Tag Archives: Health Care/Life Sciences

Moderna Covid-19 Vaccine Production Pace to Increase at Contract Manufacturer Catalent

Contract drug manufacturer Catalent Inc. is expanding its U.S. production of the Covid-19 vaccine from Moderna Inc., a development that could ensure the U.S. has ample supply as it ramps up vaccinations.

Catalent has reached an agreement with Moderna that will increase the speed of vaccine output at the contract manufacturer’s Bloomington, Ind., plant this month to about 400 vials a minute, according to people familiar with the matter.

Catalent will shift manufacturing of the shot to one faster production line from two slower ones. New doses will be ready for shipping starting next month, the people said, and the upgraded plant will be able fill an additional 80 million vials a year.

The expansion will help Moderna reach its goal of supplying an additional 100 million doses to the U.S. by the end of May and another 100 million doses by the end of July.

Production in the U.S. of several authorized vaccines has picked up speed in recent weeks, as manufacturers have scaled up production lines and taken other steps to increase output.

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Covid-19 Vaccine Developed by U.S. Army Begins Human Testing

The U.S. Army will start testing among adult volunteers an Army-developed Covid-19 vaccine that researchers say may protect against a variety of coronavirus variants.

Army doctors plan to start testing on Tuesday the protein-based shot in as many as 72 adults ages 18 to 55 at the Walter Reed Army Institute of Research in Silver Spring, Md., the institute said. The team will test whether the vaccine safely induces the desired immune response in study subjects.

Initial results of the study could become available by midsummer. If the data are positive, the Army likely would try to join with a drug company to further test and develop the vaccine, said Kayvon Modjarrad, director of the institute’s emerging infectious disease branch.

The experimental shot is among dozens in development, many aimed at improving upon available shots. Some 229 human vaccine trials are under way, according to BioCentury, which is tracking the efforts.

Army researchers say their vaccine was protective in studies of monkeys that were exposed to the coronavirus.

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Covid-19 Cases Drop. Vaccine Distribution Picks Up. How Open Is America?

The number of Covid-19 cases has dropped in most states from January highs while vaccination distribution has picked up, but life in most of the U.S. isn’t back to normal. Americans went out less in January, February and early March compared with the same period in 2020, before the Covid-19 pandemic forced state lockdowns. The number of times people spent 10 minutes or more away from home was down 6% across the U.S., according to data from the Bureau of Transportation Statistics. In some states, including Mississippi, Alabama and the Dakotas, people ventured out at almost the same rate they did in early 2020.

Foot-traffic data analyzed by The Wall Street Journal show that many people have returned to restaurants but are far less enthusiastic about movie theaters. Fewer people are filling congregation pews in every state except Wyoming. Gyms in North Dakota are busier than before the pandemic, but fewer people are hopping onto treadmills everywhere else. Nationwide people are spending less time in traffic and sticking closer to home, compared with in early 2020.

Overall, Americans are visiting houses of worship and nonessential businesses such as gyms and movie theaters a median of 19% less often than they did right before the pandemic hit. In Wyoming, North Dakota and South Dakota, these establishments have almost made a full comeback. The three states are also among the 11 states where people traveled more miles in cars than before Covid-19, while the national median dropped 6%.

In the Dakotas, which have had fewer restrictions than most states, bars have been crowded, and weddings and large gatherings have taken place. Public schools have been mostly open for in-person learning since September. South Dakota and North Dakota had the two highest Covid-19 daily case rates per 100,000 people as of April 2.

In Arizona and North Carolina, foot traffic at nonessential businesses and houses of worship in January, February and early March was closer to the national median. North Carolina Gov. Roy Cooper eased restrictions at the end of February, allowing retail stores, gyms and restaurants to open at 50% capacity. On March 23, the state announced that it would lift its 11 p.m. closing time for serving alcohol and increase occupancy limits for nonessential businesses. Bars, gyms, restaurants and theaters in Arizona were allowed to operate at full capacity in March.

