TGA approves MENVEO® vaccine to help protect babies from two months old from meningococcal disease

First ACWY combination vaccine available for use in infants under 12 months old, most at risk from meningococcal disease

GSK Australia today announced that MENVEO® is the first combination vaccine for meningococcal strains A, C, W and Y to receive Therapeutics Goods Administration (TGA) approval for use in babies aged from two months1.

MENVEO® (meningococcal ACWY oligosaccharide conjugate vaccine) is now approved for active immunisation of infants (from two months of age) and children to prevent invasive disease caused by the bacteria 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.

Although rare, meningococcal disease can be devastating. Infants less than one year and children (under five) are most at risk. Children up to the age of five accounted for 20% of meningococcal cases in Australia in 20162. Up to one in ten of those infected with meningococcal disease may die3 and around one in five may suffer from serious long-term disabilities, including brain damage, deafness, and limb loss3,4.

Professor Robert Booy, infectious diseases expert, Sydney University, said: “Notifications of meningococcal disease usually peaks in late winter and early spring, so today’s announcement is timely and gives parents a TGA-approved combination ACWY vaccine option to help protect their babies from this potentially devastating condition.”

“Vaccination against meningococcal disease is effective and should be encouraged. Protection against multiple strains is important, as the most common strains can change over time,” said Professor Booy.

The B, W and Y strains cause the majority of meningococcal cases in Australia5,6. In 2017, the B strain remains the most prevalent in babies, however an emergence of the W strain has created a need for a vaccine to help protect babies against this strain5,6.

Overall incidence of invasive meningococcal disease in Australia has decreased since the introduction in 2003 of the meningococcal C vaccine on the National Immunisation Program2. However, the total number of meningococcal cases from any strain has increased since 20132 with a total of 109 cases of meningococcal W reported to the National Notifiable Diseases Surveillance System (NNDSS) in 20165.

Eliza Ault-Connell, Director, Meningococal Australia said: “Vaccination is the best protection parents can give their children against meningococcal disease. It’s a devastating disease that can affect anyone, but the toll on the lives of infants and young people can be especially heartbreaking.”

“Meningococcal disease can appear suddenly and the signs are often difficult to recognise. All parents should familiarise themselves with the symptoms, such as a distinctive rash, sensitivity to light and a high fever. But we urge parents to speak to their GP about preventative vaccines.”

Chairman of Meningitis Centre Australia Bruce Langoulant welcomed the new TGA indication and said it was another positive step forward in providing more children with access to meningococcal vaccines.

“We are currently leading a nationwide push to ensure more people, including babies, are vaccinated against meningococcal disease. This latest TGA indication shows the momentum is with us and we hope more adults and those with small children talk to their doctor about protection against this devastating disease.”

MENVEO® is not on the National Immunisation Program. Those wanting more information about vaccination for meningococcal disease for themselves or dependents should speak to their healthcare professional.

Bishoy Rizkalla, Acting Medical Director, GSK Vaccines said: “The TGA decision is welcome news for parents who want to vaccinate their young infants against the meningococcal strains contained in MENVEO®. We are meeting the increased demand for this vaccine so parents have the option to help protect against multiple meningococcal strains as a private prescription item.”

 

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 time4. Up to one in ten of those infected with meningococcal disease may die3 and around one in five may suffer from serious long-term disabilities, including brain damage, deafness, and limb loss3,4.

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 cases5,6.

Vaccines are available in Australia to help protect against the main disease-causing strains.

 

About MENVEO®

MENVEO® may have unwanted side effects in a few people. The most common side effects include redness, firmness, and/or pain at the injection site, fever, chills, malaise, rash, headaches, muscle ache, joint ache, and nausea. Before receiving MENVEO® tell your doctor about any of the following: if you/your child has allergies to other medicines or latex, if you/your child has had previous reactions after other vaccinations, if you have/your child has an infection or high temperature, if you/your child has experience fainting or stress-related reactions in response to any needle injection, if you/your child has any medical conditions (including immune deficiency conditions, allergies or allergic reactions, a low blood platelet count), if you are pregnant or intend to become pregnant soon, if you are breastfeeding, if you / your child is taking other medicines including non-prescription medicines, if you or your child has been vaccinated recently. Your doctor or pharmacist may have more information on medicines and vaccines that require special precautions or should be avoided during vaccination with MENVEO®.

For further information about MENVEO® please speak to your healthcare professional or review the Consumer Medicine Information (CMI) available at www.gsk.com.au/menveo.

MENVEO® is not available on the National Immunisation Program (NIP) or the Pharmaceutical Benefit Scheme (PBS). MENVEO® is available as a private prescription.

 

Additional notes:

The information contained within this media release does not contain all the available information. It does not take the place of talking to healthcare professionals. Please speak to your healthcare professional for further information about MENVEO®.

 

ENDS

 

MEDIA CONTACTS:

For further information please call Ben Seal (0402 386 392 / ben@palin.com.au) or Martin Palin (0418 419 258 / martin@palin.com.au) at Palin Communications on 02 9412 2255.

GSK – Madeleine Breckon on 0477 322 431

 

About GSK

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.au.  

 

If you are an Australian healthcare professional please visit www.health.gsk.com for more information on Fluarix Tetra.

You can follow GSK on Twitter for more Australian updates @GSK_AU.If you are an Australian healthcare professional please visit www.health.gsk.com for more information on GSK vaccines.

 

You can follow GSK on Twitter for more Australian updates @GSK_AU.

 

Disclosures

GlaxoSmithKline Australia Pty Ltd. Melbourne, VIC. ABN 47 100 162 481. MENVEO is a registered trademark of the GSK group of companies. AUS/MNV/0009/17 Date of Approval: September 2017.

In relation to this GSK media announcement, no honorarium was provided to Professor Booy. He has been briefed by GSK on the approved use of the product.

References

  1. MENVEOProduct 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. Australian Government Department of Health. Meningococcal W disease http://www.health.gov.au/internet/main/publishing.nsf/Content/ohp-meningococcal-W.htm
  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]

 

This media release has been issued by Palin Communications on behalf of GSK.