significant drop since 2012 in the share of residents on the drugs.

But when residents with diagnoses like schizophrenia are included, the decline is less than half what the government and industry claim. And when the pandemic hit in 2020, the trend reversed and antipsychotic drug use increased.

For decades, nursing homes have been using drugs to control dementia patients. For nearly as long, there have been calls for reform.

In 1987, President Ronald Reagan signed a law banning the use of drugs that serve the interest of the nursing home or its staff, not the patient.

But the practice persisted. In the early 2000s, studies found that antipsychotic drugs like Seroquel, Zyprexa and Abilify made older people drowsy and more likely to fall. The drugs were also linked to heart problems in people with dementia. More than a dozen clinical trials concluded that the drugs nearly doubled the risk of death for older dementia patients.

11 percent from less than 7 percent, records show.

The diagnoses rose even as nursing homes reported a decline in behaviors associated with the disorder. The number of residents experiencing delusions, for example, fell to 4 percent from 6 percent.

Caring for dementia patients is time- and labor-intensive. Workers need to be trained to handle challenging behaviors like wandering and aggression. But many nursing homes are chronically understaffed and do not pay enough to retain employees, especially the nursing assistants who provide the bulk of residents’ daily care.

Studies have found that the worse a home’s staffing situation, the greater its use of antipsychotic drugs. That suggests that some homes are using the powerful drugs to subdue patients and avoid having to hire extra staff. (Homes with staffing shortages are also the most likely to understate the number of residents on antipsychotics, according to the Times’s analysis of Medicare data.)

more than 200,000 since early last year and is at its lowest level since 1994.

As staffing dropped, the use of antipsychotics rose.

Even some of the country’s leading experts on elder care have been taken aback by the frequency of false diagnoses and the overuse of antipsychotics.

Barbara Coulter Edwards, a senior Medicaid official in the Obama administration, said she had discovered that her father was given an incorrect diagnosis of psychosis in the nursing home where he lived even though he had dementia.

“I just was shocked,” Ms. Edwards said. “And the first thing that flashed through my head was this covers a lot of ills for this nursing home if they want to give him drugs.”

Homes that violate the rules face few consequences.

In 2019 and 2021, Medicare said it planned to conduct targeted inspections to examine the issue of false schizophrenia diagnoses, but those plans were repeatedly put on hold because of the pandemic.

In an analysis of government inspection reports, The Times found about 5,600 instances of inspectors citing nursing homes for misusing antipsychotic medications. Nursing home officials told inspectors that they were dispensing the powerful drugs to frail patients for reasons that ranged from “health maintenance” to efforts to deal with residents who were “whining” or “asking for help.”

a state inspector cited Hialeah Shores for giving a false schizophrenia diagnosis to a woman. She was so heavily dosed with antipsychotics that the inspector was unable to rouse her on three consecutive days.

There was no evidence that the woman had been experiencing the delusions common in people with schizophrenia, the inspector found. Instead, staff at the nursing home said she had been “resistive and noncooperative with care.”

Dr. Jonathan Evans, a medical director for nursing homes in Virginia who reviewed the inspector’s findings for The Times, described the woman’s fear and resistance as “classic dementia behavior.”

“This wasn’t five-star care,” said Dr. Evans, who previously was president of a group that represents medical staff in nursing homes. He said he was alarmed that the inspector had decided the violation caused only “minimal harm or potential for harm” to the patient, despite her heavy sedation. As a result, he said, “there’s nothing about this that would deter this facility from doing this again.”

Representatives of Hialeah Shores declined to comment.

Seven of the 52 homes on the inspector general’s list were owned by a large Texas company, Daybreak Venture. At four of those homes, the official rate of antipsychotic drug use for long-term residents was zero, while the actual rate was much higher, according to the Times analysis comparing official C.M.S. figures with unpublished data obtained by the California advocacy group.

make people drowsy and increases the risk of falls. Peer-reviewed studies have shown that it does not help with dementia, and the government has not approved it for that use.

But prescriptions of Depakote and similar anti-seizure drugs have accelerated since the government started publicly reporting nursing homes’ use of antipsychotics.

Between 2015 and 2018, the most recent data available, the use of anti-seizure drugs rose 15 percent in nursing home residents with dementia, according to an analysis of Medicare insurance claims that researchers at the University of Michigan prepared for The Times.

in a “sprinkle” form that makes it easy to slip into food undetected.

