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F.D.A. Authorizes Pfizer-BioNTech Vaccine for 12- to 15-Year-Olds

Receiving a dose of the Pfizer-BioNTech coronavirus vaccine at a mass vaccination site in East Hartford, Conn., last month.
Credit…Jessica Hill/Associated Press

The Food and Drug Administration on Monday authorized use of the Pfizer-BioNTech Covid-19 vaccine for 12- to 15-year-olds in the United States, a crucial step in the nation’s steady recovery from the pandemic and a boon to tens of millions of American families eager for a return to normalcy.

The authorization caps weeks of anticipation among parents, who have been grappling with how to conduct their lives when only the adults in a household are immunized. It removes an obstacle to school reopenings by reducing the threat of transmission in classrooms, and affords millions of adolescents the opportunity to attend summer camps, sleepovers and get-togethers with friends.

“This is great news,” said Dr. Kristin Oliver, a pediatrician and vaccine expert at Mount Sinai Hospital in New York. “It feels like we’ve been waiting a long time to start protecting children in this age group.” The Pfizer-BioNTech vaccine is already available to anyone over 16.

The F.D.A.’s go-ahead is not the final hurdle. An advisory committee of the Centers for Disease Control and Prevention is expected to meet shortly to review the data and make recommendations for the vaccine’s use in 12- to 15-year-olds.

If the committee endorses the vaccine for that age group, as expected, immunizations in theory could begin immediately. Clinical trials have shown that these children may safely receive the dose already available for adults.

In a clinical trial, Pfizer and BioNTech enrolled 2,260 participants ages 12 and 15 and gave them either two doses of the vaccine or a placebo three weeks apart. The researchers recorded 18 cases of symptomatic coronavirus infection in the placebo group, and none among the children who received the vaccine, indicating that it was highly effective at preventing symptomatic illness.

The vaccine also appeared to be safe for these children, with side effects comparable to those seen in trial participants who are 16 to 25 years old. Fevers were slightly more common among inoculated 12- to 15-year-olds; about 20 percent of them had fevers, compared with 17 percent in the older age group.

The trend toward more fevers at younger ages was consistent with observations in an earlier trial, said Dr. Bill Gruber, a senior vice president at Pfizer and a pediatrician.

The trial results were a “trifecta” of good news, Dr. Gruber added: “We have safety, we got the immune response we wanted — it was actually better than what we saw in the 16- to 25-year-old population — and we had outright demonstration of efficacy.”

The company is still gathering information on potential asymptomatic infections by continuing to test the trial participants for the coronavirus every two weeks and checking them for antibodies produced in response to a natural infection, according to Dr. Gruber.

The push to immunize children may run into the same problems with hesitancy that have plagued attempts to inoculate adults. In one recent poll, just over half of parents said they were likely to have their children get a vaccine as soon as one was authorized.

Dr. Megan Ranney, an emergency room physician at Rhode Island Hospital in Providence, said she had “zero safety concerns” about the Pfizer-BioNTech vaccine, noting that hundreds of millions of people worldwide have received it.

Her 12-year-old daughter is eager to be vaccinated, and her 9-year-old son will be immunized as soon as he is eligible, she said.

“The risk of your child catching Covid and getting really sick is low, but it’s not zero,” she said. “And the risk of them getting sick or hospitalized or worse with Covid or with the post-Covid multi-inflammatory syndrome is higher than the risk of something bad from this vaccine.”

Vaccinating children shields others in the community from the virus, she noted, including people who are not protected by the vaccine, such as organ transplant recipients, cancer patients and those with impaired immune responses.

“It also protects all of us from the virus continuing to spread and mutating further,” Dr. Ranney said. “That’s the thing that I’m most scared of right now.”

Pfizer and BioNTech began testing the vaccine in children ages 5 to 11 in March and extended the trial to even younger children, ages 2 to 5, last month. The companies next plan to test children who are 6 months to 2 years old.

Assuming trial results are encouraging, the companies expect to apply to the F.D.A. in September for emergency authorization to administer the vaccine to children ages 2 to 11.

Results from trials of Moderna’s vaccine in 12- to 17-year-olds are expected in the next few weeks. Findings from another trial of the company’s vaccine in children 6 months to 12 years old should be available in the second half of this year.

