Novavax says its COVID-19 shot is on track for full FDA approval after
delay
[April 24, 2025]
By MATTHEW PERRONE and LAURAN NEERGAARD
WASHINGTON (AP) — 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.
The news sent company shares soaring more than 21% in morning trading
and appeared to resolve concerns that Trump administration officials
might be holding up a decision on the shot.
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.
The FDA recently asked Novavax to develop a plan for collecting
additional clinical data from those who have gotten the shot, the
company said in a statement. It said 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 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, first reported by The Wall Street Journal,
sparked concerns of political interference under Robert F. Kennedy Jr.,
who spent decades leading antivaccine groups before joining the federal
government as health secretary.
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 Last month, FDA’s longtime vaccine
chief, Dr. Peter Marks, was forced out over disagreements with
Kennedy about vaccine safety.
With full FDA approval, Novavax would have permission to keep its
shot on the market indefinitely. Products that receive emergency
authorization can be removed by FDA after there is no longer a
health emergency.
All the COVID-19 vaccines used in the U.S. train the body to fight
the coronavirus by recognizing its outer coating, the spike protein.
The Pfizer and Moderna options deliver genetic instructions for the
body to temporarily make copies of the protein. In contrast, the
Novavax vaccine uses lab-grown copies of the spike protein packaged
into nanoparticles and combined with an immune-revving ingredient.
Protein-based vaccines have been used for years to prevent other
diseases including hepatitis B and shingles.
Each year, the three manufacturers update their vaccine recipes to
better match the latest COVID-19 variants that are circulating, just
like flu shots are updated yearly.
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