Pfizer Inc (NYSE: PFE) has announced encouraging results from the pivotal US third phase study (NCTO4382326) in infants assessing its 20-valent pneumococcal conjugate vaccine candidate for the prevention of invasive pneumococcal disease attributed to the 20 Streptococcus pneumonia (pneumococcus) serotypes contained in the vaccine for the pediatric population.
The study met two co-primary objectives
The two co-primary objectives of the study, related to immunogenicity responses one month following the third and fourth doses of the 4-dose vaccination series, were NI of IgG geometric mean concentrations after Dose-4 and noninferiority of the percentage of participants with predefined serotype-specific immunoglobin G (IgG) concentrations after dose 3 met co-primary endpoint. After Dose 4, all 20 serotypes achieved the co-primary goal of NI of IgG GMCs.
Fourteen of the 20 serotypes achieved noninferiority for the primary, secondary objective of IgG GMCs after Dose 3. All serotypes achieved noninferiority for the co-primary goal of NI of the number of subjects with predetermined IgG levels following Dose 3. In the 20-valent vaccine candidate, all 20 serotypes produced strong functional responses (OPA) and improvements in antibody levels after Dose 4. The sum of the findings supports the possible benefits of all 20 serotypes.
20vPnC showed potential in pneumococcal disease
Chief Scientific Officer Annaliesa Anderson said, “We are encouraged by today’s data which show that if approved for a pediatric indication, 20vPnC would have the potential to cover more of the clinically significant remaining burden of infant pneumococcal disease than any other available pneumococcal conjugate vaccine. We are grateful to everyone who made this study possible, including the study investigators and in particular the trial participants and their parents/guardians for their contribution to this important research.”
The safety profile of the 20vPnC candidate was consistent with Prevnar 13 provided in the same schedule. In addition, a similar percentage of infants who received either vaccine showed a local reaction, fever, and other systemic reactions. Based on the totality of the encouraging immunogenicity and safety data, Pfizer is planning to submit a supplemental Biologics License Application by the end of the year after engaging the FDA.
