Ten thousand UK volunteers will from today (Friday 25 September) be invited to join a leading phase 3 coronavirus vaccine trial, as the number of people who have signed up to take part in research hits 250,000.
The Phase 3 study will test the safety and effectiveness of a promising new vaccine, developed by US biotechnology company Novavax, across a broad spectrum of people, including those from a variety age groups and backgrounds. Phase 3 studies involve many thousands of people, giving researchers insights into the effects of a vaccine on a much larger population than phase 1 and 2 studies.
Calling on some of the thousands of volunteers who have joined the fight against coronavirus through the NHS Vaccine Registry, the phase 3 trials, which started yesterday (24 September), are the second to commence in the UK and will be undertaken at a number of National Institute for Health Research (NIHR) regional sites across the UK, including Lancashire, the Midlands, Greater Manchester, London, Glasgow and Belfast.
The Registry was launched in July to help create a database of people who consent to be contacted by the NHS to take part in clinical studies, to help speed up the development of a safe and effective vaccine.
With several more trials for potential vaccine candidates expected to start before the end of the year, UK researchers are calling for additional volunteers to sign up to take part in clinical studies. To better understand the effectiveness of vaccine candidates and help find a vaccine that works for as many people as soon as possible, researchers are particularly seeking more volunteers from black, Asian and minority ethnic backgrounds as well as those with underlying health conditions and the over 65s.
Business Secretary Alok Sharma said:
I am incredibly proud of the 250,000 volunteers who have signed up to play their part in the global fight against coronavirus.
Our scientists and researchers are working day and night to find a vaccine that meets the UK’s rigorous safety standards, but we need even more people from all backgrounds and ages to sign-up for studies to speed up this life-saving research.
The more people that sign up, the quicker we can find a safe and effective vaccine, defeat this virus and protect millions of lives.
The UK government has secured 60 million doses of the Novavax vaccine, which will be manufactured using FUJIFILM Diosynth Biotechnologies’ facilities in Stockton-on-Tees, north east England. This will ensure that, once approved by regulators, the vaccine can be supplied as quickly as possible.
Professor Paul Heath, Novavax Phase 3 trial Chief Investigator and Professor of Paediatric Infectious Diseases at St George’s University Hospitals NHS Foundation Trust said:
This is only the second Phase 3 vaccine trial to be initiated in the UK, and the first Phase 3 trial with the Novavax vaccine anywhere in the world, which shows the importance that has been placed on rapidly finding a solution for this urgent public health need. The vaccine has successfully gone through its early safety trials and we’re extremely encouraged by its performance so far.
The NHS Vaccines Registry has been key in helping us quickly identify participants who fulfil the inclusion criteria for this study – particularly those from among groups most likely to benefit from a vaccine, such as the elderly.
Chair of the government’s Vaccines Taskforce Kate Bingham said:
Finding a safe and effective vaccine that works for the majority of the UK population is the best way to tackle this devastating disease. Whilst social distancing, testing and other measures can help reduce the impact of coronavirus, the only long-term solution to beating it will be finding a vaccine. One of the ways people can help with that is by signing up to the NHS Vaccines Registry, so they can be rapidly called.
Gregory M. Glenn, M.D., President of Research & Development at Novavax said:
Today marks an important and exciting advance in addressing the global COVID-19 pandemic in Europe and around the world. We are confident in the safety of this vaccine and based on the successful phase 3 clinical trial of our influenza vaccine built using the same platform, we are optimistic that NVX-CoV2373 will prove to be effective at preventing infection and reducing the transmission of the disease.
If any of the vaccines are successful in clinical trials, they could start to be delivered to the UK in 2021. It is expected that these vaccines would first be given to priority groups such as frontline health and social care workers, ethnic minorities, adults with underlying health conditions, and the elderly based on Joint Committee on Vaccination and Immunisation (JCVI) advice.
The UK public can support the national effort to speed up vaccine research and receive more information about volunteering for clinical studies by visiting www.nhs.uk/researchcontact.