Cuba Starts Using Its Covid Vaccines Before Completing Trials

HAVANA — Cuba began a mass vaccination campaign on Wednesday in the capital, Havana, where authorities aim to eventually vaccinate 1.7 million people. The campaign is using homegrown vaccines that have not yet been shown to work, an emergency step intended to blunt the rapid spread of the coronavirus.

The country’s decision to deploy unproven vaccines mirrors the early introduction of vaccines in Russia, China and India, where regulators permitted mass vaccination campaigns to begin before the completion of Phase 3 clinical trials, which assess the vaccines’ effectiveness and safety.

In Florida, news reports critical of the Cuban government accused it of jumping the gun and endangering public health. American and European health regulators do not allow vaccines to be introduced, even for emergency use, until Phase 3 clinical trials are completed.

Though Cuba’s daily coronavirus case counts remain low by Latin American standards, they have spiked alarmingly in recent months. The island, which reported 12,225 confirmed cases in all of 2020, saw 31,465 confirmed cases in April 2021 alone.

hard for Cuba to do business with foreign suppliers and complicating international humanitarian initiatives to donate syringes to the island, which needs about 20 million more to vaccinate the whole country.

Of the 90 coronavirus vaccines around the world currently in clinical trials, five were developed in Cuba, the smallest country to develop and produce its own vaccines.

“We will probably be the first country to immunize its whole population with its own vaccine,” said Dr. Eduardo Martínez, president of BioCubaFarma, the state conglomerate overseeing vaccine development and production.

View Source

Covid Live Updates: Leaders of Biotech Firm That Ruined Vaccines Will Testify to Congress

opened a sprawling inquiry into Emergent’s manufacturing failures, and whether the company used its contacts with the Trump administration to land hundreds of millions of dollars in coronavirus vaccine contracts.

“Emergent’s actions wasted American taxpayer dollars and reduced the number of doses available for global vaccination efforts,” Representative Jim Clyburn, Democrat of South Carolina and the subcommittee’s chairman, said in a statement to The Times. He said that Congress “is looking for answers and they are long overdue.”

An investigation by The New York Times, published in March before the firm’s vaccine manufacturing troubles were known, examined Emergent’s aggressive lobbying tactics and lucrative relationship with the federal government.

The hearing will put an unwelcome spotlight on the company, which kept a low profile over the past two decades as it cornered the market on sales of anthrax vaccines and other bioterror-related products to the Strategic National Stockpile, the nation’s emergency medical reserve.

Emergent’s stock performed so well in 2020 that Mr. El-Hibri cashed in shares and options worth over $42 million, corporate filings show. Mr. Kramer, who has boasted to investors that “extensive relationships across multiple agencies within the federal government” helped build the company, took home a $1.2 million cash bonus and $2 million in stock awards.

Credit…Joe Andrucyk/Office of Governor Larry Hogan

In an interview with CNN on Wednesday morning, Mr. Clyburn indicated that the committee was also scrutinizing the executives’ market moves. “They all made millions in stock transactions while they seem to be hiding stuff from the public,” he said.

The Times reported last month that workers at Emergent’s Baltimore plant had accidentally conflated the ingredients of two coronavirus vaccines, one by Johnson & Johnson and the other by AstraZeneca. The error resulted in the loss of up to 15 million Johnson & Johnson doses, and a recent inspection by the Food and Drug Administration said that more doses may have been exposed to contamination.

In a statement on Wednesday, the company said that it had responded to the F.D.A.’s observations with a “comprehensive quality enhancement plan” and had “already started making improvements.”

On a recent call with investors, Mr. Kramer announced a management shake-up and took “full responsibility” for the manufacturing problems, acknowledging that the “loss of a batch for a viral contamination is extremely serious, and we treated it as such.” But he also said that Emergent had taken on a “herculean task” in a crisis.

In letters to the two Emergent executives last month, Mr. Clyburn and Representative Carolyn Maloney, Democrat of New York and chairwoman of the House Oversight and Reform Committee, demanded a slew of documents, including any correspondence between the company and Dr. Robert Kadlec, President Trump’s assistant secretary for preparedness and response, who previously consulted for the company. In interviews, Dr. Kadlec has said his consulting work, in 2013 and 2014, was limited and did not affect contracting decisions.

“Emergent has been in the news a lot lately, and that’s frankly not something we’re used to,” Mr. Kramer wrote in a commentary posted on the company’s website last month. “Until a year ago we were a little-known company that does our work behind the scenes.”

The company is trying to burnish its image with television and digital advertising, as part of a campaign it is calling “We Go.” The 30-second ads feature images of white-clad lab technicians and spotlight some of the company’s lesser-known work manufacturing cholera vaccines and medicine used to treat opioid overdoses, as well as its Covid-19 work.

Emergent’s plant in Baltimore is one of two federally designated Centers for Innovation in Advanced Development and Manufacturing, funded in part by taxpayers. In June 2020, the federal government awarded Emergent a $628 million contract, largely to reserve space for coronavirus vaccine manufacturing, despite staffing and quality concerns.

After The Biden administration responded to the potential contamination last month by putting Johnson & Johnson in charge of the Baltimore facility and moving out AstraZeneca. Doses made at the plant have not been cleared for use in the United States, and millions of shots made in Baltimore and sent overseas have also been put on hold.

Medical workers tending to a coronavirus patient in an emergency room in New Delhi last week.
Credit…Adnan Abidi/Reuters

A virus variant that has been spreading rapidly in India and designated a variant of concern by the World Health Organization might be more contagious than most versions of the coronavirus, the agency said in a report it published on Tuesday evening.

The W.H.O. emphasized in its report that it wasn’t yet clear how much the variant, known as B.1.617, had contributed to the devastating surge that has crushed India in recent weeks. It cautioned that India, like many countries, is only sequencing a tiny fraction of positive samples, and that with so little surveillance, it’s difficult to make firm conclusions about B.1.617.

The W.H.O. study comes amid growing condemnation of the Indian government’s response to its ferocious virus wave and calls for nationwide restrictions to try to limit the death toll, as hospitals are overrun and crematories burn nonstop.

India recorded more than 360,000 new cases on Wednesday and more than 4,200 deaths, the country’s highest daily death toll since the pandemic began. India has now reported more than 250,000 deaths from the virus, although experts believe that the true toll is far higher.

Experts also caution that it is not yet clear just how much of a factor B.1.617 has played in the explosion of cases in India. They point to a perfect storm of public health blunders, such as permitting enormous political rallies and religious festivals in recent months. It’s possible that the variant is being lifted up by the surge, rather than the other way around.

The W.H.O. speculated that another variant known as B.1.1.7, first identified in Britain and now dominant in the United States, might also be driving the swell in cases.

It’s not yet clear whether B.1.617 causes more severe Covid-19. Anecdotally, doctors in India are reporting higher numbers of young people and children testing positive for the virus and more patients with severe disease requiring oxygen support. But until more genetic sequencing is done, it’s impossible to know if the variant is to blame.

Stacia Wyman, a genomics scientist at the University of California, Berkeley, said that the W.H.O. had made the right decision. She pointed to the fact that the variant had already spread to at least 49 countries. “This appears to be posing the biggest threat right now in terms of transmissibility, with many countries reporting increasing trajectories of the B.1.617 variant,” she said.

B.1.617 is the fourth variant of concern recognized by the W.H.O. The others include B.1.1.7; B.1.351, which swept through South Africa; and P.1, which has devastated Brazil.

B.1.617 first came to light in October 2020. It had a number of mutations, some of which have been proved worrisome in other variants. Preliminary studies on the mutations suggest that some of them might give the coronavirus a tighter grip on cells, increasing their chances of a successful infection.

Other mutations could make it more difficult for antibodies produced by infections with other variants to stick to them. Studies on antibodies produced by vaccinated people also suggest that they work less successfully against B.1.617. Experts expect that most vaccines will remain effective against the variant.

W.H.O. researchers determined that B.1.617 is spreading fast in India, making up over 28 percent of samples from positive tests. The shift suggests that B.1.617 has a higher growth rate than other variants circulating in India, with the possible exception of B.1.1.7. And B.1.617 has been growing rapidly in Britain.

