Publications

Summary of Shingrix adverse events following immunisation

Prescriber Update 45(4): 85–88
December 2024

Key messages

Shingrix vaccine is used to prevent shingles and post-herpetic neuralgia. It has been the funded shingles vaccine since 1 December 2022.
Local injection site reactions (inflammation, pain, redness) and general systemic reactions (headache, tiredness, fever) were the main adverse events following immunisation reported with Shingrix.

This article provides a summary of adverse events following immunisation (AEFI) reported with Shingrix to the New Zealand Pharmacovigilance Database from 1 December 2022 to 31 August 2024.

What is Shingrix?

Shingrix is a recombinant varicella zoster vaccine used to prevent shingles (herpes zoster) and post-herpetic neuralgia. Two doses are needed: an initial dose followed by a second dose two to six months later.¹

Unlike Zostavax, Shingrix is not a live vaccine and may be given to immunocompromised people because there is no risk of shingles from vaccine strains.

Vaccine efficacy (prevention of disease) in clinical trials was more than 90% in healthy people, and slightly lower in immunocompromised people (67–87%).¹ Therefore, some vaccinated people may still get shingles.

On 1 December 2022, Shingrix replaced Zostavax as the funded shingles vaccine for people aged 65 years. Funding was widened on 1 July 2024 to include some immunocompromised people aged 18 years or older.²

What is shingles?

Shingles is a blistering and painful rash caused by reactivation of the varicella zoster virus in a person who has previously had varicella disease (usually chickenpox during childhood).^3,4 It occurs when a person’s immune response is impaired and unable to suppress the virus.³

Shingles is more common in adults, especially older people.⁴ The lifetime risk of shingles is about 1 in 3 and increases to 1 in 2 in people aged over 85 years.³

A common complication of shingles is post-herpetic neuralgia (PHN), which is chronic skin pain in an area previously affected by shingles. PHN can last for several months or longer and be severe or debilitating.^3,4

How many doses of Shingrix have been administered?

There were 76,646 doses of Shingrix administered from 1 December 2022 to 31 August 2024. Most (73,391 doses) were administered to patients aged 65 years or older, which is consistent with funding in this age group.

New Zealand case reports

Between 1 December 2022 and 31 August 2024, there were 296 case reports where Shingrix was reported as the suspect medicine. Of these, 106 cases were considered serious by the reporter.

Age was reported for 250 cases, and most people were aged 65 years or older (228 cases; median age for all cases: 65 years).

Most frequently reported AEFI terms

In all 296 cases, the most frequently reported AEFI terms were injection site inflammation, injection site pain, headache, pain in extremity and injection site erythema (Figure 1).

In the 106 serious cases, the most frequently reported AEFI terms were injection site erythema, headache, herpes zoster, vaccination failure and pain in extremity (Figure 2).

There were 17 serious cases reporting both vaccination failure and herpes zoster infection, all of which had very limited information. Seven cases reported a time to onset of vaccination failure that was at least 1 year after Shingrix vaccination. As noted above, no vaccine is 100% effective.

Overall, the majority of the AEFIs reported were local administration site reactions and general systemic reactions that are known to occur with immunisation.

Figure 1: All cases – Ten most frequently reported AEFI terms^a for Shingrix, 1 December 2022 to 31 August 2024

Notes

A case may contain more than one AEFI term. Therefore the number of cases does not equal the number of AEFIs.

Source: Suspected adverse reactions reported to the New Zealand Pharmacovigilance Database (accessed 7 October 2024).

Figure 2: Serious cases – Ten most frequently reported AEFI terms^a,b for Shingrix, 1 December 2022 to 31 August 2024

Notes

A case may contain more than one AEFI term. Therefore the number of cases does not equal the number of AEFIs.
17 cases reporting both vaccination failure and herpes zoster infection. The reports had very limited information, which was insufficient for medical assessment.

Source: Suspected adverse reactions reported to the New Zealand Pharmacovigilance Database (accessed 7 October 2024).

Additional information

More information on Shingrix is available from the following links:

References

GlaxoSmithKline NZ Limited. Shingrix New Zealand Data Sheet 14 November 2023. URL: medsafe.govt.nz/profs/Datasheet/s/shingrixinj.pdf (accessed 23 September 2024).
Pharmac. 2024. Summary of decision: Shingles vaccine for some immunocompromised people 12 April 2024. URL: pharmac.govt.nz/news-and-resources/news/summary-of-decision-shingles-vaccine-for-some-immunocompromised-people (accessed 23 September 2024).
Health New Zealand | Te Whatu Ora. 2024. Immunisation Handbook 2024 version 5. URL: tewhatuora.govt.nz/for-health-professionals/clinical-guidance/immunisation-handbook (accessed 23 September 2024).
Oakley A. 2015. Herpes zoster. In: DermNet NZ updated October 2015. URL: dermnetnz.org/topics/herpes-zoster (accessed 23 September 2024).