AstraZeneca Weighs Seeking Full U.S. Approval for Covid Shot, Skipping Emergency-Use Application--Update
By Jenny Strasburg and Thomas M. Burton
AstraZeneca PLC could skip asking the Food and Drug
Administration for emergency-use authorization for its Covid-19
vaccine, according to people familiar with the matter -- and
instead pursue the more time-intensive application for a
full-fledged license to sell the shot.
Such a move would further delay any rollout of AstraZeneca shots
in the U.S., where the vaccine has already been made and
stockpiled. But U.S. government and public-health officials have
said they probably don't need AstraZeneca shots because of ample
supplies of three other shots already authorized for use.
The British drugmaker said last week it intended to apply for
the emergency go-ahead within weeks. But it has also been
considering a different path to getting the drug approved in the
U.S., according to these people. That would involve taking what
could be several more months to compile and review data necessary
for what is known as a biologics license, essentially a more
comprehensive, nonemergency seal of approval from the FDA.
The full license is the path most new medicines take on their
way to the U.S. market. But Covid-19 vaccine makers including
Pfizer Inc., Moderna Inc. and Johnson & Johnson have all sought
and received emergency-use authorization as a stopgap, encouraged
by the government, with plans eventually to apply for full-blown
approval for their respective shots. The emergency-use application
allowed all three to win quicker FDA approval in the pandemic.
AstraZeneca has long said it would go down that same route, but
delays stretched out as it has struggled to pull together the large
amount of data from tens of millions of doses of the vaccine
already administered in the U.K.
"AstraZeneca continues to progress its FDA submission," a
company spokesman said Friday. "It is important to note the
substantial size of the file -- in addition to the U.S. trial data,
the filing will also include analyses and pharmacovigilance from
all studies to date, in addition to real-world evidence data."
The shot has been accepted for emergency use in the U.K., across
Europe and in more than a hundred other countries around the world.
The FDA is requiring AstraZeneca to provide that data from
real-world use, in addition to data from human clinical trials.
Other shots weren't yet being used widely when they went before the
The AstraZeneca shot has also been linked in Europe and
elsewhere to very rare, but sometimes-fatal, serious blood
clotting, an issue that European regulators, AstraZeneca and
outside researchers are still studying.
U.S. officials got into a rare, public spat in March over the
precise efficacy of the shot in large-scale human trials in the
U.S., an episode health experts expected to complicate any
In ongoing talks between AstraZeneca and the U.S. government,
the prospect of skipping the quicker, narrower emergency
authorization and instead going for the fuller license has gained
favor inside AstraZeneca, some of the people said. The U.S.
government, which helped fund AstraZeneca's vaccine U.S. testing
and development, must sign off on any decision to skip an
emergency-use application, according to a person close to the
process and language in AstraZeneca's U.S. government contract. A
senior company executive said last week AstraZeneca could skip the
emergency-use filing if government officials told the company to
apply for full approval instead.
Write to Jenny Strasburg at firstname.lastname@example.org and Thomas
M. Burton at email@example.com
(END) Dow Jones Newswires
May 07, 2021 18:04 ET (22:04 GMT)
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