FDA emergency use submission delayed to Q4


Novavax introduced that it’s going to delay the submission of its Covid-19 vaccine to the Meals and Drug Administration for emergency use authorization till its fourth quarter.

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

The corporate has filed for regulatory approval in India, Indonesia and the Philippines. Plans to submit the vaccine for emergency use itemizing on the World Well being Group are set for August, Novavax introduced.

Approval by the WHO will enable the vaccine to be distributed globally through vaccine sharing initiatives on the international company.

Novavax information from medical trials point out {that a} booster dose of the vaccine candidate supplies a 4-fold enhance in neutralizing antibody ranges after a two-dose routine of an authorized vaccine.

The info additionally signifies {that a} booster dose of a Novavax vaccine six months after a two-dose routine of an authorized vaccine might present elevated safety towards the delta variant and different variants.

Regardless of the delay in U.S. authorization, the corporate says it’s nonetheless on monitor to provide 100 million doses per thirty days by the tip of the third quarter and 150 million per thirty days by the tip of the fourth quarter.



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