Pfizer’s pentavalent meningococcal vaccine granted FDA approval

23 Oct 2023
www.pmlive.com
Drug ApprovalPhase 3VaccineClinical ResultQualified Infectious Disease Product
Pfizer’s Penbraya has been approved by the US Food and Drug Administration (FDA) as the first pentavalent vaccine that provides protection against the five most common serogroups causing meningococcal disease in individuals aged ten to 25 years.
PfizerocoPenbrayaease is an uncommon but serioFood and Drug Administration (FDA)within 24 hourpentavalent vaccine life-altering, significant long-term disabilities for survivors.meningococcal disease
Meningococcal diseasetwo vaccines authorised to protect against the disease, with Trumenba targeting meningococcal group B and Nimenrix protecting against groups A, C, W and Y.
Pfizerya combines the components from both vaccines and simplifies the meningococcTrumenbanation schedule by reducing the totalNimenrixof doses needed to be fully protected against the five serogroups, potentially increasing the number of vaccinated adolescents and young adults.
Penbrayas decision was supported by positive results from mid- and late-stage trials, including a phase 3 study evaluating the safety, tolerability and immunogenicity of Penbraya compared to currently US-licensed meningococcal vaccines.
AnnaFDAsa Anderson, senior vice president and head of vaccine research and development at Pfizer, said: “[The approval] marks an important step forward in the prevention Penbrayagococcal disease in the US.
"In a single vaccine, Penbraya has the potential to protect more adolescents and young aduPfizerom this severe and unpredictable disease by providing the broadest meningococmeningococcal diseaseewest shots.”
The US Centers for Disease Control and Prevention, which has noted that combining vaccines may mean that more adolescents and young adults get their recommended vaccines on time, will now meet to discuss recommendations for the appropriate use of Penbraya.
“Nearly nine out of ten adolescents have incomplete protection against invasive meningococcal disease caused by the leading serogroups,” said Jana Shaw, paediatrics infectious disease specialist at Upstate Golisano Children's Hospital in Syracuse, US.
She continued: “For the first time, we have a single vaccine that helpsinvasive meningococcal disease common serogroups and has the potential to improve coverage and increase protection among adolesUpstatenGolisano Children's Hospital
GSK is also developing a pentavalent vaccine against meningococcal disease, which combines the antigenic components of its approved Bexsero (MenB) and Menveo (MenACWY) meningococcal vaccines.
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