Pfizer announced top-line 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 (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. This clinical lot consistency study is expected to satisfy licensure requirements for manufacturing consistency by the US 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 US and globally.
Pfizer’s phase 3 adult clinical program for 20vPnC includes three clinical trials evaluating the vaccine candidate for the prevention of invasive disease and pneumococcal pneumonia in adults 18 years or older. Combined, these three trials have enrolled more than 6,000 adult subjects, including populations of vaccine-naïve adults and adults with prior pneumococcal vaccination. All three trials have been completed and the data for one remaining study will be reading out over the next few months.
On September 20, 2018, Pfizer announced the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for 20vPnC for the prevention of invasive disease and pneumonia in adults age 18 years or older. Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). Drugs and vaccines that receive Breakthrough Therapy Designation are eligible for all features of the FDA’s Fast Track designation, which may include more frequent communication with the FDA about the drug’s development plan and eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.
The FDA previously granted Fast Track designation for 20vPnC in September 2017 for use in adults aged 18 years or older. The FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.