Tag Archives: J&J

White House says it is working to speed early production of J&J COVID-19 vaccine

By Dania Nadeem, Rebecca Spalding and Julie Steenhuysen

(Reuters) – The Biden administration is exploring every option for increasing manufacturing of Johnson & Johnson’s COVID-19 vaccine, which is under regulatory review, and said on Friday that currently expected levels of early doses were less than hoped.

The White House has invoked the Defense Production Act to help Pfizer Inc ramp up COVID-19 vaccine production and that “every option” was on the table to produce more Johnson & Johnson vaccine should it be authorized.

It will also use the wartime powers to increase at-home COVID-19 tests, and make more surgical gloves in the United States, officials said at a Friday media briefing.

“As is the case with other vaccines, we have not found that the level of manufacturing allows us to have as much vaccine as we think we need coming out of the gate,” said Andy Slavitt, senior adviser to the White House’s COVID-19 response team, referring to the J&J vaccine.

J&J applied on Thursday for U.S. emergency use authorization. It expects to have some vaccine ready for distribution as soon as authorized but has not said how much.

Emergent Biosolutions’ Chief Executive Robert Kramer said in an interview on Friday that the company currently is making bulk drug substance for J&J “at large scale.” Emergent is only producing bulk vaccine, which is then filled into syringes or vials and packaged for shipment by another contractor.

Kramer said they were on track to make enough product for hundreds of millions of doses a year. It remains unclear what other supply bottlenecks may be. Kramer said his company had already benefited from the Defense Production Act under the Trump Administration, which helped the company get to the point where it’s ready to go.

Under the authority of the Defense Production Act, the government will give priority ratings to two components important to Pfizer’s vaccine production – filling pumps and tangential flow filtration units, the officials said.

“We told you that when we heard of a bottleneck on needed equipment, supplies, or technology related to vaccine supply that we would step in and help, and we were doing just that,” said Tim Manning, the supply chain coordinator for the national COVID-19 response.

The government will also invoke its powers under the Defense Production Act to increase at-home COVID-19 tests with six, unnamed manufacturers, aiming to produce 61 million tests by the summer, Manning said.

It will also invoke its powers to increase the nation’s supply of surgical gloves, which are made almost exclusively overseas.

Manning said the government will build factories that make the raw materials for surgical gloves and help build plants in the United States to make the gloves.

By the end of the year, he said, the United States would be able to produce a billion gloves a month.

Officials have said that once J&J’s vaccine is authorized, it would mean that millions more doses would be available to states. The vaccine is one-shot, as opposed to Pfizer’s and Moderna Inc’s two-dose vaccines, and can be stored in a refrigerator.

Officials have hoped that the ease of giving the J&J vaccine will mean that states will be able to more quickly immunize residents.

(Reporting by Dania Nadeem, Rebecca Spalding and Julie Steenhuysen, Editing by Peter Henderson, Steve Orlofsky and David Gregorio)

J&J adds to COVID-19 vaccine armory with 66% efficacy in global trial

By Julie Steenhuysen

(Reuters) – Johnson & Johnson said on Friday that its single-dose vaccine was 66% effective in preventing COVID-19 in a large global trial against multiple variants which will give health officials another weapon to tackle the coronavirus.

In the trial of nearly 44,000 volunteers, the level of protection against moderate and severe COVID-19 varied from 72% in the United States, to 66% in Latin America and just 57% in South Africa, from where a worrying variant has spread.

A high bar has been set by two authorized vaccines from Pfizer/BioNTech and Moderna, which were around 95% effective in preventing symptomatic illness in pivotal trials when given in two doses.

Those trials, however, were conducted mainly in the United States and before new variants emerged.

The top U.S. infectious disease specialist Anthony Fauci said the variations in effectiveness around the world underlined the need to vaccinate as many people as quickly as possible to prevent new variants from emerging.

“It’s really a wake up call for us to be nimble and to be able to adjust as this virus will continue for certain to evolve,” Fauci said.

J&J’s main goal was the prevention of moderate to severe COVID-19, and the vaccine was 85% effective in stopping severe disease and preventing hospitalization across all geographies and against multiple variants 28 days after immunization.

That “will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19,” Paul Stoffels, J&J’s chief scientific officer, said of the results, which were based on 468 symptomatic cases.

