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 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.
Nearly 500 volunteers took part through Northern Care Alliance NHS Foundation Trust and Greater Manchester was the UK’s highest recruiting region to the trial. Volunteers also participated in the trial at Stockport 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 and supported by National Institute for Health Research, 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.
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.”
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.”