“It’s a drug that’s tailor-made to chemically restrain residents without anybody knowing,” he said.

In the early 2000s, Depakote’s manufacturer, Abbott Laboratories, began falsely pitching the drug to nursing homes as a way to sidestep the 1987 law prohibiting facilities from using drugs as “chemical restraints,” according to a federal whistle-blower lawsuit filed by a former Abbott saleswoman.

According to the lawsuit, Abbott’s representatives told pharmacists and nurses that Depakote would “fly under the radar screen” of federal regulations.

Abbott settled the lawsuit in 2012, agreeing to pay the government $1.5 billion to resolve allegations that it had improperly marketed the drugs, including to nursing homes.

Nursing homes are required to report to federal regulators how many of their patients take a wide variety of psychotropic drugs — not just antipsychotics but also anti-anxiety medications, antidepressants and sleeping pills. But homes do not have to report Depakote or similar drugs to the federal government.

“It is like an arrow pointing to that class of medications, like ‘Use us, use us!’” Dr. Maust said. “No one is keeping track of this.”

published a brochure titled “Nursing Homes: Times have changed.”

“Nursing homes have replaced restraints and antipsychotic medications with robust activity programs, religious services, social workers and resident councils so that residents can be mentally, physically and socially engaged,” the colorful two-page leaflet boasted.

Last year, though, the industry teamed up with drug companies and others to push Congress and federal regulators to broaden the list of conditions under which antipsychotics don’t need to be publicly disclosed.

“There is specific and compelling evidence that psychotropics are underutilized in treating dementia and it is time for C.M.S. to re-evaluate its regulations,” wrote Jim Scott, the chairman of the Alliance for Aging Research, which is coordinating the campaign.

The lobbying was financed by drug companies including Avanir Pharmaceuticals and Acadia Pharmaceuticals. Both have tried — and so far failed — to get their drugs approved for treating patients with dementia. (In 2019, Avanir agreed to pay $108 million to settle charges that it had inappropriately marketed its drug for use in dementia patients in nursing homes.)

Ms. Blakeney said that only after hiring a lawyer to sue Dundee Manor for her husband’s death did she learn he had been on Haldol and other powerful drugs. (Dundee Manor has denied Ms. Blakeney’s claims in court filings.)

During her visits, though, Ms. Blakeney noticed that many residents were sleeping most of the time. A pair of women, in particular, always caught her attention. “There were two of them, laying in the same room, like they were dead,” she said.

In his first few months at Dundee Manor, Mr. Blakeney was in and out of the hospital, for bedsores, pneumonia and dehydration. During one hospital visit in December, a doctor noted that Mr. Blakeney was unable to communicate and could no longer walk.

“Hold the patient’s Ambien, trazodone and Zyprexa because of his mental status changes,” the doctor wrote. “Hold his Haldol.”

Mr. Blakeney continued to be prescribed the drugs after he returned to Dundee Manor. By April 2017, the bedsore on his right heel — a result, in part, of his rarely getting out of bed or his wheelchair — required the foot to be amputated.

In June, after weeks of fruitless searching for another nursing home, Ms. Blakeney found one and transferred him there. Later that month, he died.

“I tried to get him out — I tried and tried and tried,” his wife said. “But when I did get him out, it was too late.”

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They Still Live in the Shadow of Theranos’s Elizabeth Holmes

Women at tech start-ups wrote to her thanking her for saying what they had been feeling, Ms. Esponnette said.

Lola Priego, 30, the founder of Base, which offers at-home blood and saliva tests that are processed at traditional labs, hears a Theranos comparison at least once a week, she said. The references come directly or indirectly from potential partners, advisers, investors, customers and reporters, she said.

She said she understood the need for skepticism, since new health care companies should be looked at critically to prevent malpractice. Often the comparisons stopped after people learned that Base works with Quest Diagnostics, a multinational company, for analysis of its tests.

“But the additional bias and skepticism is challenging to overcome,” Ms. Priego said.

The biggest blow came from a scientific adviser whom Ms. Priego said she had tried to recruit in 2019. The adviser took the meeting only to tell her that bringing technology into health care was doing a disservice to the industry, just like Theranos. It caused Ms. Priego to question whether she could hire the caliber of advisers she had hoped for.

“It was quite demoralizing,” she said. She has since recruited six advisers.

