Phase III results for 20vPnC vaccine for pneumococcal disease.- Pfizer
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Merck Inc., has announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) date of the supplemental biologics license application (sBLA) for Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) in infants and children to July 1, 2022.
Pfizer Inc. announced that the European Medicines Agency (EMA) has approved the company’s 20-valent pneumococcal conjugate vaccine (PCV20), which will be marketed in the European Union (EU) under the brand name Apexxnar.
Pfizer Inc. announced positive top-line results from a Phase III study (B7471026) describing the safety and immunogenicity of Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine) in 570 adults in the United States 65 years of age or older when administered at the same time as the Pfizer-BioNTech COVID-19 Vaccine or when each vaccine was given with placebo.