Catalyst
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Pfizer Receives FDA Approval for Prevnar 13 in Adults Age 18 Through 49
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Additional Information
The FDA’s decision to approve the label expansion followed the submission and review of data from an open-label, Phase 3 trial of Prevnar 13 in adults who were not previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine (PPSV23).1 The study, which was published in Vaccine in October 2015, compared the immunogenicity, safety, and tolerability of Prevnar 13 in adults age 18 to 49 years with adults age 60 to 64, for whom Prevnar 13 was already approved.
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Catalyst Date
Occurred on:
Jul 12, 2016
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Related Keywords
Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine, Diphtheria Crm197 Protein, Streptococcus Pneumoniae
