Supporting the UK’s biggest COVID-19 vaccine trial
Hundreds of volunteers from across the Norwich Research Park and the local community joined the Novavax vaccine study at the Norfolk and Norwich University Hospital (NNUH) run Clinical Research Facility (CRF), part of the Quadram Institute. This was one of 33 national UK sites taking part in the trial which was supported by the National Institute for Health Research (NIHR). After thorough analysis of the data by experts at the Medicines and Healthcare products Regulatory Agency (MHRA), it was concluded that the vaccine met required standards of safety, quality and effectiveness, and the MHRA authorised Novavax’s COVID-19 vaccine for use in the UK on the 3rd February 2022.
Vaccination is the term used for the process of receiving a vaccine dose by injection or orally. Immunisation refers to the combined process of receiving the vaccine and becoming immune to the disease following vaccination. According to the World Health Organization (WHO), immunisation saves 4-5 million lives around the world each year. Vaccinations give people long-term, sometimes lifelong, protection against certain infectious diseases; they are usually recommended during early childhood to prevent diseases like measles and chickenpox and are one of the most successful and cost-effective public health interventions.
Vaccines can help protect us from:
- Conditions that affect adults
- Diseases we are exposed to while travelling
- New threats like COVID-19
Vaccines work by teaching your immune system to recognise infectious organisms, particularly certain viruses. After vaccination your body will be more prepared to fight back. Vaccines help prevent or reduce the severity of the illness if you are exposed.
Many techniques are used to make vaccines, and they each work in specific ways. Novavax is the first protein-based vaccine registered for use in the UK, but it is based on a well-understood technology. The Novavax vaccine trial was a phase III (to evaluate vaccine efficacy, safety and immunogenicity) randomised controlled study on adults aged 18-84; half of the participants received two shots of the vaccine while the other half received two shots of a placebo. Then, in the cross-over part of the trial the participants who received the placebo received the vaccine, and vice versa.
The Novavax vaccine is engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. It was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. It contains purified protein antigen and can neither replicate, nor can it cause COVID-19. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. It is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels and the current assigned shelf life of the vaccine in Great Britain is 9 months.
Phase III trials can take several years to complete. However, the Novavax trial recruited and evaluated 15,203 participants from 33 UK sites in just eight weeks between September and November 2020. It is also the largest double-blind, placebo-controlled Covid-19 vaccine trial done in the UK, to date.
The Clinical Research Facility
The Clinical Research Facility (CRF) at the Quadram Institute is home to a host of research initiatives that facilitate the development of new treatments and improve patient care. The facility brings together researchers and scientists from the NNUH, Quadram Institute Bioscience (QIB), University of East Anglia (UEA) and across the Norwich Research Park. It is home to research studies on a wide range of health conditions and involves patients and volunteers. It is also the hospital’s primary facility for all clinical trials that do not need to be located within the main hospital building. It provides a mixture of outpatient, clinical and laboratory space and a food-preparation area for diet-related studies.
This trial was an incredible milestone for the staff at CRF and NNUH due to the large number of participants recruited (500), extraordinary speed of setting up the trial (30 days) and the size of the research team involved (up to 60 staff).
“The NHS Clinical Research Facility at the Quadram Institute was instrumental in supporting the important national research to find an effective vaccine for COVID-19. The whole of NNUH’s Research Department, up to 60 staff, including research nurses, practitioners and administrators, plus staff from James Paget University Hospital and the NIHR Clinical Research Network Eastern, were diverted to work on the Novavax vaccine trial whilst continuing to run their research portfolios. Our team has shown tenacity, flexibility and sheer determination to deliver whilst caring for the trial participants and ensuring a positive experience. We are delighted to be able to host such a momentous study, the first of its kind in Norfolk.” Felicia Rowe, CRF Operations Manager, QI.
The COVID Vaccine Trial
The Novavax study was led by researchers at St George’s, University of London. When combining the results from all sites, they found that the COVID-19 vaccine was 89.7% effective at preventing the Beta variant of Covid-19.
Helped by the invaluable support of research teams in England, Scotland, Wales and Northern Ireland, Novavax became 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 Organization, 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.
“It was a real privilege to take part in the study and to feel you were doing something to help beat COVID. The Clinical Research Facility team were brilliant and very professional. Vaccines are real life savers, it was reassuring to see first-hand that safety was paramount throughout the study, and the end result was a really effective vaccine” Andrew Stronach, Novavax trial volunteer and Head of External Relations and Engagement, QI