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Novavax is set to begin its phase 3 trial of an experimental COVID-19 vaccine in the UK.
The American biotech firm plans to enroll up to 10,000 volunteers between the ages of 18 and 84 over the next four to six weeks.
The company joins AstraZeneca, Pfizer and Moderna as their vaccine candidate enters the final step of the regulatory approval process.
There are nearly 40 potential vaccines being tested globally and more than 140 in the early stages of testing, according to the World Health Organization.
Half of the volunteers in the Novavax trial will receive two injections of NVX-CoV2373 with Matrix-M, the company’s adjuvant that is intended to strengthen the vaccine. Half will be given a placebo.
Up to 400 volunteers will receive a seasonal flu vaccine and the COVID-19 vaccine to see the effectiveness of combining the two.
At least 25% of the participants will be over 65, and the trial will prioritize the groups most affected by COVID-19, including those from ethnic minorities, the company said.
In August, the UK government announced that Novavax would be provided with support and infrastructure during its phase 3 clinical trial in the UK.
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.
The Novavax candidate is the second vaccine to enter Phase 3 clinical trials in the UK; the first was the possible vaccine being developed by the University of Oxford and AstraZeneca.
Gregory M Glenn, Novavax president of research and development, said the team was “optimistic” that the trial “would provide a short-term view” of the vaccine’s efficacy.
He added: “The data from this trial is expected to support regulatory filings for licensing in the UK, EU and other countries.
“We are grateful for the support of the UK government, including the Department of Health and Social Care and the National Institute for Health Research, to advance this important research.”
Novavax said preclinical trials showed that 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 trial could begin on Friday and that the candidate vaccine is “very promising.”
Novavax shares rose more than 6% in after-hours trading in the US.
