FDA grants 'fast track' authorisation for Novavax Covid-19 vaccine

The US Food and Drug Administration has granted 'fast track' designation to Novavax's Covid-19 vaccine candidate, potentially accelerating the approval process.

The vaccine, known as NVX-CoV2373, was a stable, prefusion protein made with nanoparticle technology and included the biotechnology company's proprietary MatrixM adjuvant.

It was already in late-phase clinical trials.

"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," said Novavax head of research, Gregory M.Glenn.

A phase three clinical trial in Mexico and the US was due to start by the end of November, while the ongoing third phase clinical trial in the UK was was expected to be fully enrolled by the same date.

"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."

Shares of Novavax were trading 4.05% higher to $93.69 ahead of the opening bell in New York.