“Novavax expects its pivotal Phase 3 clinical trial in the US and Mexico to begin in the coming weeks,” the company said in a statement, adding that more than 100 trial sites have been selected.
It is the second time that Novavax, Inc. has rescheduled the Phase 3 trial, after the intended start in October was hampered by issues in scaling up its manufacturing.
“We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed,” Stanley C. Erck, president and chief executive officer of Novavax, said.
The company is also working to “put partnerships in place that would ensure widespread and equitable access worldwide,” Erck added.
Two of the three planned late-stage efficacy trials for the vaccine are fully enrolled, while more than 20,000 participants have been dosed to date.
The company says it is expecting interim data from its 15,000-participant UK trial in the first quarter of 2021 – and that trial could form the basis for some global regulatory approvals, according to the biotech firm.
After the latest delay, shares of Novavax fell six percent. The US-based company lags behind larger rivals Pfizer and Moderna in their vaccine development timelines. However, more than a quarter of enrollees in the UK trial are over the age of 65, and the firm says a large proportion of volunteers had underlying comorbid medical conditions generally representative of the population.
The US Food and Drug Administration (FDA) has previously positively reviewed “preliminary blinded data” on the vaccine in older adults needed to proceed to Phase 3, Novavax said.
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