MONKEYPOX: Jynneos vaccine PACKAGE INSERT

—  5.1   Severe Allergic Reactions

Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration

—  5.2   Syncope

Syncope has been reported following vaccination with JYNNEOS.

Procedures should be in place to avoid injury from fainting

—  6   Adverse Reactions

There is the possibility that broad use of JYNNEOS could reveal adverse reactions not observed in clinical trials

… Serious Adverse Events

Across all studies, a causal relationship to JYNNEOS could not be excluded for 4 SAEs

Crohn’s disease, sarcoidosis, extraocular muscle paresis and throat tightness

… Cardiac Adverse Events of Special Interest 

Cardiac AESIs were reported to occur in 1.3% (95/7,093) of JYNNEOS recipients

and 0.2% (3/1,206) of placebo recipients who were smallpox vaccine-naïve

Cardiac AESIs were reported to occur in 2.1% (16/766) of JYNNEOS recipients who were smallpox vaccine-experienced

—  8.1   Pregnancy

Available human data on JYNNEOS administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy

—  8.2   Lactation

It is not known whether JYNNEOS is excreted in human milk.

Data are not available to assess the effects of JYNNEOS in the breastfed infant

or on milk production/excretion

—  8.4   Pediatric Use

Safety and effectiveness of JYNNEOS have not been established in individuals less than 18 years of age

—  8.5   Geriatric Use

Clinical studies of JYNNEOS did not include sufficient numbers of subjects aged 65 and over

—  13.1   Carcinogenesis, Mutagenesis, Impairment of Fertility

JYNNEOS has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals

—  14.1   Vaccine Effectiveness

Vaccine effectiveness against monkeypox was inferred from the immunogenicity of JYNNEOS in a clinical study

and from efficacy data from animal challenge studies