Section A: Premarket registration applications
At this meeting the committee provided advice on 2 applications under evaluation by the TGA:
- applications for major variations ((new dosage form, change/increase in patient group, change in dosage, new strength, or new route of administration) (Application Type F)
Further details of the ACV discussion and advice associated with these items may be released in the Australian Public Assessment Reports (AusPAR) - browse all AusPARs.
Section B: Post-market items
The committee provided advice on the post-market item: risk of severe adverse events following immunisation (AEFI) with live attenuated vaccines (LAVs) in people with IFNAR1 deficiency.
IFNAR1 deficiency is a rare inherited immune deficiency associated with severe illness, and sometimes death, after certain viral infections or following administration of a live attenuated vaccine, mainly the measles, mumps and rubella (MMR) vaccines. IFNAR1 deficiency appears to be more common in people who have two parents of Western Polynesian ancestry (Tongan, Samoan, or Niuean). IFNAR1 deficiency is estimated to affect one child born every two years in Australia.
Adverse events to live attenuated virus vaccine in individuals with IFNAR1 deficiency are described in the Australian Immunisation Handbook and in an Australian Technical Advisory Group on Immunisation (ATAGI) statement ‘IFNAR1 Deficiency and Serious Adverse Events Following Immunisation’ published by the Australasian Society of Clinical Immunology and Allergy (ASCIA).
The ACV provided advice on the risk profile of live attenuated virus vaccines, communication activities, and possible engagement with other public health bodies.
Further information
For further information on the ACV, please visit Advisory Committee on Vaccines
or contact the ACV by email ACV@health.gov.au.