The pharmaceutical company has announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies.
This comes after positive interim results from the Company’s Phase 1/2a clinical study which found the safety profile and immunogenicity after a single vaccination were supportive of further development.
It is believed this results will be published online after being submitted to medRxiv.
Based on these initial results, the next phase will enrol up to 60,000 volunteers across three continents and will study they safety and efficacy of a single vaccine dose versus placebo.
Johnson & Johnson has continued the scaling up of its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year.
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“As COVID-19 continues to impact the daily lives of people around the world, our goal remains the same – leveraging the global reach and scientific innovation of our company to help bring an end to this pandemic,” said Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson.
“As the world’s largest healthcare company, we are bringing to bear our best scientific minds, and rigorous standards of safety, in collaboration with regulators, to accelerate the fight against this pandemic.
“This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process.
“We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”
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“We remain fully focused on developing an urgently needed, safe and effective COVID-19 vaccine for people around the world,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.
“We greatly value the collaboration and support from our scientific partners and global health authorities as our global team of experts work tirelessly on the development of the vaccine and scaling up our production capacity with a goal to deliver a vaccine for emergency use authorization in early 2021.”
The Company is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.
They anticipate the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective.
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“With our vaccine candidate now in our global Phase 3 trial, we are one step closer to finding a solution for COVID-19,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC, Johnson & Johnson.
“We used a highly scientific and evidence-based approach to select this vaccine candidate.
“We are extremely grateful for the tireless efforts of our researchers and for the vital contributions of those participants who have volunteered to take part in our studies.
“Together, we are working to help combat this pandemic.”
Prime Minister Boris Johnson addressed the nation
In a televised speech last night, Prime Minister Boris Johnson said: “Though our doctors and our medical advisers are rightly worried about the data now, and the risks over winter, they are unanimous that things will be far better by the spring, when we have not only the hope of a vaccine.
“But one day soon – and I must stress that we are not there yet – of mass testing so efficient that people will be able to be tested in minutes so they can do more of the things they love.
“That’s the hope; that’s the dream. It’s hard, but it’s attainable, and we are working as hard as we can to get there.
“We must rely on our willingness to look out for each other, to protect each other.
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“Never in our history has our collective destiny and our collective health depended so completely on our individual behaviour.
“If we follow these simple rules together, we will get through this winter together.
“There are unquestionably difficult months to come. And the fight against COVID is by no means over.
“I have no doubt, however, that there are great days ahead.
“But now is the time for us all to summon the discipline, and the resolve, and the spirit of togetherness that will carry us through.”
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Plastic visors do not stop spread of COVID-19
A terrifying study has found plastic face shields do not fully protect people from the threat of the coronavirus pandemic.
Plastic face shields have been recommended by industry experts to wear alongside face masks as protection during the COVID pandemic.
Hairdressers, barbers, nail technicians and tattooists have been advised to wear them alongside a face mask.
Doctors, nurses and other hospital workers on the frontline also wear face visors but with the addition of a fitted surgical mask.
Scotland records highest daily total ever
1.05pm update: Coronavirus rate in Wales is now 46.8 cases per 100,000 people
First Minister of Wales Mark Drakeford said the coronavirus rate in Wales is now 46.8 cases per 100,000 people and there is a “clear upward curve”.
Mr Drakeford told a press conference in Cardiff that he was asking people in the country to “think carefully about where you go and who you are meeting”.
He said the Welsh Government had considered whether to go back to ‘stay local’ regulations previously enforced but decided it was “not proportionate”.
“If you can visit a pub or restaurant close to home, where you don’t need to make a journey, that is preferable than getting in your car and going for the same experience further away from home,” Mr Drakeford said.
“It is a common sense piece of advice.”
12.50pm update: Scotland records highest daily total since outbreak began
Scotland has recorded its highest daily total since the start of the coronavirus pandemic.
Over the last 24 hours, 486 confirmed cases of the virus have been recorded.
First Minister Nicola Sturgeon said the figures were concerning, and underlined why new restrictions had been imposed.
But she said it was important to remember that many more people are being tested now than at the peak of the outbreak earlier in the year.
Ms Sturgeon said 224 of the new cases were in Greater Glasgow and Clyde, with 107 in Lanarkshire and 57 in Lothian.
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12.45pm update: UAE registers highest daily number of infections
The United Arab Emirates on Wednesday reported its highest daily number of coronavirus infections since the start of the pandemic at 1,083 new cases.
The Gulf Arab state has seen cases surge over the past seven weeks from 164 cases on Aug. 3, a trend authorities have attributed to people not adhering to social distancing measures.
The UAE has been scaling up the number of tests carried out daily and said 103,199 tests for the virus had been carried out on Tuesday in the country of around 9.9 million people.
The UAE has recorded 87,530 infections and 406 deaths from COVID-19 so far. The government does not disclose where in the country of seven emirates the infections or deaths occurred.
Nicola Sturgeon’s ally and potential successor Angus Robertson has been criticised for saying elderly deaths due to the coronavirus outbreak are a “gain” for Scottish independence.
Mr Robertson, the former SNP Westminster leader, has faced a barrage of attacks following an article which claimed deaths due to the pandemic were a gain for independence. Ms Sturgeon is looking to hold a second referendum.
In the article, Mr Robertson – one of Ms Sturgeon’s closest allies – said: “55,000 predominately No supporting voters [were] passing away every year.”
