Tag Archives: Johnson & Johnson

Oklahoma court overturns $465 million opioid award against Johnson & Johnson

By Nate Raymond

(Reuters) – The Oklahoma Supreme Court on Tuesday overturned a $465 million judgment against Johnson & Johnson in a lawsuit by the state alleging the drugmaker fueled the opioid epidemic through the deceptive marketing of painkillers.

The court on a 5-1 vote ruled that the state’s public nuisance law does not extend to the manufacturing, marketing and sales of prescription opioids and that a trial judge went too far in holding that it did.

J&J had no immediate comment. A spokesperson for Oklahoma Attorney General John O’Connor did not immediately respond to a request for comment.

The decision marked the latest setback for states and local governments pursuing lawsuits seeking to hold drug companies responsible for a drug abuse crisis the U.S. government says led to nearly 500,000 opioid overdose deaths over two decades.

The case against J&J by Oklahoma’s attorney general was the first to go to trial nationally of more than 3,000 similar cases against pharmaceutical manufacturers, drug distributors and pharmacies.

A similar trial in California pitting several large counties against J&J and three other drugmakers resulted in a judge on Nov. 1 ruling in the companies’ favor and concluding the epidemic could not be considered a public nuisance.

(Reporting by Nate Raymond in Boston,; Editing by Franklin Paul and Bernadette Baum)

U.S. to announce new warning on J&J coronavirus vaccine for autoimmune disorder -Washington Post

(Reuters) -The U.S. Food and Drug Administration is expected to announce a new warning on Johnson & Johnson’s coronavirus vaccine related to a rare autoimmune disorder, the Washington Post reported on Monday, citing four people familiar with the matter.

According to the Post, about 100 preliminary reports of Guillain-Barré syndrome (GBS) have been detected in the United States after vaccination with J&J shot, mostly in men, many of whom were 50 or older. Around 12.8 million people have received the one-dose vaccine in the United States.

J&J and the FDA were not immediately available for comment.

GBS is a rare neurological condition in which the body’s immune system attacks the protective coating on nerve fibers. Most cases follow a bacterial or viral infection.

The condition has been linked in the past to vaccinations – most notably to a vaccination campaign during a swine flu outbreak in the United States in 1976, and decades later to the vaccine used during the 2009 H1N1 flu pandemic.

Last week, European regulators recommended a similar warning for AstraZeneca’s COVID-19 shot, which is based on a similar technology as Johnson & Johnson’s vaccine.

A warning would be another setback for the J&J shot, which was supposed to be an important tool for vaccinating in hard-to-reach areas and the vaccine hesitant because it requires only one shot and has less stringent storage requirements than the two-dose vaccines from Pfizer Inc/BioNTech SE and Moderna Inc.

But use of the vaccine has already been linked to very rare, potentially life threatening blood clotting condition and slowed by production problems at the main plant where it is being made.

U.S. regulators decided in April that the vaccine’s benefits outweigh the risk from the blood clotting issue.

(Reporting by Lisa Lambert in Washington and Michael Erman in New Jersey; Editing by Chris Reese and Peter Graff)

U.S. donation of 1.4 million COVID-19 vaccine doses arrives in Afghanistan

By Doyinsola Oladipo

(Reuters) – A U.S. donation of more than 1.4 million doses of the Johnson & Johnson COVID-19 vaccine arrived in Afghanistan on Friday, the first of two shipments this month, the U.N. children’s agency UNICEF said in a statement.

A second shipment of vaccines donated by the United States through the COVAX global sharing program will bring the total to 3.3 million doses, UNICEF said. The U.S. vaccine donations come as U.S. military forces withdraw from Afghanistan, ending a 20-year war in the country.

The deliveries are part of President Joe Biden’s pledge to share 80 million vaccine doses globally, most through COVAX, which is run by the Gavi Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations, the World Health Organization and UNICEF.

“These vaccines arrive at a critical time for Afghanistan as the country faces a difficult surge in COVID-19 infections,” said UNICEF Representative in Afghanistan, Hervé Ludovic De Lys.

Over 1,200 new infections were reported in Afghanistan on July 8th down from a record peak of 1,853 new cases on June 21st, according to the Reuters COVID-19 tracker. Less than four percent of the Afghan population is vaccinated, UNICEF said.

“As many countries face vaccine supply challenges, the dose-sharing mechanism is a rapid way to close the immediate supply gap,” De Lys said. “I hope that other governments will step up and share their doses, supplies and therapeutics to protect those most in need.”