Gagandeep Kang, a pre-eminent Indian virologist, said there was not enough data to conclude whether either variant was contributing to India’s deadlier second wave.

“There is some conflicting data regarding the B.1.1.7 variant, which seems to indicate in some studies that it does cause more severe disease, in other studies not,” said Dr. Kang, the executive director of the Translational Health Science and Technology Institute in India.

Based on reports from hospitals, Dr. Kang said, it appeared that B.1.617 was causing more severe disease but that, again, there was insufficient data to draw conclusions. She said that real-time genetic information would be needed to determine whether B.1.617-infected people needed more oxygen.

Officials in India are trying to track how many fully vaccinated people have fallen ill. If an unusual number of these so-called breakthroughs are caused by a variant such as B.1.617, then that could point to the variant’s ability to evade a vaccine.

Pramod Sawant, chief minister of Goa, India, on the left and wearing personal protective gear, visited Covid-19 patients at a hospital in Panjim, a city in the state, on Tuesday.
Credit…Goa Chief Minister’s Office, via Agence France-Presse — Getty Images

NEW DELHI — Just a few months ago, the southwestern state of Goa was welcoming tourists from across the rest of India who were drawn to its picture-perfect beaches, an ideal source of relief from coronavirus rules in other regions.

Group celebrations, many without masks, were common. Life appeared to have gone back to normal.

But it did not last.

With India in the grip of a devastating coronavirus outbreak, 26 people died at the state-run Goa Medical College and Hospital on Tuesday morning, possibly because of an oxygen shortage, one official said.

“Due to interrupted supply of oxygen, we feel that between 2 a.m. and 6 a.m. many people are dying in G.M.C.,” the health minister for Goa, Vishwajit Rane, told The Times of India. He also called for a High Court inquiry to investigate the cause of the deaths.

Goa reported 75 deaths in total on Tuesday, its highest daily toll of the pandemic, and there were over 32,800 new daily infections in the state, which has a population of about 1.5 million. Officially, India has surpassed 250,000 total reported deaths from Covid.

Contradicting the health minister, Pramod Sawant, Goa’s chief minister, who visited the hospital, said that there was “no scarcity” and that the state had “abundant supplies of oxygen.” Mr. Rane said the chief minister might be “misguided.”

Goa has been reporting one of the highest infection rates in the country for at least a week.

Mr. Rane said in an interview with CNN last week, “Opening up of tourism without any restrictions in December has led to this situation.”

Goa has also created headlines for approving the use of ivermectin, an anti-parasite drug, in the treatment and prevention of Covid-19. The World Health Organization has said that there is not enough evidence to suggest that the drug reduces mortality in coronavirus patients.

On Monday, Mr. Rane announced on Twitter that the state government would make the drug available for everyone over 18 as a prophylactic.

Patients will be treated with ivermectin for a period of five days, Mr. Rane said, adding that the government would make the drug available at hospitals and primary health centers for people to “start the treatment immediately, irrespective of any symptoms.”

The W.H.O. has warned against the use of the drug, except in clinical trials.

“Safety and efficacy are important when using any drug for a new indication,” said Dr. Soumya Swaminathan, the W.H.O. chief scientist, in a post about ivermectin on Tuesday.

Marisol Gerardo, 9, is held by her mother as she gets a second dose of the Pfizer vaccine during a clinical trial for children at Duke Health in Durham, N.C., in April.
Credit…Shawn Rocco/Duke Health, via Reuters

On May 4, Dr. Hina Talib, who goes by the handle @teenhealthdoc on Instagram, asked the parents among her 33,000 followers if they were hesitant to get the coronavirus vaccine for their 12- to 15-year-olds, and if so, why. Dr. Talib, a physician in the adolescent medicine division at the Children’s Hospital at Montefiore in New York, got 600 messages in response.

More often than not, Dr. Talib said, the parents had already had the Covid-19 vaccine, and would preface their message with: “I’m not an anti-vaxxer or an anti-masker. I’m just worried.”

Although trials have shown no serious safety concerns for children thus far, some recent polls show that only about 30 percent of parents nationwide say they would get their children vaccinated right away. Parents of infants and preschoolers expressed even more anxiety about the vaccine than parents of teenagers.

These parents tend to be concerned about the vaccine affecting puberty and future fertility for their children, and its possible impact on allergies and side effects. Their fears are a key hurdle for U.S. efforts to expand vaccinations to younger teens.

Unloading an oxygen cylinder as a patient lay outside the emergency ward of a hospital in Kathmandu, Nepal, on Monday.
Credit…Niranjan Shrestha/Associated Press

As hospitals in Nepal strain to cope with one of the world’s fastest-growing coronavirus outbreaks, relief groups in the Himalayan nation are asking mountain climbers to hand over their used oxygen cylinders so that they can be refilled for Covid-19 patients.

The unusual appeal reflects the strange duality in Nepal: While hundreds of foreign climbers are attempting costly expeditions to the summits of Mount Everest and other peaks, the impoverished nation down below is facing urgent shortages of hospital beds, medical oxygen, coronavirus test kits and other supplies.

Expedition operators are preparing to airlift thousands of cylinders from the Himalayas as expeditions are completed this month, the culmination of the climbing season. Kul Bahadur Gurung, general secretary of the Nepal Mountaineering Association, estimated that tour companies would be able to provide at least 4,000 cylinders by the first week of June.

“We are asking them not to leave even a single oxygen cylinder in the mountains,” Mr. Gurung said.

Climbers attempting to reach the top of Everest, the world’s tallest peak, and other mountains carry oxygen to help them breathe in the thin air. Although Nepal prohibits leaving equipment behind in the mountains, canisters are sometimes left buried in the snow by exhausted climbers or stashed by expedition companies for later use.

Cylinders used in mountaineering are smaller to those typically found in intensive-care wards, but Mahabir Pun, a prominent Nepali scientist who is helping to lead the cylinder drive, said that they could be used by patients who cannot find a hospital bed or who are being treated at home.

“I.C.U. beds are already filled with critical Covid patients, so we want to distribute these portable expedition cylinders with regulators for those patients staying in home isolation,” Mr. Pun said.

Nepal’s outbreak has surged in recent weeks, most likely fueled by the virus’s catastrophic surge in India, with which it shares a long, porous border. On May 1, Nepal reported 26 deaths from the virus. On Tuesday, the official death toll was 225.

Doctors say that a shortage of medical oxygen is a factor in many of the deaths. Many hospitals have stopped admitting new Covid-19 patients, citing a lack of oxygen. Wealthy families are airlifting their loved ones by chartered helicopter to cities where they can find intensive-care beds. Other patients are being treated in makeshift emergency facilities set up in parking lots and other open spaces.

With almost half of Nepal’s coronavirus tests coming back positive, health experts warn that the worst is yet to come.

China has pledged to provide Nepal with 20,000 oxygen cylinders and 100 ventilators, the first batch of which arrived on Tuesday.

Expedition companies are stepping in with smaller donations. Mr. Gurung’s group said that he was sending five dozen cylinders, along with a few more from a local mountaineering museum, to hospitals treating coronavirus patients.

Mingma Sherpa, chairman of Seven Summit Treks, Nepal’s largest expeditions operator, said that he planned to ship as many as 500 cylinders used in expeditions to Everest and other peaks soon after climbers descended to base camps.

“My only condition is that those cylinders should be used for poor and helpless people rather than V.I.P.s,” he said, adding: “It’s our responsibility to help the government during these trying times. We will do it happily.”

Taking temperatures at a vaccination site in Bangkok on Tuesday.
Credit…Lillian Suwanrumpha/Agence France-Presse — Getty Images

As a resurgent coronavirus threatens countries across Southeast Asia, the health authorities in Thailand are working to contain an outbreak that is ripping through the tight-knit community of gemstone traders in the southeastern reaches of the country near the border with Cambodia.

The town of Chanthaburi — which has a long history as a center of the country’s business in rubies, sapphires and other stones — is at the heart of the outbreak, which has infected at least 166 in the community of traders from Africa who work in the country. At least 103 Thais in the town have also tested positive as a result of the latest outbreak, officials reported.

The cluster of cases comes as Thailand battles its worst outbreak since the pandemic began. For nearly three weeks, the country has averaged about 2,000 new cases a day — more than double its worst peak in January. The largest outbreak has been reported in Bangkok, which is under a partial lockdown.

