Pfizer reported data on Friday showing that its coronavirus vaccine had a 90.7 percent efficacy rate in preventing symptomatic Covid-19 in a clinical trial of children ages 5 to 11.
The company and its partner BioNTech submitted the information to the Food and Drug Administration, which was expected to release its own analysis of the data later in the day.
Children in the trial received a dose of 10 micrograms, one-third of the adult dose. Researchers said that the dosage was safe, and that trial participants had seen only mild side effects.
Of 2,268 children in the trial, twice as many were given the vaccine as received a placebo. Sixteen children who received the placebo got Covid-19, compared with three who received the vaccine.
There were no cases of severe illness. All of the cases occurred in July or later, a time when the highly transmissible Delta variant was spreading in the United States and globally, Pfizer said.
After the second shot, the children had levels of neutralizing antibodies at least equal to those of 16-to-25-year-old volunteers in another Pfizer-BioNTech trial. Although antibody levels are just one measure of the immune system’s response, experts have said such a finding would indicate that one-third strength was the proper dosage for young children.
Pfizer also reported that they were no cases of the heart conditions of myocarditis, which is inflammation of the heart muscle, or pericarditis, which is inflammation of the lining around the heart, in volunteers roughly three months after receiving the second dose. Both conditions have been tied to adult recipients of the vaccine, particularly younger men. Because the conditions are rare, it is unlikely that one of them would have occurred in a study size as small as Pfizer’s.
Studies have also shown that the risk of heart problems after Covid-19 is higher than after vaccination.
The F.D.A. released the data before a Tuesday meeting at which the agency’s expert advisers will decide whether to recommend that the agency authorize the vaccine for children in this age group. Federal regulators have already made the vaccine available for those 12 and older.
The Biden administration has been eagerly promoting the prospect of protection for the 28 million children aged 5 to 11, promising that tens of thousands of pediatric or primary care offices, pharmacies and school and rural health clinics will be ready to administer shots if regulators grant authorization. With the school year well underway, many parents anxiously awaiting the development.
If the F.D.A. grants authorization, distribution of the doses would still depend on sign-off by the Centers for Disease Control and Prevention, which sets vaccine policy. The C.D.C. has scheduled a two-day meeting of own advisory committee for Nov. 2 and 3. Federal officials have said they intend to ship 15 million doses to the states immediately if regulatory and health officials authorize the move.
About 17 million adolescents aged 12 to 15 became eligible for the Pfizer-BioNTech vaccine in May. A month ago, Pfizer and BioNTech said their vaccine was also safe and effective for young children but did not release any detailed clinical trial data.
As the United States prepares to offer Covid booster shots to tens of millions of people, representatives of the World Health Organization continue to sound the alarm over the disparity in vaccine access globally, with the world’s poorest countries struggling to get even a first dose into their citizens’ arms.
Gordon Brown, the former British prime minister who is now the W.H.O.’s ambassador for global health financing, said on Thursday that there was a shortfall of 500 million doses in the global South, while 240 million doses were lying unused in the West. The number of excess doses is projected to reach 600 million by the end of the year, Mr. Brown added.
Mr. Brown spoke on the same day the Centers for Disease Control and Prevention endorsed booster shots of the Moderna and the Johnson & Johnson Covid-19 vaccines for tens of millions in the United States.
In Africa, meanwhile, only nine countries had met a target of vaccinating 10 percent of their populations against Covid-19 by the end of September, the W.H.O. reported.
“Wealthy countries must let go of reserved doses and cede their place in the queue, allowing Covax and the African Union to buy the vaccines the continent seeks and stands ready to finance,” Dr. Matshidiso Moeti, the W.H.O. regional director for Africa, wrote in a Times guest essay last month, referring to the United Nations-backed program to inoculate the world against the coronavirus.
“Africa and other parts of the world need these vaccines. Now,” she added.
Mr. Brown called for military airlifts to help deliver unused doses to lower-income countries, particularly an estimated 100 million doses that had a use-by date before December and would otherwise end up being destroyed.
“We are talking about waste on a colossal scale if we don’t do something about this,” Mr. Brown said in an interview with BBC Newsnight on Thursday.
He and other health officials argue that low inoculation rates globally could undermine progress against the pandemic by creating room for the virus to mutate and spread.
“You can’t solve this problem without vaccinating the whole of the world, not half of the world,” Mr. Brown said.
The W.H.O. estimates that 11 billion Covid vaccine doses are needed worldwide to turn the tide of the pandemic, but so far production and distribution have been concentrated in Western countries.
Last month Covax slashed its forecast for the number of doses it expected this year, further undercutting a program that has been beleaguered by production problems, export bans and vaccine hoarding by wealthy nations.
