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Professor Saul Faust will lead a clinical trial in the UK of a potential vaccine for COVID-19, developed by global pharmaceutical company Janssen. The trial will involve 6,000 volunteers across the country.
The Janssen Pharmaceutical Companies, part of Johnson & Johnson, is the latest study in the UK, jointly funded by the UK government's Vaccine Taskforce, to test the safety and effectiveness of a potential COVID-19 vaccine. It is the third potential vaccine to enter clinical trials in the UK, alongside US biotech company Novavax and University of Oxford / AstraZeneca whose studies are currently ongoing.
6,000 UK volunteers, some from the NHS Vaccines Registry, will take part in the Janssen studies at 17 National Institute for Health Research (NIHR) sites, including in Southampton. Recruitment into the study will complete in March 2021 and the trial will last for 12 months.
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 NHS vaccine 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.
The UK government has developed a portfolio of 6 different vaccine candidates and secured access to 350 million doses to date, putting the UK in the best position for a vaccine. 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.
Saul Faust, Professor of Paediatric Immunology & Infectious Diseases at the University of Southampton, Director of the NIHR Southampton Clinical Research Facility and Chief Investigator for the Janssen Phase 3 trial, 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."
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."
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."
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 2-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 UK public can support the national effort to speed up vaccine research and receive more information about volunteering for clinical studies by visiting the NHS site to join the NHS Vaccine Research Registry.
The Registry was launched by the UK government in partnership with the NIHR, NHS Digital, the Scottish and Welsh governments and the Northern Ireland Executive in July. It aims to help create a database of people who consent to be contacted by the NHS to take part in clinical studies, to help speed up the development of a safe and effective vaccine.