- Phase 3 trial demonstrates that the investigational pentavalent meningococcal vaccine (MenABCWY) was well-tolerated with an acceptable safety profile and immunogenicity non-inferior to Trumenba® + Menveo® for all serogroups
- Based on these findings, Pfizer plans to submit an application for approval to the U.S. Food and Drug Administration in the fourth quarter of 2022
- If approved, MenABCWY could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine
PfizerInc.( NYSEPFE) moment blazoned positive top- line results from the vital Phase 3 trial( NCT04440163) assessing the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine( MenABCWY) in healthy individualities 10 through 25 times of age. The trial met all primary and secondary endpoints, with the investigational vaccine demonstratingnon-inferiority to certified vaccines for the five meningococcal serogroups that beget the maturity of invasive meningococcal complaint serogroups A, B, C, W andY.1 presently, MenACWY and MenB vaccines are certified independently, and no single vaccine is available to help cover against the five serogroups.
Actors in the trial were aimlessly assigned to admit either two boluses of MenABCWY or certified vaccines( two boluses of Trumenba ® one cure of Menveo ®). Non-inferiority was demonstrated for all five serogroups following two boluses of MenABCWY compared to two boluses of Trumenba ® and one cure of Menveo ®.
Also, a single cure of MenABCWY met thenon-inferiority criteria for serogroups A, C, W and Y compared to one cure of Menveo ®. likewise, in individualities who hadn’t preliminarily entered a meningococcal vaccine, the proportion of subjects with ≥4-fold increases in vulnerable responses was observed to be advanced following either one or two boluses of MenABCWY for serogroups A, C, W and Y compared to one cure of Menveo ®. Eventually, the proportion of subjects with ≥4-fold increases in vulnerable responses was also observed to be advanced against all four serogroup B strains following two boluses of MenABCWY compared to two boluses of Trumenba ®. The pentavalent vaccine seeker was well- permitted, with a safety profile harmonious with certified vaccines.
Grounded on these Phase 3 results, which meetpre-determined criteria for licensure, Pfizer intends to submit a Biologics License operation to theU.S. Food and Drug Administration in the fourth quarter of this time. cessions to fresh nonsupervisory authorities outside theU.S. are also planned.
“ The implicit recommendation of a pentavalent vaccine in theU.S. as an volition to the being MenACWY vaccines across both the 11- to 12- time-old and 16- time-old vaccination platforms provides a significant occasion for Pfizer to enter theU.S. MenACWY vaccine request and help cover further youthful people across the country. moment, we estimate there are roughly 52 million adolescents and youthful grown-ups who are in the age range for meningococcal vaccination according to CDC guidance, ” said Angela Hwang, President, Global Biopharma Business, Pfizer. “ We look forward to the public health impact a pentavalent vaccine may give, and to strengthening our position as a global leader in the forestallment of meningococcal complaint. ”
Implicit Public Health Impact of a MenABCWY Vaccine
Meningococcal complaint is an uncommon but serious illness that can lead to death within 24 hours, and for survivors can affect in life- altering, significant long- term disabilities.2 Together, five serogroups( A, B, C, W and Y) account for 96 percent of all invasive meningococcal complaint cases worldwide, with serogroup B account for the maturity of complaint in adolescents and youthful grown-ups in theU.S. and Europe.3
In theU.S., the current vaccination recommendations for adolescents and youthful grown-ups include a MenACWY vaccine and a separate MenB vaccine( total four boluses) to help achieve the broadest protection available against meningococcal complaint. still, lower than a third ofU.S. adolescents admit indeed one cure of a MenB vaccine, and smaller complete the two- cure series, performing in numerous adolescents being vulnerable against meningococcal complaint caused by serogroups A, B, C, W, andY.4, 5 If approved and recommended, Pfizer’s pentavalent vaccine seeker could help simplify the meningococcal vaccination schedule by potentially reducing the total number of boluses demanded for individualities to be completely vaccinated against the five serogroups.6 Routine use of a MenABCWY vaccine could help ameliorate meningococcal vaccination rates and content, thereby reducing cases of invasive meningococcal complaint and associated mortality, the rate of long- term sequelae in survivors, and costs associated with controlling outbreaks.7
About the Phase 3 Trial
The randomized, active- controlled and bystander- dazed Phase 3 trial of Pfizer’s pentavalent meningococcal vaccine seeker( NCT04440163) was initiated in June 2020 and enrolled,431 healthy adolescents and youthful grown-ups( 10 through 25 times of age) from theU.S. and Europe. The study was designed to compare vulnerable responses in individualities after MenABCWY administration to responses in control groups entering certified vaccines Trumenba ®( meningococcal group B vaccine) and Menveo ®( meningococcal group A, C, W- 135, and Y conjugate vaccine), as well as to describe the safety profile of the MenABCWY vaccine. Immune responses were assessed by mortal serum bactericidal assay( hSBA). The study enrolled both individualities who had preliminarily entered a MenACWY vaccine and those who had not. All actors hadn’t entered any meningococcal group B vaccine previous to registration.
About Pfizer improvements That Change Cases ’ Lives
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