FDA submitting for emergency purposes postponed to This autumn
Novavax announced that it will postpone filing its Covid-19 vaccine with the Food and Drug Administration for approval for emergency use until the fourth quarter.
The biotech company’s shares slipped 10% after the bell.
The company has applied for approval in India, Indonesia and the Philippines. Plans to submit the vaccine to the World Health Organization for emergency use are scheduled for August, Novavax announced.
WHO approval enables the vaccine to be distributed worldwide through vaccine exchange initiatives at the global agency.
Novavax data from clinical trials indicate that a booster dose of the candidate vaccine after two-dose treatment of an approved vaccine produces a 4-fold increase in neutralizing antibody levels.
The data also suggest that a booster dose of a Novavax vaccine six months after two-dose treatment of an approved vaccine could provide increased protection against the Delta variant and other variants.
Despite the delay in US approval, the company remains on track to produce 100 million cans per month through the end of the third quarter and 150 million per month through the end of the fourth quarter.