The Food and Drug Administration (FDA) has granted Fast Track designation to the vaccine candidate NVX-CoV2373 (Novavax) against coronavirus disease 2019 (COVID-19).

NVX-CoV2373 is engineered from the genetic sequence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using the Company’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. The vaccine candidate contains the Company’s saponin-based Matrix-M™ adjuvant technology to enhance and prolong immune responses.

The designation was based on data from a phase 1/2 trial as well as preclinical studies. The phase 1 portion of the randomized, observer-blinded, placebo-controlled phase 1/2 trial assessed the immunogenicity and safety of NVX-CoV2373 (5mcg and 25mcg doses), both with and without Matrix-M adjuvant, in 131 healthy adults aged 18 to 59 years. The phase 2 portion is assessing immunity, safety and COVID-19 disease reduction in a broader age range.

In preclinical trials, NVX-CoV2373 demonstrated an induction of antibodies that block binding of spike protein to receptors targeted by the virus. Findings from the phase 1 portion showed that NVX-CoV2373 was well tolerated and elicited antibody responses numerically superior to that seen in human convalescent sera. The vaccine was also found to induce polyfunctional CD4+ T cell responses.

The Company expects to begin a phase 3 trial of the vaccine candidate in the US and Mexico by the end of November. NVX-CoV2373 is also being assessed in an ongoing phase 3 trial in the UK with full enrollment expected by the end of November.

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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, MD, 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 US and globally.”

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Novavax COVID-19 vaccine granted Fast Track designation by U.S. FDA. [press release]. Gaithersburg, MD: Novavax, Inc; November 9, 2020.