Section A: Premarket registration applications
The ACV was not asked to provide advice on a premarket item.
Section B: Post-market item
The committee provided advice on the post-market item: Shingrix and zoster reactivation.
Herpes zoster, commonly known as shingles, is a reactivation of the varicella zoster virus in a person who has previously had varicella (chickenpox). The life-time risk of shingles is approximately 30%, with incidence of shingles increasing with age.
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 the shingles vaccine under the National Immunisation Program.
The TGA has found evidence of a possible temporal association between Shingrix and localised varicella zoster virus reactivation, that is, reports of the occurrence of shingles within 21 days following the administration of Shingrix. The evidence the TGA considered included reports in the Database of Adverse Event Notifications (DAEN).
At the time of the ACV meeting, the TGA did not find evidence of disseminated disease following Shingrix administration.
The ACV provided advice on additional data and analyses that could clarify and/or characterise this potential signal; risk minimisation activities; and communication activities.
The ACV advised that Shingrix has a high level of effectiveness in the prevention of shingles. Real-world evidence of vaccine effectiveness has accumulated: in a large US study vaccine effectiveness of Shingrix in adults aged 65 years and older was 70.1% (95% CI 68.6–71.5) (Izurieta et al).
The ACV noted that the TGA is continuing to gather information and investigate this potential safety signal.
Further information
For further information on the ACV, please visit Advisory Committee on Vaccines
or contact the ACV by email ACV@health.gov.au.