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Section A: Premarket registration applications
At this meeting, the committee provided advice on one application under evaluation by the TGA, as below.
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area | Application designations |
|---|---|---|---|
| Application for a 'new indication', or additional therapeutic use, for an already approved Vaccine (Application Type C) | |||
| FLUMIST | AstraZeneca Pty Ltd | Influenza virus | |
The dates of commencement of the evaluation of these applications are available at Prescription medicines: Applications under evaluation.
The committee also provided advice on:
- One application for major variations (new dosage form, change/increase in patient group, change in dosage, new strength, new route of administration) (Application Type F)
Further details of the ACV discussion and advice associated with items may be released within the Australian Public Assessment Reports (AusPAR).
Section B: Post-market items
The ACV was asked to provide advice on one post-market item, as below.
Recombinant Varicella Zoster Virus glycoprotein E antigen (ASO1B adjuvanted vaccine) (SHINGRIX)
Shingrix is a vaccine for the prevention of shingles and post-herpetic neuralgia that is approved for use in adults 50 years of age and older, and adults 18 years of age and older who are at increased risk of shingles. Some adults are eligible for Shingrix under the National Immunisation Program.
Shingles is a reactivation of the varicella-zoster virus in a person who has previously had varicella (chickenpox). The life-time risk of shingles in those who live to 80 years of age is approximately 50%, with incidence increasing with age.
The ACV noted the TGA has conducted a multi-part signal investigation (SI) into Shingrix and the risk of shingles and herpes zoster ophthalmicus (shingles affecting the eye) following Australian case reports in association with this vaccine. The TGA’s initial SI was previously considered at ACV meeting 49, with advice provided on additional steps that could clarify the potential signal further.
At meeting 54, the ACV noted that current evidence is insufficient to establish a causal link between Shingrix and shingles, herpes zoster ophthalmicus or disseminated shingles. It was discussed that episodes of shingles can still occur following Shingrix vaccination, including following dose 1 and dose 2, before optimal vaccine protection would be expected.
The ACV advised that no product information updates for Shingrix were warranted for this signal.
The ACV advised that the Australian Immunisation Handbook should be the main reference for information on vaccine effectiveness and clinical guidance for suspected shingles cases following Shingrix vaccination, supporting better case identification, and timely management of suspected cases.
Further information
For further information on the Advisory Committee on Vaccines, please visit: Advisory Committee on Vaccines (ACV) or contact the ACV Secretary by email: ACV@health.gov.au.