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Pfizer Announces Positive Results On 20-Valent Pneumococcal Conjugate Vaccine

Pfizer Inc. (PFE) announced positive results from a second Phase 3 study, which described the safety and evaluated the consistency of immune responses elicited across three different lots of its 20-valent pneumococcal polysaccharide conjugate vaccine or 20vPnC candidate in adults 18 through 49 years of age not previously vaccinated against pneumococcal disease.

Responses elicited by 20vPnC for all 20 serotypes were equivalent across all three lots, meeting the primary immunogenicity objective of the study.

In this study the 20vPnC safety profile was similar to the Prevnar 13 (pneumococcal 13-valent Conjugate Vaccine control group. The clinical lot consistency study is expected to satisfy licensure requirements for manufacturing consistency by the U.S. Food and Drug Administration, and other countries' regulatory agencies.

Pfizer noted that its 20vPnC vaccine candidate includes 13 serotypes already included in Prevnar 13. The seven new serotypes included in 20vPnC are global causes of invasive pneumococcal disease (IPD) and are associated with high case-fatality rates, antibiotic resistance, and/or meningitis.

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