stages.

Yasutoshi Nishimura, a government minister who is leading Japan’s Covid-19 response, said that serving alcohol would be allowed but that “governors will decide on that appropriately, according to the region’s infection situation.”

For more than a year, misinformation touting that ivermectin is effective at treating or preventing the coronavirus has run rampant across social media, podcasts and talk radio. Even as the Food and Drug Administration has said that the drug is not approved to cure Covid and has warned people against taking it, media personalities who have cast doubt on coronavirus vaccines, like the podcaster Joe Rogan, have promoted ivermectin for that purpose.

The inaccuracies have led some people to overdose on certain formulations of the drug, which has then stretched doctors and hospitals. And the false claims have even caused problems for veterinarians, who regularly use the medicine for the animal treatments that it was approved for.

While certain versions of ivermectin can treat head lice and other ailments in people, other formulations — which come in forms such as liquid and paste — are common across the equine and livestock industries as ways to get rid of worms and parasites.

People are increasingly trying to obtain those animal products to ward off or treat the coronavirus, according to farmers, ranchers and suppliers.

Overwhelmed by orders, one farm supply store in Las Vegas started selling the medicine only to customers who could prove that they had a horse. In California, a rancher was told that the backlog of orders was so large that she was 600th in line for the next batch.

The dearth has led some farm owners, ranchers and veterinarians to switch to generic or more expensive alternatives for their animals. Others have turned to expired ivermectin or stockpiled the drug.

Syria is experiencing a major surge of coronavirus infections as depleted hospitals across the country find themselves ill equipped to deal with the worst influx of cases since the pandemic began, Syrian health officials and aid groups say.

Exacerbating the crisis is the toll of a decade of war that has ravaged the economy, heavily damaged the health infrastructure and left the territory divided between competing administrations.

The government of President Bashar al-Assad, which controls only about two-thirds of the country, said that new infections had reached daily levels this week of more than 440, the highest so far in the pandemic.

Hospitals in the capital, Damascus, and in the coastal city of Latakia have reached capacity and are sending patients elsewhere, health officials said.

Syria, a country of about 20 million people, has reported more than 32,000 cases and 2,100 deaths in government-controlled areas since the start of the pandemic, but outside experts say that those numbers fail to reflect the true toll, largely because of the lack of widespread testing.

Areas outside the government’s control have struggled, too.

Around Idlib Province in the northwest — the last pocket held by armed rebels and home to millions of people displaced from elsewhere in the country — new daily Covid cases rose by a factor of 10 from the start of August to early September, reaching more than 1,500 per day, according to the International Rescue Committee, a humanitarian group. The increase left clinics running low on test kits and oxygen, the group said.

Misinformation about vaccines has been rife in Idlib, with voice notes circulated on social media telling people that vaccines cause dangerous blood clots.

The area’s health facilities were on the verge of collapse even before the pandemic hit because of years of battles between rebels and government forces and frequent airstrikes by Syrian and Russian jets.

In Syria’s northeast, the Kurdish-led administration backed by the United States that runs the territory has announced new lockdowns after a rise in coronavirus infections there.

Vaccination campaigns have proceeded slowly in all parts of Syria, with 2 percent of the population having received a single dose and only 1.2 percent having received two doses, according to the World Health Organization.

Syria had been given about 730,000 vaccine doses through the United Nations-backed Covax program and other donations as of Sept. 19, the W.H.O. said.

— Asmaa al-Omar

This fall, there is a surreal swirl of newness and oldness in the hallways of John F. Kennedy High School: Black Lives Matter face masks and exhortations to pull them up — “Over your nose, please!” — but also ribbing and laughter, bells ringing, hall passes being checked and loudspeaker reminders about the dress code (collared black or navy shirts, and khaki or black bottoms).

Kennedy was open for in-person learning most of last school year. But families in this working-class, majority Hispanic and Black school district in Waterbury, Conn., opted out in large numbers, with two-thirds of high school students ending last year fully online.

This year, only students with severe health concerns can qualify for remote learning, and so far no Kennedy families have been approved.

