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. 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),1,2,3,4,5 and are associated with high case-fatality rates,6,7,8,9 antibiotic resistance,5,10,11 and/or meningitis.12,13 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.14,15,16,17,18,19,20

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.

20vPnC Phase 3 Adult Program

Pfizer’s Phase 3 adult clinical program for 20vPnC includes three clinical trials (NCT03760146, NCT03828617, and NCT03835975) 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.21,22 All three trials have been completed and the data for one remaining study will be reading out over the next few months.

• This press release refers to NCT03828617: Phase 3 randomized, double-blind trial enrolled 1,700 adults aged 18 through 49 years with no history of pneumococcal vaccination. The study was designed to describe the safety and evaluate consistency of immune response elicited across three different lots of 20vPnC. The 20vPnC lots were three unique drug product lots. A 13vPnC arm was included in the study as a control group for safety assessments. More on the study can be found on www.clinicaltrials.gov under the identifier NCT03828617.

Additional trials include:

• NCT03760146: Phase 3 randomized, double-blind trial comparing immune responses in patients ≥60 years old after 20vPnC administration to responses in a control group receiving 13vPnC or PPSV23. The study also evaluated immune responses of 20vPnC in adults 18 to 59 years (secondary endpoints) and described the safety profile of 20vPnC in all adults ≥18 years old (primary endpoint). Additional information about the study can be found at www.clinicaltrials.gov under the identifier NCT03760146. Pfizer announced topline findings from this trial in March 2020.
• NCT03835975: Phase 3 randomized, open-label trial, designed to describe the safety and immune response of 20vPnC in an estimated 875 adults aged 65 years or older with prior pneumococcal vaccination. More on the study can be found on www.clinicaltrials.gov under the identifier NCT03835975.

About 20vPnC

On September 20, 2018, Pfizer announced the U.S. 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).23 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.24

The FDA previously granted Fast Track designation for 20vPnC in September 2017 for use in adults aged 18 years or older.25 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.25

Additionally, in May 2017 the FDA granted Fast Track status for a pediatric indication for 20vPnC.26

INDICATIONS FOR PREVNAR 13®

• Prevnar 13® is a vaccine approved for adults 18 years and older for the prevention of pneumococcal pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F
• Prevnar 13® is also approved for children 6 weeks through 17 years of age (prior to the 18th birthday) for the prevention of invasive disease caused by the 13 strains of Streptococcus pneumoniae in the vaccine, and for children 6 weeks through 5 years (prior to the 6th birthday) for the prevention of ear infections caused by 7 of the 13 strains in the vaccine
• Prevnar 13® is not 100% effective and will only help protect against the 13 strains in the vaccine

IMPORTANT SAFETY INFORMATION

• Prevnar 13® should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13® or any diphtheria toxoid–containing vaccine
• Children and adults with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune response
• In adults, the most common side effects were pain, redness, and swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, vomiting, fever, chills, and rash
• A temporary pause of breathing following vaccination has been observed in some infants born prematurely
• The most commonly reported serious adverse events in infants and toddlers were bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%)
• In children 6 weeks through 17 years, the most common side effects were tenderness, redness, or swelling at the injection site, irritability, decreased appetite, decreased or increased sleep, and fever
• Ask your healthcare provider about the risks and benefits of Prevnar 13®. Only a healthcare provider can decide if Prevnar 13® is right for you or your child