AstraZeneca is testing its vaccine in children 6 months and older. Johnson & Johnson plans to wait for results from trials in participants older than 12 before testing its vaccine in younger children.

Jan Hoffman contributed reporting.

Funeral pyres of coronavirus victims at a makeshift crematorium in New Delhi on Sunday.
Credit…Anindito Mukherjee/Getty Images

Amid a deepening crisis in India, the World Health Organization announced Monday that it had designated the B.1.617 variant, which has been growing more common in the country, as a variant of concern. Scientists still don’t know much about the variant yet, but they are worried that it may be helping to fuel the rise in the nation’s coronavirus infections, which experts say are likely undercounted.

“There is increased transmissibility demonstrated by some preliminary studies” of the variant, said Dr. Maria Van Kerkhove, the technical lead of the W.H.O.’s coronavirus response.

Dr. Van Kerkhove also said that a study of a limited number of patients, which had not yet been peer reviewed, suggested that antibodies from vaccines or infections with other variants might not be quite as effective against B.1.617. However, the agency said that vaccines will likely remain potent enough to provide protection against B.1.617.

More details will be released in a report on Tuesday, Dr. Van Kerkhove said.

The variant was first detected in India at the end of 2020 but became more common in the country starting in March. It has since been found in 32 countries including the United States and the United Kingdom. The W.H.O.’s announcement comes as growing numbers of medical experts are adding their voices to a chorus of condemnation of the Indian government’s response and calling for nationwide restrictions to try to limit the horrifying death toll.

Although the official figures are already staggering — more than 350,000 new infections daily this month and nearly 250,000 total deaths — some experts say that the numbers are a vast undercount and estimate that India is on pace to suffer more than one million deaths by August.

Initially, the W.H.O. classified B.1.617 as a “variant of interest,” because it had certain mutations that have been linked to higher transmission and the potential to evade vaccines. At a news conference on Monday, agency officials announced they were elevated it to a higher level.

Other variants of concern include B.1.1.7, which was first identified in the United Kingdom, and P.1., which was originally detected in Brazil.

But experts caution that it’s not yet clear just how much of a factor B.1.617 has played in the catastrophic rise in cases in India. They point to a perfect storm of public health blunders, such as permitting massive political rallies and religious festivals in recent months.

“I am concerned about 617 — I think we have to keep a very close eye on it,” said Kristian Andersen, a virologist at Scripps Research Institute in La Jolla, California. But he cautioned that relatively few variant samples are being analyzed in India, making it hard to know just how dangerous B.1.617 is. “We really, really need better data out of India,” he said.

Commuters exited the West 4 St. subway station in New York, in February.
Credit…Amr Alfiky/The New York Times

Officials in New York are trying to boost a flagging vaccination campaign by setting up temporary walk-in vaccination sites at eight subway and train stations this week, Gov. Andrew M. Cuomo said on Monday.

From May 12 to May 16, the walk-in sites will be open at various times at subway stations including the ones at 179th Street in Jamaica, Queens, and at Stillwell Avenue in Coney Island, Brooklyn, from 8 a.m. to 1 p.m. Sites at the Long Island Rail Road station in Hempstead and a Metro-North Railroad station in Ossining will be open from 3 p.m. to 8 p.m.

A site will be open at Penn Station in Manhattan from 3 p.m. to 8 p.m. and at Grand Central Terminal from 8 a.m. to 1 p.m.

People vaccinated at the rail and subway locations can get a free seven-day MetroCard or two free one-way tickets for the Long Island Rail Road or Metro-North. Officials will use the Johnson & Johnson vaccine at the stations, Mr. Cuomo said. The program is a pilot and may be extended, he said.

“You are walking into the subway station anyway, you are walking past the vaccination site, it’s a one-shot vaccination, stop, take a few minutes, get the vaccine,” he said.

The pop-up sites at the stations — and the free tickets — are part of a broader, nationwide push to offer creative incentives to get people vaccinated. New Jersey, for example, is offering a “shot and a beer” for residents who get their first vaccine dose in May and visit participating breweries in the state.

In New York City, Mayor Bill de Blasio announced on Monday a plan to give free tickets to events and attractions like the New York Aquarium, the Brooklyn Botanic Garden or professional soccer games to people who get vaccinated.

