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North East & North Cumbria Volunteers to Participate in Latest COVID-19 Vaccine

  • Thousands of volunteers will be invited to take part in the world's first Phase 3study 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 and Hartlepool Hospitals NHS Foundation Trust, SouthTees Hospitals NHS Foundation Trust and County Durham and Darlington NHSFoundation Trust, and will be located at University Hospital of Hartlepool.
  • 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 peoples igned 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 manythousands of people, giving researchers insights into the effects of a vaccine on a much  larger population than phase 1 and 2 studies.

The national trial run regionally from University Hospital of Hartlepool, part of North Tees andHartlepool NHS Foundation Trust, 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 theDurham Tees Valley.

Calling on some of the thousands of volunteers who have joined the fight against COVID-19through 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, GreaterManchester, London, Glasgow and Belfast.

The Registry was launched in July to help create a database of people who consent to becontacted 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 willbe manufactured using FUJIFILM Diosynth Biotechnologies's facilities in Billingham,Stockton-on-Tees. This will ensure that, once approved by regulators, the vaccine can bes upplied as quickly as possible.

With several more studies for potential vaccine candidates expected to start before the endof 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 ofthe 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."

Justin Carter, Research & Development Director at North Tees and Hartlepool NHS Foundation Trust, said:

"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 TeesHospitals 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 FoundationTrust said:

"This is only the second Phase 3 vaccine study to be initiated in the UK, and the first Phase3 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 whof ulfil the inclusion criteria for this study - particularly those from among groups most likely to benefit from a vaccine, such as the elderly." 

The UK public can support the national effort to speed up vaccine research and receivemore information about volunteering for clinical studies by visitingwww.nhs.uk/researchcontact.

Ends

Published 29th Sept 2020

'Care received was fantastic and I was very well looked after and very impressed.'

Patient, Day Surgery, Darlington Memorial Hospital