Novavax COVID-19 vaccine researched in the South West 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 (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 700 volunteers took part in the study in the South West, which took place at Royal Cornwall Hospitals NHS Trust and the NIHR Patient Recruitment Centre: Exeter at Royal Devon and Exeter NHS Foundation Trust (RD&E).

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 Ray Sheridan, Consultant Physician and Principal Investigator for the trial at RD&E said:

“It’s great news that the Novavax vaccine has now received MHRA approval for use in the UK.

“This vaccine is being manufactured in the UK and millions of doses will now be part of supplying vaccines for the whole world. It’s easy to store and so will make it easier to get vaccines to other countries. We are all safer when we are all vaccinated.

“We are really grateful to all the participants who volunteered to take part in this study, including 545 locally at the NIHR Patient Recruitment Centre: Exeter, which now gives us a 5th vaccine licensed for use in the UK.

“Two years ago we set out with other NHS hospitals across the UK to see if at least one of nine different vaccines in clinical trials might give some protection against COVID-19. Now here we are, with a fifth vaccine that provides high protection against COVID with good immune responses and a reassuring safety profile.

“The public can be assured it’s been rigorously assessed through clinical trials and by the MHRA. It’s a protein based vaccine and so offers us an alternative technology base and manufacturing process to existing vaccines, and so broadens the options we have.

“So a big thank you to the participants for volunteering and to the many NHS staff who worked on this important health advance.”

Dr Duncan Browne, Consultant Endocrinologist at Royal Cornwall Hospitals NHS Trust and Principal Investigator for the trial at the hospital, said:

“This is excellent news and I am delighted that Cornish patients had the opportunity to take part in this landmark study.”

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.”