(Reporting by Doyinsola Oladipo, editing by Michelle Nichols and David Gregorio)

U.S. FDA asks J&J to discard 60 million vaccine doses made at Baltimore plant

(Reuters) -The U.S. Food & Drug Administration has asked Johnson & Johnson to discard 60 million doses of its COVID-19 vaccine manufactured at a problem-plagued Baltimore factory, the New York Times reported on Friday, citing people familiar with the matter.

A further 10 million J&J doses would be allowed to be distributed with a warning that there was no guarantee contract manufacturer Emergent BioSolutions Inc had followed proper practices, the newspaper said.

Without disclosing or confirming the number of vaccine doses, the FDA said in a news release that it had authorized two batches of the vaccine for use, that multiple other batches were not suitable for use and that others were being evaluated.

The agency said it was not yet ready to authorize Emergent’s plant for manufacturing the J&J vaccine. Production of J&J’s vaccine at the Baltimore site was halted by U.S. authorities in April and J&J was put in charge of manufacturing at the plant.

J&J did not have an immediate comment. The FDA declined to comment beyond its statement.

The FDA said its decision allows the J&J doses to be used in the United States or exported. It said that for J&J and Emergent to export these shots, they must agree that the FDA can share information on the batches with the regulatory authorities of the countries in which the vaccine may be used.

Last month, Emergent Chief Executive Robert Kramer said it was his understanding that there are 100 million doses of J&J’s one-shot vaccine ready for FDA review and that regulators had begun the review process.

The April halt followed the discovery that ingredients from AstraZeneca’s COVID-19 vaccine, also being produced at the plant at the time, contaminated a batch of J&J’s vaccine. AstraZeneca’s shot is no longer being made there.

An FDA inspection also turned up a long list of sanitary problems and bad manufacturing practices at the Emergent plant.

Separately, Europe’s drug regulator said on Friday that batches of J&J COVID-19 vaccine made for the region around the time the contamination issues were revealed at the Baltimore plant would, as a precaution, not be used.

The European Medicines Agency did not say how many shots were affected, but Reuters has reported it involves millions of doses, making it harder for J&J to meet a target of delivering 55 million to Europe by end of June.

(Reporting by Mrinalika Roy and Ankru Bannerjee in Bengaluru and Michael Erman in New Jersey; Editing by Bill Berkrot)

J&J stands ready to roll out COVID-19 vaccine in Europe as regulators weigh risks

By Manas Mishra and Carl O’Donnell

(Reuters) -Johnson & Johnson said on Tuesday it stands ready to resume rolling out its COVID-19 vaccine in Europe, where the region’s medical regulator said the benefits of the shot outweigh the risk of very rare, potentially lethal blood clots.

Use of the company’s one-dose vaccine was temporarily halted by U.S. regulators last week after the rare brain blood clots combined with a low blood platelet count were reported in six women, prompting the company to delay its rollout in Europe.

Europe’s health regulator, the European Medicines Agency, on Tuesday recommended adding a warning about blood clots with low blood platelet count to the vaccine’s product label, but said the benefits of the one-dose shot outweigh its risks.

J&J earlier on Tuesday said it was set to resume vaccinations in Europe and was working with European countries to resume ongoing clinical trials for its shot.

“It’s an extremely rare event. We hope by making people aware as well as putting clear diagnostic and therapeutic guidance in place that we can restore the confidence in our vaccine,” said J&J’s Chief Scientific Officer Paul Stoffels.

The United States is also reviewing a handful of potential cases of severe side effects in addition to those that led to the pause.

“The outcome of the vaccine review is important for overall global vaccination efforts, given J&J’s vaccine does not have the extreme cold storage requirements of the mRNA vaccines,” Edward Jones analyst Ashtyn Evans said, referring to vaccines from Moderna Inc and Pfizer Inc with partner BioNTech SE.

Meanwhile, J&J is working with U.S. regulators to get clearance for its Baltimore-based vaccine production plant, owned by Emergent BioSolutions Inc, and expects feedback in the coming days. Emergent shut down production at its plant earlier this month after manufacturing errors ruined millions of J&J doses in March.

“We are remediating what we need to remediate. We think that will lend itself to a positive outcome,” said J&J Chief Financial Officer Joseph Wolk during a call to discuss quarterly results. He said J&J “should know more in the next couple of days.”

Nearly 8 million people had received the J&J vaccine in the United States prior to the halt.

J&J said it would fulfill its commitments to ship 200 million doses in Europe and 100 million in the United States.

