Novavax says its COVID-19 shot is on track for full FDA approval after delay

Novavax's COVID-19 vaccine is nearing full FDA approval after discussions with the agency, leading to a significant rise in its stock. The company is the only producer of a traditional protein-based COVID vaccine in the U.S. In response to FDA requests for more clinical data, Novavax aims to secure approval swiftly. The FDA's delay was partly attributed to political concerns within the agency, but it is projected that Novavax could receive a decision by April 1, enhancing its market stability compared to vaccines under emergency authorization.

With full FDA approval, Novavax would have permission to keep its shot on the market indefinitely, as emergency authorization can be revoked after a health emergency.

The FDA's ask for additional clinical data means Novavax is engaging with them to expedite the process and hopes for approval as soon as possible.

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