health
FDA approves much-debated Alzheimer’s drug panned by experts
Government health officials on Monday approved the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease.
The Food and Drug Administration approved the drug from Biogen based on study results showing it seemed “reasonably likely” to benefit Alzheimer’s patients. It’s the only therapy that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia.
The decision, which could impact millions of Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups. It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.
The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse mental decline, only slowing it in one study. The medication, aducanumab, will be marketed as Aduhelm and is to be given as an infusion every four weeks.
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Dr. Caleb Alexander, an FDA adviser who recommended against the drug’s approval, said he was “surprised and disappointed” by the decision.
“The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. In this case, I think they gave the product a pass,” said Alexander, a medical researcher at Johns Hopkins University.
The FDA’s top drug regulator acknowledged that “residual uncertainties” surround the drug, but said Aduhelm’s ability to reduce harmful clumps of plaque in the brain is expected to help slow dementia.
“The data supports patients and caregivers having the choice to use this drug,” Dr. Patrizia Cavazzoni told reporters. She said the FDA carefully weighed the input of people living with the “devastating, debilitating and deadly disease.”
Under terms of the so-called accelerated approval, the FDA is requiring Biogen to conduct a follow-up study to confirm benefits for patients. If the study fails to show effectiveness, the FDA could pull the drug from the market, though the agency rarely does so.
Biogen said the drug would cost approximately $56,000 for a typical year’s worth of treatment, and said the price would not be raised for four years. Most patients won’t pay anywhere near that thanks to insurance coverage and other discounts. The company said it aims to complete the FDA-mandated follow-up trial by 2030.
Biogen shares jumped 38% in trading Monday on the news, with analysts forecasting billions in future sales. The Cambridge, Massachusetts-based company plans to begin shipping millions of doses within two weeks.
The non-profit Institute for Clinical and Economic Review, which studies drug value, said Biogen’s drug would have to halt dementia entirely to justify its $56,000 per-year price tag.
Some 6 million people in the U.S. and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and basic daily tasks. In the final stages of the disease, those afflicted lose the ability to swallow. The global burden of the disease, the most common cause of dementia, is only expected to grow as millions more baby boomers progress further into their 60s and 70s.
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Aducanumab (pronounced “add-yoo-CAN-yoo-mab”) helps clear a protein called beta-amyloid from the brain. Other experimental drugs have done that but they made no difference in patients’ ability to think, care for themselves or live independently.
The pharmaceutical industry’s drug pipeline has been littered for years with failed Alzheimer’s treatments. The FDA’s greenlight Monday is likely to revive investments in therapies previously shelved by drugmakers.
The new medicine is manufactured from living cells and will be given via infusion at a doctor’s office or hospital.
Researchers don’t fully understand what causes Alzheimer’s but there’s broad agreement the brain plaque targeted by aducanumab is just one contributor. Evidence suggests family history, education and chronic conditions like diabetes and heart disease may all play a role.
“This is a sign of hope but not the final answer,” said Dr. Richard Hodes, director of the National Institute on Aging, which wasn’t involved in the Biogen studies but funds research into how Alzheimer’s forms. “Amyloid is important but not the only contributing factor.”
Patients taking aducanumab saw their thinking skills decline 22% more slowly than patients taking a placebo.
But that meant a difference of just 0.39 on an 18-point score of cognitive and functional ability. And it’s unclear how such metrics translate into practical benefits, like greater independence or ability to recall important details.
The FDA’s review of the drug has become a flashpoint in longstanding debates over standards used to evaluate therapies for hard-to-treat conditions. On one side, groups representing Alzheimer’s patients and their families say any new therapy — even one of small benefit — warrants approval. But many experts warn that greenlighting the drug could set a dangerous precedent, opening the door to treatments of questionable benefit.
The approval came despite a scathing assessment in November by the FDA’s outside panel of neurological experts. The group voted “no” to a series of questions on whether reanalyzed data from a single study submitted by Biogen showed the drug was effective.
Biogen halted two studies in 2019 after disappointing results suggested aducanumab would not meet its goal of slowing mental and functional decline in Alzheimer’s patients.
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Several months later, the company reversed course, announcing that a new analysis of one study showed the drug was effective at higher doses and the FDA had advised that it warranted review. Company scientists said the drug’s initial failure was due to some patients not receiving high enough doses to slow the disease.
But the changes to dosing and the company’s after-the-fact analysis made the results hard to interpret, raising skepticism among many experts, including those on the FDA panel.
The FDA isn’t required to follow the advice of its outside panelists and has previously disregarded their input when making similarly high-profile drug decisions.