In July, Verge Genomics struck a three-year partnership with the pharmaceutical giant Eli Lilly to work on drugs for the treatment of amyotrophic lateral sclerosis, or A.L.S., Ms. Zhang said. The company also published a paper about its methods in a scientific journal last year and recruited a chief science officer this year.

It was a relief to have something to show to those who were doubtful, Ms. Zhang said.

“The most fragile part of the company is the earliest stage, when you have to buy into the people, the vision and the idea,” she said. Reflecting on Ms. Holmes and Theranos, she added, “It’s where these types of associations can be really harmful and curtail potential.”

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Covid Vaccines Produced in Africa Are Being Exported to Europe

Johnson & Johnson’s Covid vaccine was supposed to be one of Africa’s most important weapons against the coronavirus.

The New Jersey-based company agreed to sell enough of its inexpensive single-shot vaccine to eventually inoculate a third of the continent’s residents. And the vaccine would be produced in part by a South African manufacturer, raising hopes that those doses would quickly go to Africans.

That has not happened.

South Africa is still waiting to receive the overwhelming majority of the 31 million vaccine doses it ordered from Johnson & Johnson. It has administered only about two million Johnson & Johnson shots. That is a key reason that fewer than 7 percent of South Africans are fully vaccinated — and that the country was devastated by the Delta variant.

At the same time, Johnson & Johnson has been exporting millions of doses that were bottled and packaged in South Africa for distribution in Europe, according to executives at Johnson & Johnson and the South African manufacturer, Aspen Pharmacare, as well as South African government export records reviewed by The New York Times.

donated by the United States. But about four million of the country’s 60 million residents are fully vaccinated.

That left the population vulnerable when a third wave of cases crested over the country. At times in recent months, scores of Covid-19 patients at Helen Joseph Hospital in Johannesburg were waiting in the emergency department for a bed, and the hospital’s infrastructure struggled to sustain the huge volumes of oxygen being piped into patients’ lungs, said Dr. Jeremy Nel, an infectious-disease doctor there.

“The third wave, in terms of the amount of death we saw, was the most heartbreaking, because it was the most avoidable,” Dr. Nel said. “You see people by the dozens dying, all of whom are eligible for a vaccine and would’ve been among the first to get it.”

a United Nations-backed clearinghouse for vaccines that has fallen behind on deliveries. South Africa was slow to enter negotiations with manufacturers for its own doses. In January, a group of vaccine experts warned that the government’s “lack of foresight” could cause “the greatest man-made failure to protect the population since the AIDS pandemic.”

announced in November. Aspen’s facility in Gqeberha, on South Africa’s southern coast, was the first site in Africa to produce Covid vaccines. (Other companies subsequently announced plans to produce vaccines on the continent.)

South African officials hailed Aspen’s involvement as indispensable.

Aspen “belongs to us as South Africans, and it is making lifesaving vaccines,” South Africa’s president, Cyril Ramaphosa, said during a visit to Aspen’s plant in March. He said he had pushed Johnson & Johnson to prioritize the doses made there for Africans.

“I want them now,” Mr. Ramaphosa added. “I’ve come to fetch our vaccines.”

results of a clinical trial suggested that the vaccine from AstraZeneca offered little protection from mild or moderate infections caused by the Beta variant that was circulating in South Africa.

Weeks later, Johnson & Johnson and the government signed a contract for 11 million doses. South Africa ordered another 20 million doses in April. That would be enough to vaccinate about half the country.

South Africa agreed to pay $10 per dose for the 11 million shots, according to the contract. That was the same price that the United Statespaid and slightly more than the $8.50 that the European Commission agreed to pay. The South African contract prohibited the government from banning exports of the vaccine, citing the need for doses to “move freely across national borders.”

introduced export controls this year to conserve scarce supplies. India halted exports produced by the Serum Institute, which was supposed to be a major vaccine supplier to poor countries. In the United States, officials said they didn’t ban exports, but they didn’t need to. The combination of the extensive vaccine production on American soil and the high prices the U.S. government was willing to pay meant that companies made the delivery of shots for Americans a priority.

Other benefits for Johnson & Johnson were embedded in the South African contract.

While such contracts typically protect companies from lawsuits brought by individuals, this one shielded Johnson & Johnson from suits by a wider range of parties, including the government. It also imposed an unusually high burden on potential litigants to show that any injuries caused by the vaccine were the direct result of company representatives engaging in deliberate misconduct or failing to follow manufacturing best practices.

