Introduction of a second MenB vaccine into Europe – needs and opportunities for public health

ABSTRACT

Introduction: Invasive meningococcal disease (IMD) can be devastating; it is associated with high case fatality rates and long-term sequelae among many survivors. Five serogroups (A, B, C, W, and Y) cause nearly all IMD cases worldwide, and serogroup B (MenB) is the most prevalent in Europe. The European Medicines Agency approved the use of MenB-fHbp (Trumenba®; Pfizer Ltd, Sandwich, UK) in individuals ≥10 years of age for the prevention of MenB IMD in May 2017. MenB-fHbp contains two lipidated recombinant fHbp variants from two different fHbp subfamilies that help provide broad coverage against circulating meningococcal strains and may also improve antibody response compared to a nonlipidated antigen.

Areas covered: This review summarizes the latest epidemiology evaluating the disease burden of MenB in Europe, introduces MenB-fHbp (the vaccine most recently approved in the European Union for the prevention of MenB IMD), and provides an overview of its development.

Expert opinion: MenB is by far the most prevalent meningococcal serogroup in Europe, and its epidemiology is not currently addressed by European immunization recommendations. New strategies to prevent MenB IMD in Europe will continue to develop with the growing use of vaccines to prevent MenB disease, with increasing support through national immunization programs.

KEYWORDS:

• Epidemiology
• Europe
• invasive meningococcal disease
• MenB-fHbp
• 4CMenB
• meningococcal serogroup B
• vaccination

Article highlights

• Lipidated fHbp antigens elicit higher bactericidal titers than nonlipidated antigens and stimulate bactericidal activity providing broader cross-reactivity of induced antibodies to MenB strains expressing heterologous fHbp proteins [57].

• Robust antibody responses to lipidated fHbp antigens are largely restricted to vaccine-heterologous proteins in the same subfamily [21].

• Thus, a bivalent MenB vaccine formulation with lipidated antigens from both fHbp subfamily A and B should provide broad protection against MenB disease [57].

• MenB-fHbp immunogenicity has been demonstrated against four primary and 10 additional test strains in phase 3 clinical studies [72], and against 27 test isolates in which the 10 most prevalent fHbp variants represent approximately 80% of US and EU MenB IMD-causing isolates [82].

• Data suggest that MenB-fHbp is immunogenic and well tolerated at either of two schedules: two doses at 0 and 6 months; or three doses with the first two doses administered ≥1 month apart followed by a third dose ≥4 months after the second [71,72].

Acknowledgments

Writing support was provided by Regina E. Burris, PhD, and Tricia Newell, PhD, at Complete Healthcare Communications, LLC (North Wales, PA), a CHC Group company, and was funded by Pfizer Inc.

Declaration of interest

J. Findlow and C. Nuttens are employees of Pfizer and may hold stock options. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer declarations

A reviewer on this manuscript has declared that they have received funds from GlaxoSmithKline Biologicals SA, Sanofi Pasteur, MSD, Novartis, Crucell/Janssen, Seqirus, Sanofi, Pasteur, Merck Italy, Pfizer, and PaxVax for being a consultant or taking part in advisory boards, expert meetings, being a speaker or an organizer of congresses/conferences and acting as investigator in clinical trials. He/She has also declared that he/she is a member of the regional Commission on Vaccines, of Emilia Romagna Region, Italy.

Additional information

Funding

This work was sponsored by Pfizer Inc.