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15 CEOs Reflect on Their Pandemic Year and the Lessons They’ve Learned

Hilton Worldwide Holdings Inc. Chief Executive Chris Nassetta worked from home in Arlington, Va., with his wife, six daughters and two dogs for two weeks before returning to the hotel chain’s nearly empty headquarters for the rest of the past year. Sharmistha Dubey has been leading Match Group Inc. from her dining room table near Dallas. Herman Miller ’s Andi Owen has her dog Finn to keep her company while working from her home office in Grand Rapids, Mich. Moderna Inc. CEO Stéphane Bancel relishes twice-daily 30-minute walks between his home in Boston and the vaccine maker’s Cambridge offices, where he resumed working in August, so he can crystallize his priorities and reflect on the day. The Wall Street Journal photographed them and 11 other business leaders in their pandemic office spaces as they discussed the past year and what’s to come.

More than a year after the coronavirus upended the way we work, the business leaders said they have found that more communication, flexibility and transparency have been crucial in staying connected to their employees.

Heads of companies across sectors including finance, hospitality and technology spoke from their current workspaces about what they’ve learned from the largely remote year, what challenges they faced and what changes they plan to leave in place during the next phase of work.

Brad Karp, chairman of the law firm Paul, Weiss, Rifkind, Wharton & Garrison LLP, predicted his schedule will remain less hectic after the pandemic is over: “Personally, I can’t see myself reflexively flying cross-country for an hour-long presentation or meeting.”

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As Covid-19 Vaccinations Ramp Up, Hesitancy Wanes

A shrinking percentage of Americans are expressing reluctance to get a Covid-19 vaccine, a positive sign for the efforts to get shots in the arms of enough people to reach herd immunity.

The findings come from the latest release of a large-scale survey conducted by the U.S. Census Bureau and developed in concert with the Centers for Disease Control and Prevention and the National Center for Health Statistics. The most recent survey gauged responses from nearly 80,000 adults between March 3 and March 15.

The survey found about 17% of adults said they would either definitely or probably not get vaccinated, down from 22% in January. The decline was almost entirely due to fewer respondents saying they probably won’t get the shot; the share saying they definitely won’t has remained essentially unchanged in the past two months.

Reluctance to get vaccinated remains highest in the South. But many Southern states have seen a steep decline in hesitancy since the January survey, particularly Alabama, Louisiana, North Carolina and South Carolina.

Another finding: vaccine hesitancy among Black Americans has diminished considerably. Black Americans are still the most likely to say they will probably or definitely not get vaccinated. But in January, Black Americans were 13 percentage points more likely than white Americans to say that; as of mid-March, the gap had shrunk to five points.

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Europe Despairs as Covid-19 Vaccine Rollout Stalls and Pandemic Grinds On

BERLIN—Susan Tabbach feels drained. She has been juggling working and caring full-time for her three small children at home during lockdowns, while worrying about her elderly parents, who aren’t vaccinated.

She sees little prospect for relief. “I’m just exhausted,” said the 41-year-old architect from Aachen, a German city near the Belgian and Dutch borders. “I would like at least to know that my parents are safe.”

Europeans of all ages, from children to grandparents, are becoming exhausted with a crisis that is now entering its second year and whose end seems to be receding beyond the horizon. Vaccinations are progressing at a glacial pace, Covid-19 cases are spiraling up again and increasingly unpopular governments impose new restrictions weekly.

The mixture of pessimism, resignation, and anger contrasts with feelings of optimism elsewhere in the West, especially in the U.S. and the U.K., where vaccinations are progressing much faster and attention is moving to reopening the economy.

Germany is a striking case of changing fortunes. The country fared well in the first phase of the pandemic last year, and authorities gained plaudits for keeping infections and deaths low. Now, after four months of largely ineffective lockdowns and with a slow and bureaucratic vaccination regime that hasn’t so far picked up speed, infections are soaring again and the government is seeing its poll ratings plummet.