“The upshot is that you have moved almost all of the risk of something being wrong with the vaccine to the government,” said Sam Halabi, a health law expert at Georgetown University who reviewed sections of the South African contract at the request of The Times.

Mr. Halabi said the contract’s terms appeared more favorable to the pharmaceutical company than other Covid vaccine contracts he had seen. South African officials have said Pfizer, too, sought aggressive legal protections.

The contract said Johnson & Johnson would aim to deliver 2.8 million doses to South Africa by the end of June, another 4.1 million doses by the end of September and another 4.1 million doses by the end of December. (The government expects the 20 million additional doses to be delivered by the end of this year, Mr. Maja said.)

The company has so far fallen far short of those goals. As of the end of June, South Africa had received only about 1.5 million of the doses from its order. The small number of doses that have been delivered to the African Union were on schedule.

The difficulties in procuring doses have revealed the limits of fill-and-finish sites, which leave countries dependent on vaccines from places like the European Union or the United States, said Dr. Salim Abdool Karim, who until March was co-chairman of South Africa’s ministerial advisory committee on Covid.

“Ultimately,” he said, “the solution to our problem has to be in making our own vaccines.”

Lynsey Chutel and Choe Sang-Hun contributed reporting.

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Paul J. Hanly Jr., Top Litigator in Opioid Cases, Dies at 70

Paul J. Hanly Jr., a top trial lawyer who had been central to the current nationwide litigation against pharmaceutical companies and others in the supply chain for their role in the deadly opioid epidemic, died on Saturday at his home in Miami Beach. He was 70.

The cause was anaplastic thyroid cancer, an extremely rare and aggressive disease, said Jayne Conroy, his longtime law partner.

Over his four-decade career, Mr. Hanly, a class-action plaintiffs’ lawyer, litigated and managed numerous complex legal cases, involving among other things the funding of terrorists, stemming from the attacks of Sept. 11, 2001, and allegations of the sexual abuse of dozens of boys by a man who ran an orphanage and school in Haiti.

But nothing compares to the national opioid cases that are pending in federal court in Cleveland on behalf of thousands of municipalities and tribes against the manufacturers and distributors of prescription opioid pain medications. The federal opioid litigation is regarded by many as perhaps the most complex in American legal history — even more entangled and far-reaching than the epic legal battles with the tobacco industry.

settled with Purdue for $75 million. It was one of the few instances in which a drug maker agreed to pay individual patients who had accused it of soft-pedaling the risk of addiction.

Mr. Hanly had a history of taking on complex cases with vast numbers of plaintiffs. Shortly after the 2001 terrorist attacks, he represented some of the families who had lost loved ones on the planes and in the World Trade Center. He also filed suit to stop the sale of tanzanite, a raw stone used as a cash alternative to fund terrorist activities. That lawsuit was expanded to include foreign governments, banks and others that supported Al Qaeda. Portions of it remain pending.

Another of his important cases was a 2013 landmark settlement of $12 million on behalf of 24 Haitian boys who said they had been sexually abused by Douglas Perlitz, who ran programs for underprivileged boys and was subsequently sentenced to 19 years in prison. Mr. Hanly said the defendants, including the Society of Jesus of New England, Fairfield University and others, had not properly supervised Mr. Perliitz. Mr. Hanly filed additional charges in 2015, bringing the total number of abused youths to more than 100 between the late 1990s and 2010.

“Paul was a lawyer’s lawyer,” said Ms. Conroy, his law partner. She said he was renowned for his exhaustive trial preparation, his creative trial strategies and his nearly photographic memory of the contents of documents.

He was also known for veering sartorially from the muted grays and blacks of most lawyers to more jaunty attire in bright yellows, blues and pinks. He favored bespoke styles that were flashy yet sophisticated. His two-tone shoes were all handmade.

John V. Kenny, a former mayor of Jersey City and a powerful Hudson County Democratic boss known as “the pope of Jersey City,” who was jailed in the 1970s after pleading guilty to charges of income tax evasion.

Mr. Hanly took a different path. He went to Cornell, where his roommate was Ed Marinaro, who went on to play professional football and later became an actor (best known for “Hill Street Blues”). Mr. Hanly, who played football with him, graduated in 1972 with a major in philosophy and received a scholar-athlete award as the Cornell varsity football senior who combined the highest academic average with outstanding ability.

He earned a master’s degree in philosophy from Cambridge University in 1976 and a law degree from Georgetown in 1979. He then clerked for Lawrence A. Whipple, a U.S. District Court judge in New Jersey.

