April 2 (Reuters) -
The U.S. Food and Drug Administration has missed the
deadline for making a decision on Novavax's ( NVAX ) COVID-19
vaccine, a source familiar with the matter told Reuters on
Wednesday.
The Wall Street Journal first reported about the regulator
missing its deadline of April 1 earlier in the day.
Senior leaders at the FDA said the company's application
needed more data and was unlikely to be approved soon, according
to the WSJ report.
Novavax ( NVAX ), the FDA and the Department of Health and Human
Services did not immediately respond to Reuters' request for
comment.
The company said in February the agency will make a decision
on its protein-based vaccine in April.
The vaccine was first approved for emergency use in the
United States in 2022.