Novavax FDA filing for 'differentiated' protein-based COVID-19 vaccine
US biotech Novavax (Nasdaq: NVAX) has submitted a request to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine.
Shares in the Maryland company closed 13% higher on Monday, when the filing was announced.
"We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic"The request for EUA is based on the totality of pre-clinical, clinical and manufacturing-related (CMC) data provided to the agency, including results of two large pivotal clinical trials that demonstrated an overall efficacy of approximately 90% and a reassuring safety profile.
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