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.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.