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10,000 UK volunteers to take part in new Covid-19 Vaccine Studies

10,000 UK volunteers to take part in new Covid-19 Vaccine Studies

Thousands of volunteers who have signed up to the Registry, including people from the West Midlands, will take part in the world’s first Phase 3 study to test the effectiveness of the new Novavax COVID-19 vaccine.

More volunteers from Black, Asian and minority ethnic backgrounds, as well as those with long-term health conditions, are being encouraged to be part of vaccine research

Ten thousand UK volunteers will be invited to join a leading phase three COVID-19 vaccine study, as the number of people who have signed up to take part in research hits 250,000, including more than 17,000 in the West Midlands.

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.

Calling on some of the thousands of volunteers who have joined the fight against Covid-19 through the NHS Vaccine Registry, the phase three 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, to help speed up the development of a safe and effective vaccine.

Those who have signed up have been thanked by NIHR CRN West Midlands Clinical Director, Professor Jeremy Kirk: “Without the selflessness of those who are willing to help researchers find an effective vaccine, our chance of fighting COVID-19 would be much reduced, so we are incredibly grateful to all volunteers.”

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.

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.

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.


ENDS

For further information contact Claire Hall, Communications Lead on 07775 800227.

Notes to editors

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 Government.

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.

About the NIHR

The National Institute for Health Research (NIHR) is the nation's largest funder of health and care research. The NIHR:

Funds, supports and delivers high quality research that benefits the NHS, public health and social care
Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
Partners with other public funders, charities and industry to maximise the value of research to patients and the economy

The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR supports applied health research for the direct and primary benefit of people in low- and middle-income countries, using UK aid from the UK government.

About the NHS vaccine registry

Launched on 20 July, the NHS COVID-19 Vaccine Research Registry is an online service allowing members of the public to register their interest in Covid-19 vaccine studies and be contacted to participate in future clinical trials. It can be found at nhs.uk/researchcontact

Vaccines are tested in stages to ensure they are safe and effective. Volunteers who are contacted to take part in trials will be given information about what stage a particular vaccine is at and details of how it has already been tested. They will be able to consider this when deciding to take part and people can withdraw from the registry at any point.

The Registry has been developed by the government, in partnership with the National Institute for Health Research (NIHR), NHS Digital, the Scottish and Welsh governments and the Northern Ireland Executive.