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AstraZeneca to bring non-US vaccine data before FDA for emergency approval

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 US Food and

Coronavirus, vaccine, covid, drugs, clinical trials

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Some experts have argued that, once a successful vaccine is widely available or soon expected, the runners-up in the vaccine race may find it difficult to recruit volunteers

Reuters

2 min read Last Updated : Nov 05 2020 | 9:00 PM IST

AstraZeneca will start discussing emergency approval of its experimental Covid-19 vaccine with US regulators once it has good trial data from Britain, South Africa and Brazil, as it has no indication the watchdog would favour US 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 US Food and Drug Administration (FDA) even though any read-out from an ongoing US trial will be months later.

"If you hit those thresholds we are going to have a conversation with them," executive team

Topics : Coronavirus AstraZeneca

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