About 900 U.S. medical facilities are ready to begin prescribing the drug, according to Biogen, with many more expected in coming months. But key practical questions remain: How long do patients benefit? How do physicians determine when to discontinue the drug? Does the drug have any benefit in patients with more advanced dementia?
With FDA approval, aducanumab is almost certain to be covered by most insurers, including Medicare, the government plan for seniors that covers more than 60 million people.
Insurers could try to manage the drug’s costs by requiring strict conditions, including brain scans to confirm plaque, before agreeing to cover it.
Additional scans will be needed to monitor potential side effects. The drug carries a warning about temporary brain swelling that can sometimes cause headaches, confusion and dizziness. Other side effects included allergic reactions, diarrhea and disorientation.
Although Biogen studied the drug in people with mild dementia or early-stage Alzheimer’s, the FDA label approved the drug for anyone with Alzheimer’s, a sweeping population given doctors have broad leeway in diagnosing the condition.
“The FDA is empowering the physician to make the decision on diagnosis,” Biogen CEO Michel Vounatsos said in an interview.
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For patients already enrolled in Biogen’s trials, Monday’s announcement means they can continue taking a drug many believe has helped.
Phillip Lynn, 63, was diagnosed with Alzheimer’s in the spring of 2017 after having trouble with conversation and memory, including forgetting a recent vacation to Hawaii.
His husband Kurt Rehwinkel says Lynn’s cognitive ability has stabilized since starting on Biogen’s drug more than three years ago. And his performance on short-term memory tests has actually improved, though the couple acknowledges most patients are unlikely to see similar results.
“But even for those who it has little or no effect, I think hope is a good thing,” said Rehwinkel. “I don’t think there’s such a thing as false hope.”
Palestinian mom fights to stave off punitive home demolition
Sanaa Shalaby says she had no idea what her estranged husband was up to until Israeli soldiers raided her home in the occupied West Bank last month.
Now she’s waging a legal battle to prevent Israel from demolishing the two-story villa where she lives with her three youngest children. It’s drawing attention to Israel’s policy of punitive home demolitions, which rights groups view as collective punishment.
Israeli security forces arrested her husband, Muntasser Shalaby, and accuse him of carrying out a May 2 drive-by shooting that killed an Israeli and wounded two others in the occupied West Bank. Israel says demolishing family homes is one of the only ways to deter attackers, who expect to be arrested or killed and who are often glorified by Palestinian factions.
The U.S. State Department has criticized such demolitions, and an internal Israeli military review in the 2000s raised questions about their effectiveness. The case of the Shalabys — who all have U.S. citizenship — could reignite the debate. Israel’s Supreme Court is expected to issue a final ruling on the demolition next week.
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Sanaa and her husband had been estranged for nearly a decade. He lived in Santa Fe, New Mexico, where he ran a profitable smoke shop and married three other women in private Muslim ceremonies not recognized by U.S. authorities.
“It’s allowed in our religion,” Sanaa said. “I didn’t agree to it.”
He came back to the West Bank in April for what she says was one of his yearly visits to see the children. He had also sought treatment for paranoia after having been institutionalized in the U.S. in recent years, according to a deposition he gave to her lawyer.
Sanaa said she knew nothing about the attack and had no indication he was planning anything.
“People commit crimes far worse than this in America and they don’t demolish their homes,” she said. “Whoever committed the crime should be punished, but it’s not the family’s fault.”
When the soldiers showed up after the attack they ransacked the home and briefly detained her 17-year-old son. She said they had a large dog that terrified her and her two younger children, a 12-year-old boy and a 9-year-old girl. The soldiers came back weeks later to map out the house for demolition.
Now Sanaa says her children spend all day in bed and refuse to go to school. “I know my children and they were never like this,” she said. “My son, Ahmed, has to take his final exams and he can’t study. He opens his book, reads a couple pages and then he walks off.”
An Israeli official said the security agencies believe home demolitions are an effective deterrent. The official declined to comment on the Shalaby case, but said everyone is notified in advance and given the right to contest demolitions in court. Someone in Sanaa’s situation would have a “good legal case” if her account is independently verified, the official said.
“There are clear checks and balances,” the official said. “We are using it only when we feel that it is necessary, and only because we understand that this is an effective deterrent.”
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The official spoke on condition of anonymity to discuss security procedures.
HaMoked, an Israeli rights group that has represented dozens of families seeking to halt punitive demolitions and is currently representing Sanaa, says such petitions rarely succeed. Of 83 cases brought since 2014, only 10 demolitions were prevented, it said. In the remaining cases, homes were partially or completely demolished, or apartments in multi-story buildings were permanently sealed off.
