Pfizer’s 20vPnC Vaccine Candidate Has FDA PDUFA Tuesday

On Tuesday, Pfizer’s 20-valent pneumococcal conjugate vaccine (20vPnC) candidate has its United States Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) action date.

The therapy includes 20 serotypes that are global causes of invasive pneumococcal disease (IPD), and is seeking approval for use in adults aged 18 years or older not previously vaccinated for IPD.

“The 20-valent pneumococcal conjugate vaccine was developed to overcome the limitations attributed to pneumococcal plain polysaccharide vaccines,” Luis Jodar, chief medical and scientific affairs officer at Pfizer Vaccines said. “20vPnC, like its predecessor Prevnar 13, is expected to provide immunological memory against the 20 serotypes included in the vaccine and to afford protection against non-bacteremic pneumonia for those 20 serotypes.”

Therapy

20vPnC is a 20-valent pneumococcal conjugate vaccine for the prevention of invasive disease and pneumonia in adults age 18 years and older. The therapy includes 13 serotypes already included in Prevnar 13, with an additional 7 new serotypes that are global causes of invasive pneumococcal disease.

The new serotypes are associated with high case-fatality rates, antibiotic resistance and/or meningitis. The 20 serotypes included in the vaccine are responsible for a majority of the currently circulating pneumococcal diseases globally.

Trial Data

The Phase 3 randomized, double-blind trial (NCT03760146) included 902 adult participants aged 18 years or older who had no history of pneumococcal vaccination. The study evaluated immune responses after the administration of 20vPnC in adults ≥60 years old, and compared them to responses in a control group receiving Prevnar 13 or a licensed pneumococcal polysaccharide vaccine (PPSV23).

Additionally, the study evaluated immune responses of 20vPnC in adults 18 to 59 years old, as well as the safety profile of 20vPnC in all adults ≥18 years old.

Results

Findings from the study demonstrated that all 20 vaccine serotypes induced robust responses across three age cohorts (≥60 years, 50-59 years, 18-49 years). In adults aged 60 years or older, primary immunogenicity objectives showed that the ratio of serotype-specific OPA geometric mean titers (GMTs) responses one month after vaccination were noninferior for all the serotypes in common with licensed Prevnar 13 and six of the seven additional serotypes when compared to a PPSV23.

Serotype 8, one of the added serotypes, missed the noninferiority lower bound criteria of >0.5 by a small margin (0.55 [0.49, 0.62]). However, it did demonstrate immune responses in other immunological parameters including fold-rises in OPA titers, proportions of subjects with ≥4-fold rise in OPA titers and proportions of subjects with OPA titer ≥ lower limit of quantification (LLOQ) after vaccination.

Younger age cohorts (18-49 years and 50-59 years) showed immune responses that were noninferior to 20vPnC responses in adults 60-64 years.

Safety

The primary safety analysis showed a similar frequency of adverse events between 20vPnC and 13vPnC, which included:

• ≥60 years: 9.8% (20vPnC) and 11.1% (13vPnC)
• 50-59 years: 10.2% (20vPnC) and 8.1% (13vPnC)
• 18-49 years: 15.2% (20vPnC) and 11.6% (13vPnC)

The most common local reaction reported was pain at the injection site, of which the majority were mild or moderate in severity. There were no serious adverse events that were considered to be related to vaccination.

PDUFA

The FDA is set to provide action on the PDUFA for 20vPnC on Tuesday, and if approved, will provide another important therapy for the prevention of invasive disease and pneumonia.

“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, senior vice president and head of Vaccine Research & Development at Pfizer said. “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.”