Vaccinations so far have helped drive down positivity rates and hospitalizations across New York State, Mr. Cuomo said. He said on Monday that the number of hospitalizations statewide was 2,016, the lowest since Nov. 15. The statewide seven-day average rate of positive test results announced by the state on Sunday — 1.45 percent — was the lowest since Oct. 28.

Still, Mr. Cuomo said the pace of vaccinations was tapering off, both in New York and nationwide, potentially allowing the coronavirus to linger. Younger people and people who question the vaccine’s safety and doubt the trustworthiness of the government in particular were not getting vaccines, he said.

Mr. Cuomo also said on Monday that the State University of New York and the City University of New York planned to require that students returning for in-person instruction in the fall be fully vaccinated. He said the requirement would be contingent on the federal government granting full approval to the Covid-19 vaccines being used now. The three in use are only authorized for emergency use.

Pfizer and the German company BioNTech said on Friday that the companies had applied to the U.S. Food and Drug Administration for full approval of their vaccine for use in people 16 and older, but the process could take months. Moderna plans to apply for full approval for its Covid-19 vaccine this month, the company said last week.

Mr. Cuomo said that half the seats at home games for the New York Islanders during the National Hockey League playoffs, which begin this month, will be reserved for people who are vaccinated. They will have to stay three feet apart, he said. The other half will be available to unvaccinated people who must remain six feet apart, he said. Everyone will be required to wear a mask.

In New York City, officials said they were making plans to provide the Pfizer vaccine to children ages 12 to 15, once it is authorized as is expected this week.

“We want to immediately get to work vaccinating young people,” Mr. de Blasio said at a news conference on Monday.

The health commissioner, Dr. Dave Chokshi, said the city would begin administering the vaccine to those adolescents at its existing network of vaccination sites. The city has also been working with pediatricians to prepare them to answer questions about the vaccine and eventually administer it in their offices, and it would distribute information about vaccination at city schools to try and reach a broad audience of eligible teenagers.

Michael Gold contributed reporting.

Health care workers administered coronavirus tests in Colombo, Sri Lanka, on Tuesday.
Credit…Ishara S. Kodikara/Agence France-Presse — Getty Images

Early in the pandemic, there was hope that the world would one day achieve herd immunity, the point when the coronavirus lacks enough hosts to spread easily. But over a year later, the virus is crushing India with a fearsome second wave and surging in countries from Asia to Latin America.

Experts now say it is changing too quickly, new more contagious variants are spreading too easily and vaccinations are happening too slowly for herd immunity to be within reach anytime soon.

That means if the virus continues to run rampant through much of the world, it is well on its way to becoming endemic, an ever-present threat.

Virus variants are tearing through places where people gather in large numbers with few or no pandemic protocols, like wearing masks and distancing, according to Dr. David Heymann, a professor of infectious disease epidemiology at the London School of Hygiene and Tropical Medicine.

While the outbreak in India is capturing the most attention, Dr. Heymann said the pervasive reach of the virus means that the likelihood is growing that it will persist in most parts of the world.

As more people contract the virus, developing some level of immunity, and the pace of vaccinations accelerates, future outbreaks won’t be on the scale of those devastating India and Brazil, Dr. Heymann said. Smaller outbreaks that are less deadly but a constant threat should be expected, Dr. Heymann said.

“This is the natural progression of many infections we have in humans, whether it is tuberculosis or H.I.V.,” said Dr. Heymann, a former member of the Epidemiology Intelligence Service at the Centers for Disease Control and Prevention and a former senior official at the World Health Organization. “They have become endemic and we have learned to live with them and we learn how to do risk assessments and how to protect those we want to protect.”

Vaccines that are highly effective against Covid were developed rapidly, but global distribution has been plodding and unequal. As rich countries hoard vaccine doses, poorer countries face big logistical challenges to distributing the doses they manage to get and vaccine hesitancy is an issue everywhere. And experts warn the world is getting vaccinated too slowly for there to be much hope of ever eliminating the virus.

Only two countries have fully vaccinated more than half of their populations, according to the Our World in Data project at the University of Oxford. They are Israel and the East African nation of the Seychelles, an archipelago with a population of fewer than 100,000. And just a handful of other countries have at least partially vaccinated nearly 50 percent or more, including Britain, tiny Bhutan, and the United States.

