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Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.1-Adapted Bivalent COVID-19 Vaccine

CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccineThe Omicron BA.1-adapted bivalent COVID-19 vaccine combines 15-µg of mRNA encoding the SARS-CoV-2 wild-type spike protein which is in the Original Pfizer-BioNTech COVID-19 Vac...
United States United Kingdom Sylke Maas Albert Bourla Ugur Sahin Fosun Pharma

DGAP-News: Moderna, Inc.: EMA Committee for Medicinal Products for Human Use (CHMP) Adopts Positive Opinion Recommending Authorization for the Use of Moderna's Omicron-Targeting Bivalent Booster in the European Union

DGAP-News: Moderna, Inc. / Key word(s): Miscellaneous EMA Committee for Medicinal Products for Human Use (CHMP) Adopts Positive Opinion Recommending Authorization for the Use of Moderna's
United States United Kingdom Lavina Talukdar Luke Mircea Willats European Commission Distribution Services

Moderna, Inc.: EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization for the Use of Moderna's Omicron-Targeting Bivalent Booster in the European Union

Study results show mRNA-1273.214 has demonstrated significantly higher antibody titers against Omicron BA.1 and BA.4/5 subvariants when compared with mRNA-1273Positive recommendation follows recent amendment
United States United Kingdom Lavina Talukdar Luke Mircea Willats European Commission Exchange Commission

DGAP-News: EMA Committee for Medicinal Products for Human Use (CHMP) Adopts Positive Opinion Recommending Authorization for the Use of Moderna's Omicron-Targeting Bivalent Booster in the European Union

DGAP-News: Moderna, Inc. / Key word(s): Miscellaneous EMA Committee for Medicinal Products for Human Use (CHMP) Adopts Positive Opinion Recommending Authorization for the Use of Modernas Omicron-Targeting Bivalent Booster in the European Union 01.09.2022 / 15:35 CET/CEST The issuer is solely re...
United States United Kingdom Lavina Talukdar Luke Mircea Willats European Commission Distribution Services

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