The company said it recorded $100 million in COVID-19 vaccine sales. J&J has said the vaccine will be available on a not-for-profit basis until the end of the pandemic.

An advisory committee to the U.S. Centers for Disease Control and Prevention is expected to meet on Friday to address the pause after it delayed making any recommendations in a meeting last week and called for more data.

Johnson & Johnson reported first-quarter earnings that exceeded Wall Street expectations and raised its dividend payouts to shareholders.

The company said it expects a big improvement in sales from its medical device business in the second quarter of 2021 compared with a year earlier, when COVID-19 lockdowns took a toll.

J&J slightly raised its full-year adjusted profit forecast and now sees earnings of $9.42 to $9.57 per share, up from its prior view of $9.40 to $9.60 per share.

Total sales rose 7.9% to $22.32 billion, beating estimates of $21.98 billion.

(Reporting by Manas Mishra, Manojna Maddipatla in Bengaluru and Carl O’Donnell in New York; Editing by Anil D’Silva and Bill Berkrot)

India, big vaccine exporter, now vaccine exporter as COVID-19 cases soar

By Alasdair Pal and Krishna N. Das

NEW DELHI (Reuters) -India on Tuesday said it will fast-track emergency approvals for COVID-19 vaccines authorized by Western countries and Japan, paving the way for possible imports of Pfizer, Johnson & Johnson, and Moderna shots.

The move, which will exempt companies from carrying out local safety trials for their vaccines, follows the world’s biggest surge in cases in the country this month.

Since April 2, India has reported the highest daily tallies of infections. It reported 161,736 cases on Tuesday, taking the total to 13.7 million, while deaths rose by 879 to 171,058.

On Tuesday, India’s richest state Maharashtra, which accounts for about a quarter of the country’s cases, said it would impose stringent restrictions from Wednesday to try to contain the spread.

India has the biggest global vaccine manufacturing capacity and had exported tens of millions of doses before its own demand skyrocketed and led to a shortage in some states.

Dozens of poor countries have relied on Indian exports to run their inoculation drives.

The health ministry said vaccines authorized by the World Health Organization or authorities in the United States, Europe, Britain and Japan could be granted emergency use approval in India.

“If any of these regulators have approved a vaccine, the vaccine is now ready to be brought into the country for use, manufacture and fill-and-finish,” Vinod Kumar Paul, a senior government health official, told a news conference.

“We hope and we invite the vaccine makers such as Pfizer, Moderna, Johnson & Johnson and others … to be ready to come to India as early as possible.”

Pfizer said it would work towards bringing its vaccine to India after withdrawing its application in February.

U.S. federal health agencies on Tuesday recommended pausing use of the J&J shot after six women under age 50 developed rare blood clots after receiving it.

India has administered more than 108 million vaccine doses, sold more than 54.6 million vaccine doses abroad and gifted more than 10 million to partner countries.

It is currently using the AstraZeneca shot and a homegrown vaccine for its own immunization drive, and this week approved Russia’s Sputnik V shot for emergency use.

RALLIES, RELIGIOUS GATHERINGS

The jump in India’s infections, for which Health Minister Harsh Vardhan acknowledged widespread failure to heed curbs on movement and social interaction, has prompted calls for the government to cancel huge public events.

Still, hundreds of thousands of devout Hindus are set to bathe in the Ganges river on Wednesday, the third key day of the weeks-long Kumbh Mela – or pitcher festival.

Nearly a million bathed in the Ganges on Monday in the belief that its waters would wash away their sins. More than 100 tested positive for COVID-19 in random testing of around 18,000 attendees, media said.

Similar concerns of a spike in cases were sparked by mass election rallies by Prime Minister Narendra Modi’s party and opposition groups during polls in four states and one federally run region.

At one rally in the eastern state of West Bengal, a key political prize, Home Minister Amit Shah posted Twitter pictures of meetings with crowds of supporters while unmasked.

DEADLY SPREAD

The second wave of infections, which began in India’s major cities, is increasingly spreading into the hinterland, where healthcare facilities are often rudimentary.

In Raipur, the capital of Chhattisgarh state known for its large tribal population, the main government hospital’s morgue was struggling to keep up, said joint director Dr Vineet Jain.

“All oxygenated and ICU beds are full in our set-up,” he told Reuters.

“Around 50 dead bodies are laying, we have a shortage of space. Some private hospitals do not have space to keep the dead bodies so they also send the bodies to us.”

India is currently reporting around double the daily cases of the United States and Brazil, the two other worst affected countries, though its daily death toll is lower.