Mr. Hanly’s marriage in the mid-1980s to Joyce Roquemore ended in divorce. He is survived by two sons, Paul J. Hanly III and Burton J. Hanly; a daughter, Edith D. Hanly; a brother, John K. Hanly; and a sister, Margo Mullady.

He began his legal career as a national trial counsel and settlement counsel to Turner & Newall, a British asbestos company, one of the world’s largest, in its product-liability cases. The company was purchased by an American firm, Federal-Mogul, in 1998, after which it was overwhelmed with asbestos claims and filed for bankruptcy in 2001.

Mr. Hanly and Ms. Conroy spent much of their time steeped in negotiations with plaintiffs’ lawyers. They soon switched to representing plaintiffs themselves.

“We recognized over time that that was more important to us,” Ms. Conroy said, “to make sure victims were compensated for what happened.”

Jan Hoffman contributed reporting.

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Pakistan’s Private Vaccinations Draw Criticism

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ISLAMABAD, Pakistan — The coronavirus was ripping through Pakistan, and Muhammad Nasir Chaudhry was worried. Long lines and tight supplies plagued the government’s free vaccine campaign. Newspapers were filled with reports of well-connected people jumping the line for a free dose.

Then Mr. Chaudhry, a 35-year-old government consultant, discovered he could pay to leapfrog the long lines himself. He registered to take two doses of the Russian-made Sputnik V vaccine for about $80 from a private hospital. That’s a lot of money in a country where the average worker makes about $110 per month, but Mr. Chaudhry was ready to make the commitment.

Critics have assailed such private sales in Pakistan and around the world, saying that they make inoculations available only to the wealthy. But in Pakistan, like elsewhere, tight supplies have stymied those efforts. The private hospitals are out of supplies, and Mr. Chaudhry still hasn’t been vaccinated.

“I am willing to pay double the price for the vaccine, but I don’t want to wait on and on,” Mr. Chaudhry said.

bought up most of the world’s vaccine supplies to protect their own people, leaving millions of doses stockpiled and in some places unused. Less developed countries scramble over what’s left.

To speed up vaccinations, some countries have allowed doses to be sold privately. But those campaigns have been troubled by supply issues and by complaints that they simply reflect the global disparities.

blocked them over fears that counterfeit vaccines would be sold. In the United States, some well-connected companies, like Bloomberg, have secured doses for employees.

can’t find vaccines to buy. Demand has been strong. The government sets a ceiling on prices but has been locked in a dispute with private importers over how much that should be.

In April, in the city of Karachi, long lines formed when two private hospitals began selling the Sputnik V vaccine to walk-ins. Private hospitals in Islamabad, the capital, and Lahore faced a similar rush of people and ran short within days. Hospitals in the major cities have now stopped taking walk-ins, and online registration has also been put on hold.

Sputnik V isn’t the only vaccine that the government allows to be sold privately. A one-dose shot made by CanSino Biologics of China is priced at around $28. Demand has been weaker because of greater public confidence in the Russian vaccine. Still, supplies sold out quickly after the CanSino doses went on sale last month. The government has said another 13.2 million doses will arrive in June.

AGP Limited, a private pharmaceutical company that has imported 50,000 doses of Sputnik, is urging patience.

“Sputnik V received an overwhelming response in Pakistan with thousands of people being vaccinated in just a few days and an even higher number of registrations confirmed in hospitals across Pakistan,” said Umair Mukhtar, a senior official of AGP Limited. He said the company has placed large orders for more.

The government price dispute could delay further expansion. The drug regulatory authority wants Sputnik V to be sold at a lower price. AGP won an interim court order on April 1 to sell the vaccine until a final price is fixed.

For those who can afford the doses, frustration is growing. Junaid Jahangir, an Islamabad-based lawyer, said several of his friends got private inoculations. He registered with a private lab for Sputnik V but got a text message later saying that the vaccination drive was on hold.

“I am being denied a fair chance to fight this virus if I end up getting infected,” Mr. Jahangir said. “The demand is there, and I don’t see what could possibly be the reason behind the inefficiency in supply.”

Some of the people who paid for private doses justified their decision by citing media reports that some well-connected people were jumping the line to get free, public doses. In May, at least 18 low-level health care workers were suspended by the authorities in Lahore for vaccinating people out of turn after taking bribes.

