NVX-CoV2373 is being studied under Phase 3 clinical trial in the UK, with additional trials planned in the US and Mexico
US FDA grants Fast Track Designation for Novavax’ Covid-19 vaccine. (Credit: pearson0612 from Pixabay.)
Novavax has secured the US Food and Drug Administration (FDA) Fast Track Designation for its potential Covid-19 vaccine candidate NVX-CoV2373.
The biotechnology company is conducting a Phase 3 study in the UK to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 and is expected to be fully enrolled by this month-end.
The interim data from the event-driven Phase 3 UK trial, based on the overall Covid-19 attack rate, is expected by the early first quarter in 2021.
Also, the company intends to commence a Phase 3 clinical trial in the US and Mexico by the end of this month, whose results are expected to support the worldwide authorisation and approval, including the US.
Novavax research and development president Gregory Glenn said: “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.
“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.”
Novavax is engaged in discovery, development, and commercialization of advanced vaccine candidates for serious infectious diseases. Its NVX-CoV2373 is a stable, prefusion protein currently in late-phase clinical development.
The vaccine has been developed from the genetic sequence of SARS-CoV-2 virus that causes Covid-19 disease, using the company’s advanced nanoparticle technology and includes its MatrixM adjuvant.
In the preclinical studies, NVX-CoV2373 has stimulated the production of antibodies that block spike protein receptors targeted by the virus, facilitating effective vaccine protection.
The Phase 1 part of the Phase 1/2 clinical trial showed that the potential Covid-19 vaccine was generally well-tolerated and induced superior antibody responses compared to human convalescent sera.
Furthermore, the company has secured $2bn financial support for its global coronavirus vaccine programme, which includes up to $399m funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and around $1.7bn from the US government.