Gaithersburg, Maryland-based Novavax Inc., one of nearly a dozen companies developing a potential COVID-19 vaccine, has entered late-stage human trials with 10,000 participants in the United Kingdom.
Novavax is one of several drug development companies that have received federal government funding under Operation Warp Speed; receiving $1.6 billion to develop and then manufacture its vaccine if proven successful.
The Novavax vaccine candidate, called NVX-CoV2372, is being tested in humans in a partnership with the UK government’s Vaccines Taskforce, and will enroll individuals between 18 and 84 years old.
Half will receive two doses of the vaccine. Half will receive a placebo.
“With a high level of transmission observed and expected to continue in the UK, we are optimistic that this pivotal Phase 3 trial will enroll quickly and provide a near term view of its efficacy,” said Gregory Glenn, M.D., president of research and development at Novavax.
The Novavax vaccine is in liquid form that can be stored at 2-degrees to 8-degrees centigrade, similar to other vaccines.
Novavax has reached manufacturing partnerships with several companies, including Gaithersburg-based Emergent BioSolutions, and purchased its own manufacturing facility in the Czech Republic.
Novavax said it would have the capacity to produce up to 2 billion doses a year, once all manufacturing availability is brought online by mid-2021.
The promise of a COVID-19 vaccine has been a boon for Novavax investors. Its stock, trading at around $15 per share in March, is now more than $100 per share.
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