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The FDA has granted Fast Track Designation for NVX-CoV2373, a vaccine candidate for COVID-19.
The FDA has granted Fast Track Designation for Novavax’s vaccine candidate for coronavirus disease 2019 (COVID-19).
The designation for NVX-CoV2373 was based on preclinical and clinical trial data; the former showed induction of the antibodies that block binding of spike protein to receptors targeted by the virus and the latter phase 1 portion demonstrated that the vaccine candidate was well-tolerated and produced antibody responses more robust than results from convalescent sera, according to the Novavax news release.
The company is also evaluating NVX-CoV2373 in a phase 3 trial in the United Kingdom, as well as 2 ongoing phase 2 studies, a phase 2b trial in South Africa, and a phase 1/2 continuation in the United States and Australia.
NVX-CoV2373 was engineered from the genetic sequence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) through Novavax’s recombinant nanoparticle technology to create antigen derived from the coronavirus spike (S) protein. The candidate also contains the company’s patented saponin-based Matrix-M adjuvant in order to bolster immune response and boost levels of neutralizing antibodies.
Novavax has amassed $2 billion to support its coronavirus vaccine program worldwide, including up to $399 million from the Coalition for Epidemic Preparedness Innovations (CEPI) and nearly $1.7 billion from the United States government.
“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 U.S. and globally,” Glenn added.