20-Valent Pneumococcal Conjugate Vaccine in Infants Posts Positive Data in Europe
New York-based Pfizer announced positive top-line results from its pivotal Phase 3 study in infants in the E.U. evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD), pneumonia, and acute otitis media caused by the 20 Streptococcus pneumoniae serotypes contained in the vaccine.
Today's press release revealed:
Positive pivotal top-line data demonstrates that 20vPnC if approved, can likely help protect against all 20 vaccine serotypes in three-dose series and potentially offer the broadest serotype coverage of any available pneumococcal conjugate vaccine (PCV).
The safety profile of 20vPnC was favorable and similar to Prevenar 13® (or Prevnar 13® in the U.S.) in this schedule, and concomitant use with common pediatric vaccines was supported and well tolerated.
20vPnC also showed robust functional antibody responses to the vaccine serotypes post Dose 2 and 3, similar to Prevenar13 and Prevnar13 (European and American PCV13 versions, respectively).
Pfizer plans to file these data with the European Medicines Agency by the end of 2022.
“Today marks another important milestone in the 20vPnC pediatric program, with these data demonstrating 20vPnC’s potential to provide the most comprehensive pneumococcal serotype coverage of any available pneumococcal conjugate vaccine,” said Annaliesa Anderson, Ph.D., SVP and Chief Scientific Officer, Vaccine Research and Development, Pfizer, in a media statement on September 19, 2022.
“Based on the totality of immunogenicity and safety data, we feel confident that 20vPnC is likely to be protective against all vaccine serotypes in a three-dose series."
"...we look forward to hopefully being able to provide infants with more robust and meaningful protection against more pneumococcal disease-causing serotypes in the near future.”
Pfizer’s 20vPnC pediatric vaccine candidate includes 13 serotypes already included in Prevenar 13® – 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
The seven new serotypes included in 20vPnC are global causes of IPD and are associated with high case-fatality rates, antibiotic resistance, and/or meningitis.
Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in the E.U. and globally.
Other pneumococcal vaccine news is posted at PrecisionVaccinations.com/pneumococcal.