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Novavax introduced that it’ll 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 by way of vaccine sharing initiatives on the world company.
Novavax information from scientific trials point out {that a} booster dose of the vaccine candidate gives a 4-fold enhance in neutralizing antibody ranges after a two-dose routine of an accredited vaccine.
The information additionally signifies {that a} booster dose of a Novavax vaccine six months after a two-dose routine of an accredited vaccine may 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 observe to supply 100 million doses per 30 days by the top of the third quarter and 150 million per 30 days by the top of the fourth quarter.
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