29 January 2021 | By Web Team |
The Novavax study is the largest ever double-blind, placebo-controlled trial to be undertaken in the UK. It recruited over 15,000 participants in just over 2 months from 35 UK research sites, including the NIHR Patient Recruitment Centre based at the Royal Devon and Exeter NHS Foundation Trust and Royal Cornwall Hospitals NHS Trust. It was the first phase 3 study for the US-based biotechnology firm Novavax’s vaccine anywhere in the world.
The interim efficacy data and safety data will be submitted to all regulators across the world – including the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK – for independent scrutiny and product approval.
A significant proportion of participants taking part in the study were recruited through the NHS COVID-19 Vaccine Research Registry. This is an online registry of over 390,000 people who have signed-up to be contacted about taking part in COVID-19 vaccine studies. More than 25 percent of enrolees in the trial were over the age of 65, and a large proportion of volunteers had underlying medical conditions which were generally representative of the population.
Volunteers were given two intramuscular injections of the vaccine (or placebo), 21 days apart.
The UK Vaccines Taskforce and National Institute for Health Research (NIHR) Clinical Research Network have played vital roles in the rapid recruitment and enrolment of volunteers.
Professor Michael Gibbons, Consultant Respiratory Physician and Clinical Director of the NIHR Clinical Research Network South West Peninsula, said: “The South West Peninsula has contributed so much to this pivotal trial. The staff at the NIHR Patient Recruitment Centre (based at the Royal Devon & Exeter NHS Foundation Trust) and at Royal Cornwall Hospital worked tirelessly to recruit more than 800 participants over a 2-month period. This was a great opportunity for the people of the South West who stepped up tremendously to support this study. We are very proud of the achievements of the teams at both Trusts and want to thank all the staff for their exceptional work and dedication.”
The study in Devon was conducted at the Nightingale Hospital Exeter site (prior to it receiving inpatients with COVID), and then at the NIHR Patient Recruitment Centre at the Royal Devon & Exeter Hospital. Staff from the hospital and the universities of Exeter and Plymouth ran the trial.
Helen Quinn, Director of the Joint Research Office at RD&E, said: “We are so pleased to have been able to support the Novavax trial at the RD&E.
“We are very grateful to the volunteers who gave up their time to go in to this study and thank them for their support and commitment. Over 100 staff worked tirelessly to make it happen, administrators, lab technicians, practitioners, pharmacy, nurses, doctors, data managers, professional services, medical students, and project managers.
“Research is teamwork! We were able to do this trial at such a volume and pace in Exeter only because everybody played their part.”
Dr Ray Sheridan, Principal Investigator for the trial at RD&E, said: “This collaboration between the NHS, the NIHR and UK Universities – here in Devon, the University of Exeter Medical School and the University of Plymouth – working with Novavax has been a great success.
“This a great result both locally in Devon and Cornwall and for the UK, but most importantly globally. We aren’t really protected until we are all vaccinated, and this adds a further vaccine to the existing list of those known to be effective.
“The more options for manufacturing these the better, enabling the whole world to get access to effective vaccines sooner.
“We owe a huge ‘thank you’ to all the participants who volunteered and took part in the study. They should be really proud of their efforts.”
In Cornwall the study was conducted at the Knowledge Spa site on the hospital grounds.
Dr Duncan Browne, Consultant Endocrinologist at Royal Cornwall Hospitals NHS Trust and Principal Investigator for the trial at the hospital, said:
“We are delighted to have been part of such a successful trial which should enable another COVID vaccine to be used in the UK in the coming months. I would like to thank all my colleagues at RCHT whose hard work helped make this possible along with the patients in Cornwall and the South West who have given up their time to take part in the study.”
The UK public can continue to support the national effort to speed up vaccine research and receive more information about volunteering for future vaccine studies by visiting www.nhs.uk/researchcontact.
The UK government has already secured 60 million doses of the Novavax NVX-CoV2373 vaccine. Provided it meets standards on safety, effectiveness and quality following publication of results, the vaccine will be manufactured using FUJIFILM Diosynth Biotechnologies’s facilities in Billingham, Stockton-on-Tees.