Less than 10 percent of India’s vast population is at least partly vaccinated, offering little check to its onslaught of infections.

In Africa, the figure is slightly more than 1 percent.

Still, public health experts say a relatively small number of countries, mostly island nations, have largely kept the virus under control and could continue keeping it at bay after vaccinating enough people.

New Zealand, through stringent lockdowns and border closures, has all but eliminated the virus. Dr. Michael Baker, an epidemiologist at the University of Otago who helped devise the country’s coronavirus response, said New Zealand would likely achieve herd immunity by immunizing its population, but it has a long way to go with only about 4.4 percent of New Zealanders at least partially vaccinated.

“All of the surveys show there is a degree of vaccine hesitancy in New Zealand, but also a lot of people are very enthusiastic,” Dr. Baker said. “So I think we will probably get there in the end.”

While new daily cases have remained at near-world record levels, the number of deaths has dropped from a peak in February, going against the normal pattern of high cases followed eventually by high deaths. If that trendline continues, it could offer a glimmer of hope for a future scenario that scientists are rooting for: Even as the virus spreads and seems to be hurtling toward becoming endemic, it could become a less lethal threat that can be managed with vaccines that are updated periodically to protect against variants.

“It may be endemic, but not in a life-threatening way,” Dr. Michael Merson, a professor of global health at Duke University and New York University, and a former director of the World Health Organization’s Global Program on AIDS, said. “It may be more like what we see with young kids, a common cold like disease.”

Madeleine Ngo contributed reporting.







England Eases More Coronavirus Restrictions

British Prime Minister Boris Johnson said on Monday that England would move into its next reopening phase May 17, loosening limits on businesses and gatherings, and allowing people to make their own decisions about close contact, like hugging.

The data now support moving to Step 3 in England from next Monday, the 17th of May. This means the Rule of 6 for two households that is applied outdoors will now apply indoors, and the limit for outdoor meetings will increase to 30 from next Monday. You’ll be able to sit inside a pub and inside a restaurant. You’ll be able to go to the cinema and children will be able to use indoor play areas. We’re reopening hostels, hotels, B&Bs; we’ll reopen the doors to our theaters, concert halls and business conference centers. We’ll, unlock the turnstiles of our sports stadia, subject to capacity limits, and from next week, everyone will be able to travel within Britain and stay overnight. We’re updating the guidance on close contact between friends and family, setting out the risks for everyone to make their own choices. This doesn’t mean, we can suddenly throw caution to the winds. In fact, more than a year into this pandemic, we all know that close contact, such as hugging, is a direct way of transmitting this disease. So I urge you to think about the vulnerability of your loved ones, whether they’ve had a vaccine, one or two doses, and whether there has been time for that vaccine to take effect. Remember, outdoors is always safer than indoors, and if you’re meeting indoors, remember to open a window and let in the fresh air.

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British Prime Minister Boris Johnson said on Monday that England would move into its next reopening phase May 17, loosening limits on businesses and gatherings, and allowing people to make their own decisions about close contact, like hugging.CreditCredit…Dylan Martinez/Reuters

One-armed, two-armed, side-armed: once an unceremonious greeting, hugging became a far from casual move during the deadly coronavirus pandemic — replaced by waves, nods and the fist or elbow bump.

But in England, hugging friends and family will be government-approved starting next Monday as the government loosens more restrictions, part of a gradual reopening of society and the economy that began this spring after months of national restrictions. Prime Minister Boris Johnson announced the changes Monday evening.

Mr. Johnson said that England was taking “the single biggest step” on its road out of lockdown, adding that the public should “protect these gains” by being cautious and using common sense. On Monday, England, Scotland and Northern Ireland reported zero coronavirus deaths in a 24-hour period. There were four deaths in Wales.

In this new stage, outdoor gatherings of up to 30 people will be allowed and indoor gatherings will be allowed for up to six people or two households. Indoor dining, movie theaters and museums will also be able to resume operations, among other places. Hostels, hotels and bed and breakfasts will reopen. Mr. Johnson said people would be allowed to make their own decisions about close contact — such as hugs — with family and friends, though he urged social distancing in places like offices, pubs, restaurants and other settings.

After a year where many people abstained from physical contact for fear of infecting themselves or others, news the embrace would be legal was welcomed, though with some mirth. Some joked that they had forgotten entirely how to execute the move. Others took issue with the fact that the government had tried to stop people from hugging at all, or worried that it was too soon to allow such close contact.

