Tag Archives: Johnson & Johnson

Peru, with world’s deadliest outbreak, readies to start vaccine tests

By Marco Aquino

LIMA (Reuters) – Peru will start testing coronavirus vaccines from China’s Sinopharm and U.S. drugmaker Johnson & Johnson in September, researchers said, which should help the country gain faster access to inoculations once the vaccines are approved.

Sinopharm began this week to recruit up to 6,000 volunteers in Peru, which Reuters data indicates has the highest number of COVID-19 deaths in relation to its population size. A team of Chinese scientists is expected to arrive in the Andean nation next week to work with local researchers, said Germán Málaga, a doctor and lead vaccine investigator at Lima’s Cayetano Heredia University.

“This is going to happen around Sept. 3, to begin vaccinations on Sept. 8,” he said. Sinopharm’s clinical trials in Peru are being done with Cayetano Heredia and the state-run Universidad Mayor de San Marcos.

Peru has recorded around 622,000 cases of the coronavirus, the fifth highest case load in the world, and 28,277 deaths. It now has the world’s deadliest fatality rate per capita, with 86.67 deaths per 100,000 people, a Reuters tally shows, just ahead of Belgium.

Sinopharm will also do clinical coronavirus vaccine trials elsewhere in Latin America, including in Argentina.

Other Chinese laboratories that will be conducting trials in the region include Sinovac Biotech, which will work in Brazil and Chile, and Walvax Biotechnology Co Ltd and CanSino Biologics Inc, which will test in Mexico, authorities have said.

Johnson & Johnson’s Janssen unit will start tests with some 4,000 volunteers in Peru around Sept. 24, Prime Minister Walter Martos told reporters on Thursday.

“We are contacting other companies, laboratories, from Britain and other countries that are going to help us immunize at least 70% of the local population,” Martos said.

J&J said earlier this week that it would conduct Phase III trials for its vaccine in Chile, Argentina and Peru.

Peru, a country of nearly 33 million people and the world’s no. 2 copper producer, has been particularly hard-hit by the pandemic, both in terms of infections and economic impact. The economy crumbled over 30% in the second quarter of the year.

The death toll could also be higher than official figures suggest. A national registry shows that between April and August there were 68,192 more deaths compared to the same period in 2019. Excess deaths often give a better indication of the true number of fatalities.

Researcher Málaga and Carlos Castillo, the chief adviser for immunizations and vaccines at Peru’s health ministry, said that carrying out clinical trials would help Peru get faster access to vaccines when they were ready.

“There is an unwritten agreement, in the sense that in the country where a clinical trial is being carried out, it has priority access to vaccine availability,” Castillo said.

(Reporting by Marco Aquino and Reuters TV; Editing by Adam Jourdan and Rosalba O’Brien)

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)

Brazil approves human trials for potential Johnson & Johnson COVID-19 vaccine

BRASILIA (Reuters) – Brazil’s health regulator Anvisa on Tuesday said it had approved human clinical trials for a potential COVID-19 vaccine developed by Johnson & Johnson’s pharmaceutical subsidiary Janssen.

Brazil is the second-worst hit country for coronavirus cases and deaths after the United States, leading many vaccine developers to seek out clinical trials here.

Brazil had registered 3.4 million cases of the disease and more than 108,000 related deaths as of Monday.

The Johnson & Johnson vaccine candidate is the fourth to be approved for human trials in Brazil, Anvisa said in its statement.

Brazil has already approved phase 3 human trials of potential vaccines developed by AstraZeneca in partnership with the University of Oxford, China’s Sinovac Biotech and Pfizer in partnership with BioNTech.

China’s Sinopharm also aims to carry out trials for a possible vaccine in Brazil in a deal with the southern state of Parana pending regulatory approval.

(Reporting by Ricardo Brito; writing by Jake Spring; editing by Alex Richardson and Jason Neely)

U.S. inks $1.5 billion deal with Moderna for 100 million doses of COVID-19 vaccine

By Jeff Mason and Carl O’Donnell

(Reuters) – The United States has entered an agreement with drugmaker Moderna Inc to acquire 100 million doses of its potential COVID-19 vaccine for around $1.5 billion, the company and White House said on Tuesday.

The United States in recent weeks has made deals to acquire hundreds of millions of doses of potential COVID-19 vaccines from several companies as part of its Operation Warp Speed program, which aims to deliver a vaccine in the country by the end of the year.

Moderna’s price per dose comes to around $30.50 per person for a two dose regimen.

With the exception of its deal with AstraZeneca, which offered a lower price per drug in exchange for upfront research and development costs, all the deals price COVID-19 vaccines between $20 to $42 for a two dose course of treatment.