On Wednesday, the government reported 34 deaths, a record, and 1,983 cases. One of those who died was from Finland.

Thailand was among the most effective countries last year in controlling the virus, but it has been slow to contain outbreaks this year and has lagged behind other countries in procuring vaccines.

Now, with the latest surge in cases, it is scrambling to obtain shots and to develop a mass inoculation program.

Some officials have declared that foreigners will not be vaccinated despite earlier outbreaks among migrant workers from Myanmar and now among the African gemstone traders. Other officials have said that Thailand will inoculate foreigners but have not provided specifics.

Thailand, which has a population of about 70 million, is home to more than two million foreigners who live in the country legally. More than two million more are believed to live in the country illegally.

Over the years, the gem business has attracted traders from several predominantly Muslim countries in Africa, including Gambia, Guinea and Mali. Many of them have settled in Thailand, married Thai wives and import gemstones from Africa.

Sankung Kongeh, a trader from Gambia, said members of the African community gathered daily at their offices and at the market, where they work, talk and eat together. During Ramadan, which began April 12, many also have prayed together, he said.

It is precisely that kind of close social contact that has fueled outbreaks around the world, but Mr. Kongeh discounted the group prayers as a significant risk.

“The possibility of the Covid spread has nothing to do with praying together,” said Mr. Kongeh, who recently tested negative. “It’s during the time hanging out at the office where we have the AC on, the door closed, and we chat with each other, drinking hot tea. There could be 10 or 12 of us sitting together. We don’t talk to each other during prayer.”

“Current institutions, public and private, failed to protect people from a devastating pandemic,” according to new reports delivered to the World Health Organization today. The Minneapolis-St. Paul International Airport in Minneapolis last November.
Credit…Tim Gruber for The New York Times

The next time the world faces an outbreak of a fast-spreading and deadly new pathogen, governments must act swiftly and be ready to restrict travel or mandate masks even before anyone knows the extent of the threat, according to a pair of new reports delivered to the World Health Organization.

The studies are intended to address missteps over the past year that led to more than 3.25 million deaths, some $10 trillion in economic losses and more than 100 million people pushed into extreme poverty.

“Current institutions, public and private, failed to protect people from a devastating pandemic,” concluded one of the reports, released on Wednesday, which called the Covid-19 pandemic “the 21st century’s Chernobyl moment.”

“Without change,” it said, these institutions “will not prevent a future one.”

The reviews, released in advance of this month’s meeting of the W.H.O.’s governing assembly, were written by appointees who donated countless hours in the midst of their own countries’ pandemic fights to interview hundreds of experts, comb through thousands of documents, gather data and seek counsel from public and private institutions around the world.

Pandemics, the authors concluded, are an existential threat on the order of a chemical or nuclear weapon, and preparing for them must be the responsibility of the highest levels of political leadership rather than only health departments, which are often among the least powerful of government agencies.

Aurora Duran, 86, is hugged by her granddaughter during a visit from her family at a long-term-care nursing community in Fort Stockton, Tex.. in April.
Credit…Tamir Kalifa for The New York Times

Epidemiologists in the United States are starting to hug again, running errands, gathering outdoors with friends and getting haircuts.

In a new informal survey this month by The New York Times, 723 epidemiologists responded to questions about how they were navigating this in-between phase of the pandemic, when vaccines have become widespread and cases are declining but herd immunity is not assured and Covid-19 remains a threat.

More than at any time in the past year, most are feeling hopeful that Covid-19 will eventually become just another risk in daily life, but not one that paralyzes us.

Nevertheless, their advice was to hold on to most precautions just a bit longer.

“There is a strong likelihood that we will experience unexpected problems due to moving about as if the Covid pandemic was no longer a threat,” said Jana Mossey, an epidemiologist who retired from Drexel University.

“It is not ‘one size fits all,’” said Alicia Riley, a sociologist and epidemiologist at the University of California, San Francisco, expressing a version of the profession’s unofficial motto: It depends. “How safe it is depends on the local levels of community transmission.”

Governor Henry McMaster of South Carolina signing a bill on April 22 requiring schools to provide in-person classes five days a week starting on April 26, in Columbia, S.C. 
Credit…Jeffrey Collins/Associated Press

Parents in South Carolina will be able to opt their children out of mask requirements in public schools, effectively ending mask mandates for schools throughout the state, according to an executive order signed by the governor that defies Centers for Disease Control and Protection guidance.

The order signed on Tuesday by Gov. Henry McMaster, a Republican, also prevented South Carolina’s local governments from using previously issued orders or states of emergency to enforce mask mandates and barred the use of “vaccine passports” in the state. South Carolina was one of several states that never had a statewide mask mandate, though several counties and cities imposed their own.

At least one school district said its legal counsel was reviewing the order. Doing away with masks in schools conflicts with C.D.C. guidance, which recommends universal masking combined with at least three feet of social distancing.

“Everybody knows what we need to do to stay safe — including wearing a mask if you’re at risk of exposing others — but we must move past the time of governments dictating when and where South Carolinians are required to wear a mask,” Mr. McMaster said in a statement, noting the availability of vaccines and falling coronavirus cases. “Maintaining the status quo ignores all of the great progress we’ve made.”

Mr. McHenry’s announcement comes as leaders in other states and cities have announced a rollback of restrictions and vaccines have become available to any adult. Mayor Muriel Bowser of Washington said on Monday that most of the city’s restrictions, including capacity limits, time restrictions and limits on types of activities would be lifted on May 21. Capacity limits on bars, nightclubs, and large sports and entertainment venues would be lifted June 11.

Mayor Jim Kenney of Philadelphia announced on Tuesday that all restrictions except the mask mandate would be lifted on June 11. The announcement came a week after Governor Tom Wolfe of Pennsylvania said that all restrictions related to gatherings, businesses and restaurants would be lifted on May 31 and that the statewide mask mandate would be lifted when 70 percent of adults in the state had been vaccinated. But the announcement came with the caveat that municipalities and school districts could continue or implement stricter mitigation efforts, despite the state’s easing restrictions.

The governor directed the Department of Health and Environmental Control and the Department of Education to develop a standardized form for opting out, the statement said.

Buying protective face masks following a small outbreak of coronavirus disease in Taipei, Taiwan, on Wednesday.
Credit…Ann Wang/Reuters

Growing concerns in Taiwan about a small but worsening coronavirus outbreak drove a sharp intraday plunge in its stock market on Wednesday, as investors worried about new government restrictions on businesses in a place that has largely escaped the pandemic.

On Wednesday morning, Taiwan’s health minister, Chen Shih-chung, said that the island’s new outbreak has reached a “very severe stage” and that restrictions could be upgraded in “the coming days.” He spoke after the government reported 16 new cases of local infection on Wednesday and seven on Tuesday.

The Taiwan Stock Exchange weighted index slumped as much as 8.6 percent intraday following the news, a nearly 13 percent loss from its April peak. The market regained some ground later in the day and finished down 4.1 percent.

Taiwan has been a rare success story in a pandemic-stricken world. The island democracy threw up its borders when the pandemic first began to spread from mainland China and has heavily limited travel. It has recorded only 1,210 total cases, according to a tally by The New York Times.

But the authorities haven’t been able to trace the handful of cases that have popped up in recent days, raising questions about whether the government will limit the number of people who can gather within restaurants or other businesses.

Taiwan instituted some Covid-related restrictions on Tuesday, the first in a long time. It suspended large events, limiting outdoor gatherings to 500 people and indoor gatherings to 100 people. On Wednesday morning, the health minister said that the restrictions might be stiffened within days.

View Source

Covid-19 Vaccines: Novavax Reports More Delays

Novavax, one of the first players in the race to vaccinate the world against Covid, delivered disheartening news on Monday, saying that its highly protective vaccine would not be authorized in the United States or Britain until at least July, and that it would not reach peak production until the end of the year.

The delays, announced during an earnings call with investors, are the latest setback for the little-known Maryland company, which was granted up to $1.6 billion from the U.S. federal government last year and whose product has shown robust results in clinical trials. Despite these wins, the company has struggled to demonstrate that it can deliver on its promise to supply the world with 2 billion doses this year. Novavax has never brought a vaccine to market in its 34-year history.

