Novavax Back On Track To Begin US Trial Of COVID-19 Vaccine This Month
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The company said that the vaccine, NVX-CoV2373 has been given a "fast-track" status from the US Food and Drug Administration and that it expected data from the trial could support US authorisation and approval
After delaying its US trial by roughly a month, Novavax Inc is back on track to begin the late-stage study of its experimental coronavirus vaccine later this month.
The company said that the vaccine, NVX-CoV2373 has been given a "fast-track" status from the US Food and Drug Administration and that it expected data from the trial could support US authorisation and approval, reported The Times of India.
The trial was postponed last month due to delays in scaling up the manufacturing process.
Many other companies are also testing their experimental coronavirus vaccines in late-stage studies. Pfizer Inc. said on Monday that its experimental COVID-19 vaccine was more than 90 per cent effective, citing an early data from a large-scale clinical trial.
Fast-track status allows companies to submit sections of a marketing application on a rolling basis as soon as some data becomes available, rather than wait for all the data before seeking approval.
Novavax said that a Phase II vaccine trial in South Africa has reached 50 per cent of its enrollment target. It's UK trial has enrolled 60 per cent of its intended participants, it said.
Novavax has received $1.6 billion from the US government's Operation Warp Speed program to speed the development and manufacturing of coronavirus vaccines and therapies. The funds will allow the company to conduct advanced human studies of its two-shot regimen, and establish manufacturing to deliver 100 million doses as soon as late 2020.
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