SEEKING APPROVAL

J&J plans to seek emergency use authorization from the U.S. Food and Drug Administration next week. It has said it plans to deliver 1 billion doses in 2021 and will produce the vaccine in the United States, Europe, South Africa and India.

Public health officials are counting on the J&J vaccine to increase much-needed supply and simplify immunization in the United States, which has a deal to buy 100 million doses of J&J’s vaccine and an option for an additional 200 million.

J&J said the vaccine would be ready immediately upon emergency approval, but Stoffels declined to say how many doses.

“Right now, any protection and additional vaccine is great. The key is not only overall efficacy but specifically efficacy against severe disease, hospitalization, and death,” Walid Gellad, a health policy associate professor at the University of Pittsburgh, said.

Michael Breen, Director of Infectious Diseases and Ophthalmology at research firm GlobalData said “Most countries are still desperate to get their hands on doses, regardless of whether or not the vaccine is considered highly effective. Moderately effective will do just fine for now.”

None of the vaccine recipients in the J&J trial died from COVID-19, compared with 5 in the placebo group, the National Institutes of Health said. Three deaths in the vaccine group overall, but none were determined to be from the virus. That compares with 16 deaths overall in the placebo arm, it added.

Unlike the Pfizer and Moderna vaccines, J&J’s does not require a second shot weeks after the first or need to be kept frozen, making it a strong candidate for use in parts of the world where transportation and cold storage are an issue.

SOUTH AFRICAN VARIANT

Several studies have emerged this month showing that a South African variant has mutated in areas of the virus that are key targets of vaccines, reducing their efficacy.

“What we are learning is there is different efficacy in different parts of the world,” Stoffels told Reuters.

In a sub-study of 6,000 volunteers in South Africa, Stoffels said, the J&J vaccine was 89% effective at preventing severe disease. In the South Africa portion of the trial, 95% of cases were infections with the South African variant.

“I am overwhelmed by the fact that this vaccine protected against severe disease even in South Africa,” said Glenda Gray, the joint lead investigator of the South African vaccine trial.

Gray, who is the chief executive of the South African Medical Research Council, said this is by far the best vaccine for South Africa to fight the mutant strain and can prevent a large number of hospitalizations and deaths.

A mid-stage trial of a Novovax coronavirus vaccine in South Africa also showed lower efficacy, proving to be 60% effective among volunteers who didn’t have HIV. In a separate, late-stage trial in Britain it was 89.3% effective.

In the J&J trial, which was conducted in eight countries, 44% of participants were from the United States, 41% from Central and South America and 15% from South Africa. Slightly more than a third of the volunteers were over 60.

J&J’s vaccine uses a common cold virus to introduce coronavirus proteins into cells in the body and trigger an immune response, whereas the Pfizer/BioNTech and Moderna vaccines use a new technology called messenger RNA (mRNA).

(Reporting by Julie Steenhuysen; Additional reporting by Manas Mishra, Dania Nadeem and Manojna Maddipatla in Bengalaru and Rebecca Spalding and Michael Erman in New York; Writing by Alexander Smith; Editing by Caroline Humer, Peter Henderson, Edwina Gibbs and Keith Weir)

J&J COVID-19 vaccine could be available in Europe in April: source

By Francesco Guarascio

BRUSSELS (Reuters) – Johnson & Johnson could deliver the first doses of its COVID-19 vaccine to Europe in April, an EU official told Reuters on Wednesday after a top lawmaker said the U.S. healthcare company was likely to seek EU regulatory approval in February.

Clinical data on the vaccine has been assessed by the European Medicines Agency (EMA) since Dec. 1 under a rolling review to speed up possible approval.

A senior EU official, who is involved in negotiations with vaccine makers and spoke on condition of anonymity, said the J&J shot could be available from April 1 in Europe.

Earlier on Wednesday, an EU lawmaker said J&J could seek EU approval for its one-shot vaccine in February.

“EU Health Commissioner Stella Kyriakides announced during our (EU lawmakers) group meeting this morning that the vaccine manufacturer Johnson & Johnson is likely to submit an application for approval to the EU for their vaccine in February,” said Peter Liese, who speaks on health matters for the EU’s center-right group, the assembly’s largest.

Following Liese’s comments, a spokesman for Kyriakides said: “We cannot give any precise indications regarding an application for conditional marketing authorization, but we of course hope that an application could be submitted in the coming weeks.”