On the call, the company’s president and chief executive, Stanley C. Erck, said that the regulatory and manufacturing hurdles causing the delay have now been resolved. “Nearly all of the major challenges have been overcome, and we can clearly see the light at the end of the tunnel,” he said.

Investors did not appear to agree: By Tuesday morning, the company’s stock had fallen to $133.86, down nearly 17 percent, although it rebounded somewhat later in the day.

finalized a deal with Gavi, a public-private global vaccine partnership, to supply 1.1 billion doses of its shot to low- and middle-income countries. Novavax has struck other deals with countries like South Korea, Japan and Australia, and has set up agreements with eight production plants around the world.

In January, the company estimated that it would hit its full production capacity of 150 million doses a month by the middle of this year, a prediction it later revised after facing a shortage of supplies like filters and the giant single-use bags that are used in vaccine manufacturing. On Monday, the company delayed its estimate again, saying it expected to reach production of 100 million doses a month by the end of the third quarter, and to make 150 million a month by the fourth quarter.

One of its major manufacturing partners, the Serum Institute in India, has faced its own production and geopolitical challenges. A fire at the facility earlier this year reduced its capacity, and in April, Serum’s chief executive, Adar Poonawalla, called out the United States for restricting access to raw vaccine ingredients. And though Novavax’s deal with Serum is intended to supply the rest of the world through its arrangement with Gavi, the Indian government has banned exports of vaccines from the country as it struggles with a deadly second wave of Covid-19.

which is tracking global vaccine deals. “I think particularly for countries in South and Southeast Asia, as well as countries in Africa, it is hard to overstate the impact that this is having.”

Regulatory hurdles have also set Novavax back. On Monday, company executives said that a now-resolved issue with an “assay” — a test that was needed to confirm that their product can be consistently manufactured at commercial scale across multiple production plants — was delaying regulatory approvals around the world, and that countries like Britain and the United States would not grant authorization until at least July. Company officials once said they hoped to gain authorization for their vaccine in April.

persuaded Novavax to set up a trial there last year in part by promising speed in clinical development and regulatory approval. But time is running out: About two-thirds of British adults have received a first dose of a coronavirus vaccine, most made by AstraZeneca, and every adult is expected to be offered one by the end of July.

The vaccine’s role in Britain depends in part on how quickly Novavax can start distributing its shot. A British factory making the vaccines has said that it would be ready by the summer. The country has recently turned away from the AstraZeneca shot in younger people because of the risk of very rare blood clots, leaving room for Novavax to be an alternative for people under 40.

The country is also studying the effects of administering a second dose of the Novavax vaccine in people who have already received a first dose from either Pfizer or AstraZeneca.

the company was on the verge of closing after a major trial failure for another vaccine, and it was forced to sell off its manufacturing facility to raise money.

Last year, the Trump administration placed a major bet on the tiny company as part of its Operation Warp Speed project, signing a $1.6 billion contract for delivery of 110 million doses by early this year. In April, the total amount of the deal was increased to $1.75 billion, according to Novavax’s financial filings. The company’s large trial in the United States and Mexico has still not been completed, although executives said on Monday that they expected results from that study “in a few weeks.”

Novavax officials said they now did not expect to deliver those doses until the end of this year or early 2022. A spokeswoman for Novavax said there was no penalty for later delivery in its contract with the U.S. government.

Novavax’s spotty track record does not offer confidence that it can rise to the challenge of producing billions of doses, said Les Funtleyder, a health care portfolio manager at E Squared Capital Management who invests in domestic and emerging markets. “It seems they were really unprepared for a challenge of this magnitude,” he said.

Recent news of internal turnover — such as the departure last month of Novavax’s chief financial officer, five months after taking the role, for personal reasons — does not help, Mr. Funtleyder said. “It’s a bad look,” he said.

children older than 12, in an effort to catch up to Moderna and Pfizer, which have already tested their products in that age group.

The vaccine can also be stored at normal refrigeration temperatures, without the freezing temperatures required by Pfizer and Moderna’s vaccines.

“By the end of 2021 there will still be a great need for safe and effective vaccines that can travel well,” said Ms. Taylor, of Duke University. “Novavax looks like it can fit that description.”

Dr. Saad B. Omer, the director of the Yale Institute for Global Health, noted that when concerns were raised over the Johnson & Johnson and AstraZeneca vaccines because of links to blood clots, countries with multiple vaccines available were able to switch to other options.

“It’s good to hedge our bets,” he said. “If we want to avoid, for example, body blow after body blow to low-income countries in many parts of the world that has an impact on everyone, we need to vaccinate a huge chunk of the world.”

Benjamin Mueller and Noah Weiland contributed reporting.

View Source

South African Filmmakers Move Beyond Apartheid Stories

JOHANNESBURG — One of South Africa’s top film producers squinted at a monitor as a hush settled over the crew. Cameras zoomed in on an actress playing a dealer of fine art — chicly dressed in a pencil skirt made from bold African textiles — who offered a coy smile as an old flame stepped into her gallery.

It’s the opening scene of a new Netflix movie about high-powered Black women, wealth and modern city life in Johannesburg — one in a flood of productions from a new generation of South African filmmakers. They are bent on telling their own stories on their own terms, eager to widen the aperture on a country after a generation of films defined by apartheid, poverty and struggle.

“We call it the legacy exhaustion, the apartheid cinema, people are exhausted with it,” Bongiwe Selane, the producer, said a few days later in the editing studio. “The generation now didn’t live it, they don’t really relate to it. They want to see stories about their experiences now.”

one of the most unequal in the world, where wealth is still concentrated mostly in the hands of whites and a small Black elite.

But in recent years, the country has also undergone major demographic and economic shifts. The first South Africans who grew up after apartheid are now adults, asserting their voices on social media and in professional workplaces. And a growing Black middle class has been eager to see itself reflected onscreen — and showing it with their wallets.

box office expectations for locally made romantic comedies.

A year later, “Happiness is a Four Letter Word” — the prequel to Ms. Selane’s latest film that opens with the art gallery scene — outperformed several Hollywood releases in South African movie theaters on its opening weekend.

The movie revolves around three bold women navigating a new South Africa. There is Princess, a serial dater and owner of a trendy art gallery; Zaza, a glamorous housewife having an illicit love affair; and Nandi, a high-powered lawyer who gets cold feet on the cusp of her wedding.

“Audiences would come up to me to tell me how they also had a guy who broke their heart and they want to see that, to watch something where apartheid is not in the foreground,” said Renate Stuurman, who plays Princess. “It can be in the background, surely, it’s what brought us here, but people were happy to be distracted.”

according to Digital TV Research, an industry forecaster. For Netflix, the investment is part of a larger push to acquire a generation of Black content.

Nollywood. Nigerian filmmakers have churned out thousands of movies — many produced with just a few thousand dollars and one digital camera — since the late 1990s.

Nollywood films won fans across English-speaking Africa, but South Africa is chipping away at its dominance, industry leaders say.

For the past two decades, South Africa has hosted major Hollywood studios drawn to its highly skilled workers and government-issued rebate on all production costs spent in the country.

Cape Town’s streets were transformed into Islamabad for the fourth season of Homeland; studios constructed models of Robben Island for “Mandela: Long Walk to Freedom;” and crews flew helicopters, crashed cars and set off massive explosions in downtown Johannesburg for “Avengers: Age of Ultron.” Of the roughly 400 films made in South Africa between 2008 and 2014, nearly 40 percent were foreign productions, according to the National Film and Video Foundation, a government agency.

“Blood Psalms,” a series for Showmax, employs massive sets reminiscent of “Game of Thrones,” green screens to concoct magical powers, and elaborate costumes of armor and golden crowns.

Inside an editing suite in Johannesburg one recent morning, Mr. Qubeka chatted with an editor slicing together shots for the show, about a queen battling a world-ending prophecy — a plot drawn from African mythology.

“The true revolution,” Mr. Qubeka said, “is that we as South Africans are being sought out for our perspective and our ideas.”

View Source

The U.S.and Europe debate how to get vaccines to countries that need them most.

A global debate is heating up over how to get Covid-19 vaccines to the nations most in need.