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Pfizer Goes It Alone to Expand Vaccine Business Beyond Covid-19 Pandemic

Pfizer Inc. aims to expand its vaccine business by becoming a leader in the new gene-based technology behind its successful Covid-19 shots.

Pfizer will develop new shots using the technology, called mRNA, to target other viruses and pathogens beyond the coronavirus, Chief Executive Albert Bourla said in an interview. He said the company’s scientists and engineers gained a decade’s worth of experience in the past year working on the Covid-19 vaccine with Germany’s BioNTech SE , and is ready to pursue mRNA on its own.

“There is a technology that has proven dramatic impact and dramatic potential,” Mr. Bourla said. “We are the best positioned company right now to take it to the next step because of our size and our expertise.”

Pfizer will increase R&D in the technology, including adding at least 50 employees whose assignments will include mRNA, and it will harness the new mRNA manufacturing network it assembled in the past year to compete.

“We are now ahead and we plan to maintain the gap,” he said of the mRNA vaccine market.

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Scientists Say They Found Cause of Rare Blood Clotting Linked to AstraZeneca Vaccine

BERLIN—Scientists in Europe said they had identified a mechanism that could lead the AstraZeneca PLC vaccine to cause potentially deadly blood clots in rare instances as well as a possible treatment for it.

Two teams of medical researchers in Norway and Germany have independently found that the vaccine could trigger an autoimmune disorder causing blood to clot in the brain, which would offer an explanation for isolated incidents across Europe in recent weeks.

Several European countries briefly halted their rollouts of the vaccine this week after more than 30 recipients were diagnosed with the condition known as cerebral venous sinus thrombosis or CVST. Most of the people affected were women under the age of 55.

The issue affected a tiny portion of those who had received the shot however, and after investigating, the European drugs regulator ruled that the benefits outweighed the potential risks of the vaccine, and recommended vaccinations resume.

Latest Vaccine Developments

Some countries, such as Germany, France and Italy, resumed vaccination with AstraZeneca’s shot on Friday, with an added warning that it could be linked to blood clotting. The French healthcare authority, which recorded three cases of CVST connected to the vaccine, advised the government on Friday to only administer the shot to people older than 55.

Others, including Norway, Sweden and Denmark, said they needed more research before restarting their rollouts. Norway registered three cases of CVST, one of them fatal. The country vaccinated around 120,000 people with the shot. Finland suspended the use of AstraZeneca on Friday, after recording two cases of what the authorities called unusual blood clotting.

Pål André Holme, a professor of hematology and chief physician of the Oslo University Hospital who headed an investigation into the Norwegian cases, said his team had identified an antibody created by the vaccine that was triggering the adverse reaction.

​Europe’s top drug regulator endorsed AstraZeneca’s vaccine after it was suspended in several countries over blood-clot concerns. WSJ explains what’s at stake for a shot that’s been widely used around the world and may soon be considered for emergency use in the U.S. Photo: Mykola Tys/SOPA Images

“Nothing but the vaccine can explain why these individuals had this immune response,” Prof. Holme said.

Norway’s health authority cited the findings when announcing that it would not resume the vaccination.

A team of German researchers around Andreas Greinacher, professor of transfusion medicine at the Greifswald University Clinic, said they had independently came to the same conclusion as Prof. Holme in a statement and a press conference on Friday.

In Germany, 13 cases of CVST were detected among around 1.6 million people who received the AstraZeneca vaccine. Twelve patients were women and three died.

The German researchers, who coordinated with colleagues in Austria, Ireland and Britain, said in a statement that patients who show symptoms four days after vaccination, such as headaches, dizziness or impaired vision, could be quickly diagnosed with a blood test. Prof. Greinacher said the news meant that people should not fear the vaccine.

