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AstraZeneca aims to bring non-U.S. vaccine data before the FDA

AstraZeneca aims to bring non-U.S. vaccine data before the FDA

ASTRAZENECA will start discussing emergency approval of its experimental COVID-19 vaccine with U.S. regulators once it has good trial data from Britain, South Africa and Brazil, as it has no indication the watchdog would favour U.S. data. If and when AstraZeneca reaches the first statistically reliable efficacy and safety results from those trials, based on more than 25,000 volunteers in total, it would present them to the U.S. Food and Drug Administration (FDA) even though any read-out from an ongoing U.S. trial will be months later. "If you hit those thresholds we are going to have a conversation with them,"…
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