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BRIEF-Health Canada Says Is Aware U.S. FDA Has Issued Emergency Use Authorization For Moderna Covid-19 Vaccine

Published 2020-12-18, 10:03 p/m
MRNA
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Dec 18 (Reuters) - Moderna Inc MRNA.O :

* STATEMENT ON THE U.S. AUTHORIZATION OF THE MODERNA COVID-19 VACCINE

* HEALTH CANADA SAYS IS AWARE U.S. FOOD AND DRUG ADMINISTRATION HAS ISSUED EMERGENCY USE AUTHORIZATION FOR A COVID-19 VACCINE MANUFACTURED BY MODERNA

* HEALTH CANADA SAYS HAS BEEN REVIEWING MODERNA'S VACCINE SINCE IT WAS SUBMITTED ON OCTOBER 12, 2020, AND IS EXPEDITING REVIEW OF COVID-19 VACCINES

* HEALTH CANADA SAYS THERE IS STILL INFORMATION, DATA TO BE PROVIDED BY MODERNA FOR REVIEW

* HEALTH CANADA SAYS CANNOT PROVIDE A DEFINITE TIMELINE FOR COMPLETION OF VACCINE REVIEW AT THIS TIME

* HEALTH CANADA SAYS REVIEW IS EXPECTED TO BE COMPLETED IN COMING WEEKS

* HEALTH CANADA SAYS IS WORKING CLOSELY WITH INTERNATIONAL REGULATORS, INCLUDING U.S. FDA, TO SHARE INFORMATION, DATA ON VACCINES UNDER REVIEW

* HEALTH CANADA SAYS REVIEW IS BEING DONE THROUGH ROLLING SUBMISSIONS, WHERE DATA IS BEING REVIEWED AS IT BECOMES AVAILABLE FROM MANUFACTURER

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