Pfizer’s pentavalent meningococcal vaccine granted FDA approval

23 Oct 2023
www.pmlive.com
Drug ApprovalPhase 3VaccineClinical ResultQualified Infectious Disease Product
Pfizer’s pentavalent meningococcal vaccine granted FDA approval
Preview
Source: PMLiVE
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.
Meningococcal disease is an uncommon but serious illness that can lead to death within 24 hours and can result in life-altering, significant long-term disabilities for survivors.
Pfizer currently has two vaccines authorised to protect against the disease, with Trumenba targeting meningococcal group B and Nimenrix protecting against groups A, C, W and Y.
Penbraya combines the components from both vaccines and simplifies the meningococcal vaccination schedule by reducing the total number of doses needed to be fully protected against the five serogroups, potentially increasing the number of vaccinated adolescents and young adults.
The FDA’s 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.
Annaliesa Anderson, senior vice president and head of vaccine research and development at Pfizer, said: “[The approval] marks an important step forward in the prevention of meningococcal disease in the US.
"In a single vaccine, Penbraya has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest 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 helps protect against the five most common serogroups and has the potential to improve coverage and increase protection among adolescents and young adults.”
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.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-
Drugs
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.