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Novavax delays Covid vaccine emergency authorization submission to FDA until fourth quarter - CNBC

1 month ago 18

Novavax announced that it volition hold the submission of its Covid-19 vaccine to the Food and Drug Administration for exigency usage authorization until its 4th quarter.

Shares of the biotechnology institution slipped 10% aft the bell.

The institution has filed for regulatory support successful India, Indonesia and the Philippines. Plans to taxable the vaccine for exigency usage listing astatine the World Health Organization are acceptable for August, Novavax announced.

Approval by the WHO volition let the vaccine to beryllium distributed globally via vaccine sharing initiatives astatine the planetary agency.

Novavax information from objective trials bespeak that a booster dose of the vaccine campaigner provides a 4-fold summation successful neutralizing antibody levels aft a two-dose regimen of an approved vaccine.

The information besides indicates that a booster dose of a Novavax vaccine six months aft a two-dose regimen of an approved vaccine could supply accrued extortion against the delta variant and different variants.

Despite the hold successful U.S. authorization, the institution says it is inactive connected way to nutrient 100 cardinal doses per period by the extremity of the 3rd 4th and 150 cardinal per period by the extremity of the 4th quarter.

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