Approval-first for meningococcal vaccine
Posted: 24 October 2023 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
The first single vaccine to immunise against the five most common meningococcal disease serogroups in adolescents has been approved in the US.
PENBRAYA ™ (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides the broadest serogroup coverage of any meningococcal vaccine available in the US for meningococcal disease in individuals aged 10 to 25 years old, has been approved by the US Food and Drug Administration (FDA).
About PENBRAYA?
The PENBRAYA vaccine combines the components from two meningococcal vaccines, Trumenba® (meningococcal group B vaccine) and Nimenrix® (meningococcal groups A, C, W-135, and Y conjugate vaccine) to help protect against the five most common meningococcal serogroups that cause the majority of invasive meningococcal disease (IMD) globally, stated 2023 research published in Epidemiology and Infection.
While meningococcal disease is uncommon, serious illness can lead to a fatal outcome within 24 hours, a Pediatrics paper highlighted. PENBRAYA is administered as a two-dose series given six months apart, Pfizer stated.
“For the first time, we have a single vaccine that helps protect against the five most common serogroups,” commented Dr Jana Shaw, Pediatrics Infectious Disease Specialist at Upstate Golisano Children’s Hospital 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,” stated Pfizer’s Senior Vice President and Head, Vaccine Research and Development, Annaliesa Anderson, PhD.
According to Pfizer, the FDA’s decision is based on the positive results from Phase II and Phase III trials, including a Phase III trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate compared to currently US licensed meningococcal vaccines.
The trials demonstrated that PENBRAYA has robust immunogenicity non-inferior to Trumenba (meningococcal group B vaccine) and Menveo® for all serogroups and was well-tolerated with a favourable safety profile.
Trumenba is indicated for active immunisation against invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years of age.
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