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Products, Regulatory

Pfizer And Biontech Submit Request To Expand Conditional Marketing Authorization Of Comirnaty

Published: 04/30/2021 11:21 GMT
BioNTech SE - ADR (BNTX) - Pfizer and Biontech Submit Request to Expand Conditional Marketing Authorization of Comirnaty® in the Eu to Adolescents.
This Submission is Based on Data From a Pivotal Phase 3 Clinical Trial, Which Enrolled 2,260 Participants Aged 12 to 15 Years.companies Have Already Submitted a Similar Request to U.S. Food and Drug Administration (fda) for Emergency Use Authorization (eua) and Plan to Request Additional Amendments With Other Regulatory Authorities Worldwide.