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Novavax Says US Regulator Fast-Tracking Its COVID-19 Vaccine for Clinical Review

WASHINGTON (Sputnik) - Novavax Inc said on Monday the US Food and Drug Administration (FDA) was fast-tracking its COVID-19 vaccine candidate NVX-CoV2373 for clinical review.
Sputnik

"The FDA’s decision to grant Fast Track Designation for NVX-CoV2373 reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access to this vaccine", Gregory M. Glenn, President of Research and Development of Novavax said in a statement.

Glenn said the regulatory review of the clinical programme would be "expedited", but assured that the company "remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy".

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Earlier on Monday, Pfizer announced that it expected to produce up to 50 million doses of its coronavirus vaccine in 2020 and up to 1.3 billion doses in 2021.

According to Pfizer, the vaccine it developed jointly with BioNTech SE proved more than 90 percent effective in the latest trials.

The World Health Organisation declared the COVID-19 outbreak a pandemic on 11 March. To date, over 50 million people have been infected with the coronavirus worldwide, with nearly 1.25 million fatalities, according to Johns Hopkins University.

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