UK recommends Novartis Bexsero® vaccine for inclusion in National Immunisation Programme to help protect against devastating meningitis B

Novartis announced today that the Joint Committee on Vaccination and Immunisation (JCVI) in the UK has recommended the inclusion of Bexsero® (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) in the National Immunisation Programme^1. According to the recommendation, Bexsero should be routinely used in infants from two months of age to help protect against meningococcal serogroup B (meningitis B)¹. The implementation will be carried out by the Department of Health through the National Health Service (NHS), following the public procurement process.

“Today’s decision by the UK authorities brings tremendous relief to many parents and families who have lost loved ones to meningitis,” said Andrin Oswald, Division Head, Novartis Vaccines. “At Novartis, it took us over 20 years of hard work to get to this point. Protecting infants who are the most vulnerable will be a great achievement. It is also a strong motivator for us to continue our efforts to protect all children and adolescents against this devastating disease, in the UK and elsewhere in the world.”

Meningitis B is a rare but aggressive and often deadly disease³; it is the leading cause of meningococcal disease and septicemia in Europe². Meningitis B can kill or cause serious life-long disabilities within 24 hours of onset, leaving little time for intervention³. Like infants, adolescents are also at an increased risk for contracting meningitis and have a high fatality rate from the disease^4,5. Approximately 3,200 people in the UK are affected by bacterial meningitis and septicemia each year, with meningitis B responsible for more than half of those cases⁶. Vaccination is therefore the best defense against this aggressive disease.

“I applaud the JCVI for taking the right decision to make this life-saving vaccine available to babies and am delighted that the UK is once again leading the way in meningococcal disease prevention. However I would urge that toddlers and adolescents should also be offered protection,” said Dr Nelly Ninis, Consultant Pediatrician, London. “No child should suffer the devastation of a preventable disease, especially one that can be fatal within hours, and leave many of its survivors maimed and impacted for life.”

Bexsero is the only licensed broad coverage vaccine approved in Europe, Canada and Australia for all vulnerable age groups from two months to help protect against meningitis B^7,8,9. It was also approved for use in the US under a treatment Investigational New Drug (IND) designation as part of vaccination programs at Princeton University and the University of California Santa Barbara (UCSB)^10,11. The recent outbreaks of meningitis B in the US demonstrate the dynamic and unpredictable nature of this disease and the need for broad coverage protection through vaccination¹². Novartis continues to work with health authorities around the world where meningitis B remains an unmet public health need to support broad and timely access to the vaccine.

References

1. JCVI position statement on use of Bexsero® meningococcal B vaccine in the UK: March 2014.
2. ECDC European Centre for Disease Prevention and Control. Annual epidemiological report 2012. Invasive meningococcal disease. Available at: http://ecdc.europa.eu/en/publications/Publications/Annual-Epidemiological-Report-2012.pdf. Accessed March 2014.
3. World Health Organization. Meningococcal meningitis factsheet. Nov 2012. Available at: http://www.who.int/mediacentre/factsheets/fs141/en/. Accessed March 2014.
4. Health Protection Agency. Epidemiological data. Available at: www.hpa.org.uk/Topics/InfectiousDiseases/InfectionsAZ/ MeningococcalDisease/EpidemiologicalData/. Accessed March 2014.
5. Harrison et al, Invasive Meningococcal Disease in Adolescents and Young Adults. Journal of the American Medical Association. August 2001, Vol 286, No. 6 Available at: http://jama.jamanetwork.com/article.aspx?articleid=194084. Accessed March 2014.
6. Meningitis Research Foundation, Meningitis and Septicaemia UK Facts & Figures. Available at: http://www.meningitis.org/facts. Accessed March 2014.
7. Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]). Summary of Product Characteristics (SmPC). 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002333/WC500137881.pdf. Accessed March 2014.
8. Summary Basis of Decision (SBD): Bexsero – 2014 – Health Canada. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_bexsero_147275-eng.php. Accessed March 2014.
9. Australian Public Assessment Report for Multi-Component Meningococcal B vaccine. Available at: http://www.tga.gov.au/pdf/auspar/auspar-meningococcal-131031.pdf. Accessed March 2014.
10. Centers for Disease Control and Prevention. Princeton University Meningococcal Disease Outbreak. December 2013. Available at: http://www.cdc.gov/meningococcal/outbreaks/princeton.html. Accessed March 2014.
11. Centers for Disease Control and Prevention. University of California, Santa Barbara Meningococcal Disease Outbreak. January 2014. Available at: http://www.cdc.gov/meningococcal/outbreaks/ucsb.html. Accessed March 2014.
12. Harrison LH, Trotter CL, Ramsay ME. Global epidemiology of meningococcal disease. Vaccine. 2009;27 Suppl 2:B51-B63.