Flu vaccine: 2016 seasonal influenza vaccines for use in children

From the age of 6 months

For the 2016 influenza season, the following trivalent and quadrivalent influenza vaccines will be registered and available for use in children from the age of 6 months:

• BGP Products – Influvac (trivalent)
• GlaxoSmithKline – Fluarix (trivalent)
• Sanofi-Pasteur – FluQuadri Junior (quadrivalent)

From the age of 3 years

For the 2016 influenza season, in addition to the trivalent vaccines mentioned above, the following quadrivalent influenza vaccines will be registered and available for use in children from the age of 3 years:

• GlaxoSmithKline – Fluarix Tetra (quadrivalent)
• Sanofi-Pasteur – FluQuadri (quadrivalent)

From the age of 5 years

For the 2016 influenza season, in addition to the vaccines mentioned above, the following trivalent influenza vaccine will be registered and available for use in children from the age of 5 years:

• Seqirus (formerly bioCSL) – Fluvax (trivalent)

The Seqirus Fluvax vaccine is not approved by the TGA for use in children under the age of 5 years because of an increased risk of fever and febrile convulsions.

While Seqirus Fluvax is registered for use in patients aged 5 years and over, febrile events have been observed in children aged 5 to under 9 years after immunisation with this product. Therefore, use of this vaccine is not recommended for children aged under 9 years. A decision to vaccinate with the 2016 Seqirus Fluvax vaccine in children aged 5 to under 9 years should be based on careful consideration of potential benefits and risks in the individual.

The Product Information for Seqirus Fluvax contains the following black box warning:

WARNING: This season’s vaccine is indicated for use only in persons aged 5 years and over. It must not be used in children under 5 years (see Contraindications). It should only be used in children aged 5 to under 9 years based on careful consideration of potential risks and benefits in the individual (see Precautions).

In addition to the black box warning Seqirus Fluvax will have the following warnings on all sides of the packaging:

The following vaccine refrigerator warning sticker will also be distributed by Seqirus and available to providers for use during the 2016 influenza season:

Vaccine strains for 2015

Following a review of the strains of influenza that were circulating in Australia and the Southern Hemisphere, the Australian Influenza Vaccine Committee (AIVC) recommended that the TGA should adopt the September 2015 World Health Organization recommendations for the strains to be covered by the 2016 seasonal influenza vaccines. Details of the strains were announced on the TGA website on 15 October 2015.

There are two categories of influenza vaccines available:

• vaccines that protect against three strains of the virus (known as trivalent influenza vaccines)
• vaccines that protect against four strains of the virus (known as quadrivalent influenza vaccines).

Trivalent vaccines include two influenza A strains and one B strain. The quadrivalent vaccines contain the same strains as the trivalent vaccines with the addition of a second influenza B strain.

For further information on individual vaccines, please refer to the relevant Product Information document or Consumer Medicine Information document.

In conjunction with the Office of Health Protection and state and territory health authorities, the TGA will be closely monitoring adverse event reports during the 2016 influenza vaccination program.

The 2016 National Seasonal Influenza Immunisation Program  will start from April 2016.

Reporting of adverse events following influenza vaccine

Health professionals and consumers are encouraged to report all adverse events associated with influenza vaccination in patients of any age to the TGA or through the current arrangements in their State or Territory.

All reports contribute to the TGA’s ongoing monitoring of the safety of influenza vaccines.

The TGA cannot give advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a vaccine or medicine.

(Source: Australian Government – Department of Health)