According to government figures collated by the University of Oxford’s World in Data project, about 77 percent of shots administered worldwide have been in high- and upper-middle-income countries. Only about 0.5 percent of doses have been administered in low-income countries. Africa is the region with the lowest inoculation rate, with less than 8 percent of the population vaccinated.
The Biden administration has said that it can provide boosters to tens of millions of Americans while also donating vaccines to poorer nations. On Thursday, the White House announced that it had delivered more than 200 million doses of the Covid-19 vaccine to more than 100 countries, the most from any country in the world, according to the State Department.
“Doing more than everyone else shouldn’t be the bar,” said Craig Spencer, director of global health in emergency medicine at NewYork-Presbyterian/Columbia University Medical Center. “It’s just not nearly enough.”
A new analysis underscores concerns about how federal aid was allocated to health care institutions under the Provider Relief Fund, a $175-billion program that has drawn sharp criticism for giving so much money to the wealthiest U.S. hospitals.
The study, published Friday in JAMA Health Forum, shows that more money flowed to hospitals that were in a strong financial position before the pandemic than went to hospitals with weaker balance sheets and smaller endowments.
Small rural hospitals, called critical access hospitals, received lower levels of funding, according to the study, by researchers at the RAND Corporation, a nonprofit group. Those rural facilities often operate under extremely tight budget constraints, and some have closed or been acquired over the course of the pandemic.
More aid also flowed to those hospitals caring for the greatest number of Covid patients, many of which were large academic medical centers and big hospitals.
“There were large differences in how much each hospital got in funding,” Christopher M. Whaley, one of the study’s authors, said in an interview.
The analysis of 952 hospitals found that 24 percent received less than $5 million, while 8 percent got more than $50 million. Overall, the small rural hospitals received 40 percent less funding than their larger and more prosperous counterparts.
The researchers did not take into account $24 billion that was specifically targeted to rural and safety-net hospitals in underserved areas, which may have helped these organizations.
Congress authorized the aid to cushion losses sustained by hospitals during the pandemic, as patients stayed away and facilities could not perform lucrative surgeries and procedures.
But some of the hospitals that received hundreds of millions of dollars in federal funds went on buying sprees during the Covid crisis, gobbling up weaker hospitals and physician groups. A few large chains, including HCA Healthcare and the Mayo Clinic, chose to return at least some of the money.
The havoc caused by the Delta variant has further strained many hospitals, overwhelming intensive care units and forcing some to renew delays in elective treatments.
A September report commissioned by the American Hospital Association predicted a third of will have operating losses in 2021. Hospitals say they are treating sicker patients, many of whom delayed care earlier in the pandemic, and are paying more for staff, supplies and drugs.
Dr. Whaley said the larger flow of money to hospitals in strong financial shape calls into question “the purpose of having these financial resources,” noting some institutions have massive endowments and sizable assets. In contrast, rural hospitals receiving the least aid were already under financial strain when the pandemic hit.
“Policymakers should continue to ensure that these types of hospitals are sufficiently funded, potentially with additional rounds of funding,” the researchers wrote.
The residents of Melbourne have spent more days in lockdown — 262, to be precise — than people anywhere else in the world. And on Friday, they emerged from it with cheers, and a dose of caution, as restrictions began to ease.
During those lockdown days, residents in Australia’s second largest city were allowed to leave their homes to buy food and to exercise, and to do authorized work. For the past two and a half months, they have also been subject to a 9 p.m. curfew.
As the clock struck midnight on Friday and these restrictions were lifted, residents greeted their new freedoms with cheers and screams
It’s hoped that this will be Melbourne’s last lockdown — with 70 percent of residents age 16 and older now fully vaccinated, the government’s pandemic recovery plan envisages such restrictions becoming rare.
“I’m trying not to sound like some kind of soppy dad here, but I am proud, bloody proud of this state,” Daniel Andrews, the premier of Victoria, the state of which Melbourne is the capital, said on Twitter. “We’ve gone through such a hard time together, this pandemic has been exhausting in every sense of the word.”
But with case numbers still high — Victoria recorded 2,232 new infections on Thursday, its second highest daily total since the start of the pandemic — the city’s reopening is happening gradually.
Up to 10 vaccinated people can gather at home. Hairdressers, restaurants and bars can take in more customers. Retail stores can reopen — but only for outdoor business, a condition some business owners have labeled “ludicrous.”
Indoor retail outlets, gyms and entertainment venues will be able to reopen once 80 percent of the population is fully vaccinated.
On Friday morning, street musicians returned to Melbourne’s central business district, which had fallen silent during the pandemic. Most shops were still closed but long lines snaked out of cafes and hair salons.
“It’s nice to see everyone out and about again,” said Lionel Lam, 33, one of a dozen people waiting outside a barbershop. He’d bought clippers to cut his own hair during lockdown, he said, “but I’m excited to get the back done.”
