NIHR supported studies find Novavax COVID-19 vaccine trialled in Yorkshire and Humber is 89.3% effective
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, including 1532 in Yorkshire and Humber. 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 world’s first participants into the study were recruited at the NIHR National Patient Recruitment Centre (NPRC) based in Blackpool, one of five regionally based centres dedicated to setting up and delivering large, late-phase commercial clinical trials across the NHS.
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 Alistair Hall, Clinical Director of the NIHR Clinical Research Network, Yorkshire and Humber said:
“These findings are very welcome at a time when we are all looking for hope and for a light at the end of a long dark winter. I am very impressed with the many volunteers in this study who have helped to advance our knowledge and options.
“This new vaccine is different to those already in use as it is a more traditional design - being protein based. This may be more acceptable to some who remain cautious about being vaccinated. The ability to protect against new variants of the SARS2 coronavirus is a major added bonus.”
Professor Dinesh Saralaya, Director of the NIHR Patient Recruitment Centre Bradford said:
“I am proud and humbled to have been involved in this trial. I feel it is the pinnacle of my research career and I also feel I have achieved something I have always wanted to do; make a difference to the people of Bradford and this city.
“The people of Bradford can also be proud at being part of a world race to find an effective vaccine against Covid-19.”
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’s facilities in Billingham, Stockton-on-Tees.