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 permit the vaccine to be distributed globally through vaccine sharing initiatives on the world company.
Novavax knowledge from scientific trials point out {that a} booster dose of the vaccine candidate offers a 4-fold enhance in neutralizing antibody ranges after a two-dose routine of an permitted vaccine.
The info additionally signifies {that a} booster dose of a Novavax vaccine six months after a two-dose routine of an permitted vaccine may present elevated safety in opposition to the delta variant and different variants.
Regardless of the delay in U.S. authorization, the corporate says it’s nonetheless on monitor to supply 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.