AstraZeneca considers seeking full U.S. approval for its COVID-19 vaccine

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.

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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.

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.”

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“It is important to note the substantial size of the file – in addition to the U.S. trial data, the filing will also include analyzes 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.

Read more: U.K. will offer alternative to AstraZeneca shot to people under 40

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 

© 2021 Reuters

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