Novavax COVID-19 vaccine researched in East of England region approved by MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) has now authorised Novavax’s COVID-19 vaccine for use in the UK.
This follows rigorous clinical trials supported by NIHR 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 500 volunteers took part in the study at the Norfolk and Norwich University Hospitals (NNUH), with a further 168 taking part at East Suffolk and North Essex NHS Foundation Trust, and 105 at Wansford and Kings Cliffe Practice in Peterborough. Other NHS organisations also provided staff to help NNUH run the study, including the James Paget University Hospital, and research nurses from CRN Eastern and Clinical Commissioning Groups in the region.
Claire, a carer from Norwich, took part in the Novavax trial at NNUH last year, and was surprised to find out she had received the real vaccine and not the placebo (a harmless fluid which looks the same as the vaccine but has no effects). Claire said:
“I had absolutely no side effects from having either of the two doses of the vaccine so assumed I’d had the placebo, particularly because I’d seen lots of my friends have side effects from the approved vaccines.
“I’m just glad I could do my bit to help, especially because I know how much COVID has affected so many people. I’d definitely think about taking part in research again, it’s so important. After all, without it, we’d have no medicines or treatments, not even paracetamol!”
Professor Jeremy Turner is Clinical Director for the NIHR’s CRN East of England and was in charge of the Novavax trial at NNUH, where he is a Consultant Endocrinologist. He said:
“We are immensely grateful to the participants in the study who so generously gave up their time to be involved. We are also hugely grateful to the other people who put themselves forward for inclusion in the study but who, for a range of reasons were, unfortunately, not able to participate in the study. Finally, we must not forget that this was a massive team effort. Thank you and congratulations to everyone involved"
The NIHR-supported Novavax study, led by researchers at St George’s, University of London, found the COVID-19 vaccine was 89.7% effective at preventing COVID-19, prior to the Omicron variant emerging.
The study 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.
