Republica Press

Your Business & Political News Source

REPUBLICA PRESS
Your Business & Political News Source

Drugs (Pharmaceuticals)

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

by

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.

View Source

>>> Don’t Miss Today’s BEST Amazon Deals! <<<<

Pakistan’s Private Vaccinations Draw Criticism

by

>>> Check Out Today’s BEST Amazon Deals!<<<<

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.

View Source

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

by

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?”

View Source

Covid-19 Vaccines: Novavax Reports More Delays

by

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

FDA Authorizes Pfizer-BioNTech Vaccine for Children 12 to 15

by

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.

View Source

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

by

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.

View Source

Pfizer Seeks Full FDA Approval for Its Covid-19 Vaccine

by

Pfizer and the German company BioNTech have become the first companies to apply to the U.S. Food and Drug Administration for full approval of 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.

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.

View Source

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

by

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

Pfizer Reaps Hundreds of Millions in Profits From Covid Vaccine

by

The pricing for the United States was in line with the cost of seasonal flu vaccines and much less expensive than vaccines for conditions like shingles, which can run into several hundred dollars.

“That price point does not seem offensive, even if you don’t spend a lot of time thinking about prescription drugs,” said Stacie Dusetzina, an associate professor of health policy at Vanderbilt University Medical Center. “Just thinking about any prescription you’d fill, you’d be hard-pressed to find pretty much anything for $20.”

But the fact that Pfizer appears to have earned something like $900 million in pretax profits from its vaccine — coupled with its comparatively small sales to poor countries — suggests that profits have trumped other considerations. That could undercut the company’s embrace of loftier principles.

“At Pfizer, we believe that every person deserves to be seen, heard and cared for,” the chief executive, Albert Bourla, said in January as the company announced it would join Covax. “We share the mission of Covax and are proud to work together so that developing countries have the same access as the rest of the world.”

But the company seems to have prioritized higher-priced sales.

“Despite all the talk about Covax, they have been far more interested in bilateral deals, because that’s where they make their money,” said Richard Kozul-Wright, director of the division on globalization and development strategies at the United Nations Conference on Trade and Development in Geneva. “It’s one of the great public relations triumphs of recent corporate history.”

Multiple factors explain the inequitable nature of Pfizer’s vaccine distribution.

The shot, which must be stored and transported at very low temperatures, is less practical for hard-to-reach parts of the world than other shots, like those from AstraZeneca and Johnson & Johnson, that can simply be refrigerated. Some poor countries were initially not hit hard by the virus, and so their governments had less urgency to place orders for the Pfizer vaccine, to the extent that they could afford to pay for the shots.

“Not everyone was interested in the vaccine or prepared to take steps; thus, conversations continue, including working with Covax beyond their initial order of 40 million doses,” said Ms. Castillo, the Pfizer spokeswoman.

View Source

Biden Confronts Coronavirus Vaccine Patents

by

WASHINGTON — President Biden, faced with surging Covid-19 crises in India and South America, is under intensifying pressure from the international community and his party’s left flank to commit to increasing the vaccine supply by loosening patent and intellectual property protections on coronavirus vaccines.

Pharmaceutical and biotech companies, also feeling pressure, sought on Monday to head off such a move, which could cut into future profits and jeopardize their business model. Pfizer and Moderna, two major vaccine makers, each announced steps to increase the supply of vaccine around the world.

The issue is coming to a head as the World Trade Organization’s General Council, one of its highest decision-making bodies, meets Wednesday and Thursday. India and South Africa are pressing for the body to waive an international intellectual property agreement that protects pharmaceutical trade secrets. The United States, Britain and the European Union so far have blocked the plan.

Inside the White House, health advisers to the president admit they are divided. Some say that Mr. Biden has a moral imperative to act, and that it is bad politics for the president to side with pharmaceutical executives. Others say spilling closely guarded but highly complex trade secrets into the open would do nothing to expand the global supply of vaccines.

promised the liberal health activist Ady Barkan, who has amyotrophic lateral sclerosis, or A.L.S., that he would “absolutely positively” commit to sharing technology and access to a coronavirus vaccine if the United States developed one first. Activists plan to remind Mr. Biden of that promise during a rally scheduled for Wednesday on the National Mall.

proposal by India and South Africa would exempt World Trade Organization member countries from enforcing some patents, trade secrets or pharmaceutical monopolies under the body’s agreement on trade-related intellectual property rights, known as TRIPS. The idea would be to allow drug companies in other countries to make or import cheap generic copies.

Proponents say the waiver would free innovators in other countries to pursue their own coronavirus vaccines, without fear of patent infringement lawsuits. They also note that the proposed waiver goes beyond vaccines, and would encompass intellectual property for therapeutics and medical supplies as well.

“Many people are saying, ‘Won’t they need the secret recipe?’ That’s not necessarily the case,” said Tahir Amin, a founder of the Initiative for Medicines, Access & Knowledge, a nonprofit dedicated to eliminating health inequities. “There are companies that feel they can go it alone, provided they don’t have to look over their shoulder and feel like they are going to take someone’s intellectual property.”

The pharmaceutical industry counters that rolling back intellectual property protections would not help ramp up vaccine production. It says that other issues are serving as barriers to getting shots into arms around the world, including access to raw materials and on-the-ground distribution challenges.

And just as important as having the rights to make a vaccine is having the technical know-how, which would have to be supplied by vaccine developers like Pfizer-BioNTech and Moderna — a process known as technology transfer.

on LinkedIn that his company would immediately donate more than $70 million worth of medicines to India and is also trying to fast-track the vaccine approval process in India. The company also posted on Twitter promising “the largest humanitarian relief effort in our company’s history to help the people of India.”

Moderna, which developed its vaccine with funding from American taxpayers, has already said it would not “enforce our Covid-19 related patents against those making vaccines intended to combat the pandemic.” But activists have been calling not just for the waiver, but for companies to share expertise in setting up and running vaccine factories — and for Mr. Biden to lean on them to do it.

issued an open letter calling on Mr. Biden to support the proposed waiver.

On Capitol Hill, 10 senators including Bernie Sanders, independent of Vermont, and Elizabeth Warren, Democrat of Massachusetts, urged Mr. Biden to “prioritize people over pharmaceutical company profits” and reverse the Trump administration’s opposition to the waiver. More than 100 House Democrats have signed a similar letter.

a handful of governments, including those of Brazil and Thailand, bypassed patents held by the developers of antiviral drugs for H.I.V./AIDS in an effort to clear the way for lower-cost versions of the treatments.

H.I.V. drugs, however, involve a much simpler manufacturing process than the coronavirus vaccines, especially those using messenger RNA technology, which has never before been used in an approved product.

In a Twitter thread, Mr. Amin offered another example: In the 1980s, Merck and GlaxoSmithKline had developed recombinant hepatitis B vaccines and held a monopoly with more than 90 patents covering manufacturing processes. The World Health Organization recommended vaccination for children, but it was expensive — $23 a dose — and most Indian families could not afford it.

The founder of Shantha Biotechnics, an Indian manufacturer, was told that “even if you can afford to buy the technology your scientists cannot understand recombinant technology in the least,” Mr. Amin wrote.

But Shantha, he added, went on “to produce India’s first home-grown recombinant product at $1 a dose.” That enabled UNICEF to run a mass vaccination campaign.

View Source

Terms and Conditions - Privacy Policy