Clinical advice for immunisation providers regarding the administration of 2013 trivalent seasonal influenza vaccines March 2013

Australian Technical Advisory Group on Immunisation (ATAGI) Statement

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Introduction

Influenza is an important vaccine-preventable disease which causes illness in people of all ages. Annual influenza vaccination is necessary to maintain immunity to influenza.

The H1N1 pandemic influenza virus strain, A(H1N1)pdm09, which was in the southern hemisphere trivalent seasonal influenza vaccine during 2010, 2011 and 2012, is again incorporated in the 2013 seasonal trivalent influenza vaccine.

The second influenza A strain and the influenza B strain will, however, be changed from previous years. The 2013 southern hemisphere trivalent seasonal influenza vaccine will include:

• A/California/7/2009 (H1N1)-like virus, 15 µg haemagglutinin (HA) per 0.5 mL dose
• A (H3N2): an A/Victoria/361/2011 (H3N2)-like virus, 15 µg HA per 0.5 mL dose
• B/Wisconsin/1/2010-like virus, 15 µg HA per 0.5 mL dose

This document provides recommendations for the use, except where otherwise contraindicated, of the inactivated trivalent seasonal influenza vaccines that are available in Australia in 2013. The vaccines recommended differ by age, as described below.

Trivalent seasonal influenza vaccines approved by the Therapeutic Goods Administration (TGA) for 2013

There are six seasonal influenza vaccines approved by the TGA for use in Australia in 2013. Of these, Agrippal^® (Novartis), Fluarix^® (GlaxoSmithKline), Influvac^® (Abbott) and Vaxigrip^® (Sanofi) are approved for use in persons aged 6 months and older.

Fluvax^® (CSL) is approved for use in persons 5 years and older; however, the Product Information for Fluvax (CSL) indicates that this vaccine should only be used in children aged 5 to 9 years based on careful consideration of potential benefits and risks to the individual.

Fluvax^® (CSL) is not approved by the TGA for use in children under 5 years of age in 2013 and must not be given to this age group.

Intanza^® (Sanofi: 9 µg per strain per 0.1 mL dose for intradermal administration) is approved only for adults aged 18 to 59 years. (See also the TGA Statement on 2013 Seasonal Influenza Vaccines at Therapeutic Goods Administration website).
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General ATAGI recommendations for influenza vaccination of children and adults

1. Annual influenza vaccination is strongly recommended for persons in the following groups because they are at an increased risk of influenza complications. Persons in these categories are able to obtain influenza vaccine under the National Immunisation Program (NIP) (Note: NIP-funded influenza vaccines for 2013 are Fluarix, Fluvax and Vaxigrip):
   • persons aged 65 years and older;
   • persons aged 15 years and older who identify as Aboriginal or Torres Strait Islander;
   • persons aged 6 months and older with specified medical conditions that put them at increased risk of influenza complications (see Appendix, Table 2, and notes below regarding influenza vaccines recommended for use in children less than 10 years of age); and
   • pregnant women.
2. Children aged 6 months to less than 10 years require two doses of seasonal influenza vaccine if they have not received two doses of seasonal influenza vaccine in any previous year(s). There should be a minimum interval of 4 weeks between the first dose and second dose.
3. Annual influenza vaccination is strongly recommended for any adult or child (over 6 months of age) who wishes (or whose parents wish them) to be protected against influenza. Seasonal influenza vaccination is not funded under the NIP for non-Indigenous people under 65 years of age who do not have a medical condition or other risk factors (see Appendix, Table 2) that place them at increased risk of influenza complications. Influenza vaccine can be obtained by private prescription.
4. Annual influenza vaccination is also strongly recommended for all household contacts and other close contacts of children and adults with a medical condition that puts them at increased risk of influenza complications.¹ Seasonal influenza vaccine is not funded under the NIP for this indication, but can be obtained by private prescription.
5. Influenza vaccination is recommended annually, even if a person has been vaccinated in any previous year(s) with an influenza vaccine that contains the same strains. This is because the immunity to influenza acquired by vaccination wanes rapidly.
6. All immunocompromised persons, irrespective of age, who receive influenza vaccine for the first time, are recommended to receive 2 vaccine doses, at least 4 weeks apart, and 1 dose annually thereafter.

