FDA Approves Pfizer’s 20vPnC Vaccine
The vaccine covers 13 S. pneumoniae serotypes plus an additional 7.
The United States Food and Drug Administration (FDA) has approved the 20-valent pneumococcal conjugate vaccine (20vPnC). The therapy was developed by Pfizer, a pharmaceutical and biotechnology corporation based in New York City.
The therapy includes 20 serotypes that are global causes of invasive pneumococcal disease (IPD) and builds on the Prevnar 13 platform. The FDA based their decision on Phase 3 data from a randomized, double-blind trial.
“Today’s approval of PREVNAR 20 marks a significant step forward in our ongoing fight to help address the burden of pneumococcal disease, including pneumonia in adults, and broadens global protection against more disease-causing serotypes than any other pneumococcal conjugate vaccines,” Kathrin U. Jansen, senior vice president and head of vaccine research & development at Pfizer said. “With a single injection, PREVNAR 20 provides adults with strong and meaningful protection against serotypes responsible for the majority of circulating pneumococcal disease around the world.”
Data from the NCT03760146 trial 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). There were 902 adult participants aged 18 years or older who had no history of pneumococcal vaccination included.
20vPnC 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.
Younger age cohorts (18-49 years and 50-59 years) showed immune responses that were noninferior to 20vPnC responses in adults 60-64 years.
“PREVNAR 20 builds on Pfizer’s legacy of more than two decades of experience in developing and supplying innovative pneumococcal conjugate vaccines that have had a tangible impact on global disease burden,” Nanette Cocero, global president of Pfizer vaccines said. “We are thrilled with this approval as it furthers our mission to expand protection against disease-causing bacteria serotypes to help prevent potentially serious respiratory infections like pneumococcal pneumonia throughout the year.”