FDA grants Fast Track Designation to Novavax COVID-19 vaccine candidate

Novavax has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the company’s COVID-19 vaccine candidate, which is currently in late-phase clinical development. NVXCoV2373 is a stable, prefusion protein made using nanoparticle technology.

NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using recombinant nanoparticle technology to generate antigen derived from the coronavirus Spike (S) protein. In pre-clinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of S protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase I portion of its Phase I/II clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. 

“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 Dr Gregory Glenn, President of Research and Development at Novavax. “While the regulatory review of this clinical programme 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.”

Novavax expects to begin its pivotal Phase III clinical trial in the US and Mexico by the end of November. Data from the event-driven trial could support global authorisation and approval. The company’s ongoing Phase III clinical trial in the UK to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 is expected to be fully enrolled by the end of November. Depending on the overall COVID-19 attack rate, interim data in the UK trial, which is also event-driven, are expected as soon as early first quarter 2021.