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A trial run in Devon by PRC: Exeter has given hope of adding another effective vaccine to the UK’s armoury against COVID

A trial run in Devon by PRC: Exeter has given hope of adding another effective vaccine to the UK’s armoury against COVID

A COVID-19 vaccine trial being run in Devon from the NIHR Patient Recruitment Centre (PRC: Exeter) has given hope of adding another effective vaccine to the UK’s armoury against COVID. The NIHR-supported Novavax COVID-19 vaccine is 89.3% effective at preventing COVID-19, shown from interim analysis of its Phase III study data, including effectiveness against the new variants of concern.

The Novavax study is the largest ever double blind, placebo-controlled trial to be undertaken in the UK. It recruited over 15,000 participants from 35 research UK sites in just over two months. 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 - 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 enrollees in the trial were over the age of 65, while a large proportion of volunteers had underlying medical conditions generally representative of the population.

Over 500 volunteers participated locally in the trial run by PRC Exeter, one of five regionally based centres dedicated to setting up and delivering large, late-phase commercial clinical trials across the NHS.

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, with staff from the hospital and the universities of Exeter and Plymouth running the trial.

The UK phase 3 trial is a randomised, placebo-controlled, observer-blinded trial during which 50% of volunteers were given two intramuscular injections of the vaccine candidate, 21 days apart, while the remaining received a placebo.

The UK Vaccines Taskforce and National Institute for Health Research (NIHR) Clinical Research Network have played vital roles in the rapid recruitment and enrollment of volunteers.

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:

“These are enormously exciting findings and show that this is a highly effective and safe COVID-19 vaccine – importantly it also shows that this is a vaccine that is effective against the UK variant that has spread so quickly. This wonderful news is a tribute to the over 15,000 volunteers in our trial, to the dedication of the UK investigators and to the huge support of the NIHR.”

Clive Dix, Chair, UK Vaccine Taskforce, said:

“These are spectacular results, and we are very pleased to have helped Novavax with the development of this vaccine. The efficacy shown against the emerging variants is also extremely encouraging. This is an incredible achievement that will ensure we can protect individuals in the UK and the rest of the world from this virus.”

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’ facilities in Billingham, Stockton-on-Tees.

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.”

 

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