CMO: Suspension of flu vaccine in children 5 yr and under - Updated 30 July 2010

26 August 2010

Australian Technical Advisory Group on Immunisation, updated advice on the use of pandemic and seasonal influenza vaccines in children <10 years of age This document replaces the ATAGI advice document ‘Use of pandemic and seasonal influenza vaccines in children <10 years of age’ published in March 2010.

Note: On 30 July 2010 the Chief Medical Officer announced the resumption of use of the 2010 trivalent seasonal influenza vaccines of either Influvac® (Abbott/Solvay) or Vaxigrip® (Sanofi Pasteur) in children less than 5 years of age. See latest CMO Advice for Health Professionals at www.immunise.health.gov.au

Summary of recommendations: (from Immunisation section, Department of Health)

  • From 26 August 2010, Panvax® Junior 0.25mL pre-filled syringes will no longer be available for use. The manufacturer has undertaken a voluntary withdrawal of remaining stock because of a reduction in vaccine antigen potency over time, related to a known issue with low dose monovalent H1N1 vaccines. This withdrawal is not related to any safety issues. 
  • Revaccination of children who have already received doses of Panvax® Junior is not necessary. 
  • All influenza vaccines previously administered are considered to have adequate potency to induce an immune response. 
  • Currently, all other influenza vaccines, including Panvax® multi-dose vials and seasonal influenza vaccines continue to meet potency specifications.
  • Children who have received two doses of Panvax® Junior do not require further influenza vaccination during the 2010 influenza season unless parents wish their children to be protected against influenza H3N2 and influenza B are available for use.
  • If a child aged ≥6 months to <3 years of age is due to receive a second dose of H1N1 containing vaccine, this can be provided by using the age appropriate dose (0.25mL) obtained from a Panvax® multi-dose vial. Alternatively, the 2010 seasonal influenza vaccines (Vaxigrip® and Influvac®)


30 July 2010

On Friday 30 July, the Chief Medical Officer (CMO) Professor Jim Bishop issued an update on the safety of administering the seasonal trivalent influenza vaccine to healthy children from 6 months to under 5 years of age lifting the current suspension.

The advice therefore is that from 6 months of age children may be vaccinated with the appropriate dose of Vaxigrip® and Influvac® following a discussion of the risks and benefits of these vaccines with parents and guardians. This includes both children at risk of medical complications of influenza and healthy children. Vaccination of children in this age group with Fluvax® and Fluvax® Junior is not recommended due to the identified increase risk of febrile convulsions.

To access the CMO advice please follow this link: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/immunise-temp-suspension#information

2 July 2010

The TGA has posted on its website a comprehensive statement on the investigation into flu vaccine in children under 5 years.  
Link: http://www.tga.gov.au/alerts/medicines/fluvaccine-report100702.htm#fullreport

 


Previous Releases:

From DoH, Immunisation Program:

Previous advice suspending the use of seasonal influenza vaccine since 23 April 2010 in children aged five years and under has been modified as follows:
The 2010 free seasonal influenza vaccine program for children with medical risk factors (as detailed in the Australian Immunisation Handbook 9th Edition) can continue as follows:

  • Six months to under 5 years of age; the increased rate of fever and febrile convulsions should be discussed as part of the consent
    process with the parent, and either Vaxigrip® or Influvac® can be administered with the dose adjusted according to age i.e. 0.25ml
    for 6 months to under 3 years of age and 0.5ml from 3 years of age and over.
  • Healthy children under 5 years of age should not be vaccinated with the 2010 seasonal influenza vaccine. This group can receive the Panvax® H1N1 vaccine.
  • Five years of age and over; any seasonal influenza vaccine may be used.
  • Please contact the Immunisation Program if you require any assistance in this matter, either by email or Ph. 1300 882 008.

Earlier:

The TGA, NCIRS and all other players are working very hard to identify if there is something that is causing the apparent increase in febrile convulsions for those under 5 who have been inoculated with the seasonal flu vaccine this year. The immunisation program has been stopped and the TGA has been asked to report early next week on any developments relating to this program.

Subsequently, the Commonwealth, TGA and NCIRS have requested assistance getting accurate data from practices so they can assume a reasonable baseline for these vaccinations this year.

  • Could practices send all under 7 year old flu data to ACIR asap and check to see if it appears on the child's history statement.
  • Could Practices check or ensure the correct vaccine details (Influvac, Fluvax or Vaxigrip and batch no.) are inputting - some software is causing issues here!
  • Practices using Best Practice or MD as their software should double check to see if ALL flu data has gone through to ACIR (there has been quite a few complaints that the flu information stored in Best Practice has not gone through for some reason...)
  • Report all adverse events that occur to SAEFVIC Fax: (03) 9345 4163 online www.saefvic.org.au  Phone: 1300 882 924
  • Report forms can be downloaded from DH website http://www.health.vic.gov.au/immunisation/general/saefvic