BRIEF-EMA Approves New Manufacturing Sites, New Formulation For Biontech/Pfizer COVID-19 Vaccine

European Medicines Agency: * EMA: NEW MANUFACTURING SITES AND NEW FORMULATION APPROVED FOR COVID-19 VACCINE FROM BIONTECH/PFIZER: 18/10/2021

* EMA SAYS ONE SITE, LOCATED IN MONZA, ITALY, IS OPERATED BY PATHEON ITALIA S.P.A. OTHER IN ANAGNI, ALSO IN ITALY, IS OPERATED BY CATALENT ANAGNI S.R.L * EMA SAYS RECOMMENDATIONS DO NOT REQUIRE A EUROPEAN COMMISSION DECISION AND SITES CAN BECOME OPERATIONAL IMMEDIATELY

* EMA: NEW SITES WILL PRODUCE UP TO 85 MLN ADDITIONAL COMIRNATY DOSES TO SUPPLY EU IN 2021 * EMA SAYS BOTH SITES WILL MANUFACTURE FINISHED PRODUCT

* EMA SAYS CHMP APPROVED A READY-TO-USE FORMULATION OF COMIRNATY THAT DOES NOT REQUIRE DILUTION PRIOR TO ADMINISTRATION * EMA: COMIRNATY READY-TO-USE FORMULATION WILL BE AVAILABLE IN A 10-VIAL (60 DOSE) PACK SIZE AND CAN BE STORED AT 2-8°C FOR UP TO 10 WEEKS

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