Without Clinical Trials, FDA Authorizes Modified Monkeypox Vaccine, Expands Eligibility to ‘High-Risk’ Children

(Source:  Children’s Health Defense)

The U.S. Food and Drug Administration (FDA) on Tuesday expanded the Emergency Use Authorization (EUA) for the Jynneos monkeypox vaccine to allow for an alternative method of injection the agency said would help conserve low supplies.

The expanded EUA also allows the vaccine to be used in children under age 18 who are at “high risk” of infection.

Prior to issuing the expanded EUA, the FDA confirmed that “numerous” children were granted access to the vaccine on a “case-by-case basis” through a special permission process — even though the vaccine was not approved or authorized for emergency use in that age group — ABC News reported on Aug. 4.