EMA, in a statement, said “a date for submission of a marketing authorization application has not yet been confirmed.”

J&J had no immediate comment on the timeline described by the EU source and the lawmaker, which appeared to be slightly behind expectations for the vaccine in the United States.

J&J Chief Scientific Officer Dr. Paul Stoffels told Reuters the drugmaker expects to have clear data on how effective its vaccine is by the end of this month or early February and was on track for a U.S. rollout in March.

The EU drugs regulator had said in December it expected the J&J to apply in the first quarter of this year.

It took EMA 20 days to approve the vaccine developed by BioNTech SE and Pfizer Inc, and just over a month to authorize the Moderna Inc shot after their applications were submitted in early December. The two vaccines are so far the only ones approved in the EU, while AstraZeneca submitted its application on Tuesday.

“If all goes well, we will already have the fourth corona vaccine available in a few weeks,” Liese added.

The EU has booked 200 million doses of the J&J vaccine and has an option to order another 200 million shots. The J&J vaccine is administered as a single shot, while those from Moderna and Pfizer/BioNTech require two doses three or four weeks apart for full protection.

The EU has invested about 360 million euros ($438 million) to secure the J&J vaccine with a down payment that would need to be complemented with payments by EU governments willing to buy the vaccine after approval.

The U.S. government secured 100 million doses from the company for $1 billion in an August agreement, with an option to buy an additional 200 million doses.

(Reporting by Francesco Guarascio; Additional reporting by Julie Steenhuysen in Chicago; Editing by Jason Neely, Louise Heavens and Bill Berkrot)

J&J to contribute up to $5 billion to potential U.S. opioid settlement

(Reuters) – Johnson & Johnson on Tuesday said it will contribute up to $1 billion more to a potential settlement of lawsuits alleging it and other companies fueled the U.S. opioid epidemic, bringing the total amount it would pay to $5 billion.

The New Brunswick, New Jersey-based drugmaker said the additional money represented an increase to a proposed $4 billion settlement framework it negotiated with a group of state attorneys general that was announced last year.

That October 2019 proposal also called for the drug distributors McKesson Corp, Cardinal Health and AmerisourceBergen to pay a combined $18 billion, but the framework met resistance from some states and local governments.

Negotiations have been ongoing since then, and the dollar amounts have been shifting. J&J in a statement said the additional $1 billion it would pay reflected continued negotiations and said additional terms are being finalized.

Lawyers for the plaintiffs in the opioid litigation and representatives for several state attorneys general did not immediately respond to requests for comment.

More than 3,000 lawsuits have been filed nationally largely by states, counties and municipalities seeking to hold drug companies responsible for the U.S. opioid addiction epidemic.

The lawsuits generally accuse drugmakers including J&J of deceptively marketing opioids and distributors of ignoring red flags indicating the painkillers were being diverted for improper uses.

The companies including J&J deny wrongdoing. J&J is separately appealing a $465 million judgment the state of Oklahoma won against it in the first case to go to trial in the litigation.

(Reporting by Nate Raymond in Boston; Editing by Chris Reese)

Johnson & Johnson to pay more than $100 million to settle over 1,000 talc lawsuits: Bloomberg

Reuters) – Johnson & Johnson will pay more than $100 million to settle over 1,000 lawsuits that allege the company’s Baby Powder caused cancer, Bloomberg news reported on Monday, citing people with knowledge of the pacts.

J&J faces more than 19,000 lawsuits from consumers and their survivors claiming its talc products caused cancer due to contamination with asbestos, a known carcinogen. The company has maintained that its talc is safe.

The drugmaker declined to comment on the Bloomberg report but reiterated that its talc is safe, does not contain asbestos and does not cause cancer.

“In certain circumstances, we do choose to settle lawsuits, which is done without an admission of liability and in no way changes our position regarding the safety of our products,” the company said in a statement.

In May, J&J said it would stop selling its talc in the United States and Canada after demand had fallen in the wake of what it called “misinformation” about the product’s safety amid a barrage of legal challenges.

J&J has faced scrutiny over the safety of its baby powder following an investigative report by Reuters in 2018 that found the company knew for decades that asbestos lurked in its talc.

