Novavax COVID-19 vaccine researched in Maidstone approved in UK by MHRA

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 100 volunteers took part in the study at Maidstone and Tunbridge Wells NHS Trust in Kent.

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.

Professor Lucy Chappell, Chief Scientific Adviser for the Department of Health and Social Care and Chief Executive of the National Institute for Health Research, said:

“It is important news that the independent regulator has now authorised the Novavax vaccine for use in the UK.
“This placebo-controlled vaccine trial was set up and carried out at a remarkable speed and scale across the UK. Many members of the public stepped forward to participate and this should be recognised and celebrated. We thank each and every one of them for their commitment to the Novavax study. Equally, this success was down to the dedication and hard work of researchers across England, Scotland, Wales and Northern Ireland.
 
“This protein-based vaccine will provide a useful additional option for countries going forwards.”

Professor Paul Heath, Novavax Phase 3 trial Chief Investigator and Director of the Vaccine Institute at St George’s, University of London and 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.”

Dr Arabella Waller, Principal Investigator for the Novavax trial at Maidstone and Tunbridge Wells NHS Trust said:
 
“The trial team at Maidstone are thrilled that Novavax has now been licensed in the UK. We are extremely grateful for the commitment, dedication and sacrifices made by our participants. We would also like to thank the many other individuals and teams at the Trust for their support and hard work with the project.”
 
Stanley C. Erck, President and Chief Executive Officer, Novavax, said:

“Novavax is proud to deliver a differentiated alternative to the current portfolio of vaccines – the first protein-based vaccine for the UK based on a well-understood technology that has been used for decades.

“We are tremendously grateful to the thousands of clinical trial participants and trial site investigators and staff across the UK, as well as the Vaccine Taskforce, for their ongoing support and vital contributions that made this possible, not only for Great Britain but also for our ability to achieve authorizations across the globe.”