The United States supports an effort to suspend intellectual property protections on Covid-19 vaccines, and European countries say that richer nations should begin exporting more of their vaccine supply to poorer ones.

The European Union — whose approval is needed for any waiver of vaccine patents — said on Thursday that it would consider the Biden administration’s proposal. But Germany, the bloc’s largest economy, said that pushing pharmaceutical companies to share vaccine patents could have “significant implications” for the production of vaccines. The European Commission signaled it wouldn’t support the U.S. proposal.

“The limiting factor in vaccine manufacturing is production capacity and high-quality standards, not patents,” a spokeswoman for Chancellor Angela Merkel of Germany said in a statement.

Europe’s position emphasized the challenges of winning support for the waivers at the World Trade Organization, where the bloc wields significant influence, and where unanimous approval would be needed for any measure to suspend patents.

inoculations have lagged behind those of richer countries.

Until the Biden administration’s announcement this week, the United States had been a major holdout at the W.T.O. over a proposal by India and South Africa to suspend some intellectual property protections. The move could give drugmakers access to the trade secrets of how the vaccines are made.

The pharmaceutical industry has argued that suspending patent protections would undermine risk-taking and innovation.

The debate arises amid a growing divide between wealthy nations that are slowly regaining normal life, and poorer countries that are confronting new and devastating outbreaks.

In India, which is suffering the world’s worst outbreak since the start of the pandemic, only 2.2 percent of the population is fully vaccinated, according to a New York Times database. South Africa has fully vaccinated less than 1 percent of its people. By contrast, vaccinations are slowing down in the United States — where one-third of people are fully inoculated — as they begin to pick up in Europe.

Even if a waiver receives support from the trade body, it alone would not increase the world’s vaccine supply. Large drug manufacturers in India and elsewhere would need extensive technological and other support to produce doses, experts say.

View Source

Covid-19 Live Updates: Pfizer Seeks Full F.D.A. Approval for Its Vaccine

their Covid-19 vaccine for use in people 16 and older. The vaccine is currently being administered to adults in America under an emergency use authorization granted in December.

The approval process is likely to take months.

The companies said in a statement on Friday that they had submitted their clinical data, which includes six months of information on the vaccine’s safety and efficacy, to the F.D.A. They plan to submit additional material, including information about the manufacturing of the vaccine, in the coming weeks.

“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. government,” Dr. Albert Bourla, Pfizer’s chief executive, said in the statement. “We look forward to working with the F.D.A. to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”

As of Thursday, more than 134 million doses of the vaccine had been administered in the United States, according to the Centers for Disease Control and Prevention. Full approval would allow Pfizer and BioNTech to market the vaccine directly to customers.

It could also make it easier for companies, government agencies and schools to require vaccinations. The Equal Employment Opportunity Commission said in December that employers could mandate vaccination, and legal experts have generally agreed.

Many companies have been hesitant to require the vaccines, especially while they have only emergency authorization, which is designed to be temporary. Some institutions, like the University of California and California State University systems, have said that they would do so only after a vaccine has full approval.

Full approval could also prompt the U.S. military, which has had low uptake of Covid-19 vaccines, to mandate vaccinations for service members.

If the F.D.A. grants full approval, it could also help raise confidence in the vaccine. The pace of vaccination has slowed in the United States in recent weeks, and a recent national survey indicated that most people in the country who planned to get the shots had already done so.

The agency is also expected to issue an emergency authorization for use of the Pfizer-BioNTech vaccine in 12- to 15-year-olds next week. The companies have said that they plan to file for emergency authorization for 2- to 11-year-olds in September.

Moderna plans to apply for full approval for its Covid-19 vaccine this month, the company said during its quarterly earnings call on Thursday.

Director of the Center for the National Center for Immunization and Respiratory Diseases Dr. Nancy Messonnier spoke in Washington in January 2020.
Credit…Amanda Voisard/Reuters

Dr. Nancy Messonnier, who famously warned the nation early last year that the coronavirus would upend their lives, resigned from her position at the Centers for Disease Control and Protection on Friday.

Dr. Messonnier’s resignation is effective May 14. She is taking on a new role as an executive director at the Skoll Foundation, a philanthropical organization based in Palo Alto, Calif., she told staff in an email on Friday.

Her exit may augur more changes at the agency. Reports have circulated for weeks that the C.D.C.’s new director, Dr. Rochelle Walensky, planned to completely reorganize the division Dr. Messonnier led.

“My family and I have determined that now is the best time for me to transition to a new phase of my career,” Dr. Messonnier wrote in the email to staff.

Dr. Messonnier began her career in public health in 1995 with a stint in the prestigious Epidemic Intelligence Service. She has since held a number of leadership posts in the C.D.C. Since 2016, she has served as director of the National Center for Immunization and Respiratory Diseases, the C.D.C. division responsible for managing influenza and other respiratory threats.

In late 2019, she became the agency’s lead in responding to the coronavirus, and initially shared a stage with President Trump at briefings about the coronavirus.

She fell out of favor with President Trump and sent stocks tumbling after she sounded a dire alarm about the coronavirus, saying it would disrupt the lives of every American.

“It’s not a question of if this will happen but when this will happen and how many people in this country will have severe illnesses,” she said on Feb. 25, just as Mr. Trump was boarding Air Force One in New Delhi for his flight home.

Soon after that, she stopped appearing at briefings of the White House and of the C.D.C.

Patients with Covid-19 in the emergency ward at the Holy Family hospital in New Delhi on Thursday.
Credit…Rebecca Conway/Getty Images

India’s worsening coronavirus outbreak has spread far outside its cities to rural areas with poor health care infrastructure and limited testing capacities, doctors and experts say.

One factor behind the surge of cases, they believe, is a series of recent campaign rallies held without social distancing.

The state of West Bengal, where Prime Minister Narendra Modi’s party lost an election last week after more than a month of campaigning to vast crowds, is recording the highest rate of positive coronavirus tests in the country. More than 31 percent of tests in the state are now coming back positive.

“There is a clear pattern here: States that went through elections and where large rallies were held are witnessing a huge rise in cases,” said Dr. Thekkekara Jacob John, a senior virologist in the southern state of Tamil Nadu.

In Uttar Pradesh, India’s most populous state, 1,028 new coronavirus cases and four deaths were recorded on March 26. On April 29, after campaigns for local village council elections were held, there were 35,104 cases and 288 deaths. A teachers’ union in the state said that 577 teachers and support staff members who were on duty as election workers had died of Covid-19.

The country’s cases as a whole have been skyrocketing since late March, from a seven-day average of more than 62,000 on March 31 to more than 385,000, according to the Our World in Data project at the University of Oxford. On Friday, the country reported more than 410,000 new daily infections, a record, and more than 3,900 deaths.

As the outbreak reaches new heights, India’s vaccination campaign has slowed down, marred by supply shortages and competition among states.

The official daily death in the country has stayed over 3,000 over the past 10 days, and experts say the numbers are much higher,.

The true scope of the outbreak remains hard to measure. Nationwide, India conducted about 1.9 million coronavirus tests on Thursday, an increase from about 1.2 million daily tests last month, but hardly enough to keep up with a daily caseload that has almost quadrupled in that time.

West Bengal, a state of 90 million people that has poor health care infrastructure and is under a partial lockdown, has carried out fewer than 60,000 coronavirus tests a day. That is one of the lowest rates in the country, according to data compiled by researchers at the University of Michigan.

Dr. Abhijeet Barua, a physician in Kolkata, the state’s capital, said that cases had exploded in every corner of the city and that infections were spreading quickly in the state’s rural areas. At his 10-bed clinic, two people have died every day over the past 15 days, Dr. Barua said.

“What is making things worse in Kolkata is that over 70 percent of the population lives in close contact,” he said, adding that he was receiving dozens of calls a day from patients seeking help. “You can’t isolate yourself, because it is so congested here.”

Mr. Modi has repeatedly refrained from imposing a nationwide lockdown. Instead nearly a dozen of India’s 28 states have imposed restrictions, though they are less stringent than the nationwide lockdown put in place last year.