“Very, very few people will develop this complication,” Prof. Greinacher said in a press conference Friday. “But if it happens we now know how to treat the patients.”

Pål André Holme’s team at Oslo University Hospital identified an antibody created by the AstraZeneca vaccine that was triggering the adverse reaction.



Photo:

Terje Pedersen/Associated Press

The German government said it was examining the findings, but stuck to its decision to resume use of the AstraZeneca vaccine.

Neither the German nor the Norwegian findings were published or peer reviewed. Prof. Greinacher said he had submitted his findings for publication to the British medical journal The Lancet.

The German Society for Thrombosis and Hemostasis Research reviewed Prof. Greinacher’s work and issued a statement Friday advising physicians how to diagnose and treat the condition should it arise in vaccine recipients.

Dr. Robert Klamroth, deputy-chairman of the Society for Thrombosis and Hemostasis Research, said the rare autoimmune reaction occurred more frequently in Germany because the country initially only authorized the vaccine for people younger than 64. Britain, which had fewer incidents but vaccinated many more people, was predominantly giving the shot to older recipients.

Once diagnosed, the condition should be treated with blood thinning medication and immunoglobulin, which targets the antibody that causes the problem.

“We believe the most likely hypothesis is that this particular vaccine is causing a rare autoimmune reaction that triggers antibodies, which then interact with the platelets, but we don’t know why this is happening,” Dr. Klamroth said.

Write to Bojan Pancevski at bojan.pancevski@wsj.com

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Spring Arrives in Paris, Along With Another Covid-19 Lockdown

PARIS—Spring was once a time for strolls along the River Seine and people-watching from sun-dappled terraces.

On Friday, however, Paris awoke to what has now become an entirely different rite of spring: a pandemic-induced lockdown.

This lockdown is less severe than the original one that paralyzed France a year ago. It is limited to Paris and 15 other areas of France that have been hit hard by the spread of Covid-19 variants. Parisians are allowed to venture 10 kilometers from their homes with a permission slip, as opposed to last year when the limit was one kilometer.

But France’s third lockdown is perhaps its most demoralizing. The country has looked abroad with envy as vaccines were developed in record time and deployed with such speed across the U.S. and the U.K. that France began to wonder if it too was on the cusp of economic renewal.

Instead Paris’ cafes and bistros are indefinitely closed. The Louvre is sealed off. The Eiffel Tower is deserted. And the line for vaccines is very long.

“My sister lives in New York—she was vaccinated and she’s younger than me,” said Cyril Dunn, a 54-year-old leather-goods artisan. “In France there are still vulnerable people who haven’t been vaccinated. I know 85-year-olds who are still waiting for an appointment.”

French President Emmanuel Macron spoke with hospital staff in Poissy, near Paris, on Wednesday.



Photo:

yoan valat/Agence France-Presse/Getty Images

President

Emmanuel Macron’s

management of the crisis has been particularly vexing to many French. The former investment banker has been steadfast in sticking with the European Union’s decision to collectively procure vaccine supplies—an approach that has led to vaccine shortfalls throughout France and the rest of the Continent. As of Friday, only 8% of France’s population had received a single dose of a Covid-19 vaccine, and only 3% had been fully vaccinated.

Mr. Macron has also fueled skepticism of a vaccine developed by Oxford University and

AstraZeneca

PLC that many European health authorities deem crucial for turning the tide of the pandemic.

In late January, Mr. Macron told a group of reporters the vaccine was quasi ineffective for people older than 65, without providing evidence to back up his claim. His government then reversed course in early March—clearing it for use in older people—only to suspend the vaccine’s use this week following reports that people who had received it in other parts of Europe developed rare blood clots, and some had died.

On Thursday, Mr. Macron’s prime minister,

Jean Castex,

said the country would resume use of AstraZeneca’s vaccine after the European Union’s health agency said it was safe and effective and didn’t increase the risk of blood clots. Mr. Castex received the AstraZeneca vaccine on Friday to reinforce the government’s message.

