- Positive pivotal top-line data demonstrates 20-valent pneumococcal conjugate vaccine candidate (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 Prevenar® and Prevenar 13®
- The company intends to file for regulatory approval in the EU in the next few months
Pfizer moment blazoned positive top- line results from its vitalE.U. Phase 3 study in babies( NCT04546425) assessing its 20- valent pneumococcal conjugate vaccine seeker( 20vPnC) for the forestallment of invasive pneumococcal complaint( IPD), pneumonia, and acute otitis media caused by the 20 Streptococcus pneumoniae( pneumococcus) serotypes contained in the vaccine for the pediatric population.
The study had three coprimary issues, associated with immunogenicity responses one month after the alternate and third boluses of a three- cure vaccination series given at roughly 2, 4, and 11- 12 months of age of 20vPnC compared to Prevenar 13 ®. For thenon-inferiority( NI)co-primary ideal of immunoglobulin G( IgG) geometric mean attention( GMCs) one month after Cure 3 at 11- 12 months of age, 19 of the 20 serotypes met the NI criteria with only one serotype hardly missing. For the NIco-primary ideal of IgG GMCs one month after Cure 2, 16 of the 20 serotypes met NI. Eventually, for the third NIco-primary ideal of the chance of actors with predefined serotype-specific IgG attention one month after Cure 2, nine of the 20 serotypes met the NI criteria. All 20 serotypes showed increased supporter responses from post cure 2 to post cure 3 which are reflective of immunological memory and long- term protection. All 20 vaccine serotypes also showed strong functional antibody responses as measured by the opsonophagocytic assay( OPA)post-dose 2 and post cure 3 analogous to Prevenar ® and Prevenar 13 ®. The summation of data is thus directionally harmonious with previous clinical experience with Prevenar ® and Prevenar 13 ® after 2 and 3 child boluses, both of which have demonstrated effectiveness in a three- cure schedule against the serotypes contained in the vaccine inpost-licensure studies.
In summary, the summation of these positive 20vPnC data, combined with the experience with Prevenar 13 ® in this schedule, demonstrates that the 20vPnC seeker, if approved, is likely to help cover against all 20 vaccine serotypes in a three- cure vaccine series.
“ moment marks another important corner in the 20vPnC pediatric program, with these data demonstrating 20vPnC’s eventuality to give the most comprehensive pneumococcal serotype content of any available pneumococcal conjugate vaccine, ” said Annaliesa Anderson,Ph.D., elderly Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “ Grounded on the summation of immunogenicity and safety data, we feel confident that 20vPnC is likely to be defensive against all vaccine serotypes in a three- cure series. We’re thankful to everyone who worked on or shared in this study, and we look forward to hopefully being suitable to give babies with further robust and meaningful protection against further pneumococcal complaint- causing serotypes in the near future. ”
The safety profile of 20vPnC was analogous to Prevenar 13 ® in this schedule, and attendant use with common pediatric vaccines were supported.
Pfizer plans to file these data by the end of this time with the European Medicines Agency( EMA). These positive data mark the conclusion of vital topline readouts for the 20vPnC pediatric program. Pfizer will also seek to present and publish issues from this clinical trial at a future date once safety and immunogenicity data have been completely anatomized.
About the 20vPnC Phase 3 Pediatric Program
In 2020, Pfizer initiated the Phase 3 clinical trial program for the pediatric suggestion for 20vPnC. Four core Phase 3 pediatric studies will help expand the data on the safety, tolerability, and immunogenicity of 20vPnC. These studies inclusively enrolled roughly,700 babies and 800 toddlers and children of all periods including
A Phase 3 study describing the tolerability and safety and comparing immunogenicity of 20vPnC to Prevenar 13 ® in babies vaccinated at 2, 4, 6, and 12- 15 months of age in theU.S.( NCT04382326)
A Phase 3 study describing the tolerability and safety of 20vPnC, with Prevenar 13 ® serving as the control in babies vaccinated at 2, 4, 6, and 12- 15 months of age in multiple countries.( NCT04379713)
A Phase 3 study describing the tolerability and safety and comparing immunogenicity of 20vPnC to Prevenar 13 ® in child vaccination at roughly 2, 4, and 11- 12 months of age in Europe and Australia( NCT04546425)
A Phase 3 study in children 15 months through< 18 times of age entering a single cure of 20vPnC in theU.S.( NCT04642079).
Pfizer’s 20vPnC pediatric vaccine seeker includes 13 serotypes formerly 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 invasive pneumococcal complaint( IPD), and are associated with high case- casualty rates, antibiotic resistance, and/ or meningitis. Together, the 20 serotypes included in 20vPnC are responsible for the maturity of presently circulating pneumococcal complaint in the EU and encyclopedically.
On Feb 14, 2022, the European Commission Decision was espoused for APEXXNAR ®( 20vPnC) for the forestallment of invasive complaint and pneumonia caused by the 20 Streptococcus pneumoniae( pneumococcus) serotypes in the vaccine in grown-ups periods 18 times and aged.
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