Protective masks are worn in March in Tokyo, the host of this summer’s Olympic Games.
Credit…Noriko Hayashi for The New York Times

TOKYO — Japan on Friday extended a state of emergency in Tokyo and other regions until the end of May to contain a surge of coronavirus cases, casting further doubt on the country’s ability to safely host the Summer Olympics, which are scheduled to begin in 11 weeks.

Prime Minister Yoshihide Suga made the announcement at a meeting of the government’s coronavirus task force, saying that the measures were necessary because infections remain at a “high level, mainly in large cities.”

The announcement extends emergency measures imposed last month to two more prefectures, covering a total of six prefectures, including Tokyo and Osaka, that are together home to over a third of Japan’s 126 million people. Another eight prefectures will be under slightly looser restrictions.

The existing state of emergency, which were imposed to curb travel during the just-ended Golden Week holiday period and had been set to expire next week, have not slowed Japan’s fourth wave of coronavirus infections. In early March, the country recorded about 1,000 daily new. It is now recording nearly 6,000, according to a New York Times database.

Health officials say that they are seeing a growing number of cases of coronavirus variants spreading in the population, including at least 26 cases of the strain first detected in India. The authorities in Tokyo say that in four out of five cases found in the city, the infected person neither traveled abroad nor had close contact with someone who had.

The outbreak is stretching health care systems even in Japan’s biggest cities. On Thursday, there were 370 people being treated for serious cases of Covid-19 in Osaka, a prefecture of nine million people, more than the number of hospital beds available for seriously ill patients.

Japan, which has recorded more than 620,000 infections and 10,000 deaths since the start of the pandemic, has controlled the virus better than many countries. But the government has faced criticism for the sluggish pace of vaccinations, and for pledging to go ahead with the Tokyo Olympics, scheduled to begin on July 23, despite widespread public opposition.

Toru Hashimoto, a lawyer and a former governor of Osaka prefecture, said on a television show on Friday that Olympic organizers were ignoring the severity of Japan’s outbreak, and that it was inappropriate to continue holding pre-Olympic “test events” during the state of emergency, even though they are taking place without spectators.

“If the government wants to reduce the number of people in the city, it’s not a time when test events can be held,” Mr. Hashimoto said.

The government has imposed two previous states of emergency during the pandemic, although they are looser than the total lockdowns seen in many nations. The measures allow the prefectures to ask businesses to close or to restrict their hours, and to fine those that do not.

Under the extended state of emergency, people are asked not to go out for nonessential matters, especially after 8 p.m., and to refrain from traveling outside their prefectures. Karaoke parlors are asked to close, and restaurants requested not to serve alcohol, with fines of up to 300,000 yen, or $2,750, for noncompliance.

A vaccination center in Johannesburg in March.
Credit…Joao Silva/The New York Times

A global debate is heating up over how to get Covid-19 vaccines to the nations most in need.

The United States is supporting an effort to suspend intellectual property protections on Covid-19 vaccines, and European countries say that richer nations should begin exporting more of their vaccine supply to poorer ones.

The European Union — whose approval is needed for any waiver of vaccine patents — said on Thursday that it would consider the Biden administration’s proposal. But Germany, the bloc’s largest economy, said that pushing pharmaceutical companies to share vaccine patents could have “significant implications” for the production of vaccines.

“The limiting factor in vaccine manufacturing is production capacity and high-quality standards, not patents,” a spokeswoman for Chancellor Angela Merkel of Germany said in a statement.

On Friday, Canada shared similar concerns. “Our government firmly believes in the importance of protecting intellectual property and recognizes the integral role that industry has played in innovating to develop and deliver lifesaving Covid-19 vaccines,” the minister of small businesses, Mary Ng, said in a statement.

She added many barriers to vaccine access, like supply shortages, were unrelated to intellectual property.

The European Commission president, Ursula von der Leyen, said the bloc was “ready to discuss any proposals that address the crisis in an effective and pragmatic manner.”

She also suggested, however, that the focus should be on getting more vaccines to countries that needed them by following the bloc’s example in allowing significant exports of doses. The United States has balked at that approach, keeping most doses produced domestically for use at home.

“We call upon all vaccine-producing countries to allow export and to avoid measures that disrupt the supply chains,” Ms. von der Leyen said.

The European statements emphasized the challenges of winning E.U. support for the waivers at the World Trade Organization, where the bloc wields significant influence, and where unanimous approval would be needed for any measure to suspend patents.

Many experts believe that the waivers are needed to expand the manufacturing of vaccines and get them to poorer parts of the world where inoculations have far lagged behind those of richer countries.

Until the Biden administration’s announcement this week, the United States had been a major holdout at the W.T.O. over a proposal by India and South Africa to suspend some intellectual property protections. The move could give drugmakers access to the trade secrets of how the vaccines are made.

The pharmaceutical industry has argued that suspending patent protections would undermine risk-taking and innovation.

“Who will make the vaccine next time?” Brent Saunders, the former chief executive of Allergan, which is now part of AbbVie, wrote on Twitter.

But Stephane Bancel, the chief executive of Moderna, told investors on Thursday, “We saw the news last night, and I didn’t lose a minute of sleep.”

Mr. Bancel said his company never planned to enforce the patent because few, if any, other drug makers can easily manufacture mRNA, the genetic script that carries DNA instructions to each cell’s protein-making machinery.

The debate arises amid a growing divide between wealthy nations that are slowly regaining normal life, and poorer countries that are confronting new and devastating outbreaks.

In India, which is suffering the world’s worst outbreak since the start of the pandemic, only 2.2 percent of the population is fully vaccinated, according to a New York Times database. South Africa has fully vaccinated less than 1 percent of its people. By contrast, vaccinations are slowing down in the United States — where one-third of people are fully inoculated — as they begin to pick up in Europe.

If the European Union agrees to support patent waivers, it would take months for developing nations to see the impact. Ngozi Okonjo-Iweala, the head of the W.T.O., told The Washington Post that she would press member countries to reach an agreement by Dec. 3.

Even if a waiver receives support from the trade body, it alone would not increase the world’s vaccine supply. Large drug manufacturers in India and elsewhere would need extensive technological and other support to produce doses, experts say.

Lifting intellectual property protections “is only one element,” said Anant Bhan, a health researcher at Melaka Manipal Medical College in southern India. Because of the additional steps required to begin making a vaccine on a huge scale, he said, “it is not going to mean increased access to vaccines in the near future.”

The American jobs engine slowed markedly last month, confounding rosy forecasts of the pace of the recovery and sharpening debates over how best to revive a labor market that was severely weakened by the coronavirus pandemic.

Employers added 266,000 jobs in April, the government reported Friday, far below the vigorous gains registered in March. The jobless rate rose slightly to 6.1 percent, as more people rejoined the labor force.

5

10

15%

’06

’08

’10

’12

’14

’16

’18

’20

6.1%

RECESSION

“It turns out it’s easier to put an economy into a coma than wake it up,” Diane Swonk, chief economist for the accounting firm Grant Thornton, said of the disappointing report. “It’s understandable, it’s going to take some time, you’re not just going to snap your fingers and get everyone back to work,

Economists had forecast an addition of about a million jobs. The increase for March was revised down to 770,000 from 916,000.

The Alliance for American Manufacturing blamed supply chain problems for the loss of 18,000 jobs in that sector, noting in particular the impact that a shortage of semiconductors has had on the automotive industry.

And many offices are not yet ready to reopen fully. “I just think it takes a while for businesses to figure out how many people they need,” Ms. Swonk said, noting there is still a lot of skittishness on the part of employers and workers. “I don’t view this as terribly troubling or distressing.”

Ben Herzon, executive director of U.S. economics at the financial services company IHS Markit, agreed. “A single report with unexpected weakness in job gains is not a cause for concern,” he said. “Demand is picking up, activity is picking up.”

He noted that labor force participation had been on the upswing for two months in a row, rising to 61.7 percent last month from 61.4 percent in February.

More opportunities are bubbling up as coronavirus infections ebb, vaccinations spread, restrictions lift and businesses reopen. Job postings on the online job site Indeed are 24 percent higher than they were in February last year.

“There’s been a broad-based pickup in demand,” said Nick Bunker, who leads North American economic research at the Indeed Hiring Lab. The supercharged housing market is driving demand for construction workers. There is also an abundance of loading, stocking and other warehousing jobs — a side-effect of the boom in e-commerce.