Jessica Montell, the group’s executive director, says that from a legal perspective the question of whether it serves as a deterrent is irrelevant.
“You don’t collectively punish innocent people just because they’re related to a criminal in the hope that that will deter future criminals. It’s an illegal and immoral policy regardless of the effectiveness,” she said.
The Israeli military prepared a report on punitive home demolitions in 2004 that led to a moratorium on the practice the following year, according to HaMoked, which received a Power Point presentation of the classified report in 2008 through a court petition.
The presentation raises concerns about the legality of such demolitions and international criticism of them. It also questions their effectiveness, saying the demolitions might even motivate more attacks. Such demolitions were mostly halted until 2014, when three Israeli teenagers were kidnapped and killed in the occupied West Bank.
A campaign by Jewish settlers to evict dozens of Palestinian families from their homes in east Jerusalem was one of the main causes of last month’s 11-day Gaza war, in which Israeli airstrikes demolished hundreds of homes in the militant-ruled territory.
Both forms of displacement summon bitter memories of what the Palestinians refer to as the Nakba, or “catastrophe,” when some 700,000 Palestinians fled or were driven out of what is now Israel during the 1948 war surrounding its creation.
Shalaby said she has been in continual contact with the U.S. Embassy but was told it couldn’t do anything about the demolition.
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The State Department declined to comment on the case, citing privacy concerns. But it said it was opposed to the punitive demolition of Palestinian homes. “The home of an entire family should not be demolished for the actions of one individual,” it said in a statement.
The Israeli Supreme Court will hear Sanaa’s case on June 17.
She hopes she will be able to remain in the house that she and her husband built in 2006. She said she had sold her bridal jewelry to help finance the construction. She raised her youngest children in the house, and an older daughter had her wedding there last year during a pandemic lockdown.
“My daughter got married here during the time of the coronavirus,” she said, pointing to the front courtyard and smiling at the memory. “It was better than any wedding hall.”
Covid-19: Restrictions imposed in Kushtia
Amid the worsening Covid-19 situation in the frontier districts of the country, the local administration in Kushtia has imposed strict restrictions on public movement.
The local administration has issued a circular asking people to complete their necessary works from 10 am to 8 pm every day in order to prevent transmission of Covid-19, said deputy commissioner Mohammad Saidul Islam.
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The restrictions came into effect from Sunday midnight and will continue till June 16.
According to the circular, all shops and markets will remain open from 10 am till 8 pm following health guidelines.
Legal action will be taken if anyone violates the order.
All hotels, restaurants, kitchen markets, shops will be closed at 8 pm. The restaurants and hotels can supply food through online service and no one will be allowed to dine in at hotels and restaurants.
All kinds of tourist spots, resorts, community centres and entertainment centres will remain closed during this period.
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No one will be allowed to hold public gatherings, social events, political and religious programmes.
According to the District Covid-19 prevention Committee, the Covid-19 cases are on the rise in the district as the infection rate has stood at 24.13 percent till Sunday.
The Health authorities said 56 people have been found infected with the virus in the past 24 hours till Monday morning after testing 181 samples.
Besides, 227 people have been tested positive for coronavirus in a six days till June 6 in the district with 30 percent infection rate.
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A total of 5,205 people have so far been tested positive for coronavirus in the district and of them 3,157 are from Sadar upazila.
So far, 119 people have died of Covid-19 in the district.
‘Conjuring 3’ tops ‘A Quiet Place 2’ as moviegoing returns
The domestic box office is getting back to normal, with moderate wins and sizable second weekend drops. After its triumphant first weekend, “A Quiet Place Part II” fell 59% at the North American box office leaving room for the third movie in the “Conjuring” franchise to take first place. Warner Bros.’ “The Conjuring: The Devil Made Me Do It” earned an estimated $24 million, according to studio estimates Sunday, making it the biggest R-rated opening of the pandemic. Paramount’s “A Quiet Place” sequel meanwhile earned $19.5 million in ticket sales, bringing its domestic total to $88.6 million.
“You normally don’t see two horror movies at the top of the chart. But it was a solid weekend for both movies,” said Paul Dergarabedian, the senior media analyst for Comscore. “The movie theaters are coming back and Memorial Day was no flash in the pan ... It feels like summer again.”
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“The Conjuring 3” has Patrick Wilson and Vera Farmiga returning as paranormal investigators Ed and Lorraine Warren. Although there’s a whole extended universe set around these films that have thus far grossed over $1.8 billion, this is the first “Conjuring” since 2016, and the first to be helmed by someone other than James Wan (Michael Graves directed). With an additional $26.8 million from international territories, globally, the R-rated pic has grossed over $57.1 million.