That means most juniors and seniors have returned to the building for the first time in 18 months. They are taller and more mature — sometimes physically unrecognizable, a counselor noted — but often reeling from what the pandemic has wrought: anxiety, economic precarity and academic struggle.

The school is teeming with over 1,300 students, more than before the pandemic, because of the closing of a nearby Catholic school and an influx of families moving from New York City in search of affordable housing.

The Times interviewed students and teachers at Kennedy to get a sense of what it’s like to be back after such a tumultuous year.

Romania recorded its highest-yet number of daily coronavirus cases on Tuesday — the same day that the country’s government began a campaign to offer vaccine booster shots to a population in which only about 33 percent of adults are fully inoculated.

The record 11,049 confirmed new cases came as areas around the country face a possible return to harsher restrictions. And hospitals are filling up: Of 1,336 intensive care unit beds set aside for Covid-19 patients nationwide, only 26 are currently empty.

Valeriu Gheorghita, the head of Romania’s national coronavirus vaccination campaign, said at a news conference on Tuesday, “We need to be responsible in the next period.”

“We need the involvement of each of us to follow the rules and get vaccinated, given that through vaccination we avoid the risk of severe cases, the risk of hospitalization, the risk of death and the risk of spreading the virus,” he added.

Romania’s caseload has grown sharply in recent weeks, with the country reporting around 1,500 new cases per day at the start of September.

The country is second only to Bulgaria among E.U. member states when it comes to low vaccine uptake: Romania’s rate is less than half the bloc average of 72 percent of adults fully inoculated. In recent months, Romania has sold or given away millions of doses before they expired as the authorities struggle to persuade people to have the shots.

But the uptake of boosters, which as of Tuesday are being offered to anyone who wants one, was relatively high.

As of noon on Tuesday, 13,963 people had received a third vaccine dose — higher than the total number of vaccine shots administered most days in Romania in recent months. A further 25,000 people are already scheduled to receive the extra shots.

Romania has had more than 36,000 Covid-related deaths since the pandemic began, according to the Our World in Data project at the University of Oxford. But although low rates of infection over the summer may have created a false sense of security, that is likely to change fast.

Romania’s capital, Bucharest, is nearing the infection rate at which the government has said that schools will have to return to online learning and that stricter measures will have to be reintroduced, including a nighttime weekend curfew.

Many other cities could follow.

“It is important to understand that the Delta variant is spreading so fast,” Mr. Gheorghita said, “that for people who have no protection, the risk of becoming infected in the next period is very high.”

— Kit Gillet

A popular shaman in Sri Lanka who claimed to be able to cure coronavirus patients with a holy water died last week after being infected with the virus, a health ministry official said this weekend.

The shaman, known as Eliyantha Lindsay White, was not vaccinated. He died on Wednesday after being taken to a hospital, the official said.

Mr. White was an influential and divisive figure in Sri Lanka, where about 53 percent of people have been fully vaccinated against the coronavirus, according to the Our World in Data project at the University of Oxford. The shaman, who was 48, practiced alternative medicine involving questionable potions whose ingredients were never publicly disclosed.

Some high-ranking officials in the Sri Lankan government and several professional athletes have said publicly that they believed in Mr. White’s healing powers. But he was denounced by medical professionals.

“There is no credible evidence to show if there was a positive result from his work,” said Dr. Samantha Ananda, a spokeswoman for the Government Medical Officers’ Association, a major trade union for doctors in Sri Lanka. “We do not recommend anything that is not proven in a scientific method.”

Dr. Ananda said that the politicians who had publicly endorsed Mr. White might have done so to ingratiate themselves with his legion of fans.

Contact information for Mr. White’s family was not available, and a telephone message left with a person close to the family was not returned.

In November, three ministers in Sri Lanka’s government, including a former health minister, were shown on video throwing pots containing Mr. White’s holy water into several rivers that serve as the main sources of drinking water in the country. Mr. White had said that ingesting the concoction would cure Covid-19.

Pavithra Wanniarachchi, the former health minister, subsequently contracted the virus and spent two weeks in intensive care, according to the BBC. None of the three ministers in the video responded to phone calls seeking comment.