BioNTech SE (Nasdaq: BNTX) today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY
® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. The extended indication for the CMA for COMIRNATY
® is valid in all 27 EU member states.
COMIRNATY
® was the first COVID-19 vaccine to receive authorization in the EU and is the first to have its CMA extended to adolescents. Distribution and administration of COMIRNATY
® by the EU member states will continue to be determined according to the populations identified in the EU and per national guidance.
NEW YORK and MAINZ, GERMANY, May 28, 2021 - Pfizer Inc.(Nasdaq: BNTX) today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY in the European Union (EU) has been expanded to include
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY® in the European.
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Pfizer Initiates Study Exploring Coadministration of Its 20-valent Pneumococcal Conjugate Vaccine Candidate Along With a Third Dose of Pfizer-BioNTech COVID-19 Vaccine
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that the first enrolled subjects have received their immunizations as part of a new study in adults ages 65 or older exploring the coadministration of the company’s 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine, currently authorized by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA). The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines.