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TGA Approves Meningococcal Vaccine MENVEO® for Infants from Two Months

First and only combination vaccine approved to help protect infants from two months of age from A, C, W, Y strains1
GSK increases supply as cases of meningococcal W strain rise in Australia2
Survey of parents shows low awareness of strains and reliance on healthcare professionals3

GSK Australia today announced MENVEO® (meningococcal ACWY oligosaccharide conjugate vaccine) has received Therapeutics Goods Administration (TGA) approval for use in younger age groups1.

This is the first time a combination vaccine for the meningococcal strains A, C, W and Y has been approved for infants aged two months and above1.

MENVEO® is now approved for active immunisation of infants (from two months of age) and children to prevent invasive disease caused by Neisseria meningitidis serogroups A, C, W135 and Y1.

The vaccine can also be used in adolescents and adults to help protect against the four strains of meningococcal disease contained in the vaccine1.

Meningococcal bacteria can infect anyone, however infants less than one year and children (under five) are most at risk of disease.

Children up to the age of five accounted for 20% of meningococcal cases in Australia in 20162.

The disease can be deadly or lead to serious long-term disabilities, including brain damage, deafness, and limb loss3,4.

Bishoy Rizkalla, Acting Medical Director GSK Vaccines said: “The TGA decision is welcome news for parents who want to vaccinate their young infants against a broad range of meningococcal strains. We have increased supply to ensure parents in Australia who want to vaccinate their children can access MENVEO® as a private prescription item.”

“It’s important that parents talk to their healthcare professional about any vaccination decision regarding their children,” said Dr Rizkalla.

A recent survey5 of parents with young children showed the important role GPs, nurses, pharmacists play in alerting people to meningococcal disease and vaccination options.

Almost half (43%) of parents with young children surveyed rely on their doctor for information about vaccinations.

However, nearly a quarter (24%) of parents did not know that there is more than one strain causing meningococcal disease in Australia5.

Furthermore over a third (36%) had no idea if additional vaccinations to those provided by the Government were available to their child or not5.

Dr Rizkalla said: “Our research suggests that parents need support with meningococcal disease and vaccination options. GPs, nurses and pharmacists are best placed to provide qualified information so parents feel comfortable in making informed health decisions for their children.”

“Protection against different meningococcal strains is important given that dominant circulating strains can change. In 2017, the B strain is still the most prevalent in babies under one, however meningococcal disease is unpredictable and in recent years an emergence of the W and Y strains across all age groups has created a need for a vaccine to help protect babies against these strains6,7.”

Overall incidence of invasive meningococcal disease in Australia has decreased since the introduction of the meningococcal C vaccine on the National Immunisation Program in 20032,7. However, the number of cases due to serogroup W have increased since 20136,7.

A total of 109 cases of meningococcal W were reported to the National Notifiable Diseases Surveillance System (NNDSS) in 20167.

Professor Robert Booy, infectious diseases expert, Sydney University, said the vaccine is an important option for Australians wanting to help protect themselves and their children from meningococcal strains A, C, W and Y.

He said: “Notifications of meningococcal usually peak in late winter and early spring, so today’s announcement is timely and gives parents the option to protect their children from this potentially devastating condition.”

“Protection against multiple strains is important as multiple strains are circulating and the predominance of strains can change over time”.

Healthcare professionals who would like further information about the MENVEO® vaccine should contact GSK medical information on 1800 033 109.
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About Meningococcal Disease

Meningococcal disease is a bacterial infection of the blood and/or membranes that line the spinal cord and brain.

The disease can lead to death within 24 hours if not recognised quickly and treated in time3,4.

Up to one in ten of those infected with meningococcal disease may die3 and around one in five will suffer from serious long-term disabilities, including brain damage, deafness, and limb loss 3,4.

There are six main strains that most commonly cause meningococcal disease (A, B, C, W, X & Y)4. In Australia, strains B, W and Y currently cause the majority of meningococcal cases6,7.

Vaccines are available in Australia to help protect against strains A, C, W, Y and B.

In 2016, reported cases of meningococcal disease in Australia were caused by strain W (42%), strain B (35%), strain Y (16%), strain C (1%) and other strains (6%)6.

Overall, there has been a decline in cases since the 2003 introduction of the Men C vaccine on the National Immunisation Program2,7.


References
1. MENVEO Product Information
2. Australian Government Department of Health. National Notifiable Diseases Surveillance System (NNDSS). http://www9.health.gov.au/cda/source/cda-index.cfm [accessed August 2017]
3. Australian Technical Advisory Group on Immunisation (ATAGI). Australian Immunisation Handbook 10th Edition (2017 update). Canberra.
4. WHO Meningococcal Fact Sheet. http://www.who.int/mediacentre/factsheets/fs141/en/
5. Data on file. Ipsos. Meningococcal Consumer Perceptions 2017. May, 2017. Information derived from an online questionnaire of 1,000 parents with children under the age of four, conducted by Ipsos on 5-12 May 2017 AUS/VAC/0047/17. The purpose of the questionnaire was to collect information on Australian parent’s habits and perceptions on vaccination, meningococcal disease and general child health concerns.
6. Department of Health. Annual Reports from the Australian Meningococcal Surveillance Programme. http://www.health.gov.au/internet/main/publishing.nsf/content/cda-pubs-annlrpt-menganrep.htm [accessed August 2017]
7. Australian Government Department of Health. Meningococcal W disease http://www.health.gov.au/internet/main/publishing.nsf/Content/ohp-meningococcal-W.htm

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