‘Real world’ data shows 83 percent effectiveness for Bexsero® in infants in first year of UK national meningitis B immunisation programme

Issued: London

Cases of meningitis B halved after ten months

Preliminary data from the world’s first national meningitis B immunization program with Bexsero1, launched one year ago in the UK, shows the estimated effectiveness of the vaccine at 83 percent against any meningitis B strain and 94 percent against vaccine preventable strains, for all children receiving the first two of three recommended doses 2. Reported cases of the disease have dropped 50 percent in the vaccine-eligible population in the first ten months of the program, compared to the average number of cases over the last four years. These data were presented today by Public Health England (PHE) at the International Pathogenic Neisseria Conference (IPNC) in Manchester, UK.

Uptake of the vaccine in the UK national immunization program is high. In more than 600,000 infants aged 0-1 year old, eligible for the vaccine, more than 90 percent received two doses.

Dr. Thomas Breuer, Chief Medical Officer, GSK Vaccines commented: “We are extremely encouraged by the initial results of the UK program, which demonstrate that Bexsero helps to protect babies in the UK from this often life-threatening disease. The data substantially advance our understanding of the impact of meningitis B vaccines in a real world setting and may help inform public health authorities around the world about their future use. The report shared provides reassurance to parents who have already vaccinated their children or wish to help protect their children from meningitis B in the future.”

Invasive meningococcal B disease is the leading cause of life-threatening meningitis in the industrialized world. Although not common, invasive meningococcal B disease develops rapidly, typically amongst previously healthy children and adolescents, and results in high morbidity and mortality. Initial symptoms can often resemble flu, making it difficult to diagnose. About one in 10 of those who contract the disease will die, even with appropriate treatment. Additionally, up to 20 percent of those who survive bacterial meningitis may suffer a major physical or neurological disability (limb loss, hearing loss or seizures).3,4

Bexsero is currently the only meningococcal B vaccine licenced in Europe. The UK national immunization program is the first such program for the prevention of meningitis B in the world. Infants are immunized at two and four months of age, with a booster dose at 12 months, outside of the licensed dosing schedule*, but in line with recommendations issued by the UK advisory body on immunization2. The data presented today demonstrate the immediate impact on meningococcal B disease rates in the eligible population following two doses of the vaccine. More data are expected as the first infants from the program receive their booster dose later this year.

Linda Glennie, head of research at the Meningitis Research Foundation said, “It is great to see this early evidence that the national meningitis B immunization program for children under age one is effective. We hope that other countries burdened by meningitis B will now consider protecting their people from this deadly disease. Meningitis and septicaemia can kill in hours, and leave a substantial number of survivors with life-changing after-effects. We will continue to gather evidence that will unlock expertise about meningitis B vaccination.”

Incidence of meningitis B is highest in infants under one year old and the ultimate goal of meningococcal vaccination is to reduce the total burden of disease. The data presented today at IPNC shows this is now happening in the UK. GSK looks forward to further analyses from PHE on the vaccine’s effectiveness over the coming months and years.

Notes to Editors

Bexsero®▼ [Meningococcal group B Vaccine (rDNA, component, adsorbed)]

Bexsero is licensed in more than 35 countries5, including the U.S. These countries include the member states of the European Union and European Economic Area, Australia, Argentina, Chile and Uruguay, where Bexsero is approved for individuals two months of age and older, and in Canada for those aged 2 months to 17 years of age. In the U.S., Bexsero is approved for use in individuals from 10 years through 25 years of age. In Brazil, Bexsero is approved for use in individuals from two months to 50 years of age.

BEXSERO® (Meningococcal Group B Vaccine) Important Safety Information

Bexsero is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Bexsero is approved for use in individuals 10 through 25 years of age.

Approval of Bexsero is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of Bexsero against diverse serogroup B strains has not been confirmed.

  • Bexsero is contraindicated in cases of hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of Bexsero.
  • Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine.
  • The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals.
  • Syncope (fainting) can occur in association with administration of Bexsero. Ensure procedures are in place to avoid injury from falling associated with syncope.
  • The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥28%), nausea (≥18%), and arthralgia (≥13%).
  • Vaccination with Bexsero may not provide protection against all meningococcal serogroup B strains.
  • Vaccination with Bexsero may not result in protection in all vaccine recipients.

View full Prescribing Information.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2015. 


1 Bexsero Summary of Product Characteristics https://www.medicines.org.uk/emc/medicine/28407

2In line with the recommendations made by the Joint Committee on Vaccination and Immunisation, (JCVI). JCVI position statement on use of Bexsero® meningococcal B vaccine in the UK. March 2014. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/294245/JCVI_Statement_on_MenB.pdf

3WHO factsheet: http://www.who.int/mediacentre/factsheets/fs141/en/

4Viner RM, et al. Lancet Neurol. 2012;11:774-783

5Watson PS, Turner DPJ. Clinical experience with the meningococcal B vaccine, Bexsero®: Prospects for reducing the burden of meningococcal serogroup B disease. Vaccine 34 (2016) 875–880 http://dx.doi.org/10.1016/j.vaccine.2015.11.057

*SPC : http://www.medicines.org.uk/emc/medicine/28407/SPC/Bexsero+Meningococcal+Group+B+vaccine+for+injection+in+pre-filled+syringe/ Last accessed September 2016