On Friday, the authorities in Victoria announced that, starting Nov. 1, vaccinated Australian citizens returning to the state from overseas would not need to quarantine. That brought the state in line with the state of New South Wales, which made a similar announcement last week.
Thailand said it would vastly expand the number of countries from which fully vaccinated people can visit starting Nov. 1, racing to attract tourists who might otherwise decide to visit other countries first as Europe and the Americas continue their reopening plans.
Fully vaccinated travelers from 46 countries will be granted quarantine-free entry to 17 tourist provinces including Bangkok, up from the 10 previously announced, under a plan unveiled by Prime Minister Prayuth Chan-ocha on Thursday. The United States and China are among the countries on the list.
The plan would make Thailand one of the least restrictive countries for tourists to visit in Asia. South Korea now allows travelers of 49 nationalities to apply for permission to enter without a visa.
Currently, vaccinated visitors must quarantine for seven days upon entering Thailand, except if they arrive on a direct flight to the island of Phuket, where they are exempt from quarantine as long as they stay on the island. After seven days in Phuket, they can tour other parts of the country.
Even as Asia makes strides in vaccinations and slowly eases its Covid curbs, travelers across the region remain under some of the strictest international border rules in the world. Those restrictions have hampered economic recovery, particularly in countries that relied heavily on foreign tourists before the pandemic.
While some Asian countries have cautiously allowed small numbers of tourists to enter, others, including China and Japan, have kept borders closed to tourists since the start of the pandemic.
Beijing began offering booster vaccinations against the coronavirus to residents 18 and older this week as China prepares to host the Winter Olympics in the capital early next year.
Several other parts of the country have also recently started administering third doses to people who had their second shot more than six months ago, according to reports in state-run news outlets. Beijing government notices said priority would be given to high-risk people, including those over 60 or in certain jobs, and to those organizing or attending “major events.”
More than 2.2 billion vaccine doses have already been administered in China, according to the government. Chinese health officials have maintained a zero-tolerance approach to the virus, even as other countries, such as New Zealand, have moved away from trying to eradicate infections using heavy restrictions.
China reported 28 locally transmitted coronavirus cases on Thursday, the highest one-day figure in a month. The authorities in the northern-central areas where the latest cases are concentrated have shut tourist sites, curbed travel and imposed neighborhood lockdowns.
On Friday, Beijing said it would conduct rapid testing for 34,700 residents of the capital after four new cases were discovered in the city’s Changping District.
The 2022 Beijing Olympics are poised to be the most restricted large-scale sporting event since the start of the pandemic. Athletes, officials, journalists, workers and more will have to spend all their time in a bubblelike environment and take daily coronavirus tests. Only residents of mainland China will be allowed as spectators.
New Zealand, which for most of the pandemic has pursued a “Covid zero” strategy, announced on Friday a new plan to manage life with the virus and move away from lockdowns, beginning once the country meets an ambitious vaccination target.
A new, color-coded system of restrictions will take effect once 90 percent of people ages 12 and up have received two doses of a vaccine, Prime Minister Jacinda Ardern announced at a news conference.
With Auckland, the country’s largest city, under a lockdown that has stretched to nine weeks because of an outbreak of the Delta variant that has proven frustratingly difficult to stamp out, officials in New Zealand have acknowledged that eliminating the virus completely may no longer be possible.
“Delta has made it very hard to maintain our elimination strategy,” Ms. Ardern said, “but as our longstanding strategy was challenged, we also had a new tool. That tool is the vaccine.”
Other Asia-Pacific countries have begun reopening after reaching lower levels of vaccination. The Australian city of Melbourne on Friday ended a lockdown that began in August after officials reported that it had inoculated 70 percent of its eligible population. Singapore set a vaccination target of 80 percent to begin reopening, but has struggled to lift restrictions as cases resurge.
In the New Zealand plan, the highest level of restrictions will be “red,” under which masks will be mandatory in most public venues and vaccine certificates will be required at most establishments like restaurants and houses of worship, with limits on capacity.
At “orange,” businesses will not be required to limit how many people they serve at once, though vaccine certificates will still be widely used. Only at “green” could most businesses open without requiring patrons to produce vaccine certificates.
As of Oct. 22, central Auckland, where the country’s latest outbreak is concentrated, was the only region to report that nearly 90 percent of the eligible population had received first doses.
On Friday, New Zealand reported 129 new cases, its highest daily total since the pandemic began, according to the Ministry of Health.
Auckland would be permitted to move to “red” once all three districts within the city’s borders had reached the 90 percent target, Ms. Ardern said, while the rest of the country would move to “orange” once every district had reached the 90 percent target.
