Novavax U.S. Phase III results unblinded next week, EUA submission in 3Q

Novavax expects to disclose results from the U.S. Phase III trial of its COVID-19 vaccine next week, Stanley Erck, its president and CEO, said Thursday at an event marking the start of construction of the company’s new campus in Gaithersburg, Maryland.

The company plans to submit an emergency use authorization (EUA) application to FDA in the third quarter, President of R&D Gregory Glenn told BioCentury. Novavax Inc. (NASDAQ:NVAX) had hoped to submit an EUA earlier this year based on data from a U.K. Phase III study and a Phase II study conducted in South Africa, but FDA pushed for the U.S data...