FDA approves Novavax COVID-19 shot but with unusual restrictions
[May 19, 2025]
By LAURAN NEERGAARD
WASHINGTON (AP) — The Food and Drug Administration has issued a
long-awaited approval of Novavax’s COVID-19 vaccine but with unusual
restrictions.
Novavax makes the nation’s only traditional protein-based coronavirus
vaccine – and until now it had emergency authorization from FDA for use
in anyone 12 and older.
But late Friday, the FDA granted the company full approval for its
vaccine for use only in adults 65 and older – or those 12 to 64 who have
at least one health problem that puts them at increased risk from
COVID-19.
Vaccines made by Novavax’s competitors Pfizer and Moderna already are
fully licensed for use in anyone 12 and older, and also are authorized
for use in children as young as 6 months.
Next month, influential advisers to the Centers for Disease Control and
Prevention were set to debate if yearly COVID vaccines still should be
recommended for everyone or only certain people at higher risk. The
Novavax decision suggests the Trump administration may already have
decided how to proceed in advance of that meeting.
Novavax chief executive John C. Jacobs welcomed the licensure.
“Market research and U.S. CDC statistics indicate that older individuals
and those with underlying conditions are the populations most likely to
seek out COVID-19 vaccination seasonally. This significant milestone
demonstrates our commitment to these populations and is a significant
step towards availability of our protein-based vaccine option,” he said.
[to top of second column]
|
Food and Drug Administration commissioner Martin Markary speaks
during an event in the Roosevelt Room at the White House, Monday,
May 12, 2025, in Washington. (AP Photo/Mark Schiefelbein)
 In its Friday approval letter, the
FDA didn’t explain the restrictions although they reflect skepticism
about vaccines from Health Secretary Robert F. Kennedy Jr. and other
Trump officials.
Novavax originally showed its vaccine was safe and effective in a
30,000-person clinical trial. The FDA had been on track to grant
Novavax full approval – without restrictions -- 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.
Novavax later announced the FDA instead was asking it to run an
additional trial after approval, which is highly unusual. FDA did
order several additional trials to be completed in the next few
years, some examining whether the vaccine might be associated with
some heart conditions. Another required study must assess the
benefits of continuing vaccination in 50- to 64-year-olds who don’t
have health problems that increase their risk from COVID-19.
All contents © copyright 2025 Associated Press. All rights reserved |