The zigzagging has deepened confusion in a country that has a history of vaccine hesitancy.

“I don’t understand why they stopped,” said Eric Vigor, a 52-year-old banker. “If I could get vaccinated, I would immediately—with AstraZeneca too.”

Jean Benmussa, a 74-year-old retiree who resides in the Saint-Mandé suburb just east of Paris, said the millions of people who had already taken the vaccines convinced him the shots were safe, not the government.

“It’s been the same with everything. The entire management of the pandemic has been nonsense,” he said.

In waiting until spring to impose a lockdown, Mr. Macron has also delayed the possibility of reopening France’s economy.



Photo:

ian langsdon/Shutterstock

Frustrations are running particularly high over Mr. Macron’s approach to the latest lockdown. He rejected calls from city officials to lock down Paris in the depths of winter when the weather was icy cold and variants of the virus were beginning to spread across the country.

Now Paris’ hospital system is on the brink, forcing authorities to transfer patients to areas with fewer cases. Nationwide, intensive-care units are 83% full.

In waiting until spring to impose a lockdown, Mr. Macron has also delayed the possibility of reopening France’s economy. French officials said they expected the lockdown to shave 0.2% off France’s gross domestic product this year.

That is a bitter pill for businesses across the country that have been closed since November. When France came out of its second lockdown in mid-December, Mr. Macron stipulated that restaurants and bars were to remain closed to reduce social contact. The same rule applied to museums, concert halls and other venues where people gather.

“What matters most for the economy is the lack of progress toward lifting restrictions,” said Andrew Kenningham, chief Europe economist at Capital Economics, who had expected a large increase in France’s economic output in the second quarter. “We had anticipated that by now governments would be preparing to ease restrictions, or would even be doing so.”

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Do you think European countries will go into a broader lockdown again? Why or why not? Join the conversation below.

For now, Parisians are learning to curb their springtime enthusiasm. Earlier this month, Parisians flocked to the banks of the Seine amid a spell of warm weather. The national police force, which reports to the central government, responded by sending columns of police officers onto the riverbanks to clear them out.

Paris Mayor

Anne Hidalgo

said the operation was shocking, adding that the government acted without informing her ahead of time.

“You can intervene when people aren’t social-distancing or when they’re drinking without masks. But the scenes I saw were not like that,” Ms. Hidalgo said. “There were lots of parents with strollers, people out for a walk.”

NIAID Director Anthony Fauci says it is risky to pull back on public health measures, because cases could plateau and then rebound, as they did in Europe.

Write to Stacy Meichtry at stacy.meichtry@wsj.com and Matthew Dalton at Matthew.Dalton@wsj.com

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Germany, France, Italy Suspend Use of AstraZeneca’s Covid-19 Vaccine

BERLIN—Germany, France and Italy joined a group of smaller European countries that have temporarily stopped administering Covid-19 vaccines made by

AstraZeneca

AZN 0.40%

PLC, saying the move was precautionary amid a small number of cases of blood clotting reported on the continent.

Denmark last week said it had paused AstraZeneca shots for two weeks following reports of blood clotting, and several other European countries quickly followed suit, saying they were doing so out of an abundance of caution. Norway, Ireland and the Netherlands are among countries that have paused vaccinating with AstraZeneca’s shot.

Health regulators in the U.K. and Europe, along with AstraZeneca and its vaccine development partners at the University of Oxford, say there is no known connection between severe clotting and the shot. AstraZeneca has said the number of cases of blood clotting among the roughly 17 million people in the European Union and U.K. who have received the shot is lower than for the general population.

Europe’s medicines regulator said last week it was looking into around 30 reported cases of severe clotting, out of around five million people who have received the shot in the bloc. Last week, the regulator, the European Medicines Agency, said the “vaccine’s benefits currently still outweigh risks” and has continued recommending its use. The agency said most side effects are mild or moderate. Clinical trials didn’t raise flags about blood clotting as a risk.

