The fast-track designation speeds the FDA's review of drugs designed to treat life-threatening illnesses that have no medical remedy.
"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 Gregory Glenn, a physician who is president of research and development for Novavax, Gaithersburg, Md.
Novavax expects to begin its Phase 3 clinical trial of the drug in U.S. and Mexico by the end of November. The company's continuing Phase 3 clinical trial in the U.K. is expected to be fully enrolled by the end of the month.
Novavax shares at last check jumped 10% to $98.95.
The move comes on the same day that Pfizer said that its coronavirus vaccine candidate had a 90% efficacy rate in late-stage trials and that the company planned to seek emergency-use authorization from the FDA.
Its Phase 3 trial should be concluded in early December, Pfizer said, with analysis from around 164 infections. The 90% efficacy rate, Pfizer said, was identified from 94 confirmed cases who received two doses of the vaccine.
“The first set of results from our Phase 3 covid-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent covid-19,” Pfizer Chief Executive Albert Bourla said in a statement.