Moderna’s vaccine candidate, mRNA-1273, is one of the few that have already advanced to the final stage of testing and is on track to be completed in September, the company said this month.

Moderna’s deal with the U.S. only pays out in full if the drugmaker hits certain unspecific timing benchmarks for vaccine delivery.

The United States has advanced purchase agreements with Johnson & Johnson, AstraZeneca Plc, Pfizer Inc and BioNTech SE, and Sanofi SA and GlaxoSmithKline Plc for their respective vaccine candidates.

The agreements would lock in more than 500 million doses of COVID-19 vaccine for the U.S., assuming that the companies involved receive regulatory approval. Some deals also give the United States an option to purchase additional doses.

The U.S. government previously gave Moderna around $1 billion to fund its research efforts, bringing total U.S. funding to around $2.5 billion.

Other countries, including Japan, the United Kingdom and Canada, have forged similar deals with drugmakers.

(Reporting by Jeff Mason and Carl O’Donnell; Editing by Peter Henderson, Chris Reese and Tom Brown)

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)

Mexico to conduct late-stage trials for China, US COVID-19 vaccines

MEXICO CITY (Reuters) – Mexico will conduct late-stage clinical trials for COVID-19 vaccines in development by Johnson & Johnson and two Chinese companies, the foreign ministry said on Tuesday.

Large-scale, phase three human testing for the J&J unit Janssen Pharmaceuticals’ candidate could start in the second half of September, the company has previously said.

Mexico will also help test candidates for Chinese companies CanSino Biologics Inc and Walvax Biotechnology Co Ltd, the ministry said in a presentation at a news conference.

More than 150 vaccines are being developed and tested around the world to stop the COVID-19 pandemic, with 25 in human clinical trials, according to the World Health Organization.

Russia is the first country to approve a COVID-19 vaccine, which it named ‘Sputnik V’ for foreign markets, an official said on Tuesday.

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

Walvax’s experimental vaccine is currently under early testing at a Chinese military research institute.

CanSino Biologics’ vaccine candidate is already in clinical trials. The company is also collaborating with Canada’s National Research Council to “pave the way” for future trials in Canada, the research council in May.

Mexico has lobbied in world forums including at the G20 group of nations and the United Nations to secure equitable access for an eventual vaccine.

Latin America’s second largest economy has suffered more than 50,000 deaths from COVID-19, according to official data, making it the third country with most deaths globally.

It ranks 13th adjusted for deaths per capita, according to Johns Hopkins University School of Medicine.

(Reporting by Frank Jack Daniel; Editing by Chizu Nomiyama and Alistair Bell)

U.S. to pay over $1 billion for 100 million doses of Johnson & Johnson’s potential COVID-19 vaccine

(Reuters) – The United States government will pay Johnson & Johnson over $1 billion for 100 million doses of its potential coronavirus vaccine, its latest such arrangement as the race to tame the pandemic intensifies, the drugmaker said on Wednesday.

It said it would deliver the vaccine to the Biomedical Advanced Research and Development Authority (BARDA) on a not-for-profit basis to be used after approval or emergency use authorization by the U.S. Food and Drug Administration (FDA).

J&J has already received $1 billion in funding from the U.S. government – BARDA agreed in March to provide that money for the company to build manufacturing capacity for more than 1 billion doses of the experimental vaccine.

The latest contract equates to roughly $10 per vaccine dose produced by J&J. Including the first $1 billion deal with the U.S government, the price would be slightly higher than the $19.50 per dose that the United States is paying for the vaccine being developed by Pfizer Inc. and German biotech BioNTech SE.

The U.S. government may also purchase an additional 200 million doses under a subsequent agreement. J&J did not disclose that deal’s value.

J&J plans to study a one- or two-dose regimen of the vaccine in parallel later this year. A single-shot regimen could allow more people to be vaccinated with the same number of doses and would sidestep issues around getting people to come back for their second dose.

This is J&J’s first deal to supply its investigational vaccine to a country. Talks are underway with the European Union, but no deal has yet been reached.

J&J’s investigational vaccine is currently being tested on healthy volunteers in the United States and Belgium in an early-stage study.

There are currently no approved vaccines for COVID-19. More than 20 are in clinical trials.

(Reporting by Michael Erman in Maplewood, New Jersey, Shariq Khan in Bengaluru and Josephine Mason; Editing by Shinjini Ganguli, Emelia Sithole-Matarise and Jonathan Oatis)

J&J to begin human trials of COVID-19 vaccine in second half of July

(Reuters) – Johnson & Johnson said on Wednesday it would start human trials of its potential COVID-19 vaccine in the second half of July, two months earlier than planned, as drugmakers race to develop a shot for the deadly respiratory disease.