Iffat Omar, an actor and talk show host, apologized publicly in April for jumping ahead of the line to get the vaccine. “I am sorry,” she said on Twitter. “I am ashamed. I apologise from the bottom of my heart. I will repent.”

Fiza Batool Gilani, an entrepreneur and the daughter of Yusuf Raza Gilani, the former prime minister, said she knows of several young people who jumped the queue and got the free government vaccine in recent weeks.

“I was myself offered out of turn, free vaccine, but I declined as I wanted to avail the private vaccine,” said Ms. Gilani. Wealthy people should pay for their doses, she said, adding that her family would pay for CanSino shots for its household staff.

Many people, like Tehmina Sadaf, don’t have that option.

Ms. Sadaf, 35, lives along with her husband and a seven-year old son in a working-class neighborhood on the outskirts of Islamabad. Her husband is a cleric at a mosque. She gives Quran lessons to young children. She said the pandemic had negatively impacted the family’s income of around $128 per month. “After paying the house rent and electricity bill, we are not left with much,” she said.

She had her doubts about the public vaccine, “but the price of the private vaccine is very high,” she said. “It should have been lower so that poor people like us can also afford it.”

Zia ur-Rehman contributed reporting from Karachi, Pakistan. Richard C. Paddock and Muktita Suhartono contributed reporting.

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Biden Dips Into U.S. Vaccine Supply to Send 20 Million Doses Abroad

WASHINGTON — President Biden, heeding widespread calls to step up his response to the pandemic’s surge abroad, said on Monday that his administration would send 20 million doses of federally authorized coronavirus vaccine overseas in June — the first time he has pledged to give away doses that could be used in the United States.

The donation is another step toward what Mr. Biden promised would be an “entirely new effort” to increase vaccine supplies and vastly expand manufacturing capacity, most of it in the United States. He also put Jeffrey Zients, the White House coronavirus response coordinator, in charge of developing a global strategy.

“We know America will never be fully safe until the pandemic that’s raging globally is under control,” Mr. Biden said in a brief appearance at the White House. “No ocean’s wide enough, no wall’s high enough, to keep us safe.”

With new cases and deaths plummeting as vaccination rates rise in the United States, the epicenter of the crisis has moved to India and other nations. A growing and bipartisan chorus of diplomats, health experts and business leaders has been pushing the president to do more to end what the AIDS activist Asia Russell calls “vaccine apartheid.”

There is a huge disconnect growing where, in some countries with the highest vaccination rates, there appears to be a mind-set that the pandemic is over, while others are experiencing huge waves of infection,” Dr. Tedros said.

Variants like B.1.617, first discovered in India and recently designated a variant of concern by the W.H.O., are contributing to the spread of infections and worry many researchers.

Dr. Tedros called for well-supplied nations to send more of their vaccine allocations to harder-hit countries, and for vaccine developers and manufacturers to hasten delivery of hundreds of millions of doses to Covax, an international initiative dedicated to equitable distribution of the vaccine, noting an appeal by Henrietta Fore, UNICEF’s executive director.

Mr. Biden took office vowing to restore the United States as a leader in global public health, and he has taken certain steps to do so: rejoining the World Health Organization, pledging $4 billion to an international vaccine effort and providing financial support to help Biological E, a vaccine manufacturer in India, produce at least one billion doses of coronavirus vaccines by the end of 2022.

To broaden supply further, Mr. Biden recently announced he would support waiving intellectual property protections for coronavirus vaccines. But activists say simply supporting the waiver is not enough; Mr. Biden must create the conditions for pharmaceutical companies to transfer their intellectual property to vaccine makers overseas, they argue. They view his efforts as piecemeal.

“We’re after 100 days into the administration, and what Biden should be delivering is a global battle plan against vaccine apartheid, and the announcement today is lines on a Post-it note,” Ms. Russell said, adding, “There must be a global strategy led by the U.S. that’s based on technology transfer, on forcing pharma to come to the table to share the recipe.”

assert that a fix is already at hand as they aggressively expand production lines and contract with counterparts around the world to yield billions of additional doses.

An open letter to the president, made public last week by a bipartisan group including business leaders, diplomats and a former defense secretary, argued that such a waiver “would make little difference and could do harm.”

While global health activists are strongly in favor of the waiver, some said they welcomed the views of the business community. They see clear parallels to their work fighting the global AIDS epidemic.

