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Urgent call for West Midlands volunteers to take part In a new Covid-19 vaccine study

Janssen


● West Midlands residents encouraged to help continue the search for safe and effective Covid-19 vaccines that work for all by joining the latest phase 3 trial

● Thousands of volunteers will begin taking part in a study to test the effectiveness of the new Janssen’s two-dose Covid-19 vaccine

● Researchers urge the public to keep volunteering for vital studies to ensure people in the UK have access to different types of vaccines that work for them

Six thousand UK volunteers will from today (Monday 16 November) be called upon to join another leading phase three Covid-19 vaccine study, as researchers around the world continue to work to secure a range of vaccines to help tackle coronavirus.

The latest study, co-funded by the UK government’s Vaccine Taskforce, will test the safety and effectiveness of a new two-dose regimen for a vaccine candidate, developed by The Janssen Pharmaceutical Companies of Johnson & Johnson. The study will recruit up to 30,000 people worldwide.

Volunteers from a variety of age groups and backgrounds, including some of the thousands who have registered to be contacted about vaccine studies through the NHS Covid-19 Vaccine Research Registry, will begin taking part in the latest study at 17 National Institute for Health Research (NIHR) sites across the UK. These include Birmingham Southampton, Bristol, Cardiff, London, Leicester, Sheffield, Manchester, Dundee and Belfast. Recruitment into the study will complete in March 2021 and the study will last for 12 months.

Dr Christopher Green, Principal Investigator for the trial at University Hospitals Birmingham NHS Foundation Trust said: “We need to fully evaluate different vaccine technologies to answer important questions on how we can best protect our health and the health of our communities from COVID-19. As ever, we need the help of the public to do this and we work hand-on-hand with our volunteers to complete these clinical trials. It’s so important that people come forward to help us investigate vaccines for the benefit of everyone.”

Business Secretary, Alok Sharma, said: “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.

“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.”

The UK government has developed a portfolio of six different vaccine candidates and secured access to 350 million doses to date. Of this, an agreement has been made in principle to include 30 million doses of the Janssen vaccine will be made available to the UK if it is safe and effective.

To date, over 300,000 people have signed up to the NHS Covid-19 Vaccines Research Registry to take part in vital coronavirus vaccine studies. With a range of vaccine types needed to ensure people across the UK have access to one that works for as many people as possible, researchers are calling for volunteers to continue to sign up to take part in clinical studies. With several more phase 3 studies for potential vaccine studies expected to start over the next six months, researchers are highlighting the need for volunteers from across the UK to continue to join the fight against coronavirus. In particular the NHS Covid-19 registry 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.

With a range of vaccine types needed to ensure people across the UK have access to one that works for as many people as possible, researchers are calling for volunteers to continue to sign up to take part in clinical studies.

Professor Saul Faust, Professor of Paediatric Immunology and Infectious Diseases, University of Southampton and Chief Investigator for the Janssen Phase 3 study, said: “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.

"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.”

Dr Vanessa Apea, a Black, Asian and minority ethnic Clinical Champion at NIHR Clinical Research Network North Thames, and a consultant in Sexual Health and HIV at Barts Health NHS Trust, said: “Covid-19 still poses a significant threat to our health and our communities and many of us are still vulnerable to it. One of the ways we can reduce the threat and impact of this disease is a vaccine.

“The topic of vaccines divides communities. For many, and in particular, Black, Asian and ethnic minority communities, the word vaccine generates a lot of fear, rooted in mistrust, which can understandably lead to reluctance in taking part in a trial. 

“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. 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.” 

Chair of the Government’s Vaccine Taskforce, Kate Bingham said: “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.

“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."

Paul Stoffels, M.D., 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.”

Notes to editors

Volunteering for COVID-19 vaccine clinical trials:

People wishing to volunteer to support clinical trials can sign up for information on Covid-19 vaccine trials with the NHS Covid-19 vaccine research registry, developed in partnership with NHS Digital. It is helping large numbers of people to be recruited into trials rapidly over the coming months - potentially meaning an effective vaccine for coronavirus can be found as soon as possible.

The service was commissioned as part of the UK Government’s Vaccine Taskforce in conjunction with the National Institute for Health Research (NIHR) and the Northern Ireland, Scottish and Welsh Governments.

Anyone living in the UK can sign up online to take part in the trials through the NHS, giving permission for researchers to contact you if they think you’re a good fit. Once you sign up, you can withdraw at any time and request that your details be removed from the COVID-19 vaccine research registry. The process takes about 5 minutes to complete.

More information can be found here: NHS.UK/coronavirus