James Totterdell1, Anastasia Phillips2, Catherine Glover3, Kendal Chidwick4, Julie Marsh1, Tom Snelling5, Kristine Macartney6. 1. Wesfarmers Centre of Vaccines & Infectious Diseases, Telethon Kids Institute, 15 Hospital Ave, Nedlands, Western Australia 6009, Australia. 2. Wesfarmers Centre of Vaccines & Infectious Diseases, Telethon Kids Institute, 15 Hospital Ave, Nedlands, Western Australia 6009, Australia; The University of Sydney, School of Public Health, Sydney, New South Wales 2006, Australia; National Centre for Immunisation Research and Surveillance, Cnr Hawkesbury Rd & Hainsworth St, Westmead, New South Wales 2145, Australia. Electronic address: aphi7007@uni.sydney.edu.au. 3. National Centre for Immunisation Research and Surveillance, Cnr Hawkesbury Rd & Hainsworth St, Westmead, New South Wales 2145, Australia. 4. NPS MedicineWise, Level 7 / 418a Elizabeth St Surry Hills, New South Wales 2010, Australia. 5. Wesfarmers Centre of Vaccines & Infectious Diseases, Telethon Kids Institute, 15 Hospital Ave, Nedlands, Western Australia 6009, Australia; Perth Children's Hospital, 15 Hospital Ave, Nedlands, Western Australia 6009, Australia; Curtin University, School of Public Health, Bentley, Western Australia 6102, Australia; Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia. 6. National Centre for Immunisation Research and Surveillance, Cnr Hawkesbury Rd & Hainsworth St, Westmead, New South Wales 2145, Australia; The University of Sydney, Faculty of Medicine and Health, Sydney, New South Wales 2006, Australia.
Abstract
BACKGROUND: Australia introduced a funded shingles vaccination program for older adults in November 2016, administered predominantly in primary care clinics. MedicineInsight, a nationally representative primary care database, was used to investigate the risk of pre-specified outcomes following live attenuated herpes zoster vaccine (ZVL) in Australia. METHODS: Individuals aged 70-79 years who received ZVL between 1 November 2016 and 31 July 2018 were identified from MedicineInsight. The self-controlled case series (SCCS) method was used to estimate the seasonally-adjusted relative incidence (RI) of seven pre-specified outcome events (injection site reaction (ISR) [positive control], burn [negative control], myocardial infarction (MI), stroke, rash, rash with an antiviral prescription, and clinical attendance) during a plausible post-vaccination at-risk window compared with times distant from vaccination. Sensitivity analyses examined the effect of common concomitant vaccinations and restriction to first outcome events. RESULTS: A total of 332,988 vaccination encounters among 150,054 individuals were identified during the study period; over 2 million clinical attendances were observed. There was an increased RI of ISR in the seven days following ZVL (RI = 77.4, 95% CI 48.1-124.6); the RI of clinical attendance (RI = 0.94, 95% CI 0.94-0.95) and stroke (RI = 0.58, 95% CI 0.44-0.78) were lower in the 42 days following administration of ZVL compared to control periods. There was no evidence of a change in the RI of MI (RI = 0.74, 95% CI 0.41-1.33), rash (RI = 0.97, 95% CI 0.88-1.08), or rash with antiviral prescription (RI = 0.83, 95% CI 0.62-1.10) in the 42 days following ZVL compared to control periods. CONCLUSION: No new safety concerns were identified for ZVL in this study based on a novel, Australian primary care data source. An expected increased risk of ISR was identified; findings in relation to cardiovascular disease were reassuring but require confirmation using additional data, including hospital records.
BACKGROUND: Australia introduced a funded shingles vaccination program for older adults in November 2016, administered predominantly in primary care clinics. MedicineInsight, a nationally representative primary care database, was used to investigate the risk of pre-specified outcomes following live attenuated herpes zoster vaccine (ZVL) in Australia. METHODS: Individuals aged 70-79 years who received ZVL between 1 November 2016 and 31 July 2018 were identified from MedicineInsight. The self-controlled case series (SCCS) method was used to estimate the seasonally-adjusted relative incidence (RI) of seven pre-specified outcome events (injection site reaction (ISR) [positive control], burn [negative control], myocardial infarction (MI), stroke, rash, rash with an antiviral prescription, and clinical attendance) during a plausible post-vaccination at-risk window compared with times distant from vaccination. Sensitivity analyses examined the effect of common concomitant vaccinations and restriction to first outcome events. RESULTS: A total of 332,988 vaccination encounters among 150,054 individuals were identified during the study period; over 2 million clinical attendances were observed. There was an increased RI of ISR in the seven days following ZVL (RI = 77.4, 95% CI 48.1-124.6); the RI of clinical attendance (RI = 0.94, 95% CI 0.94-0.95) and stroke (RI = 0.58, 95% CI 0.44-0.78) were lower in the 42 days following administration of ZVL compared to control periods. There was no evidence of a change in the RI of MI (RI = 0.74, 95% CI 0.41-1.33), rash (RI = 0.97, 95% CI 0.88-1.08), or rash with antiviral prescription (RI = 0.83, 95% CI 0.62-1.10) in the 42 days following ZVL compared to control periods. CONCLUSION: No new safety concerns were identified for ZVL in this study based on a novel, Australian primary care data source. An expected increased risk of ISR was identified; findings in relation to cardiovascular disease were reassuring but require confirmation using additional data, including hospital records.
Authors: Anastasia Phillips; Catherine Glover; Alan Leeb; Patrick Cashman; Parveen Fathima; Nigel Crawford; Thomas L Snelling; David Durrheim; Kristine Macartney Journal: BMJ Open Date: 2021-03-25 Impact factor: 2.692