FDA emergency use submission postponed to fourth quarter

Novavax has announced that it will delay submitting its Covid-19 vaccine to the Food and Drug Administration for emergency use authorization until its fourth quarter.

Shares of the biotech 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 to the World Health Organization are set for August, Novavax said.

The WHO approval will allow the vaccine to be distributed globally through vaccine sharing initiatives within the global agency.

Novavax data from clinical trials indicate that a booster dose of the candidate vaccine increases neutralizing antibody levels by 4 times 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 US 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 third quarter. fourth trimester.