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(Adds response from AstraZeneca in paragraphs 3 and 4)
May 7 (Reuters) - AstraZeneca Plc may skip asking
the U.S. Food and Drug Administration for emergency-use
authorization for its COVID-19 vaccine and instead pursue the
more time-intensive application for a full-fledged license to
sell the shot, the Wall Street Journal reported on Friday.
Such a step would further delay any rollout of the British
drugmaker's shots in the United States, according to the report
https://on.wsj.com/3eWvrry, which cited people familiar with the
matter.
Asked about the Wall Street Journal report, AstraZeneca did
not comment directly, saying in an emailed statement that it
"continues to progress our FDA submission for AZD1222."
"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 company added.
Last week, AstraZeneca said it was working as fast as
possible to compile data on its COVID-19 vaccine to apply for
U.S. approval. The company said it planned to apply for U.S.
approval in the coming weeks.
The White House said late in April that the United States
would start to share up to 60 million doses of AstraZeneca's
coronavirus vaccine with other countries over the next few
weeks.
AstraZeneca's COVID-19 shot, developed by Oxford University,
has resulted in reports of rare blood clots with low platelet
levels that occur more commonly in younger adults. Some
countries have advised the shot be given only to older people.
(Reporting by Kanishka Singh in Bengaluru
Editing by Chris Reese and Sonya Hepinstall)
