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Submission of FDA emergency use delayed to Q4

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

The shares of the biotechnology company fell 10% after the bell.

The company has submitted regulatory approval in India, Indonesia and the Philippines. Plans to send the vaccine to the emergency use list at the World Health Organization are scheduled for August, Novavax announced.

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

Novavax data from clinical trials indicate that a booster dose of vaccine candidate provides a 4-fold increase in neutralizing antibody levels after a two-dose regimen of an approved vaccine.

The data also indicate that a booster dose of a Novavax vaccine six months after a two-dose regimen of an approved vaccine could provide increased protection against the delta variant and other variants.

Despite the delay in U.S. authorization, the company says it is still in the process of producing 100 million doses per month by the end of the third quarter and 150 million per month by the end of the fourth quarter.


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