FDA emergency use submission delayed to This fall
Novavax announced that it will delay the submission of its Covid-19 vaccine to the Food and Drug Administration for emergency use authorization until its fourth quarter.
Shares of the biotechnology company slipped 10% after the bell.
The company has filed for regulatory approval in India, Indonesia and the Philippines. Plans to submit the vaccine for emergency use listing at the World Health Organization are set for August, Novavax announced.
Approval by the WHO will allow the vaccine to be distributed globally via vaccine sharing initiatives at the global agency.
Novavax data from clinical trials indicate that a booster dose of the vaccine candidate provides a 4-fold increase in neutralizing antibody levels after a two-dose regimen of an approved vaccine.
The data also indicates 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 on track to produce 100 million doses per month by the end of the third quarter and 150 million per month by the end of the fourth quarter.