“It’s a terrific result,” said Jeff Goldstein, the head of domestic distribution for Warner Bros. “We’re continuing to see a ramp up of return to life outside of our homes. It was never going to be a light switch.”
In a pre-pandemic world, “The Conjuring 3” might have been considered a bit disappointing—the previous installments both opened around $40 million. But, as Goldstein noted, the third films in a horror franchise often take a hit. It has another caveat too: The film is also currently streaming free for subscribers on HBO Max. Warner Media did not say how many people watched it on streaming over the weekend or how many new customers signed up for the service.
It has become more normal than not for films to embrace a hybrid day-and-date release strategy, with the major studios using their biggest titles to drive potential subscribers to their streaming services. “A Quiet Place Part II” had the rare distinction of being exclusively in theaters, but even so it will be a shorter stint than usual before it hits Paramount+.
The Walt Disney Co.’s “Cruella,” which opened in theaters last weekend, was also made available to rent on Disney+ for $29.99. The Emma Stone and Emma Thompson pic added $11.2 million from 3,922 theaters this weekend to take third place. Disney also did not say how much it earned from streaming rentals, but the company did note the drop from last weekend was only 48%. Globally, “Cruella” has earned $87.1 million thus far.
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The animated family film “Spirit Untamed” also opened wide theatrically this weekend in 3,211 theaters to an estimated $6.2 million. The DreamWorks Animation film features the voices of Isabela Merced, Eiza González, Julianne Moore, Marsai Martin and Jake Gyllenhaal.
Most family films have gone straight to streaming over the past year and many big studios are opting to continue with the strategy for the near future. Disney and Pixar’s “Luca” is skipping theaters and going straight to Disney+, where it will be free for subscribers on June 16. DreamWorks Animation’s “Boss Baby” sequel is also debuting on Peacock Kids and in theaters on July 2.
The North American theatrical landscape is still a bit hobbled by the pandemic. Most Canadian theaters remain closed and around 27% of U.S. locations are still shuttered too. Many chains have also said vaccinated customers can now go mask free in theaters.
Hollywood titles have also started performing better than they have been internationally during the pandemic over the past few weekends. In particular, Universal’s latest in the “Fast & Furious” franchise, “F9,” continued to pick up speed prior to its U.S. debut on June 25. This weekend “F9,” which has already grossed $256 million from eight territories, became one of only 19 U.S. movies to have earned more than $200 million in China.
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And although release strategies continue to differ company by company in unprecedented ways, Dergarabedian said the numbers are promising for the theatrical business even with the at-home viewing options.
“Over the past two weeks, the industry has been able to test out theatrical only (“A Quiet Place Part II”), a day and date with a (pay) subscription model (“Cruella”) and a day and date that’s part of a subscription (“The Conjuring 3″). The numbers have been solid,” Dergarabedian said. “As long as we keep getting solid movies released, we’re going to see the box office ramp up week after week.”
As India’s surge wanes, families deal with the devastation
Two months ago Radha Gobindo Pramanik and his wife threw a party to celebrate their daughter’s pregnancy and the upcoming birth of their long-awaited grandchild. They were so happy that they paid little attention to his wife’s cough.
It’s an oversight that may forever haunt him. Within days, his wife, his daughter and his unborn grandchild were all dead, among the tens of thousands killed as the coronavirus ravaged India in April and May.
“Everyone whom I loved the most has left me,” the 71-year-old said on a recent night as a Hindu priest chanted mantras and performed a ritual for the dead at his home in the northern city of Lucknow. “I am left alone in this world now.”
As India emerges from its darkest days of the pandemic, families across the country are grieving all that they’ve lost and are left wondering if more could have been done to avoid this tragedy.
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There are also signs that the virus is not done devastating India’s families because even as new infections are down, thousands are still dying each day and the illness is believed to be spreading undetected in areas without access to testing.
Ruby Srivastava lost her family in a single week in April. First her mother and father to the virus. Then her brother to a motorcycle accident. And finally her grandmother to shock.
Now the 21-year-old is left dealing with the insurmountable pain and the questions she asks herself.
She wonders if things might have been different if her father, a government worker in Lucknow, hadn’t been called away to help hold local elections in their state of more than 200 million people.
Health experts had warned against holding the polls. Fearing the virus, many of the hundreds of thousands of government workers ordered to help out had begged not to go. But the ruling Bharatiya Janata Party’s government in Uttar Pradesh state insisted the vote would go ahead as planned.
For four days, more than 1.3 million candidates fought for nearly 800,000 seats. Tens of millions voted as the virus spread unchecked.
