Novavax gathers its COVID-19 vaccine data for long-delayed FDA filing

Novavax spent much of 2021 working to file its COVID-19 vaccine with U.S. regulators but falling short of its own deadlines. As the year came to a close, the company celebrated the fact that it was nearly there. Friday, Novavax said it 'completed submission of the final data package, including the complete chemistry, manufacturing and controls module, to fulfill the prerequisites for emergency use authorization (EUA) application request.' This step is not an official emergency use application. Novavax plans to complete that process by the end of this month, the company said. The news comes after a 2021 filled with missed deadlines for the Gaithersburg, Maryland-based biotech. The company originally hoped to file for an EUA by 2021's second quarter, but later pushed that deadline to the third quarter thanks to a manufacturing issue. By October, Novavax said it was eyeing an end-of-year deadline to submit its 'complete regulatory package' to the FDA