India’s total infections rank after only the United States, having overtaken Brazil on Monday.

(Reporting by Krishna N. Das and Alasdair Pal in New Delhi and Jatindra Dash in Bhubaneswar; Editing by Nick Macfie, Ana Nicolaci da Costa and John Stonestreet)

U.S. pauses J&J COVID-19 vaccine over rare blood clots

By Manas Mishra and Michael Erman

(Reuters) – U.S. federal health agencies on Tuesday recommended pausing the use of Johnson & Johnson’s COVID-19 vaccine after six women under 50 developed rare blood clots after receiving the shot, dealing a fresh setback to efforts to tackle the pandemic.

The move comes a week after European regulators said they had found a possible link between AstraZeneca’s COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.

Johnson & Johnson’s (J&J) single dose vaccine – most COVID-19 shots are delivered over two doses – and AstraZeneca’s low-cost vaccine are seen as vital tools in the fight against a pandemic that has claimed more than three million lives.

Most of the available J&J vaccine has been used in the United States due to production issues that have limited the company’s supply. As of April 12, more than 6.8 million doses of the J&J vaccine had been administered in the United States, compared with more than 180 million shots combined of the Moderna and Pfizer/BioNTech shots.

An advisory committee to the U.S. Centers for Disease Control and Prevention (CDC) will meet on Wednesday to review the cases, and the U.S. Food and Drug Administration (FDA) will review the analysis, the agencies said in a joint statement.

All six cases involved women between the ages of 18 and 48, and the symptoms occurred six to 13 days after vaccination.

In the cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

The CDC and FDA said the adverse events appeared to be extremely rare.

“I think this is a very low risk issue, even if causally linked to the vaccine: 6 cases with about 7 million doses (lower than the risk of clots with oral contraceptives) is not something to panic about,” Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said in an email.

“People are asking me if they should cancel their J&J vaccine appointments and I have told them not to but I know many will and this will stall progress in controlling the pandemic.”

J&J said it was working closely with regulators and noted no clear causal relationship had been established between the cases and the COVID-19 vaccine made by its Janssen unit.

One woman died and a second in Nebraska has been hospitalized in a critical condition, the New York Times reported, citing officials.

‘ABUNDANCE OF CAUTION’

“The FDA recommendation to pause the administration of the Johnson and Johnson vaccine out of an abundance of caution makes sense in terms of the nature of the unusual and serious side effect not seen with the other vaccines,” said Dr. Robert Klugman at the UMass Memorial Medical Center in Massachusetts in an email.

“While the incidence is very low, the severity and potential for brain damage and other blood clot-related injuries is of great concern.”

J&J’s shares were down 3% before the opening bell.

The U.S. move comes less than a week after Europe’s drugs regulator said it was reviewing rare blood clots in four people in the United States who had received the J&J shot.

The J&J and AstraZeneca vaccines both use an adenovirus vector – a harmless cold virus that instructs human cells to produce a protein found on the surface of the coronavirus, thereby spurring the immune system to prepare an arsenal against the COVID-19-causing virus.

Among leading global COVID-19 vaccine developers, China’s CanSino Biological and Russia’s Gamaleya Institute with its Sputnik V vaccine are also relying on this approach. The Pfizer/BioNtech and Moderna vaccines use mRNA technology.

The rollout of J&J’s vaccine has been slowed by issues at production plants.

The company has supplied the United States with at least 20 million doses but is behind schedule on its deliveries. Problems at a Baltimore, Maryland plant run by outside contractor Emergent BioSolutions forced the companies to trash a batch of vaccine substance.

The plant – meant to be one of J&J’s main U.S. manufacturing facilities – has yet to be approved by U.S. regulators to supply vaccine doses, and J&J shipments to the states were expected to fall sharply next week.

J&J only began delivering its COVID-19 vaccine to European Union countries this week. It has committed to delivering 55 million doses to the bloc by the end of June and another 120 million in the third quarter.

J&J has been doing vaccinations in South Africa to study the effects on health workers, and had vaccinated just under 300,000 people there as of Monday, according to data from the country’s health department. J&J recently struck a deal with the African Union for up to 400 million doses.

Europe’s drugs regulator continues to recommend the use of AstraZeneca’s COVID-19 vaccine, saying the benefits outweigh the risks. Several EU countries, however, have limited its use to certain age groups.

