PCV20 Demonstrates ‘Robust Immune Response,’ with Tolerability and Safety Comparable to Prevnar 13
By Jeff Craven /alert Contributor
October 21, 2020
Results from a large phase 3 trial of Pfizer’s 20-valent pneumococcal conjugate vaccine (PCV20) showed the vaccine had a “robust immune response” in both younger and older adults and the safety and tolerability of the vaccine is comparable to the 13-valent pneumococcal conjugate vaccine (PCV13) Prevnar 13, according to recent research presented at IDWeek 2020.
“Based on the robust immune responses and comparability to licensed pneumococcal vaccines, as well as bridging to the younger age group, these data support that PCV20 will be protective against pneumococcal disease due to the 20 serotypes in adults,” Brandon Essink, MD, CPI, of the Meridian Clinical Research Omaha in Omaha, Nebraska, and colleagues wrote in their study abstract.
In September 2018, FDA granted Breakthrough Therapy designation for PCV20 in adults as well as Fast Track designation for adults and children in 2017. PCV20 covers all the pneumonia serotypes in Prevnar 13, which is also developed by Pfizer, in addition to seven pneumococcal conjugates not included in Prevnar 13: serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F.
“We are encouraged by the phase 3 adult and phase 2 pediatric data. The data suggest that 20vPnC would be anticipated to help protect against the serotypes covered by Prevnar 13, and also expand coverage to include seven additional pneumococcal serotypes causing potentially serious and life-threatening disease,” Kathrin U. Jansen, PhD, Senior Vice President and Head of Vaccine Research & Development, Pfizer, said in a press release. “Since the 20 S. pneumoniae serotypes included in 20vPnC are responsible for the majority of global pneumococcal disease cases, we are excited by the potential broader coverage this investigational vaccine may offer people.”
In the trial, 3,889 participants who had never had a pneumococcal vaccine received PCV20 and were divided into age cohorts of 18-49 years old, 50-59 years old, and 60 years or older. The oldest group with participants at least 60 years old received PCV20 and saline (1,507 participants), or Prevnar 13 plus and 23-valent pneumococcal polysaccharide (PPSV23) (Merck) as a control (1,490). In the two other age groups, participants received either PCV20 or PCV13. Dr. Essink and colleagues examined the immunogenicity, safety and tolerability of PCV20 in each age group.
There was a “robust response” from the 20 serotypes within PCV20 and non-inferior levels of opsonic pneumococcal antibody (OPA) geometric mean titers (GMTs) in the serotypes covered by Prevnar 13. Of the 7 additional serotypes in PCV20, 6 serotypes were non-inferior to matched serotypes within PPSV23. There were also non-inferior levels of OPA GMT in the 18-49-year-old group and the 50-59-year-old group compared with adults in the group at least 60 years old. Dr. Essink and colleagues noted the “tolerability and safety profile of PCV20 was similar to PCV13.”
In a press release announcing top-line results from the trial, Pfizer said they planned to file the adult indication for PCV20 with the FDA by the end of the year.