(Reporting by Dania Nadeem in Bengaluru; Editing by Saumyadeb Chakrabarty)

J&J to start mid-stage coronavirus vaccine trials in three European countries

By Nathan Allen

MADRID (Reuters) – Johnson & Johnson’s Janssen unit will begin mid-stage trials for its coronavirus vaccine in Spain, the Netherlands and Germany next week, Spain’s health minister said on Friday, as the U.S. drugmaker expands testing for its experimental shot.

The Phase II trial will last two months and include 550 participants across the three countries, including 190 people in Spain, Salvador Illa told a news conference in Madrid.

“It’s a vote of confidence in our health system,” Illa said, adding it was the first human trial for a coronavirus vaccine to be approved in Spain.

The study will focus on healthy people between the ages of 18 and 55 as well as people over 65.

Johnson & Johnson said the study will evaluate the safety and the ability to induce an immune response from single dose and two-dose regimens of the vaccine candidate, the company said in a statement.

Spain, which has western Europe’s highest tally of coronavirus cases, is also working with AstraZeneca via the European Union’s vaccine procurement program to secure sufficient doses.

J&J’s website says if the latest trials are successful, it will begin final Phase III studies, in which even more volunteers will receive the experimental vaccine.

More than 150 potential vaccines are being developed and tested globally to combat the COVID-19 pandemic, with 30 in human trials.

There is so far no approved vaccine, except one authorized in Russia before large-scale trials.

J&J is carrying out tests in the United States and Belgium, and this week added Chile, Argentina and Peru to the list of Latin American nations where it plans to conduct Phase III trials on 60,000 volunteers, in a study that will also cover Brazil, Colombia and Mexico.

The company’s potential vaccine uses “viral vectors” to generate immune responses, similar to the approach taken by the University of Oxford and AstraZeneca in their experimental vaccine, as well as China’s CanSino.

(Reporting by Nathan Allen and Jose Elías Rodríguez; editing by Mark Potter and Jason Neely)

J&J eyes one billion doses of potential COVID-19 shot in 2021, weighs challenge trials

By Francesco Guarascio

BRUSSELS (Reuters) – Johnson & Johnson could produce 1 billion doses of its potential COVID-19 vaccine next year if it proves successful and would consider injecting healthy volunteers with the novel coronavirus if there are not enough patients for final trials, a company executive said.

J&J kicked off in July early-stage human safety trials for its potential COVID-19 vaccine after releasing details of a study in monkeys that showed its best-performing candidate offered strong protection in a single dose.

It is developing the vaccine in collaboration with its Belgian subsidiary, Janssen.

Large-scale trials are set to start by the beginning of October and J&J aims to have results on the vaccine’s efficacy between the end of this year and mid-2021, Johan Van Hoof, head of vaccines at Janssen, told Reuters on Tuesday in a telephone interview.

Earlier on Tuesday, President Vladimir Putin said Russia had become the first country to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing, and before large-scale trials had been conducted.

Van Hoof said that production of the vaccine had already begun despite the financial risks involved, to make sure it would be available as soon as possible should it prove effective against the new coronavirus.

Several million doses will be ready by the beginning of 2021, with a total capacity of 1 billion shots by the end of the year, he said. He added that the company was likely to favor a single-jab approach, although a final decision on whether a booster would be needed had not yet been made.

ETHICAL ISSUES

Outcomes of large-scale, or Phase III, trials will depend on the incidence of infections, Van Hoof said, with faster results expected with higher virus transmission.

That is why J&J is likely to conduct those trials in the United States and Latin America, the world’s regions currently with the highest number of cases.

If infections drop significantly, J&J is also considering so-called challenge trials, in which volunteers are infected with the virus so that a vaccine candidate can be tested on them.

“We are looking into that possibility,” Van Hoof said, noting though that such trials posed ethical issues that needed to be resolved before they could be conducted. For instance, an effective therapy against the disease should be available to minimize risks for volunteers exposed to the virus.

In May British drugmaker AstraZeneca, which is developing a leading coronavirus vaccine with Oxford University, said it was too early to deliberately expose trial participants to the pathogen, but that may become an option if ongoing tests hit a snag.

Van Hoof said that preparations to stock the virus for possible challenge trials were already underway and J&J was part of ongoing discussions with universities and other bodies involved in these projects.

“We find it a very interesting idea,” he said, adding however, that setting up facilities for such trials would perhaps take longer than testing vaccines on people who are already infected in the community – as long as transmission remained relatively high.

(Reporting by Francesco Guarascio; editing by Emelia Sithole-Matarise)