The US Food and Drug Administration will not release AstraZeneca's coronavirus vaccine for export to other countries until it is sure the doses have been manufactured to US quality standards and will be safe and effective, a government official told CNN on Thursday.
According to CNN, The White House said on Monday it would ship doses of AstraZeneca vaccine to other countries, including India, after a safety review by the FDA.
AstraZeneca has yet to apply for emergency use authorisation (EUA) in the US, but the company has been making tens of millions of doses in the US in the expectation that it will apply for and receive EUA eventually.
Many other countries have been clamouring for vaccine and international groups have criticized the US for buying up vaccine doses while billions of people around the world go without.
The safety review will be thorough, a government official with knowledge of the process who was not authorized to speak on the subject and requested anonymity told CNN.
While a EUA is not needed to export vaccines, the official said, the US would not export any vaccine that did not meet US safety, efficacy and manufacturing quality standards.
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