Age-specific recommendations for influenza vaccination

Table 1 indicates which influenza vaccines are recommended for use by age, irrespective of whether they are NIP-funded or not. Information to support these recommendations is provided below.
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Table 1. ATAGI recommendations for the use of 2013 seasonal influenza vaccine by brand and age group

Age group	Fluvax	Agrippal	Fluarix	Influvac	Vaxigrip	Intanza (9 µg per strain)
≥6 months to <5 years	No	Yes	Yes	Yes	Yes	No
≥5 years to <10 years*	Note 1	Yes	Yes	Yes	Yes	No
≥10 years	Yes	Yes	Yes	Yes	Yes	Note 2

_{* The age limit of less than 10 years (rather than less than 9 years as stated in Product Information statements) is to maintain consistency with the existing ATAGI age-based recommendations for influenza vaccines, which state that two vaccine doses are required in the first year of seasonal influenza vaccine administration for all children aged less than 10 years.
Note 1: The use of Agrippal, Fluarix, Influvac or Vaxigrip in children aged 5 years to less than 10 years is strongly preferred; however, Fluvax may be used when no timely alternative vaccine is available and parents are informed of the potential increased risk of fever.
Note 2: Do not use in children. The 9 µg per strain formulation of Intanza is approved for use in adults aged 18 to 59 years only.}

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Children aged 6 months to less than 5 years

Children in this age group must not receive Fluvax (CSL). Fluvax (CSL) has not been registered for use in this age group since late 2010 because of unacceptably high rates of adverse events, specifically fevers and febrile convulsions, in children under 5 years of age who received Fluvax (CSL) in 2010. Four other influenza vaccines are recommended for use in this age group: Agrippal, Fluarix, Influvac and Vaxigrip. Available data indicate a low rate of fever attributable to vaccination with these four vaccines. None of them has been found to be associated with febrile convulsions above the expected rate of less than 1 per 1000 doses in this age group.^2-5

Children aged 5 years to less than 10 years

Children in this age group should preferably be given Agrippal, Fluarix, Influvac or Vaxigrip, rather than Fluvax. One randomised controlled trial in the USA identified that children aged up to less than 9 years who were vaccinated with Fluvax (known as Afluria in the USA) also experienced higher rates of fever than children given another influenza vaccine brand.^6,7 The available data have not indicated any increased association with fever or febrile convulsions following vaccination with Agrippal, Fluarix, Influvac and Vaxigrip in this age group. However, as complications of fever, such as febrile convulsions, are rare in this age group, the use of Fluvax can be considered in children aged 5 to less than 10 years if it is the only available brand of vaccine and parents are informed of the increased risk of fever.

Persons aged 10 years and older

Any of the available 2013 seasonal influenza vaccines (Agrippal, Fluarix, Influvac, Vaxigrip or Fluvax) can be administered to persons in this age group, except for Intanza (9 µg per strain per dose) which can only be used in adults aged 18 to 59 years. The 2011 joint ATAGI/TGA Influenza Vaccine Safety Working Group identified a possible modest increased risk for adverse events in children aged 10 years and older and adults who received Fluvax in 2010 and 2011.⁸ This was most marked for the 2010 vaccine and the available evidence primarily indicated an increased risk of injection site, but not systemic, reactions. However, it was considered that the absolute rate of adverse events following Fluvax was within an acceptable range. The Working Group’s report is available on the Immunise Australia website.

Pregnant women

Influenza vaccination is strongly recommended for pregnant women and is funded under the NIP for this indication (see General ATAGI recommendations above). Influenza vaccination is safe at any stage of pregnancy and there is no preference for any influenza vaccine in pregnancy; all are considered acceptable for use in pregnant women.

Co-administration of influenza vaccines with other vaccines

Influenza vaccines can be administered concurrently with any other vaccines, including the 13-valent pneumococcal conjugate vaccine (13vPCV). There may, however, be a small increased risk of fever and febrile convulsions with the concurrent administration of inactivated influenza vaccine and 13vPCV in children aged 6 months to less than 5 years, especially those 12 to 24 months of age, compared with that if these vaccines were given separately. A study from the US Vaccine Safety Datalink surveillance system found the increased risk of febrile convulsions following concomitant administration of 13vPCV with the first dose of influenza vaccine to be relatively small (18 excess cases per 100 000 doses for those aged 6 to 59 months).⁹ However, providers should discuss this risk with parents, and the option of administering these two vaccines separately, with an interval of at least three days between them, can be offered as an alternative to concomitant administration.
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For more detailed background information on influenza, influenza vaccines and febrile convulsions, see previous ATAGI statements at Immunise Australia website.

How to report adverse events following immunisation

• Immunisation service providers and health professionals in all states and territories, except Tasmania, who have a concern regarding a patient who has experienced an adverse event following influenza vaccination (or any vaccine) should contact their relevant state or territory health department to report the adverse event.
• Tasmanian immunisation service providers and health professionals should directly report all suspected adverse reactions to the TGA.
• State/territory health departments should forward reports of suspected adverse reactions to the TGA.
• Parents/guardians or other persons who are worried about an adverse reaction following influenza vaccination (or any other vaccine) should contact their GP or usual immunisation provider. Alternatively parents/guardians or other persons wishing to report an adverse event following influenza vaccination (or any other medication, including vaccines) can contact the Adverse Medicines Events Line on 1300 134 237.
  This phone-in service, provided by the National Prescribing Service, is available for members of the general public who suspect they have experienced an adverse medicine event. The service forwards reports of suspected adverse reactions to the TGA.
• Alternatively, anyone can report an adverse event directly to the TGA through the ‘Report a problem’ link on the TGA website at Therapeutic Goods Administration website.

