- Thousands of volunteers will take part in the world’s first Phase 3 study to test the effectiveness of the new Novavax COVID-19 vaccine
- More than 250,000 people in the UK have now volunteered to take part in COVID-19 vaccine studies through the NHS Vaccines Registry
- Vaccine study to be led regionally by the Durham Tees Valley Research Alliance, representing North Tees & Hartlepool, South Tees and County Durham & Darlington NHS Trusts and will located at University of Hartlepool Hospital
- If successful, 60 million doses will be manufactured in Stockton-on-Tees
Volunteers from the North East and North Cumbria will today (Friday 25th September) be invited to join a leading phase three COVID-19 vaccine study, as the number of people signed up to take part in vaccine research has reached over 250,000 nationally.
The study will test the safety and effectiveness of a promising new vaccine, developed by US biotechnology company Novavax, across a broad spectrum of people, including those from a variety age groups and backgrounds within the region. Phase 3 studies involve many thousands of people, giving researchers insights into the effects of a vaccine on a much larger population than phase 1 and 2 studies.
Run regionally from University of Hartlepool Hospital, part of North Tees and Hartlepool NHS Foundation Trust, it will be the second COVID-19 vaccine study to be delivered within the region. It is a truly collaborative approach to delivering a vaccine study, as it will be staffed by medical and research colleagues from the three acute trusts in the Durham Tees Valley.
Calling on some of the thousands of volunteers who have joined the fight against COVID-19 through the NHS Vaccine Registry, the phase three trial is the second to commence in the UK and will be undertaken at a number of National Institute for Health Research (NIHR) regional sites across the UK, including the North East, Lancashire, the Midlands, Greater Manchester, London, Glasgow and Belfast.
The Registry was launched in July 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.
The government has secured 60 million doses of the Novavax vaccine for the UK, which will be manufactured using FUJIFILM Diosynth Biotechnologies’s facilities in Billingham, Stockton-on-Tees. This will ensure that, once approved by regulators, the vaccine can be supplied as quickly as possible.
With several more studies for potential vaccine candidates expected to start before the end of the year, UK researchers are calling for additional volunteers to sign up to take part in research. To better understand the effectiveness of vaccine candidates and help find a vaccine that works for as many people as soon as possible, researchers are particularly seeking more volunteers from Black, Asian and minority ethnic backgrounds as well as those with underlying health conditions and the over 65s.
Professor Caroline Wroe, Clinical Director, NIHR Clinical Research Network North East & North Cumbria, said:
“It’s fantastic news that people in the North East will have the opportunity to take part in these trials and help the NHS develop a vaccine to protect us. It’s a tribute to the quality of the health service staff and scientists in this region that potentially ground-breaking studies are taking place here, with the possibility of a vaccination mass produced in Teesside.”
“We are proud that the three acute hospital Trusts in our region are coming together to provide our patients with the chance to take part in vital COVID vaccine research, which is the next step in our fight against this disease.”
Dr David Chadwick, Infectious Diseases Consultant and study lead at South Tees Hospitals Foundation Trust, said:
“We’re delighted to be able to run this trial in the region and contribute to the wider effort to find a safe and effective COVID vaccine”.
Business Secretary Alok Sharma said:
“We are fighting coronavirus with all our might and we all have our part to play. One of the most effective ways we can defeat coronavirus is by finding a safe successful vaccine as quickly as possible, so that our lives can start returning to normal.
“I am incredibly proud of the 250,000 invaluable volunteers who have signed up for vaccine clinical studies across the UK. We want even more people to join them and sign up to the Vaccines Registry, so that scientists and researchers can make sure potential vaccines are completely safe and effective.”
Professor Paul Heath, Novavax Phase 3 trial Chief Investigator and Professor of Paediatric Infectious Diseases at St George’s University Hospitals NHS Foundation Trust said:
“This is only the second Phase 3 vaccine study to be initiated in the UK, and the first Phase 3 study with the Novavax vaccine anywhere in the world, which shows the importance that has been placed on rapidly finding a solution for this urgent public health need. The vaccine has successfully gone through its early safety trials and we’re extremely encouraged by its performance so far.
“The NHS Vaccines Registry has been key in helping us quickly identify participants who fulfil the inclusion criteria for this study – particularly those from among groups most likely to benefit from a vaccine, such as the elderly.”
Chair of the government’s Vaccines Taskforce Kate Bingham said:
“Finding a safe and effective vaccine that works for the majority of the UK population is the best way to tackle this devastating disease. Whilst social distancing, testing and other measures can help reduce the impact of coronavirus, the only long-term solution to beating it will be finding a vaccine. One of the ways people can help with that is by signing up to the NHS Vaccines Registry, so they can be rapidly called.”
Gregory M. Glenn, M.D., President of Research & Development at Novavax said:
“Today marks an important and exciting advance in addressing the global COVID-19 pandemic in Europe and around the world. We are confident in the safety of this vaccine and based on the successful phase 3 clinical trial of our influenza vaccine built using the same platform, we are optimistic that NVX-CoV2373 will prove to be effective at preventing infection and reducing the transmission of the disease.”
If any of the vaccines are successful in clinical studies, they could start to be delivered to the UK in 2021. It is expected that these vaccines would first be given to priority groups such as frontline health and social care workers, ethnic minorities, adults with underlying health conditions, and the elderly based on JCVI advice.
The UK public can support the national effort to speed up vaccine research and receive more information about volunteering for clinical studies by visiting www.nhs.uk/researchcontact.