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

Without Clinical Trials, FDA Authorizes Modified Monkeypox Vaccine, Expands Eligibility to ‘High-Risk’ Children By Megan Redshaw for Children’s Health Defense

Bypassing normal clinical trial guidance, the U.S. Food and Drug Administration on Tuesday expanded the Emergency Use Authorization for the Jynneos monkeypox vaccine to allow for an alternative method of injection and for “high-risk” children under 18 to get the vaccine.

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.

News of the potential dose-sparing recommendations prompted some congressional staff — including from the Centers for Disease Control and Prevention (CDC) and U.S. Department of Health and Human Services — to question federal health officials about whether using the alternative injection method could affect the efficacy of the shot.

“They seemed to have no good answers for us, other than denying that it would impact things,” an individual who attended a briefing on the matter told Politico. “But they didn’t present any data.”

According to CNBC, monkeypox is rarely fatal and no deaths have been reported in the U.S. However, some patients need to be hospitalized to manage lesions, which can be painful.

Under the expanded EUA, healthcare providers can administer Bavarian Nordic’s Jynneos vaccine through intradermal injection — meaning between layers of the skin rather than below the skin — instead of subcutaneously, or beneath the skin.

The change in injection method will increase available doses fivefold — from 441,000 to more than 2.2 million — as intradermal injection uses only a fraction of the dose but provides the same protection, health officials said at a White House briefing.

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