He also argued with more pro-separation young people reaching voting age, that had produced a “gain of over 100,000 for independence” since the 2014 referendum.
Boris urges people to summon discipline
10.40am update: 27 cautionary suspensions issued by Northern Ireland university
The Holyland district near Queen’s University in Belfast has been the focus of concern and police action over house parties and disease spread, the Stormont committee was told.
By Wednesday, a total of 27 cautionary suspensions had been issued to students by the university, Diane Dodds said.
“We know if a university gives sanctions it could have significant repercussions for students in professional subjects where those may trigger fitness-to-practice issues.
“It might seem like fun now but it could have dreadful health consequences for those you love and it could have consequences for your later life.”
10.20am update: Boris Johnson calls for all of us to “summon the discipline, the resolve and the spirit”
The Prime Minister has urged people to summon the “discipline, the resolve and the spirit” to fight against the coronavirus pandemic.
Mr Johnson tweeted: “Never in our history has our collective destiny and our collective health depended so completely on our individual behaviour.
“Now is the time for all of us to summon the discipline, the resolve, and the spirit of togetherness that will carry us through.”
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10.05am update: Russia reports highest daily increase since July
Today, Russia reported 6,431 new coronavirus cases in the last 24 hours, its highest daily increase since July 13.
The authorities said 150 people had died in the day, bringing the official death toll to 19,799.
The new figures pushed Russia’s national tally of cases to 1,122,241, the fourth-largest in the world.
9.15am update: Tory rebels could be denied vote coronavirus powers
According to The Times, Tory rebels could be denied vote coronavirus powers after clerks said Sir Graham Brady’s amendment would have no legal force.
Clerks say the amendment cannot change the coronavirus act and Lindsay Hoyle now has to decide whether to allow a vote on it next week.
Steven Swinford, Deputy Political Editor at The Times, tweeted: “Clerks have advised motion on extending coronavirus powers next week is binary – MPs can either reject them or extend them.
“They say that as a result the Brady amendment to the government’s motion has no legal force.
“It’s now up to Lindsay Hoyle whether there’s a symbolic vote.
“Tory rebels want to push ahead with amendment to give parliament votes on coronavirus powers.
“They say that even if it does not have legal force, if MPs back it the Govt cannot ignore the will of House, which brings us back to the very difficult decision facing Lindsay Hoyle.”
Dominic Raab on second national lockdown
8.25am update: France to ban groups of more than 10 people
The French government are believed to be planning to ban groups of more than 10 people as cases continue to soar.
Among the measures planned are a ban on public gatherings of more than 10 people while attendance at major events could be limited to 1,000 people from the 5,000 allowed now, the reports said.
The sale of alcohol outdoors will be prohibited after 8 pm they added, citing several sources.
The new rules for Paris, if confirmed, would follow similar measures in Lyon, Marseille, Bordeaux and Nice as the coronavirus resurges across the country.
8.15am update: Dominic Raab says national lockdown might not happen if people follow rules
Foreign Secretary Dominic Raab has said another national lockdown over Christmas may not happen if people follow the rules.
He insisted the Government’s approach was “focused, balanced and proportionate”, in an interview with Sky News.
“Let’s hope that we can get through the winter months if we take these measures and if everyone plays by the rules, and we go into Christmas not needing to go into that national lockdown with all the impact on society and families but also the damage it would do to businesses.”
Mr Raab also defended the 10pm curfew on hospitality, despite figures suggesting just five percent of coronavirus cases are linked to pubs, bars and restaurants.
“We know that in bars and restaurants, particularly after people have had a few drinks, as you go into the later hours of the evening, that there’s a risk that the compliance with the guidance ebbs a little bit.
“So we’re taking this measure, we’re confident based on the evidence that we’ve got domestically and internationally that it’s one element of those that we need to make.”
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8.05am update: Chairman of the National Police Chiefs’ Council says no plans to have military taking on policing roles
Chairman of the National Police Chiefs’ Council Martin Hewitt has said there are no plans to have military personnel taking on frontline policing roles during the Covid-19 pandemic.
He was asked on BBC Radio 4’s Today programme about the Prime Minister’s comments that the military will be able to provide support to the police if necessary.
Mr Hewitt was also asked if this suggested police were not capable of doing their job.
He responded: “I don’t think it suggests that at all.
“We are now six months in and I think the service across the whole UK has stepped up during that six months to deal appropriately and deal really well with these unusual regulations and the situation we’re in.
“The military had been involved with us throughout the Covid crisis, using their engineering skills, their logistics skills and we already have plans that allow the military to backfill into roles to release police officers in certain circumstances.
“We’re not in that situation now. But I think it is sensible to have those conversations and think about that plan.
“And it’s really important to make the point that under no circumstances would that be military personnel in frontline, public-facing roles instead of policing. That isn’t what we would do. It isn’t any part of the planning.
“But there may be a point where using military personnel to backfill roles to release police officers might be necessary, but it is not necessary at the moment and I don’t anticipate that situation.”
8am update: US death toll passes 200,000
The US death toll has now passed 200,000 according to data from John Hopkins University.
More than 6.8 million people are known to have been infected in the US – making Donald Trump’s country the worst in the world.
Mr Trump said on Tuesday the new death toll was a “horrible thing” and claimed China “should have stopped” the virus.
Source:Daily Express :: UK Feed