The temporary halt to the AstraZeneca shots is another major setback in a wider vaccine rollout in Europe hamstrung by supply shortages and other hurdles at the same time as the continent wrestles with rising Covid-19 cases. Europe’s vaccination rates are far lower than in the U.S. and the U.K., where Covid-19 cases have stabilized or are falling.

Delays in giving out the AstraZeneca vaccine threaten to exacerbate vaccination-drive woes and could put further pressure on governments trying to speed things up. AstraZeneca has become a particular target of European politicians who have accused it of not doing enough to provide the continent with more shots.

French President

Emmanuel Macron,

in announcing his country’s pause, said the EMA was expected to publish a recommendation regarding the vaccine on Tuesday. The agency didn’t immediately respond to a request for comment.

The series of pauses across Europe threatens to undermine the AstraZeneca vaccine’s credibility just three months into its rollout. The U.K. was the first country to adopt the shot for mass use, at the end of December.

The shot previously faced skepticism over clinical-trial results that suggested it wasn’t as effective as other vaccines hitting the market. Some of those perceptions have faded as the U.K. inoculated millions of people with the shot, generating real-world data that showed it to be strongly effective in preventing severe disease and death.

The U.K.’s relatively quick vaccination program—with some 11 million AstraZeneca shots playing a key role—hasn’t raised blood-clotting concerns. The British medicines regulator has said it maintains its confidence in the vaccine and its safety.

Last week, reports surfaced of a potential clotting issue, with one death and a case of severe illness, in Austria. That country suspended one batch of the vaccine but said it didn’t have evidence of a connection between the health incidents and the shot and kept using it otherwise.

AstraZeneca has warned it would fall short of projected vaccine deliveries to Europe in coming months.



Photo:

Sean Gallup/Zuma Press

On Thursday, Denmark, Norway and Iceland halted use of the vaccine altogether. Danish authorities said they would wait at least two weeks before administering it again. The EMA, which acts much like the Food and Drug Administration in regulating medicine across the European Union, has already said serious blood clots weren’t any more common among vaccinated people than among the general population. It has said it is investigating the reported cases of multiple thrombosis, or the formation of blood clots within blood vessels, and similar conditions.

Last week, AstraZeneca warned it would fall short of projected vaccine deliveries to Europe in coming months, by 100 million doses—almost two-thirds less than what the continent was expecting based on the company’s earlier pledges.

AstraZeneca Chief Executive

Pascal Soriot

has repeatedly pushed back against doubts about the shot’s effectiveness and criticism of its rollout. Last month, AstraZeneca said it would roughly double global vaccine production to 200 million doses a month by April.

In Germany, the Paul Ehrlich Institute, which regulates vaccine use, said it became concerned by an unspecified number of new cases showing thrombosis, blood-platelet deficiency and bleeding in people soon after vaccination with the AstraZeneca shot. In a statement on its website Monday, the institute said it recommended temporarily halting use of the vaccine until further study by the EMA after seeing what it called a “striking accumulation” of those symptoms.

The regulator recommended that people who “feel increasingly unwell” more than four days after receiving a vaccination should seek medical attention. It flagged severe, persistent headaches or “pinpoint bleeding” of the skin as symptoms of concern.

On Friday, a nonprofit global organization of specialists in blood-clotting disorders and research, the Chapel Hill, N.C.-based International Society on Thrombosis and Haemostasis, advised continued use of the AstraZeneca vaccine. The society said that based on available data, the benefits of vaccination outweigh the risks “even for patients with a history of blood clots or for those taking blood-thinning medications.”

Covid-19 itself is known to cause blood clots, a factor researchers say they are taking into account when considering the benefits versus potential risks of vaccination.

Write to Bojan Pancevski at bojan.pancevski@wsj.com and Jenny Strasburg at jenny.strasburg@wsj.com

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