Bavarian Nordic is preparing for a clinical trial to assess the immunogenicity and safety of its Moneypox vaccine in children between the ages of 2 and 12 in the Democratic Republic of Congo and Uganda. They’re going to do this to poor, uneducated people in Africa. It’s another emergency use situation, so they can skate if it goes wrong.
They call it Monkeypox, MPox now, but it’s still Monkeypox.
Emergency use Authorization of Jynneos (smallpox and moneypox vaccine, live, non-replicating) for prevention of moneypox disease in individuals determined to be at high risk for moneypox infection
Serious Adverse Events
Across all studies, a causal relationship to JYNNEOS could not be excluded for 4 Serious Adverse Events, all non-fatal, which included Crohn’s disease, sarcoidosis, extraocular muscle paresis, and throat tightness. (page 9)
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Cardiac Adverse Events of Special Interest
Cardiac Adverse Events of Special Interest were reported to occur in 1.3% (95/7,093) of JYNNEOS recipients and 0.2% (3/1,206) of placebo recipients.
Among the cardiac AESIs reported, 6 cases (0.08%) were considered to be causally related to JYNNEOS vaccination and included tachycardia, electrocardiogram T wave inversion, electrocardiogram abnormal, electrocardiogram ST segment elevation, electrocardiogram T wave abnormal, and palpitations. (page 9)
8.4 Pediatric Use
The safety and effectiveness of JYNNEOS have not been assessed in individuals less than 18 years of age. (page 12)
8.5 Geriatric Use
Clinical studies of JYNNEOS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.(page 12)
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. (page 12)
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