Five-hundred Greater Manchester and East Cheshire volunteers will, from today, be invited to join a leading phase three COVID-19 vaccine study taking place in the region. Also, 1,950 people in East Cheshire have signed up so far to the vaccine registry.
The 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.
Stockport NHS Foundation Trust is among the sites selected to undertake the Novavax study. It will be carried out in a community setting, in cooperation with the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Greater Manchester.
Calling on some of the thousands of volunteers who have joined the fight against COVID-19 by signing-up to the NHS Vaccine Registry, the phase three trials are the second to commence in the UK.
A total of 9,000 volunteers are needed to take part in the trials which will also be undertaken at a number of NIHR regional sites across the UK, including Lancashire, the Midlands, London, Glasgow and Belfast.
At Stockport, 500 volunteers are needed. Volunteers who sign up to the Registry and live in Stockport, East Cheshire and parts of South East Manchester could potentially take part.
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.
More than 250,000 people nationally have now signed up, including 26,785 in the North West and 11,955 in Greater Manchester and East Cheshire.
With several more studies 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 research. 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.
Professor Andrew Ustianowski, NIHR Clinical Research Network (CRN) national specialty lead for Infection and NIHR CRN Greater Manchester Deputy Clinical Director, said:
“This launch represents a landmark in the fight against COVID-19 and our Greater Manchester research community is proud to be contributing to this important vaccine study.
“We are really grateful to the thousands of people who have signed up to the vaccine registry so far. It is important we keep this up and that more people from across our range of Greater Manchester communities join the registry because we are going to need large numbers of volunteers to get involved in testing the vaccines.
“We need a really good mix of people of different ages and ethnicities, and people with and without existing health problems. This will help identify vaccines that work for everyone.”
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.”
The government has secured 60 million doses of the Novavax vaccine for the UK, which will be manufactured using FUJIFILM Diosynth Biotechnologies’s facilities in Billingham, Stockton-on-Tees. 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 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.”
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 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.
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 Cell and Gene Therapy Catapult.
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.
The Novavax vaccine comprises a recombinant nanoparticle technology containing an engineered covid-19 spike protein and the saponin-based adjuvant Matrix-M designed to enhance the immune response and stimulate high levels of neutralising antibodies. Half the study participants will receive the trial COVID-19 vaccine, delivered in two doses, and half will receive a saline placebo, also delivered in two doses – a so called ‘blinded trial’ in which none of the participants are aware if they are receiving the vaccine or a placebo. Study participants can expect to make around six visits to their local trial centre over 13 months.
The UK has secured access to a total of six different candidates, across four different vaccine types, reflecting the Government’s strategy to ensure the UK has a supply of vaccines should any of these prove safe and effective through clinical trial research. This is in addition to the University of Oxford’s vaccine being developed with AstraZeneca, and includes agreements with the BioNTech/Pfizer alliance, Janssen, Valneva and GSK/Sanofi Pasteur.
The 4 different vaccine classes that the government has secured to date for the UK are:
● adenoviral vaccines (Oxford/AstraZeneca, Janssen)
● mRNA vaccines (BioNTech/Pfizer)
● inactivated whole virus vaccines (Valneva)
● protein adjuvant vaccines (GSK/Sanofi, Novavax)
In addition the UK has secured rights to AstraZeneca’s antibody treatment to neutralize the virus which can be used both as a short term prophylactic for those people who cannot receive vaccines (e.g. cancer and immunosuppressed patients) and front line workers exposed to the virus, as well as a treatment for infected patients in hospitals.
The UK is actively working with the vaccine alliance GAVI, The Coalition for Epidemic Preparedness Innovations (CEPI), the World Health Organisation and a group of other countries to help buy vaccines as well as to ensure equitable distribution of vaccines to low-income countries.
Volunteering for COVID-19 vaccine clinical trials:
A new NHS service was launched in July 2020 to enable people across the UK to sign up for information on COVID-19 vaccine studies.
The NHS Covid-19 vaccine research registry, developed in partnership with NHS Digital, will help facilitate the rapid recruitment of large numbers of people into research over the coming months - potentially meaning an effective vaccine for coronavirus can be found as soon as possible.
The service was commissioned as part of the UK Government’s Vaccine Taskforce in conjunction with the National Institute for Health Research (NIHR) and the Northern Ireland, Scottish and Welsh Governments
Anyone living in the UK can sign up online to take part in the studies through the NHS, giving permission for researchers to contact you if they think you’re a good fit. Once you sign up, you can withdraw at any time and request that your details be removed from the COVID-19 vaccine research registry. The process takes about 5 minutes to complete.
More information can be found: NHS.UK/researchcontact
About the Vaccine Taskforce
The Vaccine Taskforce (VTF) was set up under the Department for Business, Energy and Industrial Strategy (BEIS) in May 2020, to ensure that the UK population has access to clinically effective and safe vaccines as soon as possible, while working with partners to support international access to successful vaccines. This is to place the UK at the forefront of global vaccine research, development, manufacture and distribution.
The Vaccine Taskforce comprises a dedicated team of private sector industry professionals and officials from across government who are working at speed to build a portfolio of promising vaccine candidates that can end the global pandemic. It is chaired by biotech and life sciences expert Kate Bingham, who was appointed by the Prime Minister Boris Johnson.
The Vaccine Taskforce’s approach to securing access to vaccines is through:
● procuring the rights to a diverse range of promising vaccine candidates to spread risk and optimise chances for success;
● providing funding for clinical studies, diagnostic monitoring and regulatory support to rapidly evaluate vaccines for safety and efficacy; and
● providing funding and support for manufacturing scale-up and fill and finish at risk so that the UK has vaccines produced at scale and ready for administration should any of these prove successful.