Belgian firm Janssen begins major new COVID-19 vaccine trial in UK

LONDON: Belgium-headquartered global pharmaceutical company Janssen began a major new clinical trial of its potential vaccine against COVID-19 in the UK from Monday, which will involve 6,000 volunteers across the country.

Recruitment into the Phase 3 study will complete in March 2021 and the trial will last for 12 months.

It marks the third potential vaccine to enter clinical trials in the UK, alongside US biotech company Novavax and University of Oxford/ AstraZeneca, whose studies remain ongoing.

"The start of further clinical trials in the UK is yet another step forward in the race to discover a safe and effective vaccine, and comes alongside recent news that we could be on the cusp of the first major breakthrough since the pandemic began," said UK Business Secretary Alok Sharma.

"While we are optimistic with the progress being made, there are no guarantees and it is possible there will be no one-size-fits-all vaccine. That is why it is absolutely vital that while our scientists are cracking on with the job, we continue to follow the guidance to control the virus, protect the NHS and save lives," he said.

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The UK volunteers will take part in the trial at 17 National Institute for Health Research (NIHR) sites, including in Southampton, Bristol, Cardiff, London Leicester, Sheffield, Manchester, Dundee and Belfast, according to the government's Department for Business, Energy & Industrial Strategy (BEIS).

It said the government has developed a portfolio of six different vaccine candidates and secured access to 350 million doses to date.

Of this, 30 million doses of the Janssen vaccine could be made available to the UK if it is safe and effective by mid-2021.

"Finding an effective vaccine with a good safety profile is a top priority in helping to protect us all more quickly against COVID-19. While the news of a potential vaccine is tremendously exciting, our ambition in the scientific community is to ensure we leave no stone unturned in the search for a solution to help end this pandemic," said Professor Saul Faust, Director of the NIHR Southampton Clinical Research Facility and Chief Investigator for the Janssen Phase 3 trial.

"All the vaccines that are being trialled work by generating immune responses to the same part of the coronavirus as the RNA vaccine that has announced some interim early results," he said.

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The trial by Janssen Pharmaceutical Companies, part of Johnson & Johnson, is jointly funded by the UK government's Vaccine Taskforce to test the safety and effectiveness of a potential COVID-19 vaccine.

Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said: We are delighted to be initiating our global Phase 3 trial in the UK to study the safety and efficacy of a two-dose regimen of our investigational COVID-19 vaccine candidate.

"This collaboration with UK researchers and the NIHR demonstrates our continued commitment to working together with partners around the world, and marks another positive step forward as we strive to find solutions to this global health crisis."

The thousands to be involved in the latest UK trial will partly be recruited from the National Health Service (NHS) Vaccine Registry, which has over 300,000 people signed up to take part in vital coronavirus vaccine studies.

However, the government stressed the registry particularly needs volunteers who are most vulnerable to the effects of coronavirus, including frontline health and social care workers and people from Black, Asian and ethnic minority backgrounds.

"We know that these communities are disproportionately affected by COVID-19 and this makes it even more important that any outcomes from research, including new treatments and ways to prevent the disease, work for all communities," said Dr Vanessa Apea, Black, Asian and minority ethnic Clinical Champion at NIHR Clinical Research Network North Thames.

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"Only by doing this can we truly take control of Covid-19, so we really need people from Black, Asian and ethnic minority communities to sign up to learn more and be part of research," she said.

Experts have cautioned that no one vaccine is likely to be suited for everyone, and that a wide range of types are needed to ensure people across the UK have access to one that works for them, so they are urging more people to sign-up to ensure clinical trials that test the safety and effectiveness of potential vaccine candidates continue.

"The recent news about progress on the search for a vaccine is enormously exciting for the whole world, but we must not take our focus off continuing the important research to work out which vaccines work best for different people to provide long lasting, effective protection against Covid-19," said Kate Bingham, Chair of the government's Vaccine Taskforce.

"Many vaccines are needed both here in the UK, and globally, to ensure we can provide a safe and effective vaccine for the whole population."

That is why the launch of this trial to establish the safety, effectiveness, and very importantly the durability, of the Janssen vaccine is so significant, and I would continue to encourage people to sign up and take part in vaccine trials.

"By co-funding this study we are helping generate data for future regulatory submissions internationally as well as for the UK," she said.