The company has already signed deals with the U.S. government to create enough manufacturing capacity to produce more than 1 billion doses of its vaccine through 2021.

There are currently no approved treatments or vaccines for COVID-19, the illness caused by the new coronavirus that has killed more than 400,000 people globally.

J&J’s study will test the vaccine against a placebo and assess the shot’s safety and immune response in 1,045 healthy people aged 18 to 55 years, as well as those 65 years and older. The trial will take place in the United States and Belgium.

U.S. biotech Moderna Inc is at the forefront of COVID-19 vaccine development and has started testing its candidate in a mid-stage trial that will enroll 600 patients. The company expects to begin late-stage trials in July.

AstraZeneca, Sanofi, Pfizer and GlaxoSmithKline are all at various stages of development of their vaccine candidates.

There are currently about 10 coronavirus vaccines being tested in humans and experts have predicted that a safe and effective vaccine could take 12 to 18 months from the start of development.

(Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Saumyadeb Chakrabarty)

J&J, U.S. government plan 1 billion doses of coronavirus vaccine

By Julie Steenhuysen

(Reuters) – Johnson & Johnson said on Monday that it and the U.S. government will invest $1 billion to create enough manufacturing capacity to make more than 1 billion doses of a vaccine it is testing to stop the new coronavirus that has killed more than 35,000 people around the world.

As part of the arrangement, the U.S. government will pay $421 million to support the company’s efforts to build new manufacturing capacity in the United States.

J&J said it had selected its own lead vaccine candidate and would start human testing by September, with an eye on having it ready under an emergency use authorization in early 2021, far quicker than the typical 18 month period that it takes for vaccines to be tested, approved and then manufactured.

J&J Chief Scientific Officer Dr. Paul Stoffels told Reuters the company had to start ramping up manufacturing capacity now, even before it has a signal that its experimental vaccine candidate works. The company will start making the vaccine at risk, without knowing for sure that it works.

“That is the only option for us to get it on time,” Stoffels said in a phone interview.

The company has a manufacturing plant in the Netherlands that can make up to 300 million doses of vaccine, Stoffels said, adding that “absolutely will not be sufficient for the world.”

He said J&J is starting to build a plant in the United States now so it can be ready to manufacture vaccines by the end of the year, when data from its clinical trials will show whether the vaccine works.

Nearly half of the $1 billion will come from the U.S. Biomedical Advanced Research and Development Authority (BARDA), which is looking to expand on J&J’s previous collaboration with the agency.

Stoffels said the company is also scouting for manufacturing plants in other parts of Europe and Asia that are capable of making the type of vaccine the company is working on.

So far, J&J has not given any doses of its vaccine to humans. But Stoffels said the coronavirus vaccine will be based on the same technology used to make its Ebola vaccine, which has been widely used in people, and the company believes it will prove safe.

Safety testing of vaccines is even more important than for treatments as they are given to healthy people to prevent infection. That could be 1 billion people or more around the world.

In lab studies, the vaccine candidate has produced strong neutralizing antibodies to the virus – the type needed to make a successful vaccine.

J&J will continue testing the vaccine in animal studies this summer and plans to start human trials in September.

The new coronavirus, which began in Wuhan, China, has infected people in most countries around the world. The United States, with over 143,00 confirmed case of COVID-19 – the illness caused by the virus – has the most cases globally.

Moderna Inc <MRNA.O> this month began initial testing of it’s experimental coronavirus vaccine in healthy volunteers, making it the early front-runner in the race to develop a viable vaccine.

(This story corrects to say “$421 million” in second paragraph)

(Reporting by Manas Mishra in Bengaluru and Caroline Humer in New York; Editing by Nick Zieminski and Bill Berkrot)

Deployment of second Ebola vaccine would not be quick fix, experts warn

FILE PHOTO: Congolese health workers collect data before administering ebola vaccines to civilians at the Himbi Health Centre in Goma, Democratic Republic of Congo, July 17, 2019. REUTERS/Olivia Acland/File Photo

By Fiston Mahamba, Kate Kelland and Aaron Ross

GOMA, Democratic Republic of Congo (Reuters) – The resignation of Congo’s health minister in the midst of the country’s worst Ebola outbreak could clear the way for a second experimental vaccine to be deployed. But the new shot would likely take months to win the trust of frightened locals and show results, health officials say.

Oly Ilunga, who opposed using the vaccine developed by U.S. pharmaceutical giant Johnson & Johnson, resigned as minister on Monday after being bumped off the Ebola response team.

