Pfizer’s 20vPnC vaccine candidate in Pahse 3 study showed responses elicited by 20vPnC for all 20 serotypes equivalent across all three lots, meeting the primary immunogenicity objective of the study.
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced top-line results from a second Phase 3 study (NCT03828617), which described the safety and evaluated the consistency of immune responses elicited across three different lots of its 20-valent pneumococcal polysaccharide conjugate vaccine (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 [Diphtheria CRM197 Protein]) control group.
Pfizer said that this 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.
“We are excited by the progress of our adult development program for 20vPnC as this is the second phase 3 trial for this investigational vaccine for which we have positive topline data,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “These new data highlight Pfizer’s strong heritage, expertise and success in manufacturing highly-complex biological products such as pneumococcal conjugate vaccines. Demonstration of lot consistency is critical to help ensure that vaccine recipients receive the same level of protection irrespective of the manufactured lot used.”
Pfizer’s 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. Globally, pneumococcal pneumonia is estimated to cause about 500,000 deaths and 30 million episodes in adults 70 years and older annually. Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in the U.S. and globally.
Pfizer will seek to present and publish outcomes from this clinical trial at a future date once safety and immunogenicity data have been fully analyzed.