The US Food and Drug Administration (FDA) has approved Pfizer’s PENBRAYA (MenABCWY) for the prevention of meningococcal disease in adolescents.

Penbraya is the first vaccine that provides coverage of the five most common meningococcal serogroups that cause illness, groups A, B, C, W and Y. 

Meningococcal disease is a major cause of meningitis and septicaemia, two life-threatening diseases that mostly affect children and adolescents. The vaccine is a combination of components from Pfizer’s licensed meningococcal vaccines, Trumenba, which covers group B, and Nimenrix, which covers groups A, C, W and Y.  

The approval of Penbraya is based on positive data from a Phase III study (NCT04440163), which recruited more than 2,400 patients from the US and Europe, as well as observed the safety, tolerability and immunogenicity of Penbraya compared to currently licensed vaccines.  

The FDA accepted the Biologics License Application (BLA) for Penbraya in December 2022.  

Senior vice-president and head of Pfizer’s vaccine research and development department Annaliesa Anderson said: “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.” 

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Multivalent MenABCWY vaccines provide broader protection while reducing the vaccine burden and being more cost-effective. In addition to Pfizer, GSK has its own pentavalent MenABCWY vaccine, which had positive Phase III clinical data in March 2023.

According to GlobalData’s Pharmaceutical Intelligence Centre, multivalent meningococcal vaccines will considerably impact the vaccine market in the next few years, with the share for MenABCWY vaccines reaching 42% of the $1.32bn market in 2029. In addition, Pfizer’s market share in the overall meningococcal vaccine market across nine major markets (the US, France, Germany, Italy, Spain, the UK, Argentina, Brazil, and China), is forecast to increase from 11.8% in 2019 to 19.4% in 2029. 

GlobalData is the parent company of Pharmaceutical Technology.