Bavarian Nordic Announces Commercial Launch of Mpox Vaccine in the U.S. - Seite 3

Important safety information
Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration of JYNNEOS. Anyone who has experienced a severe allergic reaction following a previous dose of JYNNEOS or following exposure to any component of JYNNEOS may be at increased risk for severe allergic reactions.

Syncope (fainting) has been reported following vaccination with JYNNEOS. Procedures should be in place to
avoid injury from fainting.

Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to JYNNEOS.

Vaccination with JYNNEOS may not protect all recipients.

In smallpox vaccine-naïve healthy adults, the most common (>10%) solicited injection site reactions were pain (84.9%), redness (60.8%), swelling (51.6%), induration (45.4%), and itching (43.1%); the most common solicited systemic adverse reactions were muscle pain (42.8%), headache (34.8%), fatigue (30.4%), nausea (17.3%) and chills (10.4%).

In healthy adults previously vaccinated with a smallpox vaccine, the most common (>10%) solicited injection site reactions were redness (80.9%), pain (79.5%), induration (70.4%), swelling (67.2%), and itching (32.0%); the most common solicited systemic adverse reactions were fatigue (33.5%), headache (27.6%), and muscle pain (21.5%).

The frequencies of solicited local and systemic adverse reactions among adults with HIV infection and adults with atopic dermatitis were generally similar to those observed in healthy adults.

Across all studies, a causal relationship to JYNNEOS could not be excluded for 4 serious adverse events (SAEs), all non-fatal, which included Crohn’s disease, sarcoidosis, extraocular muscle paresis and throat tightness.

Cardiac adverse events of special interest (AESIs) considered causally related to study vaccination were reported in 0.08% of subjects who received JYNNEOS and included tachycardia, electrocardiogram T wave inversion, electrocardiogram abnormal, electrocardiogram ST segment elevation, electrocardiogram T wave abnormal, and palpitations. None of the cardiac AESIs considered causally related to study vaccination were considered serious.

To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health and Human Services by either visiting www.vaers.hhs.gov/reportevent.html or calling 1-800-822-7967.

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