Coronavirus: Potential vaccine passes another hurdle as 10,000 UK volunteers to test jab
Early studies show the potential innoculation produced "robust antibody responses" greater than those seen in recovering patients.
Friday 25 September 2020 13:33, UK
Novavax has started its Phase 3 trial of an experimental COVID-19 vaccine in the UK.
The US biotechnology firm is to enrol 10,000 people out of 250,000 volunteers aged between 18 and 84 over the next four to six weeks.
The company joins AstraZeneca, Pfizer, and Moderna as its coronavirus vaccine candidate enters the final step of the regulatory approvals process.
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There are almost 40 potential vaccines being tested globally and more than 140 others in the early stages of testing, according to the World Health Organisation.
Half of the volunteers in the Novavax trial will have two shots of NVX-CoV2373 with Matrix-M, the company's adjuvant which is intended to strengthen the vaccine. Half will be given a placebo.
Up to 400 volunteers will get a seasonal flu vaccine and the COVID-19 vaccine to see the effectiveness of combining the two.
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At least 25% of participants will be aged over 65 and the trial will prioritise groups most affected by COVID-19, including those from ethnic minorities, the company said.
In August, the UK government announced that support and infrastructure would be given to Novavax during its Phase 3 clinical trial.
This includes plans to manufacture the vaccine in the UK and the promise of 60 million doses for the UK if the vaccine turns out to be safe and effective.
And researchers are calling for more volunteers to take part in trials for other potential vaccine candidates expected to start before the end of the year.
The government said there was a particular need for more volunteers from black, Asian and minority ethnic backgrounds, along with people with underlying health conditions and the over 65s.
Business Secretary Alok Sharma said: "I am incredibly proud of the 250,000 volunteers who have signed up to play their part in the global fight against coronavirus.
"Our scientists and researchers are working day and night to find a vaccine that meets the UK's rigorous safety standards, but we need even more people from all backgrounds and ages to sign-up for studies to speed up this life-saving research.
"The more people that sign up, the quicker we can find a safe and effective vaccine, defeat this virus and protect millions of lives."
The Novavax candidate is the second vaccine to enter Phase 3 clinical trials in the country, the first being the potential vaccine being developed by Oxford University and AstraZeneca.
Gregory M Glenn, president of research and development at Novavax, said the team was "optimistic" that the trial would "provide a near-term view" of the vaccine's efficacy.
He added: "The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries.
"We are grateful for the support of the UK government, including from its Department of Health and Social Care and National Institute for Health Research, to advance this important research."
Novavax said pre-clinical trials showed the potential vaccine was "generally well-tolerated" and produced "robust antibody responses" greater than those seen in recovering patients.
Thomas Moore, Sky's science correspondent, said the Novavax vaccine candidate showed "huge promise".
Novavax shares were up more than 6% in after-hours trading in the US.