FDA emergency use submission delayed to Q4

Novavax announced that it will delay the submission of its Covid-19 vaccine to the Foods and Drug Administration for emergency use authorization right up until its fourth quarter.

Shares of the biotechnology firm slipped 10% after the bell.

The corporation has submitted for regulatory approval in India, Indonesia and the Philippines. Ideas to post the vaccine for crisis use listing at the Planet Wellbeing Group are established for August, Novavax announced.

Acceptance by the WHO will let the vaccine to be dispersed globally through vaccine sharing initiatives at the global company.

Novavax data from scientific trials indicate that a booster dose of the vaccine applicant provides a 4-fold increase in neutralizing antibody amounts right after a two-dose regimen of an authorized vaccine.

The knowledge also suggests that a booster dose of a Novavax vaccine 6 months after a two-dose routine of an permitted vaccine could give improved safety versus the delta variant and other variants.

In spite of the hold off in U.S. authorization, the organization suggests it is nevertheless on monitor to generate 100 million doses for every month by the stop of the 3rd quarter and 150 million for each month by the close of the fourth quarter.