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Thousands of volunteers will take part in Phase 3 study on Novavax vaccine

Ten thousand volunteers have been invited to join a leading phase three COVID-19 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 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 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.

The Novovax 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.

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.

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.”

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.

“One of the ways people can help with that is by signing up to the NHS Vaccines Registry, so they can be rapidly called.”

The UK public can support the national effort to speed up vaccine research and receive more information about volunteering for clinical studies HERE.

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.

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