“I’m a hugger ,” said the mayor of London, Sadiq Khan, to reporters on Monday, adding that many Londoners were looking forward to relaxation of the ban. “I enjoy people’s company and I know people are ready for me to be hugging again. The first person I’m going to hug is my mum.”

And there were hints that hugs, among other types of physical touch, had already made a comeback.

Still, some experts warned that those wanting to hug their friends with wild abandon should save those arms for their favorite friends.

“It would worry me if we were advocating we can hug all of our friends every time we meet them again,” said Catherine Noakes, a professor from the University of Leeds and member of a government advisory body, to the BBC. Hugging should not be “too frequently,” she advised. “Keep it short, try and avoid being face to face, so perhaps turn your face away slightly, and even wearing a mask could help.”

Mr. Johnson seemed to agree, saying, “I urge you to think about the vulnerability of your loved ones.”

That impulse control may be too much for writer and actor Stephen Fry, who joked on Twitter that while he had largely abided by the rules this past year, he may have a hard time showing restraint. “If you see me in the street — run for it,” he wrote.


Saying evening prayers around the Kaaba in the holy city of Mecca, Saudi Arabia, on Sunday.
Credit…Abdulghani Essa/Agence France-Presse — Getty Images

Saudi Arabia said on Sunday that it would hold the hajj, the annual pilgrimage to Mecca that in normal times draws millions of Muslims to the kingdom, but did not say how many pilgrims would be allowed to come, which countries would be allowed to send them or what coronavirus precautions they would have to take.

The hajj, the ritual all Muslims are supposed to complete at least once, was also held last summer, but under tightly controlled conditions. Only about 1,000 Muslims from Saudi Arabia, including Saudis and foreign nationals living in the kingdom, were able to take part, down from about 2.5 million pilgrims in 2019; the rituals were performed at social distance, with masks, and the pilgrims were not allowed to kiss the Kaaba, the holy shrine at the center of Mecca that pilgrims are supposed to circle as they complete the hajj.

For the first time in living memory — the hajj had not been canceled since Saudi Arabia’s founding in 1932, though it has been restricted at various points in history during plagues, wars and political disputes — the holiest mosque in Islam was nearly empty, with a few carefully spaced circles of pilgrims dressed in white rather than the throngs who normally crowd the Grand Mosque.

The near-cancellation came as a spiritual and emotional blow to Muslims who had been hoping (and saving up) to participate, in many cases for years. Because of the demand, it is normally difficult to secure a hajj visa even in normal times.

It is unclear whether Saudi Arabia, which is balancing the much-needed tourism revenue it stands to gain from the hajj with the public health requirements of the coronavirus pandemic, will again restrict the hajj so tightly.

Fahad Nazer, a spokesman for the Saudi Embassy in Washington, said only that details would “be announced at a later date,” though he noted on Twitter that there would be “preventative & precautionary measures that ensure the health & safety of pilgrims.”

In other news from around the world:

  • Doctors in India are concerned about an increasing number of potentially fatal fungal infections affecting either people who have Covid-19 or those who have recently recovered from the disease. The condition, known as mucormycosis, has a high mortality rate and was present in India before the pandemic.

  • European soccer’s governing body is holding talks with Britain’s government on Monday to discuss moving this month’s Champions League final to London or another city because of travel restrictions. Those rules have made it almost impossible for English fans of the finalists — the Premier League rivals Manchester City and Chelsea — to attend the match, set for May 29 in Istanbul. A decision will most likely be announced within 48 hours.

  • China said on Sunday that it had taken steps to prevent coronavirus cases from entering the country — over the top of the world’s tallest mountain — including the installation of a dividing line on the summit to prevent climbers from the Chinese side and the Nepal side from coming into contact.

  • President Cyril Ramaphosa of South Africa called for the world’s wealthiest nations to waive patents on Covid-19 vaccines, Reuters reported. He added that the world risked having a “vaccine apartheid” if poor nations continue to lack access to shots while wealthier ones vaccinate large portions of their people.

  • The Czech Republic began easing restrictions as new infections fell to the lowest level since August, The Associated Press reported. Last year, the government removed them too quickly leading to a surge in deaths. Shops opened in Prague, the capital, and outdoor mask restrictions were lifted on Monday. Children also headed back to schools on Monday.