In the days that followed, scores of government employees who worked the polls would die. One teachers union said 1,600 educators alone were killed, many of them complaining of fever and breathlessness.
Srivastava wonders what would have happened if her father’s superiors believed him and hadn’t denied his requests for sick leave until finally he fainted in his office and was sent home.
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She wonders if her father could have been saved had he gotten better treatment at the government-run hospital they took him to before deciding they would take care of him themselves at home.
At the height of the surge, Indian hospitals were overwhelmed and life-saving drugs and oxygen were were in short supply. People were dying on their way to health centers, gasping for breath. Families were panicking.
Once back home, Srivastava’s family paid an exorbitant price for an oxygen cylinder for her father. They were so relieved they almost didn’t notice that her mother was also coughing.
“Our full attention was on our father,” Srivastava said. “So we did not realize that she was also facing problems.”
Her mother’s situation quickly grew worse and on April 22 she died. A day later so did her father.
After their cremations, Srivastava’s younger brother was taking their ashes on his motorcycle for a ceremony to immerse them in the Ganges River when he was killed in an accident. Three days after that, her heartbroken grandmother died of cardiac arrest.
Srivastava’s entire family had been wiped out in a few devastating days.
Pramanik also has regrets about his family’s final days.
Most of all he wishes he had paid attention to his wife’s cough and off-and-on fever and never held the party for his daughter, Navanita. They had been so excited that their daughter was finally pregnant after nine years of trying and had grown complacent with health protocols at a time when they thought they were safe from the virus.
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Friends suggested his wife get tested for COVID-19, but she refused.
To make matters worse, the day after the party he and his wife traveled to Navanita’s house on the fringes of the capital. There the two women talked all night, making arrangements for the baby’s birth in June.
Within 24 hours Pramanik’s wife’s fever returned, she complained of breathlessness and she was hospitalized. Three days later she died.
Distraught, the father and daughter returned to Lucknow by train. A promise was made that Navanita would take care of him.
“She told me: ‘You are not alone. I am with you,’” he recalled.
When they got home, Navanita started showing symptoms.
Over the next five days the virus took over her body. She was hospitalized and finally shifted to an intensive-care unit and hooked up to a ventilator.
On the night of April 17, Pramanik and his son-in-law sat outside the ICU trying to console one another. Together they wept.
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The next morning, doctors told them they needed to find a better-equipped medical facility for Navanita. Frantic calls around the city were met with refusals. Beds were full nearly everywhere.
After hours of trying, they finally found space for her. It was too late. Navanita died on the way to the new hospital, her unborn child inside her.
Two months later, Pramanik is still wracked with guilt. If only he had made different decisions, he tells himself, his wife and daughter would still be alive. He would be a grandfather.
“Sometimes I feel I have killed my wife and daughter,” he said. “This thought keeps me awake the whole night.”
UK urges commitment to vaccinate the world by end of 2022
British Prime Minister Boris Johnson will use the Group of Seven wealthy democracies’ summit next week to urge world leaders to commit to vaccinating the global population by the end of 2022.
Johnson is expected to stress the importance of a global vaccination drive when he meets with fellow world leaders on Friday in Cornwall, on England’s southwestern coast, for the first face-to-face G-7 summit since the pandemic hit.
Read:European regulators OK Pfizer vaccine for children 12-15
“The world is looking to us to rise to the greatest challenge of the postwar era: defeating COVID and leading a global recovery driven by our shared values,” he said in a statement Sunday. “Vaccinating the world by the end of next year would be the single greatest feat in medical history.”
U.S. President Joe Boden and the leaders of Canada, France, Italy and Japan will arrive in Cornwall from Friday for three days of talks focusing on the global recovery from the pandemic.
Read:In time for summer, Europe sees dramatic fall in virus cases
Britain’s government pledged in February to give most of the country’s surplus vaccine supply to COVAX, the U.N.-backed program aiming to supply poorer countries with jabs.
But the U.K. hasn’t yet put a figure on how many doses it will donate. The country, with a population of about 70 million people, has ordered around 400 million doses of vaccines. Health Secretary Matt Hancock has said that the U.K. doesn’t have any excess doses at the moment and that “we’re just getting them into arms as quickly as possible.”
Read:Rise in UK coronavirus cases stoke concerns over 3rd wave
The Sunday Times reported that Johnson is set to announce at the summit that the U.K. will pledge to donate over 2 billion pounds’ worth of jabs this year, with further donations in 2022.
The U.S. has said it plans to share 80 million doses of its surplus vaccine globally by the end of June, most of them through COVAX.
