BRIEF-Joint Statement From Moderna, Takeda On Deaths Of Two Individuals Who Recently Received Moderna COVID-19 Vaccine

Reuters2021-08-28

Aug 28 (Reuters) - Moderna Inc :

* JOINT STATEMENT FROM MODERNA AND TAKEDA

* MODERNA-TAKEDA, MODERNA NOTIFIED ON AUG 28 JST, OF DEATHS OF 2 INDIVIDUALS WHO RECEIVED MODERNA COVID-19 VACCINE FOR INTRAMUSCULAR INJECTION IN JAPAN

* MODERNA - AT THIS TIME, DO NOT HAVE ANY EVIDENCE THAT THESE DEATHS ARE CAUSED BY THE MODERNA COVID-19 VACCINE

* MODERNA - TAKEDA AND MODERNA ARE WORKING WITH MINISTRY OF HEALTH, LABOUR AND WELFARE (MHLW) TO INVESTIGATE TWO DEATHS

* MODERNA- ON AUGUST 26 JST, TAKEDA ANNOUNCED DECISION TO SUSPEND USE OF THREE LOTS OF MODERNA’S COVID-19 VACCINE IN JAPAN

* MODERNA- THE SUSPENSION WAS IN ALIGNMENT WITH MHLW FOLLOWING REPORTS FROM VACCINATION SITES OF A FOREIGN SUBSTANCE FOUND IN VIALS

* MODERNA- TO DATE, HAVE NO PRODUCT QUALITY COMPLAINTS RELATED TO PARTICULATE MATTER IN THE LOT RELATED TO UNFORTUNATE PASSING OF THE TWO INDIVIDUALS

* MODERNA-TAKEDA REQUESTED MODERNA,MODERNA’S EUROPEAN CONTRACT MANUFACTURING ORGANIZATION,CONDUCT INVESTIGATION TO DETERMINE NATURE OF FOREIGN SUBSTANCE

* MODERNA- AWARE OF UNOFFICIAL REPORTS THAT HAVE PROVIDED INITIAL INDICATION OF THE TYPE OF PARTICLE MATTER IN THE VIALS

* MODERNA-IN PROCESS OF CONDUCTING INVESTIGATION, VIALS HAVE BEEN SENT TO QUALIFIED LAB FOR ANALYSIS;INITIAL FINDINGS WILL BE AVAILABLE EARLY NEXT WEEK

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