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FDA stays pause of AstraZeneca Covid vax study to probe possible safety signal

September 14, 2020

Reuters reports that the FDA has not given the green light to resume the U.S. portion of AstraZeneca’s (NYSE:AZN) pivotal study of COVID-19 vaccine candidate AZD1222.

The trial was suspended after a UK participant fell ill after inoculation. Enrollment has restarted there but will remain on hold in the U.S. while the FDA and a safety panel investigate the event. Enrollment of new participants and other procedures have been rescheduled until at least Wednesday although it is unclear how long the FDA inquiry will take.

The trial in Brazil has restarted as well. The status of studies in South Africa and India is unknown.

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