Australia has no current plans to add J&J’s coronavirus vaccine to its immunization drive, authorities said on Tuesday, as it moves away from procuring vaccines under review for potential links to blood clots.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in Maplewood, N.J., additional reporting by Julie Steenhuysen in Chicago and Ludwig Burger in Frankfurt; Editing by Sriraj Kalluvila and Mark Potter)

U.S. administers 168.6 million doses of COVID-19 vaccines: CDC

(Reuters) – The United States has administered 168,592,075 doses of COVID-19 vaccines in the country as of Tuesday morning and distributed 219,194,215 doses, the U.S. Centers for Disease Control and Prevention said.

The tally is for Moderna, Pfizer/BioNTech, and Johnson & Johnson’s vaccines as of 6:00 a.m. ET on Tuesday, the agency said.

According to the tally posted on April 5, the agency had administered 167,187,795 doses of the vaccines, and distributed 207,891,395 doses.

The agency said 108,301,234 people had received at least one dose while 63,016,976 people are fully vaccinated as of Tuesday.

A total of 7,748,620 vaccine doses have been administered in long-term care facilities, the agency said.

(Reporting by Manojna Maddipatla in Bengaluru)

U.S. to distribute 11 million Johnson & Johnson COVID-19 shots next week – White House

By Carl O’Donnell

(Reuters) – The U.S. government will distribute 11 million doses of Johnson & Johnson’s COVID-19 vaccine next week in its continued effort to get 200 million shots in people’s arms in the first 100 days of President Joe Biden’s term, the White House said on Friday.

The United States is still on track to deliver on its goal of making shots available to all adults by the end of May, Jeff Zients, the White House’s COVID-19 response coordinator, told reporters.

Vaccine manufacturers Pfizer Inc and Moderna Inc expect to hit their target of supplying 220 million shots between them in the first quarter of 2021, he added.

J&J had said last month it would deliver 20 million doses of its single-dose inoculation in March. However, shipments were delayed because key U.S. manufacturing partners, including Catalent Inc, did not immediately receive U.S. regulatory clearance to send out doses made in their facilities.

The White House is also working to speed up administration of shots by increasing the number of active duty troops assisting with vaccinations, to more than 6,000 from 2,900, Zients said.

As of Friday, 71% of adults aged 65 and over have received at least one vaccine dose, Zients said.

Dr. Rochelle Walensky, head of the U.S. Centers for Disease Control and Prevention, said she was deeply concerned about the trajectory of COVID-19 cases in the United States. The country’s seven-day average daily case count is up 7% over last week, to 57,000 daily cases.

“We know from higher surges that if we don’t control things now, there is a real potential for the epidemic curve to soar again,” she said.

(Reporting by Carl O’Donnell; Editing by Chizu Nomiyama and Frances Kerry)

FDA advisory panel to review Johnson & Johnson COVID-19 vaccine with thumbs up expected

By Manas Mishra and Michael Erman

(Reuters) – A panel of expert advisers to the U.S. Food and Drug Administration began a meeting to discuss Johnson & Johnson’s one-dose COVID-19 vaccine on Friday, setting the stage for a possible emergency use authorization as early as this week.

After it receives the recommendation, the FDA is likely to authorize the vaccine for emergency use within a day or so, making it the third available in the United States, and the only one that requires just one shot.

The panel, consisting of doctors, infectious disease experts and medical researchers, began the meeting at 9:00 a.m. ET (1400 GMT), and will vote in favor or against the vaccine’s use several hours later at the end of the meeting.

The panel will consider whether the benefits of the vaccine outweigh its risk for use in people aged 18 and older.

In a 44,000-person trial, the vaccine overall was 66% effective at preventing moderate-to-severe cases of COVID-19 compared with a placebo.

The effectiveness of the one-dose vaccine varied over time and location. In the United States, the effectiveness was 74% at 14 days and 72% two weeks later, while the shot was 64% effective at stopping moderate-to-severe COVID-19 after 28 days in South Africa, where a worrying new variant has swept across the country.

The vaccine was 100% effective at preventing hospitalizations 28 days after vaccination and there were no COVID-19 deaths among those who received the shot.

“In the context of the pandemic, the FDA is likely to issue an emergency use authorization (EUA) based on the data,” said UBS analyst Navin Jacob ahead of the panel meeting.

The J&J vaccine can be stored in normal refrigerator temperatures, making distribution easier than that of the Pfizer Inc/BioNTech SE and Moderna Inc vaccines that use mRNA technology and must be shipped and stored frozen.

J&J’s vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response.

Three to four million doses of the vaccine are expected to be rolled out next week.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New York; Editing by Caroline Humer, Bill Berkrot and Shounak Dasgupta)