


WASHINGTON — Novavax’s closely watched COVID-19 vaccine is on track for full approval after additional discussions with the Food and Drug Administration, the company said Wednesday.
Novavax makes the nation’s only traditional protein-based COVID-19 vaccine. It is still being sold under emergency use authorization — unlike mRNA vaccines made by Pfizer and Moderna that have earned full FDA approval for certain age groups.
Novavax said in a statement that it is “engaging with the FDA expeditiously” in hopes of receiving approval “as soon as possible.”
At FDA, full vaccine approval is the gold standard. The agency was on track to sign off on Novavax’s license by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss confidential agency matters.
But the FDA’s acting commissioner, Dr. Sara Brenner, directed the agency’s lead official overseeing the vaccine to pause the decision, according to one of the people. The delay sparked concerns of political interference under Robert F. Kennedy Jr., who spent decades leading antivaccine groups before joining the federal government as health secretary.
Last month, the FDA’s longtime vaccine chief, Dr. Peter Marks, was forced out over disagreements with Kennedy about vaccine safety.
With full FDA approval, Novavax would be allowed to keep its shot on the market indefinitely. Products that receive emergency authorization can be removed by the FDA after a health emergency ends.