Public Health England (PHE) has announced that preliminary data for the real-life efficacy of GlaxoSmithKline’s (GSK’s) Bexsero indicate a vaccine efficiency of 83 percent among immunized infants. Bexsero, which has been on the UK immunization schedule since September 2015, protects against meningococcal disease caused by serogroup B (MenB). The findings were presented at the Pathogenic Neisseria Conference in Manchester, UK, in September 2016.
Additionally, PHE revealed a general decrease in the number of MenB cases among the cohort eligible for routine vaccinations. In the first 10 months of the program, the average number of cases fell from 74 to 37. GlobalData anticipates these results could aid GSK in persuading other countries around the world, especially in Europe, to add Bexsero as a routine vaccine for age populations most at risk of contracting meningococcal disease. This would also strengthen GSK’s place at the forefront in meningococcal vaccines in Europe by tackling an unmet need in the MenB vaccine arena.
Meningococcal disease is a rare but dangerous disease caused by the Gram-negative bacterium Neisseria meningitidis. Although the bacterium is found asymptomatically in approximately 10 percent of the population, only infants and adolescents are at a high risk of developing meningococcal disease, resulting in high morbidity and mortality rates even among otherwise healthy individuals. The disease is typically caused by one of five different serogroups, all of which have commercial vaccines available. The vaccines protecting against four of these serogroups (serogroups A, C, W135, and Y) are based on relatively conserved exterior polysaccharide layers of the bacterium. Vaccines protecting against the most prevalent strains have been included in the routine vaccination schedule in many countries, including those in Europe.
However, developing a vaccine to protect against serogroup B required an alternative approach. Only two companies, GSK and Pfizer, have successfully launched a protein-based MenB vaccine in the US and/or Europe. This alternative approach has resulted in vaccines with higher reactogenicity compared with polysaccharide-based vaccines. More importantly, the efficacy of these protein-based vaccines has only been determined indirectly, through serum bactericidal assays (BSA). Since the MenB strains found in the population can vary significantly in their protein expression, composition, and sequences, the real-life efficacy of these vaccines has been questioned. Key opinion leaders (KOLs) interviewed by GlobalData have described the lack of real-life efficacy data as a main barrier for MenB vaccines to be included in the routine vaccination schedules. Consequently, only the UK currently uses a MenB vaccine, Bexsero, as a routine administration in healthy infants. The decision by PHE to include Bexsero in the vaccination schedule can be attributed to an overall high prevalence rate of MenB cases in the UK compared to other countries in the 5EU or the US, to advocacy groups in the UK raising awareness of meningococcal disease, and also to successful negotiations between GSK and PHE, resulting in a steep price discount for PHE.
GSK’s gamble to accept a price far below the list price for the vaccine in the UK is now starting to pay off, as GSK is the first (and so far, only) company able to provide data demonstrating the efficacy of the vaccine in preventing meningococcal disease on a national level via a routine administration targeting a specific age cohort. This advantage will be vital when the competition for market share in Europe between Pfizer and GSK heats up, as Pfizer has recently filed for market access in Europe for its MenB vaccine, Trumenba. However, Pfizer will face additional barriers after its anticipated launch in Europe, as the US pharmaceutical giant has only filed for the approval of Trumenba to be administered in adults, while the European countries focus their routine meningococcal vaccination programs on individuals at the highest risk of contracting meningococcal disease, specifically infants and children. Furthermore, GSK is currently developing a pentavalent vaccine, MenABCWY, a combinatorial vaccine possibly protecting against all five serogroups simultaneously. Depending on the outcome of ongoing clinical trials, this pentavalent vaccine has the potential to replace most other meningococcal vaccines from national routine immunization recommendations.
As it will face future competition in the lucrative meningococcal vaccine market in Europe, GSK has taken multiple steps to establish Bexsero as the leading MenB vaccination, using a strategy that will keep their entire meningococcal vaccine franchise ahead of the competition. A cornerstone of this strategy has been the introduction of the vaccine into the UK’s routine immunization schedule to establish real-life efficacy. Assuming there are no significant changes in the epidemiology of the disease in Europe, eliminating the concerns of the UK’s national immunization boards regarding the vaccine’s real-life efficacy will allow GSK to make a strong case in the rest of Europe for the inclusion of Bexsero into other routine immunization recommendations in the near future. GlobalData expects that the combination of the newly released real-life efficacy data by PHE, GSK’s current monopoly in the MenB vaccine market in Europe, and GSK’s pentavalent vaccine will all propel GSK to be an unassailable market leader for meningococcal vaccines in Europe.
*This article first appeared on GlobalData Expert Insights on September 12th 2016