Asia-Pacific trade ministers mull vaccine access, supply
Improved access to coronavirus vaccines and other tools needed to fight the pandemic are vital to crushing the pandemic and hastening a recovery, officials said Saturday in an online meeting of Pacific Rim economies.
The unprecedented crisis brought on by COVID-19 requires a coordinated, cooperative response, said New Zealand’s Trade and Export Growth Minister Damien O’Connor, who hosted the meeting. The 21-member APEC gathers economies all along the Pacific Rim, from tiny Brunei to the United States to Chile and New Zealand. One of its long-term aims is to promote a free trade area of the Asia-Pacific region.
The focus Saturday was on “the most pressing problem our region faces, getting people vaccinated against COVID-19 as quickly as possible,” O’Connor said, adding he would be asking his counterparts how they could speed up trade in vaccines and other needed goods.
“The successful distribution of vaccines across our region will be critical to our recovery,” he said.
Read:Amid brutal case surge, Afghanistan hit by a vaccine delay
APEC has long focused on dismantling trade barriers, and many of its members are still struggling to obtain and deploy enough COVID-19 vaccines to vanquish coronavirus flare-ups.
Nearly 5 billion doses are still needed for the region of almost 3 billion people, O’Connor noted.
In much of the Asia-Pacific region, the share of people vaccinated so far is in the low single digits. That includes places like Thailand and Taiwan that initially managed to avoid initial massive outbreaks but have seen cases rebound recently.
APEC members Japan, South Korea and New Zealand are ranked among the worst among all developed nations in vaccinating their people for COVID-19, below some developing countries such as Brazil and India. Australia is also performing comparatively poorly.
This week, President Joe Biden announced the U.S. will swiftly donate an initial allotment of 25 million doses of surplus vaccine overseas through the United Nations-backed COVAX program, promising infusions for Asia, South and Central America, Africa and others.
Read:Senators say US donating vaccines to Taiwan amid China row
That would be a substantial and immediate boost to the lagging COVAX effort, which to date has shared just 76 million doses with needy countries.
While some countries at times have limited exports of vaccines, chemicals needed to make them or of protective equipment such as surgical masks, it’s unclear whether tariffs and other trade barriers have been the main problem since countries like Japan and New Zealand imposed onerous approval requirements that have slowed inoculations.
The average tariff on vaccines is a low 0.8%, according to the APEC Secretariat. But duties on some other products such as freezing equipment, vials and alcohol solutions can be as high as 30% for some countries.
Control of patents for the vaccines is a contentious issue. The U.S. has urged countries and pharmaceutical companies to waive COVID-19 patents to help increase supplies, and officials said they expected to discuss that issue during their talks this weekend.
But some say such intellectual property rights are crucial for boosting vaccine production and should not be waived.
Read: Sinopharm vaccine: Efforts underway to normalise things after price disclosure
A broad waiver of such rights requires a consensus under World Trade Organization rules, O’Connor said.
“We’re very mindful that the development of the intellectual property is what’s enabled us to very quickly get vaccines developed, in a time we previously haven’t seen across the globe,” he said. “We have to respect that intellectual property.”
These are “extraordinary times,” O’Connor said. “We believe if there clearly are barriers to the rollout of vaccines caused by IP, then we should seek a waiver.”
“We’re actually really encouraged to see more WTO members come forth with proposals on what they can support at the WTO with respect to the intellectual property rules of the WTO and how they apply to the COVID vaccine,” said U.S. Trade Representative Katherine Tai.
She said the U.S. was carefully reviewing proposals on the issue and hoping to move toward “text-based negotiations.”
Read: Share vaccines to cope with new surges, variants: UN
At a vaccine summit last month, the head of the WTO said it was also crucial to diversify manufacturing and have more jabs produced in Africa and Latin America.
Much is at stake. Beyond potential lives saved or lost, trade in vaccines and related supplies and equipment was estimated at $418.5 billion in 2019, according to the latest available data, and likely surged in 2020.
The APEC meeting additionally focused on “building back better” by reallocating resources to improve health care, education and social safety nets.
Even with the region still staggering from the pandemic and tourism still paralyzed by quarantines and border restrictions, Pacific Rim economies are forecast to regain momentum this year, with growth rebounding to more than 6% from a 1.9% contraction in 2020.
Amid brutal case surge, Afghanistan hit by a vaccine delay
Afghanistan is battling a brutal surge in COVID-19 infections as health officials plead for vaccines, only to be told by the World Health Organization that the 3 million doses the country expected to receive by April won’t be delivered until August.