Critics have attacked the new strategy for failing to make special provisions for vulnerable groups, including New Zealand’s Indigenous Maori population, which has far lower vaccination rates. Just over 47 percent of eligible Maori have received two doses of a vaccine, compared with nearly 70 percent of the wider population.
“The current monocultural strategies are harmful to Maori and we require frameworks that reflect our worldview,” Debbie Ngarewa-Packer, the co-leader of the Maori Party, said in a statement that called for hitting a specific vaccination target for Maori before the country reopened. “The more they tell our people to get vaccinated, the more they don’t want to.”
Other critics said the new goals are not high enough to prevent more deaths.
“The proposed vaccination targets are insufficient to protect the most vulnerable, and risk opening up before everyone is safe on an equal basis,” said Julie Anne Genter, a member of the Green Party, which has pushed for a 95 percent target.
For the last four months, Britain has run a grand epidemiological experiment, lifting virtually all coronavirus restrictions, even in the face of a high daily rate of infections. Its leaders justified the approach on the grounds that the country’s rapid rollout of vaccines had weakened the link between infection and serious illness.
Now, with cases, hospital admissions and deaths all rising again, the effect of vaccines beginning to wear off, and winter looming, Britain’s strategy of learning to live with the virus is coming under its stiffest test yet.
New cases surpassed 50,000 on Thursday, an 18 percent increase over the last week and the second time cases have passed that level since July. The number of people admitted to hospitals rose 15.4 percent over the same period, reaching 959, while 115 people died of Covid-19, an increase of almost 11 percent.
The sudden resurgence of the virus is a rude jolt for a country that believed it had put the worst of the pandemic behind it after a remarkably successful vaccine deployment.
At issue is the core trade-off British officials made last summer. They decided they could tolerate a widely circulating virus as the price of reopening the economy, so long as only a small fraction of infected people ended up in the hospital.
The percentage of infected people who are later hospitalized is still much lower now than it was during the last peak of the pandemic in January, about 2 percent compared with 9 percent. But the National Health Service is already feeling the strain, and with fears of a virulent flu season, hospitals face the prospect of a double-whammy this winter.
Not a single international flight carrying tourists has landed in Bali, one of the world’s most popular destinations, and none are scheduled, even though Indonesia announced more than a week ago that the popular island was finally open again for tourists.
Arriving foreign tourists must spend their first five days in quarantine, but so far, hotels offering quarantine on the island report that no one has booked a room.
“We have been waiting every day for a week,” said Fransiska Handoko, vice chair of the Bali Hotels Association. “Where are they?”
Before the pandemic, tourism accounted for more than half of Bali’s economy but the island has been closed to foreign tourists since April 2020, leaving many workers desperate for income.
The Indonesian government abruptly reopened Bali on Oct. 14 to tourists from 19 countries who are fully vaccinated and test negative for the coronavirus. But it gave hotels and airlines little time to prepare and included numerous restrictions that make a Bali holiday unappealing.
Hotel operators say they have received many inquiries from abroad, but once they explain the rules, the callers lose interest.
One factor is the required five days of quarantine. Most Bali tourists come for a week, travel operators said, and don’t want to spend most of their visit confined to a hotel room.
“Two days’ holiday and spending most of the time in quarantine is nonsense,” said Wayan Adika, a reservation clerk at Bali Golden Tour, who has been fielding calls from around the world. “They think it’s better to wait until the quarantine requirement is revoked.”
Requiring even minimal quarantine has left Bali at a disadvantage in competing with other destinations. Thailand, for example, announced on Thursday that it would accept fully vaccinated tourists from 46 countries without quarantine starting Nov. 1.
Adding to the cost of a Bali trip, Indonesia will no longer issue free tourist visas. Instead, tourists must pay in advance for a visa that can cost $65 or more and entails a complicated application process.
Another deterrent for families has been a regulation barring children under 12 from entering Bali because they cannot be vaccinated. That rule will be lifted on Sunday.
Tourists arriving from the 19 nations, including China, India and Japan, must arrive on flights directly from their countries of origin. But most countries on the list, especially those in Western Europe, do not offer such flights.
Among those listed is the tiny European country of Liechtenstein, with a population of 38,000. Yet Indonesia excluded nearby Australia, whose travelers once flocked to Bali.
The regulations also are not easy on airlines. Indonesians traveling to Bali from overseas must fly first to Jakarta, leaving only non-Indonesian travelers to fill the Bali flights.
So far, no airline has scheduled a flight to bring tourists to Bali from abroad, according to a Bali airport spokesman, Taufan Yudhistira.
“We hope the government will re-evaluate the regulations,” said Rai Suryawijaya, Bali chairman of the Indonesian Hotel and Restaurant Association. “It is not productive when we are open but nobody is coming. If we are really open, we should make it easy.”
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