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Novartis Bexsero® meningitis B vaccine receives clinical recommendation for use in infants and adolescents in Australia

Posted: 13 March 2014 | | No comments yet

Novartis has announced that Australia has joined the growing number of countries where following licensure, Bexsero® has received a clinical recommendation…

Novartis
  • Australian recommendation adds to clinical recommendations in the Czech Republic, Poland and funding decisions in regions of Germany and Italy
  • Recommendations highlight support for inclusion of Bexsero on routine childhood immunization schedules to help protect against this devastating disease
  • Bexsero is licensed in the EU, Canada and Australia, and has been available privately since 2013 with more than 500,000 doses shipped to date1,2,3,4,5

Novartis has announced that Australia has joined the growing number of countries where following licensure, Bexsero® (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) has received a clinical recommendation for the vaccine’s routine use to help protect against meningitis B. These recommendations follow recent access milestones for Bexsero in multiple regions across Europe, including some regions of Italy and Germany. Bexsero is the only broad coverage vaccine to help protect against meningitis B, a potentially deadly disease that disproportionately affects infants and adolescents6,7.

Australia’s advisory body on immunization matters, the Australian Technical Advisory Group on Immunisation (ATAGI), has recommended Bexsero for all young Australians, with an emphasis on infants and children under 2 years of age and adolescents 15-19 years of age8. Inclusion in the National Immunisation Program is under consideration.

In Europe, Bexsero continues to gain endorsements from health authorities and experts:

In Italy, the Basilicata region recommends Bexsero for the routine vaccination of infants and will have an active call to parents that includes providing the vaccine free of charge. The Board of Calendario per la Vita, comprised of the country’s foremost scientific societies, has recommended Bexsero for all infants with three doses in the first year of life and one dose at 13 months of age9.

In Germany, more than 35 statutory sickness funds (semi-public health insurance providers) have chosen to voluntarily reimburse Bexsero for all children (ages 2 months to 18 years). Bexsero is also recommended by the German Academy of Child and Adolescent Medicine (DAKJ), a leading pediatric association10,11.

Poland has a clinical recommendation for routine vaccination with Bexsero for infants, children and adolescents (starting at 2 months of age)12.

In addition, the Czech Vaccinology Society has recommended vaccination with Bexsero for infants, toddlers and children (ages 2 months to 10 years), adolescents (ages 13-15 years) and other high-risk individuals13.

“For a vaccine-preventable disease, every child lost or disabled is one too many,” said Andrin Oswald, Division Head, Novartis Vaccines. “These regional milestones are a testament to the public health benefits of Bexsero and we are hopeful that governments around the world will continue to act with a sense of urgency to help protect those most vulnerable from the devastation of meningitis B.”

Meningitis B is a rare but aggressive and often deadly disease; it is the leading cause of meningococcal disease and septicemia in the developed world6,14. Meningitis B can kill or cause serious life-long disabilities within 24 hours of onset, leaving little time for intervention14. Vaccination is therefore the best defense against this aggressive disease.

Bexsero is the only licensed broad coverage vaccine approved in the European Union, Canada and Australia to help protect against meningitis B, and has been available privately since 2013 with more than 500,000 doses shipped to date1,2,3,4,5. Bexsero was also recently provided to students at Princeton University and the University of California Santa Barbara (UCSB) in the United States (US) under a treatment Investigational New Drug (IND) designation from the US Food and Drug Administration (FDA), which was issued in response to meningitis B outbreaks on these campuses15,16. To date, over 30,000 doses of Bexsero have been distributed in the US17.

References

  1. EMA. Authorization Details for Bexsero. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002333/human_med_001614.jsp& mid=WC0b01ac058001d124. Accessed March 2014.
  2. EMA. EU Member States. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000219.jsp&mid=WC0b01ac058003174e. Accessed March 2014.
  3. Health Canada. Bexsero. 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.
  4. Australian Government: Department of Health: Therapeutic Goods Administration. Available at: http://www.tga.gov.au/pdf/auspar/auspar-meningococcal-131031.pdf. Accessed March 2014.
  5. Novartis Data on File.
  6. World Health Organization. Meningococcal Meningitis. Fact sheet 141. November 2012. Available at: http://www.who.int/mediacentre/factsheets/fs141/en/index.html. Accessed March 2014.
  7. Cohn, A. et al. Changes in Neisseria meningitides Disease Epidemiology in the United States, 1998-2007: Implications for Prevention of Meningococcal Disease. Clinical Infectious Diseases 2010:50. Accessed March 2014.
  8. Australian Technical Advisory Group on Immunisation. Advice for immunisation providers regarding the use of Bexsero. http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/85A6879534C02B4DCA257B640002F38E/$File/ATAGI-advice-bexsero.pdf. Accessed March 2014.
  9. Proposta del Board del ‘Calendario per la Vita’ (Sltl, SIP, FIMP e FIMMG) sull’inserimento del vaccine anti-meningococco B nel calendario delle vaccinazioni dell’infanzia. Available at: http://www.panoramasanita.it/docs/documentocongiuntositifimpsipfimmg.pdf. Accessed on March 2014.
  10. Novartis Data on File.
  11. Deutsche Akademie fur Kinder – und Jugendmedizin E.V. Impfprophylaxe invasiver Erkrankungen mit Meningokokken der Serogruppe B. Available at: http://dakj.de/media/stellungnahmen/infektionskrankheiten-impffragen/2013-meningokokkenB-impfprophylaxe.pdf. Accessed March 2014.
  12. Poland Ministry of Health. W sprawie Programu Szczepien Ochronnych na rok 2014. http://www.gis.gov.pl/ckfinder/userfiles/files/EP/informacje%20dla%20podr%C3%B3%C5%BCuj%C4%85cych/PSO%202014.pdf. Accessed March 2014.
  13. Novartis Data on File.
  14. World Health Organization. Bacterial Meningitis. Available at: http://apps.who.int/nuvi/meningitis/en/. Accessed March 2014.
  15. 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.
  16. 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.
  17. Novartis Data on File.

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