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UPDATE 1-AstraZeneca weighs seeking full U.S. approval for COVID shot - WSJ

05/07/2021 18:23
UPDATE 1-AstraZeneca weighs seeking full U.S. approval for COVID shot - WSJ

Adds background related to AstraZeneca vaccine

- AstraZeneca Plc AZN.L 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, which cited people familiar with the matter.

The company did not immediately respond to a request for comment late on Friday.

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, but that the dataset was very big. The company said it planned to apply for U.S. approval in the coming weeks. nS8N2K20A2

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. nL1N2MJ1XM

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.

UK says under-40s should be offered alternative to AstraZeneca vaccinenL8N2MU3BX

AstraZeneca says U.S. data load for U.S. COVID-19 vaccine approval very bignS8N2K20A2

U.S. to share up to 60 mln AstraZeneca vaccine doses globally -White HousenL1N2MJ1XM

(Reporting by Kanishka Singh in Bengaluru
Editing by Chris Reese and Sonya Hepinstall)

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