Earnings

FDA emergency use submission delayed to Q4

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Novavax announced that it will delay the submission of its Covid-19 vaccine to the Food and Drug Administration for emergency use authorization until its fourth quarter.

Shares of the biotechnology company slipped 10% after the bell.

The company has filed for regulatory approval in India, Indonesia and the Philippines. Plans to submit the vaccine for emergency use listing at the World Health Organization are set for August, Novavax announced.

Approval by the WHO will allow the vaccine to be distributed globally via vaccine sharing initiatives at the global agency.

Novavax data from clinical trials indicate that a booster dose of the vaccine candidate provides a 4-fold increase in…



Source cnbc.com

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