Investigational COVID-19 Vaccine Gets FDA Fast Tracked

Novavax announced today the US Food and Drug Administration (FDA) had granted the company fast track status for its investigational COVID-19 vaccine, NVX-CoV2373.

“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,” Gregory Glenn, MD, president of Research and Development, Novavax, said. “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.”

The company is looking to begin a phase 3 trial in the US and Mexico at the end of this month. Data from the event-driven trial could support global authorization and approval, including in the US. 

Back in September, the company announced it had initiated a phase 3 trial for the vaccine in the United Kingdom. That trial is evaluating the efficacy, safety, and immunogenicity of NVX-CoV2373, and 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 event-driven, are expected as soon as early first quarter 2021.

The trial is being conducted in partnership with the UK Government’s Vaccines Taskforce, and is expected to enroll and immunize up to 10000 individuals between 18-84 (inclusive) years of age, with and without relevant comorbidities.

“With a high level of SARS-CoV-2 transmission observed and expected to continue in the UK, we are optimistic that this pivotal phase 3 clinical trial will enroll quickly and provide a near-term view of NVX-CoV2373’s efficacy,” Gregory M. Glenn, MD, president, Research and Development at Novavax, said at the time. “The data from this trial is expected to support regulatory submissions for licensure in the UK, EU, and other countries.”