logo
Plus   Neg
Share
Email

FDA Grants Fast Track Designation For Novavax COVID-19 Vaccine

Novavax Inc. (NVAX) said Monday that the U.S. Food and Drug Administration has granted Fast Track Designation for its COVID-19 vaccine candidate, NVX-CoV2373.

Fast Track Designation by the FDA is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, with the intent of getting important new drugs to the patient earlier.

The Fast Track Designation facilitates meetings with the FDA to discuss all aspects of development to support licensure and provides the opportunity to submit sections of a BLA on a rolling basis as data become available.

Novavax expects to begin a late-stage trial of its COVID-19 vaccine in the United States and Mexico by the end of November. Previously, it was reportedly expected to start in October 2020.

The company also expects interim data from an ongoing phase 3 U.K. trial of its COVID-19 vaccine as soon as early first quarter 2021.

NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations and almost $1.7 billion from the U.S. government.

NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. It contains Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Best Buy said it is partnering Popsockets to bring products designed by teens from the company's community programs to its store shelves. The electronics retailer will sell the teen-designed PopGrips in its stores as part of its "Black History Month" campaign. The campaign is intended to celebrate and encourage young artists. Goldman Sachs Group Inc. (GS) on Tuesday reported a fourth-quarter profit that more than doubled from last year, reflecting a surge in investment banking revenues and lower provisions for bad loans. Net revenues for the quarter rose 18 percent. Both quarterly earnings per share and revenues topped analysts' expectations. U.S. holiday retail sales in 2020 were unexpectedly high compared to last year and came in significantly higher than the previous forecast, according to the National Retail Federation or NRF. Retail sales for the November-December 2020 holiday season grew 8.3 percent from the prior-year period to $789.4 billion. The figures exclude automobile dealers, gasoline stations and restaurants.
Follow RTT