References

1. National Health and Medical Research Council. The Australian Immunisation Handbook. 10th ed. Canberra: Australian Government Department of Health and Ageing, 2013.
2. Therapeutic Goods Administration. Investigation into febrile reactions in young children following 2010 seasonal trivalent influenza vaccination. Status report as at 2 July 2010. Accessed 10 December 2012.
3. Therapeutic Goods Administration. Overview of vaccine regulation and safety monitoring and investigation into adverse events following 2010 seasonal influenza vaccination in young children; 8 October 2010. Accessed 10 December 2012.
4. Australian Government Department of Health and Ageing. ATAGI statement: Clinical advice for immunisation providers on resumption of the use of 2010 trivalent seasonal vaccines in children less than 5 years of age: 30 July 2010. Accessed 10 December 2012.
5. Armstrong PK, Dowse GK, Effler PV, et al. Epidemiological study of severe febrile reactions in young children in Western Australia caused by a 2010 trivalent inactivated influenza vaccine. BMJ Open 2011;1:e000016. doi:10.1136/bmjopen-2010-000016.
6. CSL Limited. Afluria, influenza virus vaccine 2010 [package insert]. 2010. Accessed 10 December 2012.
7. Update: Recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding use of CSL seasonal influenza vaccine (Afluria) in the United States during 2010–11. MMWR Morbidity and Mortality Weekly Report 2010;59:989-92. Accessed 10 December 2012.
8. Joint Australian Technical Advisory Group on Immunisation (ATAGI) and Therapeutic Goods Administration (TGA) Seasonal Influenza Vaccine Safety Ad Hoc Working Group. Review of data on the safety of seasonal influenza vaccines, particularly Fluvax (CSL Biotherapies) in adults and children >10 years. 2012. Accessed 10 December 2012.
9. Tse A, Tseng HF, Greene SK, et al. Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010–2011. Vaccine 2012;30:2024-31.

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Appendix: Information regarding influenza vaccine and the National Immunisation Program

NIP eligibility for seasonal influenza vaccine:

• All individuals aged 65 years and older;
• All Aboriginal and Torres Strait Islander peoples aged 15 years and older;
• Pregnant women; and

• Individuals aged 6 months and older with medical conditions predisposing to severe influenza, as stated in Table 2 below.

Table 2. Medical conditions that are associated with an increased risk of influenza disease complications and for which individuals are eligible for vaccination under the NIP*

Category	Vaccination strongly recommended but not limited to children with the following clinical conditions
Cardiac disease	Cyanotic congenital heart disease Congestive heart failure Coronary artery disease
Chronic respiratory conditions†	Severe asthma (for which frequent hospitalisation is required) Cystic fibrosis Bronchiectasis Suppurative lung disease Chronic obstructive pulmonary disease (COPD) Chronic emphysema
Chronic neurological conditions†	Hereditary and degenerative CNS diseases† (including multiple sclerosis) Seizure disorders Spinal cord injuries Neuromuscular disorders
Immunocompromising conditions	Immunosuppressive therapy due to disease or treatment (e.g. malignancy, transplantation, HIV and/or chronic steroid use) Asplenia or splenic dysfunction HIV infection
Diabetes and other metabolic disorders	Type 1 diabetes Type 2 diabetes Chronic metabolic disorders
Renal disease	Chronic renal failure
Haematological disorders	Haemoglobinopathies
Long-term aspirin therapy in children aged 6 months to 10 years	These children are at increased risk of Reye syndrome following influenza infection

^† Persons who have any condition that compromises the management of respiratory secretions and is associated with an increased risk of aspiration should be vaccinated.
# All immunocompromised persons, irrespective of age, who receive influenza vaccine for the first time, are recommended to receive 2 vaccine doses, at least 4 weeks apart, and 1 dose annually thereafter.
* NOTE: This list is adapted from The Australian Immunisation Handbook, 9^th edition. However, some of these groups are not currently included as eligible for vaccination under the NIP. Influenza vaccination is recommended, but not funded under the NIP, for persons with:

• Down syndrome, who do not have congenital heart disease or one of the other underlying medical conditions stated above
• Significant obesity defined as a BMI ≥ 30kg/m2 who do not have one of the underlying medical conditions stated above
• alcohol dependency requiring regular medical follow-up or hospitalisation in the preceding year.

See The Australian Immunisation Handbook, 10^th Edition, 2013 for further details.

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Page last modified: 21 March, 2013

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