The World Health Organization recommended the two-dose shot to complement a vaccine by U.S. drugmaker Merck, which has proved highly protective but is in relatively short supply.

Proponents, including medical charity Medecins Sans Frontieres (Doctors Without Borders) and the Wellcome Trust, said the new vaccine could be deployed to areas not yet affected by Ebola to create a firewall against the virus, which the WHO declared an international health emergency last week.

But Ilunga said the J&J vaccine had not been proven effective and could confuse people in eastern Democratic Republic of Congo, where wild rumors are hampering the response.

“Congolese have the right to have the gold standard, the best vaccine,” he told Reuters on Thursday, in his first public comments since resigning. “They don’t need to be the subject of experimentation.”

“You can’t have a group of promoters, producers of the vaccine (and) university researchers wanting to introduce the vaccine without contacting the health authorities,” he said, without elaborating further.

Paul Stoffels, J&J’s chief scientific officer, denied there were any efforts to secretly introduce the vaccine and said the company had been in full communication with Congolese authorities.

But skepticism about new medicines can resonate strongly on a continent where some pharmaceutical trials have faced accusations in the past of failing to obtain informed consent and providing sub-par care to participants.

For example, some U.S. government-funded trials of HIV drugs in the 1990s were accused of double standards for giving placebos to women in Africa when effective therapies existed, a practice that is not generally allowed in the United States and other Western nations on ethical grounds. Researchers defended the use of placebos as scientifically necessary.

Jean-Jacques Muyembe, an epidemiologist and Ebola expert named to lead Congo’s response team, dismissed Ilunga’s concerns and said authorities would revisit whether to deploy a second vaccine. However, he downplayed the importance of the decision.

“I don’t think that a vaccine is what’s holding back the response,” he told Reuters, noting that previous Ebola outbreaks had been contained quickly without a vaccine.

“We could use or not use. It won’t change the evolution of the epidemic,” he said.

“NOT ETHICAL”

The nearly year-long outbreak has infected more than 2,500 people and killed more than 1,700, numbers topped only by a 2014-16 outbreak in West Africa that killed more than 11,300. This month, a case was detected in Goma, a city of 2 million on the border with Rwanda, heightening fears about the spread of the hemorrhagic fever.

Efforts to contain it have been undermined by mistrust of health workers and violence by armed militias. Treatment centers have been attacked. Local campaigners say people are scared and confused about the various medicines being used. In addition to the vaccine, four experimental treatments are being given to Ebola patients.

All are still unlicensed, which means they can only be used in clinical trials overseen by Congo’s health ministry. “It is not ethical to test vaccines on people,” said Matina Mwanack, the administrator of an advocacy group in the eastern Congo city of Butembo called Families United Against Ebola.

“(We) have suffered a lot from the lack of needed information about the vaccines and treatments being tested.”

Omar Kavota, who heads a group of religious and political leaders in eastern Congo, said “introducing a second vaccine would amplify rumors”, including over why some patients got one while others received the second.

Muyembe said communicators had been appointed to make the process more transparent.

STOCKPILES

Proponents of a second vaccine argue it can only be tested in a live outbreak since it would be unethical to deliberately infect trial volunteers. They propose deploying it where the disease has not yet spread, while the Merck vaccine continues to be used to protect contacts of suspected cases.

“Both vaccines should work hand in hand,” said Peter Piot, director of the London School of Hygiene and Tropical Medicine and one of the scientists who first discovered the Ebola virus.

Since the West African outbreak, J&J has tested its vaccine on more than 6,000 volunteers in a dozen trials, confirming its safety and ability to generate an immune response.

It requires two injections 56 days apart – another obstacle cited by Ilunga – in an area where fighting causes frequent displacement but should last longer.

“The goal is to give a long-term safe profile for people who may never be exposed to Ebola,” said J&J’s Stoffels, adding that 1.5 million doses were available.

Josie Golding, head of epidemics at the Wellcome Trust, said “we could run out of Merck vaccines” if the outbreak extends into a second year. Health authorities have already begun using smaller doses to ration supplies.

Congo’s health ministry disputes there is a shortage of the Merck vaccine. The company said it expects to produce about 900,000 doses over the next six to 18 months, in addition to 440,000 doses that have already been donated or are available.

The ministry has also considered potential vaccines developed by China’s CanSino Biologics and the Russian research institutes Rospotrebnadzor and Gamaleya, but those discussions are less advanced.

(Mahamba reported from Goma, Kelland from London and Ross from Dakar; Additional reporting by Stanis Bujakera in Kinshasa and Manas Mishra in New York; Editing by Tim Cocks, Alexandra Zavis and Giles Elgood)