Behind the Novavax vaccine trial: UK recruits welcome results

The Novavax vaccine has been found to be 89.3% effective at preventing COVID-19.

Stockport NHS Foundation Trust in the UK recruited 762 participants, and was the second largest contributor to the study in the UK.

Dr David Baxter, Principal Investigator for the trial at Stockport NHS Foundation Trust, said: “We in the Stockport vaccine team were delighted to read these results and see just how safe and effective this vaccine is in providing protection against COVID-19, including the UK variant. Staff from every speciality in the trust have stepped forward and delivered an excellent service on this.

“We have, in partnership with NHS colleagues from across Greater Manchester, put a great deal of time and effort into carrying the study and should feel very proud of the roles they have played in this significant development.

“As should the participants who have selflessly volunteered to be part of the study. Without their participation, none of this would have been possible.”

Researchers and volunteers at the trust have been supporting studies with the National Institute for Health Research (NIHR) in testing the effectiveness of the new vaccine. The strong success rate marks an important new step in research to help save people from the effects of coronavirus.

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.

The UK Phase III 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 those 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.

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 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.

Image credit: Daniel Schludi

 

 

 

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