“We are in the middle of a crisis,” Health Ministry spokesman Ghulam Dastigir Nazari said this week, expressing deep frustration at the global vaccine distribution that has left poor countries scrambling to find supplies for their people.
Nazari has knocked on the door of several embassies, and so far, “I’ve gotten diplomatic answers” but no vaccine doses, he said.
Over the past month, the escalating pace of new cases has threatened to overwhelm Afghanistan’s health system, already struggling under the weight of relentless conflict. In part, the increase has been blamed on uninterrupted travel with India, bringing the highly contagious Delta variant, first identified in India.
Also, most Afghans still question the reality of the virus or believe their faith will protect them and rarely wear masks or social distance, often mocking those who do. Until just a week ago, the government was allowing unrestricted mass gatherings.
Read:NATO chief says Afghan forces can cope alone
The Delta variant has helped send Afghanistan’s infection rate soaring, hitting 16 provinces and the capital Kabul the hardest. This week, the rate of registered new cases reached as high as 1,500 a day, compared to 178 a day on May 1.
Hospital beds are full, and it is feared rapidly dwindling oxygen supplies will run out. Afghan ambassadors have been ordered to seek out emergency oxygen supplies in nearby countries, Foreign Minister Haneef Atmar said in a tweet Friday.
By official figures, Afghanistan has seen a total 78,000 cases and 3,007 deaths from the pandemic. But those figures are likely a massive undercount, registering only deaths in hospitals, not the far greater numbers who die at home.
Testing is woefully inadequate. In only the past month, the percentage of positive COVID tests has jumped from about 8% to 60% in some parts of the country. By WHO recommendations, anything higher than 5% shows officials aren’t testing widely enough, allowing the virus to spread unchecked.
At most only 3,000 tests a day are carried out, as Afghans resist testing, even after the country dramatically ramped up its capabilities to 25,000 a day.
Only recently, the government tried to take steps to clamp down to contain the surge. It closed schools, universities and colleges for two weeks. It also shut down wedding halls, which had been operating unhindered throughout the pandemic.
But it is rare to see anyone wearing a mask in the streets, and even where masks are mandatory, like in government offices, it’s rarely enforced. As many as 10 flights arrive daily from India, packed with Afghans, particularly students and people who had gone to India for medical treatment.
Read: Afghans who helped the US now fear being left behind
Nazari said banning flights was not an option since many Afghans cannot afford to be stranded in India and the government cannot prevent citizens from re-entering their own country.
For vaccines, Afghanistan so far has relied on a donation of AstraZeneca doses from India and then purchases of Sinopharm from China. About 600,000 people have had at least one dose, about 1.6% of the population of 36 million. But the number who have gotten a second dose is minute — “so few I couldn’t even say any percentage,” Nazari said.
Last month, the ministry received a letter from WHO saying the expected shipment of 3 million vaccine doses will not arrive until August due to supply problems, Nazari said. With just 35,000 vaccine doses remaining in the country, the authorities were forced to stop giving first jabs to use remaining supplies to give second jabs, he said.
Poor countries around the world have been pleading for vaccines even as developed nations have been able to inoculate significant portions of their populations. COVAX, set up with U.N. help to try to prevent vaccine inequities, has struggled to fill the gap. It faced a major setback when its biggest supplier, the Serum Institute of India, announced last month that it would not export any vaccines until the end of the year because of the surge in that country.
“Honestly speaking, I lost my faith in COVAX,” Nazari said.
“Unfortunately, there are countries who vaccinated more than their 50% or 60% percent of the population ... and there are countries who did not receive vaccines to even vaccinate 1% of their population.”
At the Afghan-Japan Communicable Disease Hospital, Kabul’s only hospital dedicated solely to COVID treatment, all 174 beds are full. The Health Ministry opened roughly 350 more beds for coronavirus patients in another three hospitals, but they too quickly filled up. This week, people were being turned away.
Read: Death toll soars to 50 in school bombing in Afghan capital
Each day three or four people die of COVID at the Afghan-Japan Hospital, said hospital administrator Dr. Zalmai Rishteen.
Doctors struggle with the public’s refusal to take precautions and follow safety protocols. “Our people believe it is fake, especially in the countryside,” Rishteen said. “Or they are religious and believe God will save them.”
In the hospital’s intensive care unit, Dr. Rahman Mohtazir said that only makes it more dangerous for him as he does his job. “I am afraid I will catch it, but I am here to help,” he said. “I listen to people and they say it’s fake. Then they come here.”
The Health Ministry has recruited clerics, prominent religious figures and local elders to encourage vaccination and anti-coronavirus precautions.
