GAITHERSBURG, Md. (WJZ) — A coronavirus vaccine developed in Maryland was given fast track designation by the Food and Drug Administration, Novavax announced Monday. The Gaithersburg-base biotechnology company has been developing a COVID-19 vaccine for months, even moving into a trial phase.
It’s coronavirus vaccine candidate, NVX-CoV2373, is in the late-phase of clinical development using a Novavax’ nanoparticle technology and includes its proprietary MatrixM™ adjuvant.
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“The FDA’s decision to grant Fast Track Designation for NVX-CoV2373 reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access to this vaccine,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. and globally.”
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Novavax is expecting to begin Phase 3 of its clinical trial in the U.S. and Mexico by the end of November.
Data from that trial could allow for the COVID-19 vaccine to get global approval, including in the U.S.
Currently, its in phase 3 of the trial in the UK to evaluate its efficacy, safety and immunogenicity.