Mujib Mashal, Abby Goodnough, Austin Ramzy and Tariq Panja contributed reporting.

A helicopter over the Khumbu glacier, en route to the Everest base camps this month.
Credit…Prakash Mathema/Agence France-Presse — Getty Images

China said on Sunday that it had taken steps to prevent coronavirus cases from entering the country — over the top of the world’s tallest mountain.

Nyima Tsering, head of the Tibet Sports Bureau, told the state-run Xinhua News Agency that control measures would be put in place on Mount Everest, including the installation of a dividing line on the summit to prevent climbers from the Chinese side and the Nepal side from coming into contact.

Last week, a team of Sherpa guides affixed a rope to the summit of Mount Everest from the Nepal side, allowing expeditions to resume for the first time since the pandemic forced a cancellation of attempts last year.

Nepal has this year approved a record 408 permits to climb Everest, even as coronavirus cases have surged in the country and several climbers have been flown from base camp with symptoms of Covid-19.

China, which has approved just 21 permits to climb the mountain from its side this year, has expressed concern about the risk of coronavirus transmission on the mountain. Since the coronavirus first emerged in China in 2019, the country has carried out strict measures to prevent its spread internally and reintroduction from abroad.

The border between Nepal and China crosses the peak of Everest, a small area where a handful of climbers can stand after making a successful ascent. At the summit, 29,031.7 feet above sea level, most climbers already wear masks to supply oxygen and protect themselves from the cold. But China will implement additional steps to reduce the risk of transmission.

In addition to restrictions on the summit, a checkpoint has been installed outside the Chinese base camp. People returning from the Chinese side will have to undergo disinfection, temperature checks and potentially isolation, Xinhua reported.

Stranded migrant workers in India waited to board a train to return to their home regions on Monday after a lockdown was imposed in Chennai.
Credit…Agence France-Presse — Getty Images

Amid a deepening crisis in India, growing numbers of medical experts are adding their voices to a chorus of condemnation of the government’s response and calling for nationwide restrictions to try to limit the horrifying death toll.

Although the official figures are already staggering — more than 350,000 new infections daily this month and nearly 250,000 total deaths — some experts say that the numbers are a vast undercount and estimate that India is on pace to suffer more than one million deaths by August.

Over the weekend, the Indian Medical Association said in a statement it was time for a “complete, well-planned, pre-announced” lockdown to replace the scattershot regional restrictions currently in place across the nation of 1.4 billion.

The association said it was “astonished to see the extreme lethargy and inappropriate actions from the Ministry of Health in combating the agonizing crisis born out of the devastating second wave of the Covid-19 pandemic.”

Several states haven’t waited for a national lockdown. As of Monday Karnataka, Tamil Nadu, Puducherry and Rajasthan had begun lockdowns that will last for two weeks. Delhi, Haryana and Uttar Pradesh extended their lockdowns until next Monday.

Much of the criticism has been directed at Prime Minister Narendra Modi and his government, which allowed hundreds of thousands to gather at a large religious festival and held campaign rallies even as the virus surged.

An editorial published on Saturday in The Lancet, a medical journal, said that Mr. Modi “seemed more intent on removing criticism” on social media than “trying to control the pandemic.”

“India squandered its early successes in controlling Covid-19,” the editorial said.

The medical journal also cited an estimate by the Institute for Health Metrics and Evaluation that projected that India would witness a total of more than a million coronavirus deaths by August — far higher than government figures would suggest.

On May 2, for example, the institute said that total deaths were actually about 642,000, about three times higher than the government’s own number for that date, just over 217,000.

Referring to the possibility that there may actually be a million victims by August, the Lancet editorial said, “If that outcome were to happen, Modi’s government would be responsible for presiding over a self-inflicted national catastrophe.”

On Monday, India recorded more than 365,000 new cases and 3,754 deaths, according to data from the Health Ministry.

Dr. Ashish K. Jha, dean of the School of Public Health at Brown University, wrote in a tweet on Sunday that it was likely that between two to five million people were being infected every day and that India’s “true” coronavirus death toll was “closer to 25,000 deaths” each day.

He based his own calculations, he wrote, on the number of cremations taking place in the country.


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