Novavax Coronavirus (COVID-19) Vaccine Starts Health Authority Review in US and Multiple Countries

By : Yung Shop

Published On: 2021-02-05

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07:16

FDA (Food and Drug Administration) have begun to review Coronavirus (COVID-19) vaccine clinical trial data required for clearance of Novavax Inc.’s vaccine while final-phase clinical trials are still underway, the company said in a statement.

The process, called a rolling submission, has also begun in the U.K. and Canada, Novavax said. On Wednesday, the company said European regulators were doing a similar review.

The Gaithersburg, Maryland-based company will submit more trial data and information about its manufacturing processes to the regulatory authorities as they become available, Novavax said.

Novavax said last week an interim analysis of a trial in the U.K. showed its vaccine to be 89.3% effective in preventing symptomatic Covid-19 and remained effective against the B.1.1.7 strain more common there that has been found in the U.S. The vaccine would help bolster vaccine doses in the U.S. where the FDA has authorized shots from Pfizer Inc. and Moderna Inc. and will likely do the same for one from Johnson & Johnson in the coming weeks.

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