Published: 25 September 2020
Ten thousand UK volunteers have been invited to join the world’s first phase three COVID-19 vaccine study to test the effectiveness of the new Novavax COVID-19 vaccine.
This comes as the number of people in the UK who have signed up to take part in COVID-19 research through the NHS COVID-19 vaccine research registry hits 250,000.
Participants aged between 18-85 years will help test the safety and effectiveness of a new COVID-19 vaccine, developed by US biotechnology company Novavax, at a number of NIHR regional sites across the UK, including Lancashire, the Midlands, Greater Manchester, London, Glasgow and Belfast.
The Novavax trials are Phase 3, a large trial focusing on the vaccine’s effectiveness, with further checks on safety in a larger population. This followed earlier, smaller studies (phase 1 and phase 2) that reported positive results, and which focused on safety and whether there were signs the vaccine could work.
The Novavax trials are the second to commence in the UK, following AstraZeneca phase 3 trials at University of Oxford. Participants for the Phase 3 trial will be drawn from the NHS Covid-19 vaccine research registry.
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 with the aim to help speed up the development of a safe and effective vaccine against coronavirus. It has been developed as part of the UK Government’s Vaccine Taskforce, in partnership with the NIHR, NHS Digital, and the Northern Ireland, Scottish and Welsh Governments.
With several more studies for potential vaccine candidates expected to start before the end of the year, UK researchers are particularly encouraging additional volunteers from Black, Asian and minority ethnic backgrounds, and people with underlying health conditions and the over 65s, to be part of vaccine research so that any vaccines developed will work for as many people 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 study to be initiated in the UK, and the first Phase 3 study 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.”
Business Secretary Alok Sharma said:
“We are fighting coronavirus with all our might and we all have our part to play. One of the most effective ways we can defeat coronavirus is by finding a safe successful vaccine as quickly as possible, so that our lives can start returning to normal.
“I am incredibly proud of the 250,000 invaluable volunteers who have signed up for vaccine clinical studies across the UK. We want even more people to join them and sign up to the Vaccines Registry, so that scientists and researchers can make sure potential vaccines are completely safe and effective.”
If any of the vaccines are successful in clinical studies, 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 JCVI advice.
To find out about volunteering for clinical studies, visit: www.nhs.uk/researchcontact. More information about taking part in research and other opportunities to take part in COVID-19 research can be found at www.bepartofresearch.uk