The economy still has a lot of ground to regain before returning to prepandemic levels. Millions of jobs have vanished since February 2020, and the labor force has shrunk.

–20

–15

–10

–5 million

April

June

Sept.

Jan. ’21

–8.2 million since February 2020

152.5 million jobs in February 2020

As the economy fitfully recovers, there are divergent accounts of what’s going on in the labor market. Employers, particularly in the restaurant and hospitality industry, have reported scant response to help-wanted ads. Several have blamed what they call overly generous government jobless benefits, including a temporary $300-a-week federal stipend that was part of an emergency pandemic relief program.

But there are other forces constraining the return to work. Millions of Americans have said that health concerns and child care responsibilities — with many schools and day care centers not back to normal operations — have prevented them from returning to work. Millions of others who are not actively job hunting are considered on temporary layoff and expect to be hired back by their previous employers once more businesses reopen fully. At the same time, some baby boomers have retired or switched to working part time.

An 18-year-old student received a shot of a coronavirus vaccine in Los Angeles last month.
Credit…Etienne Laurent/EPA, via Shutterstock

A series of vaccine developments and the loosening of restrictions amid an improving virus trajectory may foreshadow a welcome return to normalcy for many young Americans, just as summer vacation nears.

By early next week, the Food and Drug Administration is expected to issue an emergency use authorization allowing the Pfizer-BioNTech coronavirus vaccine to be used in children 12 to 15 years old, a major step ahead in the United States’ efforts to tackle Covid-19. Pfizer also expects to seek federal clearance in September to administer the vaccine to children age 2 to 11, the company said on Tuesday.

Vaccinating children is key to raising the level of immunity in the population, experts say, and to bringing down the numbers of hospitalizations and deaths. It could also put school administrators, teachers and parents at ease if millions of adolescent students become eligible for vaccination before the next academic year begins.

The move would be a major leap forward, experts say, and comes as the director of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, said that vaccinated adolescents would be able to remove their masks outdoors at summer camps.

Yet the eagerness of parents to let their children be vaccinated is limited, according to a new national poll, which found that three in 10 parents surveyed said they would get their children vaccinated right away and 26 percent said they wanted to wait to see how the vaccine was working. About 23 percent said they would definitely not get their children vaccinated, and 18 percent said they would do so only if a child’s school required it. The survey also noted that only 9 percent of respondents said they had not yet gotten a shot but still intended to do so, one more indication that achieving widespread immunity in the United States is becoming increasingly challenging.

As health experts focus on the future of vaccinating children, a growing number of students have returned to in-person learning this school year. In March, 54 percent of K-8 schools were open for full-time in-person learning, and 88 percent were open for either full-time in-person and/or hybrid learning, according to data from a federal government survey released on Thursday. But Black, Hispanic and Asian students are enrolled in full-time in-person learning at much lower rates than white students.

The Biden administration has made an aggressive push for reopening schools in recent months, including an effort to prioritize vaccinations for teachers and employees.

Administering the AstraZeneca vaccine in Nottingham, England, last month.
Credit…Oli Scarff/Agence France-Presse — Getty Images

Britain’s vaccines regulator advised on Friday that all adults under 40 in the country should be offered alternatives to AstraZeneca’s Covid-19 vaccine. It factored in concerns over very rare blood clots, the dwindling risk of severe coronavirus infection in younger adults and the availability of alternatives.

The guidance extends earlier advice that people under 30 would be offered alternative doses.

The use of the AstraZeneca vaccine has been marred by uncertainty after reports of a possible link between the doses and very rare blood clots, but public health experts around the world say that the vaccine’s benefits far outweigh the risks for most people.

Britain’s Joint Committee on Vaccination and Immunization stressed that the chances of younger people becoming seriously ill with the coronavirus had grown smaller as infection rates decrease across the country. It said that this new reality paired with the availability of alternative vaccines had factored into the decision.

But the country is also closely monitoring new variants of the coronavirus, and on Friday public health officials in England noted that a variant first detected in India was now considered a “variant of concern” — meaning that it is at least as transmissible as the dominant variant in Britain. The cases identified in the country more than doubled from 202 to 520 in the week, but still account for just a fraction of the cases there.

While there is still not enough evidence to indicate whether any of the variants recently detected in India cause more severe illness or render vaccines any less effective, Britain is proceeding with caution. Most of the identified cases of the variant are in London and in the town of Bolton in the northwestern England.

Regarding the AstraZeneca vaccine, the regulator advised that where available, an alternative should be offered to healthy adults under 40, though it stressed that potentially severe side effects from the doses were “extremely rare.” It noted that “for the vast majority of people, the benefits of preventing serious illness and death far outweigh any risks.”

The vaccination committee advised that anyone who received a first dose of the AstraZeneca vaccine should still receive a second, except those who experienced clotting.

Britain’s medicines regulatory agency had received reports of 242 cases of blood clots accompanied by low platelet counts in people who received the AstraZeneca vaccine through April 28. As of that date, about 22.6 million AstraZeneca doses had been administered in Britain, including about 5.9 million second doses.

Over all, about 35 million people in the country have received at least one dose of a coronavirus vaccine.

An airplane landing at the airport in Frankfurt, Germany.
Credit…Michael Probst/Associated Press

One returning pilot lost control of an aircraft during landing and skidded off the runway into a ditch. Another just returning from furlough forgot to activate a critical anti-icing system designed to prevent hazards in cold weather. Several others flew at the wrong altitudes, which they attributed to distractions and lapses in communication.

In all of these incidents, which were recorded on NASA’s Aviation Safety Reporting System, a database of commercial aviation mistakes that are anonymously reported by pilots and other airline crew, the pilots involved blamed the same thing for their mistakes: a lack of practice flying during the pandemic.

In 2020, global air passenger traffic experienced the largest year-on-year decline in aviation history, falling 65.9 percent compared with 2019, according to the International Air Transport Association. Flights were grounded, schedules reduced and thousands of pilots were laid off or put on furlough for up to 12 months.

As vaccination programs pick up speed across some parts of the world and travel starts to rebound, airlines are beginning to reactivate their fleets and summoning pilots back as they prepare to expand their schedules for the summer. But returning pilots can’t just pick up where they left off.

“It’s not quite like riding a bike,” said Joe Townshend, a former pilot for Titan Airways, a British charter airline, who was laid off when the pandemic hit in March last year.

“You can probably go 10 years without flying a plane and still get it off the ground,” he said, “but what fades is the operational side of things.”

Marc Johnson, a virologist at the University of Missouri, examining samples of wastewater to track the coronavirus.
Credit…MichaelB Thomas for The New York Times

Although Covid-19 is primarily a respiratory disease, research conducted early in the pandemic revealed that people infected with the coronavirus often shed it in their stool. This finding, combined with the scale and urgency of the crisis, spurred immediate interest in tracking the virus by sampling wastewater.

In the past year, many scientists have been drawn into the once niche field of wastewater epidemiology. Researchers in 54 countries are tracking the coronavirus in sewage, according to the Covid19Poops Dashboard, a global directory of the projects.

These teams have found that the wastewater data seemed to accurately indicate what was happening in society. When the number of diagnosed Covid-19 cases in an area increased, more coronavirus appeared in the wastewater. Levels of the virus fell when areas instituted lockdowns and surged when they reopened.

Several teams have also confirmed that sewage can serve as an early warning system: Wastewater viral levels often peaked days before doctors saw a peak in official Covid-19 cases.

And wastewater analysis has allowed scientists to detect the arrival of certain variants in a region weeks before they are found in people — and to identify mutations that have not yet been detected in people anywhere.

The surveillance is not a replacement for clinical testing, experts said, but can be an efficient and cost-effective complement. The approach is likely to be especially valuable in low- and middle-income countries, where testing resources are more limited.

“Not every population gets tested, not everyone has access to health care,” said Dr. Marc Johnson, a virologist at the University of Missouri. “If there’s groups of people that are asymptomatic, they probably aren’t getting tested either. So you aren’t really getting the full big picture. Whereas for our testing, everyone poops.”

global roundup

Australian residents at the Sydney airport last year, returning from India.
Credit…Bianca De Marchi/EPA, via Shutterstock

Australia will resume repatriation flights for Australian nationals in India after May 15, Prime Minister Scott Morrison said on Friday.

