Tag Archives: Johnson & Johnson

Explainer: When will COVID-19 vaccines be generally available in the U.S.?

By Carl O’Donnell and Michael Erman

(Reuters) – U.S. President Donald Trump and the head of the Centers for Disease Control and Prevention (CDC) this week disagreed about when a COVID-19 vaccine would become widely available. Trump has said one could initially be available by the Nov. 3 election, while the CDC director said vaccines were likely to reach the general public around mid-2021, an assessment more in line with most experts.

WHAT DOES IT MEAN FOR A VACCINE TO BE GENERALLY AVAILABLE?

General availability is when every American who wants the vaccine can get it. There are currently no COVID-19 vaccines approved by U.S. regulators, although a handful are in late-stage trials to prove they are safe and effective.

Experts estimate that at least 70% of roughly 330 million Americans would need to be immune through a vaccine or prior infection to achieve what is known as herd immunity, which occurs when enough people are immune to prevent the spread of the virus to those unable to get a vaccine.

HOW LONG BEFORE VACCINE PRODUCTION IS FULLY RAMPED UP?

Most vaccines in development will require two doses per person.

The CDC anticipates that 35 million to 45 million doses of vaccines from the first two companies to receive authorization will be available in the United States by the end of this year. The current front runners are Pfizer Inc and Moderna Inc.

Drugmakers have been more ambitious with their calculations. AstraZeneca Plc has said it could deliver as many as 300 million doses of its experimental vaccine in the United States by as early as October. Pfizer and German partner BioNTech SE have said they expect to have 100 million doses available worldwide by the end of 2020, but did not specify how much of that was earmarked for the United States. Moderna on Friday said it is on track to make around 20 million doses by the end of the year and between 500 million and 1 billion doses a year beginning in 2021.

Obtaining enough doses to inoculate everyone in the United States will likely take until later in 2021. CDC Director Robert Redfield told a congressional hearing on Wednesday that vaccines may not be widely available to everyone in the United States until the second or third quarter of next year.

WHO WOULD GET AN APPROVED VACCINE FIRST?

The CDC decision will likely broadly follow recommendations from the National Academies of Sciences, Engineering and Medicine. The CDC has said the earliest inoculations may go to healthcare workers, people at increased risk for severe COVID-19, and essential workers.

It is unclear when a vaccine will be available for children as major drugmakers have yet to include them in late-stage trials. Pfizer and BioNTech have filed with regulators seeking to start recruiting volunteers as young as 16 for vaccine studies.

WHICH COMPANIES WILL LIKELY ROLL OUT A VACCINE QUICKLY?

Pfizer has said it could have compelling evidence that its vaccine works by the end of October. Moderna says it could have similar evidence in November. The vaccines would first need to be approved or authorized for emergency use by U.S. regulators.

Drugmakers have already started manufacturing supplies of their vaccine candidates to be ready as soon as they get the go ahead. The U.S. Department of Defense and the CDC plan to start distribution of vaccines within 24 hours of regulatory authorization.

Several drugmakers including Pfizer, AstraZeneca, Johnson & Johnson and Novavax Inc have all said they expect to produce at least 1 billion doses of their vaccines next year if they get regulatory authorization.

Sanofi SA and GlaxoSmithKline Plc are also working on developing a vaccine they say could be authorized next year.

(Reporting by Carl O’Donnell and Michael Erman in New York; additional reporting by Caroline Humer; editing by Peter Henderson and Bill Berkrot)

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)