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**Hugh** · 25-02-2021, 13:27

Quote:

Originally Posted by 1andrew1

Whilst many European countries have age-limited the Oxford-AstraZenecca vaccine, at least they've approved it. The US, Korea, Japan, Switzerland, New Zealand and many other countries have yet to approve it.

Explanation in this article why it’s not been approved in the USA.

https://www.forbes.com/sites/leahros...-hasnt-the-us/

Quote:

So, why hasn’t the FDA authorized it yet? The main reason is simple: the company hasn’t applied for emergency-use authorization yet. The process must be initiated by the company—regulators can’t get the ball rolling themselves.

In the U.S. there are several things holding the AstraZeneca/Oxford vaccine back, says Andrew Berens, an analyst at SVB Leerink. “I think a large part of the reason it hasn’t gotten an EUA in the U.S. yet is because the FDA wants to see the U.S. trial that’s ongoing,” he says. Berens estimates that the trial data will be available sometime in the first half of this year. A spokesperson for the company said this data would be available in “the coming weeks,” but wouldn’t provide a more concrete time line...

... clinical trials for the AstraZeneca vaccine have been plagued by starts and stops. Last fall, all global phase 3 clinical trials of the vaccine were suddenly halted after a patient in the U.K. showed symptoms of a serious neurological disorder called transverse myelitis. After a 45-day pause, the trial resumed in the U.S., but the delay put AstraZeneca more than a month behind its competitors...

... until it has positive phase 3 data from its U.S. clinical trials, AstraZeneca won’t submit an EUA application to the FDA. Once AstraZeneca applies, experts at the agency will review all the vaccine data in a process that can take several weeks and includes public committee hearings. Only after all that has been finished could another Covid-19 vaccine be available in the U.S.