01 Feb 2021
Greater Manchester plays significant role as Novavax announces COVID-19 vaccine is 89.3% effective
The NIHR-supported Novavax COVID-19 vaccine is 89.3% effective at preventing COVID-19. This is according to the interim analysis of Phase III study data, including effectiveness against the new variants of concern.
More than 1,240 Greater Manchester volunteers are taking part in the study.
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.
In Greater Manchester, the study has been carried out by local research teams at two community sites. Stockport NHS Foundation Trust recruited 762 participants and the Northern Care Alliance NHS Group recruited 480 in Oldham. Greater Manchester was the highest recruiting region in the country.
Both sites worked in collaboration with the National Institute for Health Research (NIHR) Clinical Research Network Greater Manchester, and NHS staff from other local trusts were part of the teams which delivered the study.
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, including 20,000 in Greater Manchester, 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 NIHR Clinical Research Network have played vital roles in the rapid recruitment and enrollment of volunteers.
Professor Andy Ustianowski, Deputy Clinical Director at NIHR Clinical Research Network Greater Manchester, and NIHR national Specialty Lead for Infection, said: “These results are fantastic and something Greater Manchester’s NHS research community – and the amazing trial participants – can proudly say they have played a big part in. This huge research project has been made possible thanks to a ‘One Greater Manchester’ approach which involved colleagues from across various NHS organisations working together to ensure local communities had the opportunity to be part of this groundbreaking research. We sincerely thank all the staff and participants whose contribution should now benefit so many people.”
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 out the study and staff 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.”
Professor Phil Kalra, Principal Investigator for the trial at Northern Care Alliance NHS Group, said: “Our team has worked incredibly hard to undertake the Novavax trial and we are thrilled to learn of these findings which show such a high degree of effectiveness. We are proud that the Northern Care Alliance, with support from our research colleagues in Greater Manchester, has made a real contribution to this marvellous achievement and we are extremely grateful for the efforts of all our staff and, of course, the volunteers who stepped forward to be part of this vital research.”
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.