Novavax COVID-19 vaccine trialled with over 1,655 Greater Manchester participants approved in UK

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Novavax’s COVID-19 vaccine for use in the UK.

This follows rigorous clinical trials supported by National Institute for Health Research and a thorough analysis of the data by experts at the MHRA, which has concluded that the vaccine has met its strict standards of safety, quality and effectiveness.

Over 1,655 volunteers took part in Greater Manchester, which was the UK’s highest recruiting region to the trial. The volunteers participated in the trial at Stockport NHS Foundation Trust and the Northern Care Alliance NHS Foundation Trust.

The Novavax study found the COVID-19 vaccine was 89.7% effective at preventing COVID-19, prior to the Omicron variant emerging.

The study, led by researchers at St George’s, University of London, is the largest ever double blind, placebo-controlled vaccine trial to be undertaken in the UK, recruiting 15,203 participants from 33 research UK sites in just eight weeks, between September 2020 and November 2020.

Helped by the invaluable support of these participants, and research teams in England, Scotland, Wales and Northern Ireland, Novavax has become the fifth COVID-19 vaccine to be authorised by the MHRA. It follows the Pfizer/BioNTech, Oxford/AstraZeneca, Moderna and Janssen vaccines - but is the first protein-based vaccine approved in the UK.

The Novavax vaccine has also been authorised by the European Medicines Agency and the World Health Organisation, meaning participants in the study will have their vaccination status recognised outside of the UK. Until this time, a number of countries had refused to recognise the vaccinated status of people who had taken part in this trial, leading to them facing difficulties in international travel.

Professor Andy Ustianowski, Deputy Clinical Director at NIHR Clinical Research Network Greater Manchester, and Clinical Lead for the NIHR’s COVID Vaccine Research Programme, said:

“We are extremely grateful to the participants in Greater Manchester and across the country who volunteered in such strong numbers to be part of this vital trial and waited patiently for the regulator’s announcement. 

“The delivery of this major project in our region was made possible thanks to a ‘One Greater Manchester’ approach. This involved colleagues from various NHS organisations working together across two sites to ensure our local communities had the opportunity to be part of this groundbreaking research which will now benefit people around the world."

Dr David Baxter, Principal Investigator for the trial at Stockport NHS Foundation Trust, said:

“The Stockport vaccine team is delighted to learn that the vaccine has been approved for use in the UK. We are indebted to the hundreds of participants who were involved in the trial at our trust. It’s thanks to their willingness to be part of this research that we now have another safe and effective vaccine to protect people against COVID-19 in the UK and globally.

“I would also like to thank staff from across our trust and our NHS partner organisations in Greater Manchester who have worked tirelessly on this trial from start to finish.  An incredible amount of commitment and dedication from a great many NHS Research and Innovation colleagues has made this announcement possible.”

Professor Phil Kalra, Principal Investigator for the study at Northern Care Alliance NHS Foundation Trust, said:

“It is excellent news that we have another effective vaccine as we continue to face the challenges of COVID-19. We are proud that Northern Care Alliance, with support from our research colleagues in Greater Manchester, has made a real contribution to evaluation of this novel vaccine and we are extremely grateful to all the volunteers who generously stepped forward to be part of this vital research.”

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:

“On behalf of the participants and trial teams I am delighted that the MHRA have now authorised the Novavax vaccine, in addition to the recent authorisations from the World Health Organisation and the European Commission.

“The altruism, willingness and patience of the over 15,000 participants across the UK and that of the 33 trial teams has been exceptional. This has been despite huge challenges, including with certification and travel. The participants and teams alike should take great pride in their part in having brought another effective vaccine to the UK and, through the COVAX programme, to the global population.”