The worsening COVID situation prompted the U.S. Embassy on Thursday to issue a health alert warning of shortages of supplies, oxygen and beds at hospitals and urging American citizens to “to leave Afghanistan as soon as possible.”
Covid in Jashore: Movement of people restricted in 2 wards
The local administration has imposed a strict restriction on the movement of people in two wards of Jashore municipality following a sharp rise in Covid-19 cases.
Read: 8 Indian variant cases identified in Jashore
The local Corona prevention committee took the decision at an emergency meeting held on Saturday night over the overall Covid-19 situation in the district, said additional district magistrate Kazi Mohammad Sayemuzzaman, a member of the committee.
The residents of the two wards -- No 3 and 4 -- have been asked not to go outside their homes without any emergency reason. “Those who’ll violate the order will face legal action,” warned Sayemuzzaman.
According to health officials, they have recorded 33 new cases of Covid-19 from the two wards of the municipality till June 5, showing a significant rise in Covid-19 cases.
Read: Residents of Jashore village along 'Indiapara' worried about spread of new variant
Besides, the Abhaynagar upazila administration will impose the same restriction in ward No 5 and 6 of Nauapara municipality as the health authorities reported 18 and 11 cases respectively in these two wards.
Meanwhile, the authorities concerned have found 11 people with Covid-19 infections in No 4 Gadkhali union of Jhikargacha upazila.
Read: Separate quarantine centre for single women in Jashore
The committee also decided to identify the houses of those infected people and isolated them.
Senators say US donating vaccines to Taiwan amid China row
The U.S. will give Taiwan 750,000 doses of COVID-19 vaccines, part of President Joe Biden’s move to share millions of jabs globally, three senators said Sunday, after the self-ruled island complained that China is hindering its efforts to secure the injections amid an outbreak.
Democratic Sen. Tammy Duckworth of Illonois, who arrived in Taiwan with her two colleagues, said the trip underscores the bipartisan support for the democratic island that Beijing claims as its own renegade territory.
“We are here as friends, because we know that Taiwan is experiencing a challenging time right now, which was why it was especially important for the three of us to be here in a bipartisan way,” said Duckworth.
“It was critical to the United States that Taiwan be included in the first group to receive vaccines, because we recognize your urgent need, and we value this partnership.”
Read: China may buckle down to reunify Taiwan after crackdown on Hong Kong
Republican Sen. Dan Sullivan of Alaska, a member of the Armed Services Committee, and Democratic Sen. Christopher Coons of Delaware, a member of the Foreign Relations Committee, also arrived Sunday morning.
Taiwan’s Foreign Minister Joseph Wu received the senators at the airport said he was “delighted” to welcome them and thanked them for their staunch support.
“Taiwan is facing unique challenges in combating the virus,” he said. “While we are doing our best to import vaccines, we must overcome obstacles to ensure that these life-saving medicine are delivered free from troubles of Beijing.”
He said China continues to try block Taiwan’s international assistance and prevent it from participating in the World Health Organization. “We are no strangers to that kind of obstructionism,” he said.
Read: Taiwan struggles with testing backlog amid largest outbreak
Wu said Taiwan was fortunate to have many like-minded countries showing their support, which he said is about sustaining freedom and democracy in the face of autocracy.
China has in recent months increased pressure on the island, including flying warplanes into Taiwan’s airspace.
Taiwan and China split amid civil war in 1949, and most Taiwanese favor maintaining the current state of de facto independence while engaging in robust economic exchanges with the mainland.
But vast improvements in China’s military capabilities and its increasing activity around Taiwan have raised concerns in the U.S., which is legally bound to ensure Taiwan is capable of defending itself and to regard all threats to the island’s security as matters of “grave concern.”
Taiwan, which has weathered virtually unscathed the initial outbreak last year, is now facing its most serious flare-up with over 10,000 cases since the end of April.
Read: Coronavirus: Taiwan has another jump, capital closing schools
On Friday, Japan donated 1.24 million doses of the AstraZeneca vaccine to Taiwan.
Biden announced last week the U.S. will swiftly donate an initial allotment of 25 million doses of surplus vaccine overseas through the U.N.-backed COVAX program, which to date has shared just 76 million doses with needy countries. Overall, the White House has announced plans to share 80 million doses globally by the end of June, most through COVAX.
The Thai-born Duckworth said the American donation also reflects gratitude for Taiwan’s support for the U.S., as Taiwan donated personal protective equipment and other supplies to the U.S. in the early days of the pandemic.
The three senators plan to meet Taiwan President Tsai Ing-wen and senior government officials to discuss U.S.-Taiwan relations and other issues during their one-day trip.