People in Northern Ireland have played a key role in the development of a new COVID-19 vaccine, Novavax, as part of a UK-wide trial.
The Northern Ireland Clinical Research Network (NICRN)/ Clinical Research Facility (NICRF) - 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 (including Belfast) 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.
Nearly 500 participants were recruited from Northern Ireland for the trial which was led by researchers Professor Danny McAuley, Professor Judy Bradley and Dr Johnny Stewart from Queen’s University Belfast and the Belfast Health and Social Care Trust.
The researchers helped to bring a large group of GPs from General Practice, nurses from the NICRF and NICRN, as well as a large team of administrators together to deliver this trial in the Northern Ireland Clinical Research Facility at Belfast City Hospital.
A number of Health and Social Care and academic organisations and individuals worked on and supported the trial, including the Public Health Agency R&D Division; the Belfast Health and Social Care Trust; the NI Clinical Research Facility; the NI Clinical Research Network; NI Clinical trial Unit, Queen’s University Belfast and Ulster University, involving medical staff and nursing staff from across Northern Ireland as well as medical, nursing and physiotherapy students, community GPs and Belfast COVID Centre staff.
Dr Janice Bailie, Assistant Director of HSC R&D Division Public Health Agency (PHA), said: “As funder of Research and Development infrastructure, we are very proud of the part played by Northern Ireland researchers in delivering the Novavax vaccine trial. This required a huge effort and many long hours of work, and I would like to take this opportunity to commend each and every one of those involved.
“I would also like to extend a particular thanks to the volunteers who came forward to participate in the trial – of whom there were almost 500 participants in Northern Ireland – without their willingness to take part, it could not have happened. This is a great outcome, which again demonstrates the critical contribution R&D makes and the importance of investing in research, not only now during the pandemic, but at all times for the better health and social care of the population in Northern Ireland and beyond.”
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-wide clinical trial was supported by the National Institute for Health Research (NIHR).
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