Thu, 09/08/2022 | News

World-first real-time safety data for JYNNEOS monkeypox vaccine available from AusVaxSafety

World-first active surveillance data on JYNNEOS monkeypox vaccine safety published by AusVaxSafety show more than half of the participants (54%) experienced no side effects in the first 7 days following dose 1 vaccination.  

AusVaxSafety received data from more than 1,300 JYNNEOS monkeypox vaccine dose 1 recipients who participated in active vaccine safety surveillance via the AusVaxSafety system.

In those who did experience a side effect, local reaction (including pain, itching, redness and swelling at injection site, 43%), fatigue (18%), headache (11%) and muscle/joint pain (10%) were most common. These side effects are known to occur after this vaccine. They were generally mild and short-lived, with most resolving within one day or less. 

The rate of impact on routine activities was low, with only 4% of respondents reporting missing work, study or routine duties in the week following vaccination. The vast majority of respondents reported missing 1 day or less, and reported medical attendance rates also remained low at 1%.

Associate Professor Nick Wood, Associate Director of Clinical Services and Vaccine Safety at the National Centre for Immunisation Research and Surveillance (NCIRS), said, “This is the first post-marketing active surveillance data published worldwide for the JYNNEOS monkeypox vaccine and is testament to Australia’s commitment to ongoing vaccine safety through robust monitoring.”

“These real world data from the first people in Australia to receive the JYNNEOS vaccine inform individuals of the most common side effects they may experience in the days following JYNNEOS monkeypox vaccination.” 

“The data will be collected, analysed and published on an ongoing basis, including side effects after dose 2 and will inform our use of JYNNEOS monkeypox vaccine in Australia,” continued Associate Professor Wood.

JYNNEOS monkeypox vaccine is not registered for use in Australia and has not been formally assessed by the Therapeutic Goods Administration (TGA). It has been made available via a special emergency pathway under section 18A of the Therapeutic Goods Act 1989 (Cth), highlighting the importance of ongoing safety data collection and monitoring.

To collect data, AusVaxSafety distributes a short online survey via SMS or email to individuals who received their JYNNEOS monkeypox vaccine at a participating AusVaxSafety site, allowing participants to report any adverse events they may have experienced at different time points after their vaccination. 

De-identified data from completed surveys are analysed and monitored by epidemiologists and vaccine experts to ensure that the vaccine is performing as safely and effectively as it is expected to in real-world conditions.

Click here to access the latest JYNNEOS monkeypox vaccine safety data

Media contact: NCIRS | 0429 350 279 | SCHN-NCIRSMedia@health.nsw.gov.au

AusVaxSafety is led by the National Centre for Immunisation Research and Surveillance, and is funded by the Australian Government Department of Health and Aged Care. AusVaxSafety active vaccine safety surveillance system complements the enhanced safety surveillance activities of the Therapeutic Goods Administration (TGA).