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

Novavax COVID-19 vaccine researched in Oxford 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 460 volunteers took part in the study at the Warneford Hospital in Oxford, one of 33 UK centres to host the research.

The 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 in just eight weeks, between September 2020 and November 2020.

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.

Dr Angela Minassian, site Principal Investigator for the Novavax trial in Oxford, said:

“This adds strength and flexibility to the current armoury of licensed COVID-19 vaccines and its potential to facilitate global vaccination against this disease couldn’t be more timely.

“The public’s willingness to participate in this trial and the many other UK COVID-19 vaccine trials has been so humbling from the outset.

“I’d like to thank our dedicated staff from Oxford Health NHS Foundation Trust, the NIHR and many medics from across Oxfordshire, who have worked so hard on this trial over the past 16 months. It has been a privilege to work alongside them.”

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.”

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.”

Published: 4 February 2022