Novartis vaccine Bexsero® approved in Australia to help protect against MenB disease

Novartis announced today that the Australian Therapeutic Goods Administration (TGA) has added Bexsero®, a multi-component Meningococcal B (MenB) vaccine (recombinant, adsorbed) suspension for injection 0.5 ml pre-filled syringe, to the Australian Register of Therapeutic Goods (ARTG) for use in individuals from two months of age and older[6]. Bexsero is the first and only broad coverage vaccine to help protect all age groups against MenB disease, including infants who are at the greatest risk of infection[7],[8].

Across Australia, approximately 85 percent of all meningococcal disease and sepsis cases have been caused by MenB, a percentage that has risen in recent years as the number of cases in other serogroups has fallen[3],[5]. The introduction of vaccines for other strains of bacterial meningitis has been successful in reducing the disease burden in Australia; specifically, following the rollout of a national meningococcal serogroup C vaccination program in Australia, cases decreased from 162 in 2002 to nine by 2011[3],[5].

“Novartis welcomes the Australian health authorities’ decision to license Bexsero, which is further testament to the vaccine’s demonstrated robust efficacy and safety profiles and an important step in preventing further suffering caused by MenB disease,” said Andrin Oswald, Division Head, Novartis Vaccines and Diagnostics. “We are committed to bringing Bexsero to parents around the globe that want to protect their children against this devastating disease.”

MenB is a potentially deadly disease which is easily misdiagnosed and can kill within 24 hours of onset. About one in 10 of those who contract the disease will die despite appropriate treatment. Up to one in five survivors may suffer from devastating, life-long disabilities such as brain damage, hearing impairment or limb loss[4]. The consequences for those affected and the healthcare system are significant[9].

“Today marks another victory, particularly for Australian children, parents and pediatricians, in the fight against meningococcal disease,” said Bruce Langoulant, President and Asia Pacific Regional Leader, Confederation of Meningitis Organisations. “We are now entering a critical period for public health authorities to provide funding to include the new MenB vaccine in the routine immunization schedules to ensure community-wide protection against the tragic deaths and lasting disabilities MenB can cause.”

As a next step, Novartis will work with Australian regulatory authorities to make doses of Bexsero available in the private market in the coming months. In parallel, the Pharmaceutical Benefits Advisory Committee (PBAC), taking into account advice from the Australian Technical Advisory Group on Immunisation (ATAGI), is expected to make recommendations regarding reimbursement and potential inclusion of Bexsero in the National Immunisation Program (NIP)[10],[11].

In January 2013, Bexsero received marketing authorization from the European Commission which applies to all 28 European Union (EU) member states, Iceland, Liechtenstein and Norway[1],[2]. With this TGA decision, Bexsero is now licensed in more than 30 countries and further regulatory filings are underway.

Meningococcal disease is a leading cause of bacterial meningitis. Five main groups of meningococcal bacteria (A, B, C, W-135 and Y) cause the majority of all cases around the world[12]. Prior to Bexsero, vaccines were available to help protect only against A, C, W-135 and Y[4].

Bexsero Important Safety Information

Hypersensitivity to the active substances or to any excipients of Bexsero is a contraindication to administration. Administration of Bexsero should be postponed in subjects suffering from an acute severe febrile illness. Minor infection, such as cold, should not result in the deferral of vaccination.

There are no data on the use of Bexsero in individuals above 50 years of age, in patients with chronic medical conditions or in individuals with impaired immune responsiveness. In immunocompromised individuals, vaccination may not result in a protective antibody response. Insufficient clinical data on exposed pregnancies are available and there are no data on fertility in humans.

Bexsero is not expected to provide protection against all circulating meningococcal group B strains.

The most common adverse reactions observed in clinical trials of infants were tenderness and erythema at the injection site, fever, and irritability. Fever occurred more frequently when Bexsero was co-administered with other routine infant vaccines than when it was given alone.

When Bexsero was given alone, the frequency of fever was similar to that associated with routine infant vaccines administered during clinical trials. When fever occurred, it generally followed a predictable pattern, with the majority resolving by the day after vaccination.

The safety profiles of the co-administered vaccines were unaffected by concomitant administration of Bexsero with the exception of more frequent occurrence of fever, tenderness at the injection site, change in eating habits and irritability. Prophylactic use of paracetamol reduces the incidence and severity of fever without affecting the immunogenicity of either Bexsero or routine vaccines.

In adolescents and adults the most common local and systemic adverse reactions observed were pain at the injection site, malaise and headache.

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 August 7, 2013.
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 August 7, 2013.
3. Australian Meningococcal Surveillance Program Annual Report 2002. Available at: http://www.health.gov.au/internet/main/publishing.nsf/Content/cda-pubs-annlrpt-menganrep.htm. Accessed August 7, 2013.
4. World Health Organization. Meningococcal meningitis. Fact sheet #141. November 2012. Available at: http://www.who.int/mediacentre/factsheets/fs141/en/. Accessed August 7, 2013.
5. Australian Meningococcal Surveillance Program Annual Report 2011. Available at: http://www.health.gov.au/internet/main/publishing.nsf/Content/cda-pubs-annlrpt-menganrep.htm. Accessed August 7, 2013.
6. Bexsero Prescribing Information.
7. Novartis Bexsero EU Approval Press Release. Available at: http://www.novartis.com/newsroom/media-releases/en/2013/1672036.shtml. Accessed August 7, 2013.
8. Rosenstein, NE. et al. Meningococcal disease. N Engl J Med. 2001. 344:1378-1388. Available at: http://www.nejm.org/doi/full/10.1056/NEJM200105033441807. Accessed August 7, 2013.
9. Wright, Claire et al. Counting the Cost of Meningitis: A severe case of bacterial meningitis. Meningitis Research Foundation. 2011. Available at: http://www.meningitis.org/assets/x/53379. Accessed August 7, 2013.
10. Pharmaceutical Benefits Advisory Committee. Available at: http://www.pbs.gov.au/info/industry/listing/elements/pbac-guidelines/a-part-1/section-1. Accessed August 7, 2013.
11. Australian Government Department of Health. Immunisation Advisory Bodies. Available at: http://www.health.gov.au/internet/immunise/publishing.nsf/Content/advisory-bodies. Accessed August 7, 2013.
12. Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book: Course Textbook). 12th Edition, 2nd printing. May 2012 update. Available at: http://www.cdc.gov/vaccines/pubs/pinkbook/mening.html. Accessed August 7, 2013.