Novavax COVID-19 vaccine researched in Hartlepool approved in UK by MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) has today authorised Novavax’s COVID-19 vaccine for use in the UK.
534 volunteers from the North East took part in the study at the University Hospital of Hartlepool.
The NIHR-supported Novavax study found the COVID-19 vaccine was 89.7% effective at preventing COVID-19, prior to the Omicron variant emerging.
The study is the UK’s largest ever double blind, placebo-controlled vaccine trial, recruiting 15,203 participants from 33 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.
Professor Caroline Wroe, Clinical Director for the NIHR Clinical Research Network North East and North Cumbria and Co-Principal Investigator of the Novavax study at Hartlepool, said: “I am extremely proud that the region played its part in testing the Novavax vaccine. Huge thanks to all the participants for their time and effort contributing to this important research - it would not have happened without you.
“I would also like to give my heartfelt thanks to the research team at Durham Tees Valley Research Alliance for their hard work and fantastic team effort in delivering this study in our region.”
Dr Justin Carter, Clinical Director of Research and Development at the North Tees and Hartlepool NHS Foundation Trust, said: "I am delighted that MHRA have approved the Novavax vaccine and it is great to see participants and staff from North Tees, Hartlepool and the surrounding region playing such a key part in this research. We are proud that local people have contributed to testing a vaccine that will be manufactured locally and that will be for the benefit of people across the world."
Professor Paul Heath, Chief Investigator and Professor of Paediatric Infectious Diseases at 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 participants across the UK and 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.”
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.”
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.
ENDS
Notes to Editor:
For more information, contact: Lisa Howarth, Communications Officer, 07342058139, lisa.howarth@nihr.ac.uk
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