WHO recommendation BioNtech Tozinameran/US FDA - COVID-19 mRNA vaccine (nucleoside modified)

Product Overview

Type:                           COVID-19 mRNA Vaccine

INN:                            Tozinameran

Trade name:               COMIRNATY

EUL holder:               BioNTech Manufacturing GmbH

Country:                     Germany

Responsible NRA:     Food and Drug Administration

Country:                     United States of America


WHO EUL recommendation

Effective date:             16 July 2021


Product description

Drug Substance - Manufacturing sites​

BioNTech Manufacturing GmbH
An der Goldgrube 12, 55131 Mainz, Germany

Rentschler Biopharma SE
Werwin-Rentschler-Str. 21, 88471 Laupheim, Germany

Pfizer Andover ACMF
Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC. 1 Burtt Road Andover, MA 01810, United States

Drug Product - Manufacturing sites

Pharmacia & Upjohn Company LLC
7000 Portage Road Kalamazoo, MI 49001, United States

Hospira Inc., a Pfizer company
1776 Centennial Drive, McPherson, Kansas 67460, United States

Exelead, Inc.
6925 Guion Road, Indianapolis, IN 46268, United States

Exela Pharma Sciences, LLC, NC
320 Cooperative Way Lenoir, NC 28645 United States,  and
1245 Blowing Rock Blvd Lenoir, NC 28645 United States