- Pivotal top-line data demonstrate a four-dose series of 20-valent pneumococcal conjugate vaccine candidate (20vPnC), if approved, would provide the broadest serotype coverage of any pneumococcal conjugate vaccine in infants
- 20vPnC elicited robust immune responses to all 20 serotypes meeting the statistical non-inferiority criteria for the co-primary objective after Dose 4
- 20vPnC demonstrated a favorable safety and tolerability profile similar to Prevnar 13®
- Pfizer plans to submit an sBLA by the end of this year, subject to discussions with U.S. FDA
PfizerInc.( NYSEPFE) moment blazoned positive top- line results from its vitalU.S. Phase 3 study( NCT04382326) in babies assessing its 20- valent pneumococcal conjugate vaccine seeker( 20vPnC) for the forestallment of invasive pneumococcal complaint( IPD) caused by the 20 Streptococcus pneumoniae( pneumococcus) serotypes contained in the vaccine for the pediatric population.
The study had twoco-primary objects, associated with immunogenicity responses one month after the third and fourth boluses of the four- cure vaccination series, independentlynon-inferiority( NI) of the chance of actors with predefined serotype-specific immunoglobin G( IgG) attention after Cure 3 and NI of IgG geometric mean attention( GMCs) after Cure 4. All 20 serotypes met theco-primary ideal of NI of IgG GMCs after Cure 4. Fourteen of the 20 serotypes met theco-primary ideal of NI of the chance of actors with predefined IgG situations after Cure 3( two serotypes missed by a wider periphery while four hardly missed), and all serotypes met noninferiority for the crucial secondary ideal of IgG GMCs after Cure 3. All 20 serotypes inspired robust functional responses( OPA) and increases in antibody responses after Cure 4, with the summation of data supporting the implicit benefit of all serotypes in this 20- valent vaccine seeker.
“ We’re encouraged by moment’s data which show that if approved for a pediatric suggestion, 20vPnC would have the eventuality to cover further of the clinically significant remaining burden of child pneumococcal complaint than any other available pneumococcal conjugate vaccine, ” said Annaliesa Anderson,Ph.D., elderly Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “ We’re thankful to everyone who made this study possible, including the study investigators and in particular the trial actors and their parents guardians for their donation to this important exploration. ”
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 Prevnar 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 Prevnar 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 Prevnar 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 Prevnar 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 theU.S. and encyclopedically.
On August 14, 2020, Pfizer’s 20vPnC entered the FDA’s Advance remedy Designation for the forestallment of complaint caused by Streptococcus pneumoniae serotypes in the vaccine in babies, children, and adolescents.
The FDA preliminarily granted Fast Track Designation for 20vPnC in May 2017 for the pediatric suggestion.
On June 8, 2021, the FDA approved PREVNAR 20 ® 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.
Suggestions FOR PREVNAR 13 ®
Prevnar 13 ® is a vaccine approved for grown-ups 18 times and aged for the forestallment of pneumococcal pneumonia and invasive complaint caused by Streptococcus. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F
Prevnar 13 ® is also approved for children 6 weeks through 17 times of age( previous to the 18th birthday) for the forestallment of invasive complaint caused by the 13 strains ofS. pneumoniae in the vaccine, and for children 6 weeks through 5 times( previous to the 6th birthday) for the forestallment of observance infections caused by 7 of the 13 strains in the vaccine
Prevnar 13 ® isn’t 100 effective and will only help cover against the 13 strains in the vaccine
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