“It shows an unprecedented willingness of pharma and its allies in the private sector to admit what all of us having been saying for months — the private sector alone cannot and will not ensure global vaccine access,” James Krellenstein, a founder of PrEP4All, a nonprofit aimed at ensuring universal access to H.I.V. prevention and treatment, wrote in an email on Sunday. “It really shifts the burden to the Biden administration,” he added.

The organizer of the open letter, Hank Greenberg, the chairman of Starr Companies and former chairman of American International Group, the insurance industry giant, said in an interview on Monday that Mr. Biden’s announcement did not go far enough.

Mr. Greenberg, 96, a veteran of World War II, said he was inspired to write after a former chief executive of an A.I.G. subsidiary who later became the ambassador from the Philippines to the United States told him he was not able to get vaccinated. Like Mr. Biden, he used language that evoked the war effort.

“If we don’t do it,” he asked, “who will?”

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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.

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FDA Authorizes Pfizer-BioNTech Vaccine for Children 12 to 15

Vaccinating children is crucial to building up population levels of immunity and curtailing the spread of the coronavirus. Though children spread the virus less efficiently than adults do, they make up about 23 percent of the population.

Experts have said that the country is unlikely to reach the “herd immunity” threshold — the point at which virus transmission essentially stalls — but vaccinating children will be important for getting as close as possible.

Ty Dropic, 14, one of the trial participants, urged others his age to be vaccinated so they could build up widespread immunity and protect themselves. He had no side effects, leading him to suspect that he got the placebo. If that turns out to be the case, he plans to be immunized as soon as possible.

“I know it can be kind of scary, but it’s really not as bad as it seems,” he said. “If you do get Covid, it’ll be a lot worse than getting stuck with a needle for, like, two seconds.”

Ty’s three siblings, ages 8, 10 and 16, are also enrolled in vaccine trials for their age groups. Their mother, Dr. Amanda Dropic, a pediatrician in northern Kentucky, said that in her practice, most parents were eager to have their children vaccinated so they could regain some semblance of normalcy.

“The anxiety and depression that we’re seeing with kids, the social delays, has been tremendous,” she said.

Dr. Dropic said her children understood the risks and were willing to volunteer because they saw it as a civic duty. Every medicine available today came to be because “somebody was willing to go first,” she added.

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W.H.O. approves China’s Sinopharm vaccine for emergency use.

The World Health Organization on Friday approved China’s Sinopharm’s Covid-19 vaccine for emergency use, easing the way for poorer nations to get access to another much-needed shot to help end the pandemic.

The approval allows the Sinopharm vaccine to be included in Covax, the World Health Organization’s global initiative that is designed to promote equitable vaccine distribution around the world.

The need is dire.

Rich countries are hoarding doses. India, a major vaccine maker, has stopped exports to address its worsening coronavirus crisis. Questions about safety after exceedingly rare side effects led some countries to briefly pause using AstraZeneca and Johnson & Johnson doses or change their guidance around the use.

Reliable vaccine access could improve further next week when the W.H.O. considers another Chinese shot, made by the company Sinovac.

Andrea Taylor, who analyzes global data on vaccines at the Duke Global Health Institute, called the potential addition of two Chinese vaccines into the Covax program a “game changer.”

“The situation right now is just so desperate for low- and lower-middle-income countries that any doses we can get out are worth mobilizing,” Ms. Taylor said. “Having potentially two options coming from China could really change the landscape of what’s possible over the next few months.”

But the fanfare may be short-lived. While China has claimed it can make up to 5 billion doses by the end of this year, Chinese officials say the country is struggling to manufacture enough doses for its own population and are cautioning a pandemic-weary world to keep expectations in check.

“This should be the golden time for China to practice its vaccine diplomacy. The problem is, at the same time, China itself is facing a shortage,” said Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations. “So in terms of global access to vaccines, I don’t expect the situation to significantly improve in the coming two to three months.”

Still, the approval represents a high point in its vaccine diplomacy efforts and a chance to fill the gap left by Western nations and pharmaceutical companies in low- and middle-income countries. Sinopharm is the first Chinese shot to be classified as safe and effective by the W.H.O., and its approval could ease concerns about the lack of transparency from Chinese vaccine companies.

Regulators from China and other countries have approved the Sinopharm vaccine in recent months, though the company has not released Phase 3 clinical trial data for scientists to independently assess.

The W.H.O. was given access to this data before the announcement, but there is limited data on how well the vaccine will work against the many coronavirus variants cropping up around the world.

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