Safety data from both clinical trials and post-licensure observational studies for MVA-BN used in healthy adults were largely consistent. In randomised clinical trials, 74.6% to 98.1% of participants experienced any local adverse event and 35.9% to 80.5% experienced any systemic adverse event after vaccination.8-10,13,15-20Post-licensure surveillance safety data from Australia and the United States showed a self-reported adverse event rate of 25% to 47%.21,22The most commonly reported local adverse events were injection site pain, redness, swelling and induration. The most commonly reported systemic adverse events were muscle pain, headache, fatigue, nausea and chills.
Adverse event rates reported after any vaccination dose (1st, 2nd or booster) were similar. However, anecdotally the frequency of adverse events, particularly local site reactions, appears to be higher in people who had received a previous live smallpox vaccine.4
Serious vaccine-related adverse events have been very rarely reported in clinical trials. More than 1 million doses of MVA-BN were administered during the 2022 international mpox outbreak, with no major safety concerns identified. However, most doses were given to younger adult males (more than 90% of vaccine recipients were aged 18-49 years),23so safety data must be interpreted with caution.
The United States Food and Drug Administration (FDA) has added “myocarditis, pericarditis” as an observed adverse reaction in the “Post-marketing Experience” section of the JYNNEOS product information.4However, a causal relationship to vaccine exposure has not been established.
https://immunisationhandbook.health.gov.au/contents/vaccine-preventable-diseases/mpox-previously-known-as-monkeypox#adverse-eventsread more about mpox and the vaccine on the link.
do some reading and learn. when searching for any real info, other than the poor quality warnings that are included in patient information inserts, include "pharmacology" in your search. this brings up the medical information.
