EU OKs Meningococcal Disease Vaccine

During its September 2024 meeting, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave the go-ahead for Penbraya (Pfizer) — meningococcal groups A, C, W, Y conjugate and group B vaccine — to be used to protect individuals from invasive meningococcal disease.

The pentavalent vaccine is indicated for active immunization of individuals 10 years of age and older against invasive disease caused by Neisseria meningitidis, a gram-negative bacterium, often referred to as meningococcus, that colonizes the upper respiratory tract. In some individuals it can cause serious, life-threatening invasive meningococcal disease.

Penbraya is a meningococcal vaccine and contains the active substances Neisseria meningitidis serogroups A, C, W, Y polysaccharides and serogroup B factor H binding protein (fHbp) subfamilies A and B. The vaccine combines the components of two meningococcal vaccines: Trumenba (meningococcal group B vaccine, Pfizer) and Nimenrix (meningococcal groups A, C, W-135, Y conjugate vaccine, Pfizer). Its aim is to help protect against the five most common meningococcal serogroups that cause most types of invasive meningococcal disease globally. 

Immunization with Penbraya stimulates the production of antibodies that recognize polysaccharides or factor H-binding protein expressed by the bacteria.

The CHMP decision is based on a review of the evidence from a randomized, active-controlled and observer-blinded Phase 3 trial that assessed the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate compared with currently licensed meningococcal vaccines. The goal was to determine its immunologic noninferiority. It involved more than 2400 patients from the United States and Europe. Healthy individuals aged 10 to 25 years who had or had not previously received a MenACWY vaccine were randomly assigned to receive 0.5 mL of MenABCWY (months 0 and 6) and placebo (month 0), or MenB-FHbp (months 0 and 6) and MenACWY-CRM (month 0). 

The clinical trial investigators wrote that MenABCWY immune responses were robust and non-inferior to MenACWY-CRM and MenB-FHbp administered separately. MenABCWY was well-tolerated. 

Penbraya will be available as a powder and suspension for reconstitution prior to injection. The most common side effects of Penbraya are pain at injection site, fatigue, headache, muscle pain, and swelling and redness at injection site.

Spikevax and Comirnaty Vaccines

The CHMP also gave a positive opinion to update the composition of the mRNA vaccine Spikevax (Moderna), previously COVID-19 Moderna vaccine, to target the SARS-CoV-2 JN.1 variant of the virus.

It also gave a positive opinion during the meeting to update the composition of Comirnaty (Pfizer) for the KP.2 subvariant. 

The CHMP pointed out that the revision of these COVID-19 vaccines was in line with recommendations by the EMA Emergency Task Force to update COVID-19 vaccines to target the SARS-CoV-2 variants for the 2024/2025 vaccination campaign.