New vaccine trialled in Hartlepool has high success rate

The 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.

COVID-19 research team celebrate surpassing their recruitment target– Vaccine shown to be 89.3% effective in preventing coronavirus in participants and also effective against variants of concern

– Novavax publishes phase 3 trial data from largest ever double blind, placebo-controlled trial in the UK, with over 15,000 participants

– 60 million doses secured for UK, with manufacturing set to take place in Billingham, Teesside

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; including 532 from the Durham Tees Valley area, 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.

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.

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.

Professor Caroline Wroe, Clinical Director at NIHR Clinical Research Network North East and North Cumbria and Co-Principal Investigator of the Novavax study at Hartlepool said: “I am delighted to hear the results of the Novavax study. It is fantastic news. I’d like to offer my heartfelt thanks to the participants who volunteered to take part in this important study.

“The entire team across the Durham Tees Valley Research Alliance should be rightly proud of their contribution to this major achievement and I eagerly await to hear if the Novavax vaccine is given MHRA approval.”

Dr David Chadwick, Novavax Principal Investigator for the Durham Tees Valley Research Alliance and Consultant in Infectious Diseases said: “This is wonderful news and means we are on the way to having a fourth vaccine approved to prevent COVID-19 infections, which will hopefully be available soon and will be produced in Teesside.

“This trial couldn’t have happened without the amazing support of research delivery staff across the three Durham Tees Valley Research Alliance Trusts and the participants willing to volunteer.”

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.

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