The resumption will end a travel ban that made it a criminal offense for citizens and residents of Australia to enter the country from India. No other democratic nation has issued a similar ban on all arrivals.

Australians who test positive for the coronavirus will not be allowed to travel, officials said, and the government has introduced a pre-departure testing regime in India in an effort to catch infections before they reach Australia.

Critics of the travel ban have accused the government of racism and insensitivity, but officials have said that the restrictions are necessary to prevent transmission from the devastating outbreak in India.

Australian officials initially said that anyone trying to return from India faced up to five years in prison and nearly 60,000 Australian dollars ($46,300). But as the measure came under withering criticism this week, Mr. Morrison said it was “highly unlikely” that those seeking to return home would actually face jail.

In other news from around the world:

View Source

New studies suggest that vaccines can protect against some variants and severe Covid cases.

Several new studies released on Wednesday offered encouraging news about the ability of widely used vaccines to protect against severe Covid-19 cases, including illness caused by some dangerous variants.

Two published studies found that the Pfizer-BioNTech vaccine was extraordinarily effective against severe disease caused by two variants, including the dominant one in the United States. And the results of an early-stage trial of the Moderna vaccine — though not published or vetted by scientists — suggested that a single dose given as a booster was effective against variants first identified in South Africa and Brazil, the company said.

The emergence of new variants, and whether vaccines are effective against them, is a subject of continued concern as a variant first detected in India, called B.1.617, spreads across the country. There is also a risk that further variants will arise there as the country’s outbreak grows, experts say. Another worrisome variant, P.1, is wreaking havoc across South America.

In the Pfizer studies, which were based on real-world use of the vaccine in Qatar and Israel, the two variants of focus were B.1.1.7, first identified in Britain and now detected in over 100 countries, and B.1.351, first identified in South Africa. The studies showed that the vaccine can prevent some of the most severe outcomes from Covid-19, such as pneumonia and death, caused by those variants.

One of the Pfizer studies showed that the vaccine was 87 to 89.5 percent effective at preventing infection with B.1.1.7 among people who were at least two weeks past their second shot. It was 72.1 percent to 75 percent effective at preventing infection with B.1.351. The study was based on information about more than 200,000 people that was pulled from Qatar’s national Covid-19 databases from Feb. 1 to March 31.

Another study, conducted by researchers at Pfizer and at Israel’s Health Ministry, found that the vaccine was more than 95 percent effective at protecting against a coronavirus infection, hospitalization and death among fully vaccinated people 16 and older.

In the United States, experts now believe that attaining herd immunity is unlikely because of the spread of variants and hesitancy among some people in the country to be vaccinated. The variant that has caused the most alarm is B.1.1.7, which is about 60 percent more transmissible than original versions of the virus.

Moderna’s announcement was greeted cautiously, because the results of an early-stage trial have not been published or peer-reviewed. But the company said it was encouraged by results that suggested that a single booster shot of its vaccine would rapidly increase antibodies in vaccinated people, and that those antibodies were effective against the original form of the virus as well as the variants first identified in South Africa and Brazil.

A second booster specifically designed to counter the variant identified in South Africa produced an even stronger immune response, the company said.

View Source

Baltimore Vaccine Plant’s Troubles Ripple Across Africa, Europe and Canada

WASHINGTON — Quality-control problems at a Baltimore plant manufacturing Covid-19 vaccines have led health officials on three continents to pause the distribution of millions of Johnson & Johnson doses, as the troubles of a politically connected U.S. contractor ripple across the world.

Doses made at the plant owned by Emergent BioSolutions have not been cleared by the Food and Drug Administration for use in the United States, and the Biden administration has repeatedly assured Americans that none of the Johnson & Johnson shots administered domestically were made there.

But millions of doses have been shipped abroad, including to Canada, the European Union and South Africa. Regulators in various countries are now working to ensure that those doses are safe after the disclosure in March that workers at the Baltimore plant accidentally contaminated a batch of Johnson & Johnson’s vaccine with the harmless virus used to manufacture AstraZeneca’s. Both vaccines were produced at the same site. The mistake forced Emergent to throw out up to 15 million Johnson & Johnson doses after tests showed that the batch failed to meet purity requirements.

E.U. officials, as well as those in Canada and South Africa, said there was no evidence that any of the doses they had received were tainted. But the problems identified in Baltimore have slowed their vaccination efforts while they perform additional quality assessments as a precaution.

said they would “not allow the release of any product until we feel confident that it meets our expectations for quality.” The plant is still finishing batches of vaccine that were already in process.

previously acknowledged that it had allowed doses of AstraZeneca’s Covid-19 vaccine made at the same Emergent plant to be sent to Canada and Mexico but said it had not attested to their quality, instead leaving that assessment to the company and authorities in both countries. Unlike the Johnson & Johnson vaccine, the AstraZeneca vaccine is not approved for use in the United States.

The Times reported last month that Emergent had discarded five lots of AstraZeneca vaccine — each the equivalent of two million to three million doses — between October and January because of contamination or suspected contamination at the same Bayview plant in Baltimore.

The European Union’s drug regulator, the European Medicines Agency, said in a statement to The Times that one batch of vaccine manufactured at the Emergent facility “is being used” after “a thorough testing of the batch and a review of the controls in place at the manufacturing site.” There is no indication of any problems with those doses.

That batch was distributed for use in the European Union only after meeting “the rigorous quality standards of our company and the European Medicines Agency,” Johnson & Johnson said in a statement.

Two more batches, amounting to about 2.5 million doses, are on hold as regulators in Europe and the United States investigate the cause of the contamination at the Emergent plant and ensure that problems have been fixed, the E.M.A. said.

“When the investigations conclude, E.M.A. may decide on actions to prevent future contamination of batches,” the statement said.

Batches of vaccine made at Emergent are not released for bottling until they have passed required safety tests, including one designed to identify “adventitious agents” such as a virus used in the manufacture of another product. People familiar with Emergent’s processes said the tests were much the same whether the vaccine was destined for domestic or foreign use.

one of the lowest vaccination rates of any country, and the Johnson & Johnson vaccine is particularly important to the nation’s plans. Many developing countries are relying on AstraZeneca’s vaccine, but South Africa stopped using it in February after a trial indicated that it was less effective against the dominant coronavirus variant then circulating in the country.

Under its contract with Johnson & Johnson, Emergent manufactured the active ingredient for the vaccine in bulk, and the substance was then sent to other facilities for final processing and packaging. One of the sites performing these final manufacturing stages is a plant run by the South African company Aspen Pharmacare. Johnson & Johnson announced in March that the site would support the company’s pledge to provide vaccine to countries throughout Africa.

The Canadian regulatory authority, Health Canada, said in a statement that officials were working with Johnson & Johnson and the F.D.A. to perform further assessments of vaccine manufactured at the Emergent facility and that the doses “will only be released for distribution once Health Canada is satisfied that they meet the Department’s high standards for quality, safety and efficacy.”

The newly disclosed delays underscore the global impact of the problems at the Baltimore factory operated by Emergent, a government contractor known for its aggressive lobbying and political connections.

As The Times previously reported, the federal government last year banked on Emergent to be the main domestic manufacturer for both the Johnson & Johnson and AstraZeneca vaccines even as evidence of serious quality problems mounted.

announced “significant revenue growth and corresponding profitability” for the first quarter of this year and projected record revenues for 2021, driven largely by the company’s Covid-19 vaccine manufacturing deals.

Emergent built a profitable business largely by cornering the market for biodefense products, a Times investigation found. Throughout most of the last decade, sales of the company’s anthrax vaccines accounted for nearly half of the annual budget of the nation’s emergency medical reserve, the Strategic National Stockpile, leaving the federal government with less money to buy supplies needed in a pandemic.

Emergent has repeatedly touted its influence in Washington in presentations to investors. Six of its 10 board members have previously served in government, and since 2010, the company has spent an average of $3 million a year on lobbying — far outspending similarly sized biotech firms, and roughly matching the outlays of some larger pharmaceutical companies.

Matina Stevis-Gridneff contributed reporting from Brussels and Ian Austen from Ottawa.

View Source