By Integrated Care Journal-
Ten thousand UK volunteers have been invited to join a leading phase three Covid-19 vaccine trial from Friday 25 September, as the number of people who have signed up to take part in the research hits 250,000.
The phase three 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 of age groups and backgrounds. Phase three studies involve many thousands of people, giving researchers insights into the effects of a vaccine on a much larger population than phase one and two studies.
The thousands of volunteers have joined the trail to fight against Covid-19 through the NHS Vaccine Registry. The trials 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 in order to help speed up the development of a safe and effective vaccine.
Professor Paul Heath, Novavax phase three 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 three vaccine trial to be initiated in the UK, and the first phase three 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. ”
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.
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. This will ensure that, once approved by regulators, the vaccine can be supplied as quickly as possible.
Gregory M. Glenn, M.D., President of Research and 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 three 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 widely 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.
In August this year, the UK government and Valneva made a multi-million-pound joint investment in a vaccine manufacturing facility in Livingston, West Lothian, which will be at the heart of efforts to produce a new Covid-19 vaccine. This is in addition to the new Vaccines Manufacturing and Innovation Centre (VMIC), currently under construction in Oxfordshire, and the new vaccine manufacturing plant in Braintree, Essex recently acquired by the government-funded Cell and Gene Therapy Catapult.