FDA Gives OK to Pediatric Use of Monkeypox Vaccine


The FDA has granted Emergency Use Authorization EUA of the Jynneos vaccine for pediatric patients <18 years who are at high risk of monkeypox infection.

With the continuing rise in monkeypox infections in the United States, the US Food and Drug Administration has granted Emergency Use Authorization (EUA) of the Jynneos (Bavarian Nordic) vaccine for pediatric patients <18 years who are at high risk of monkeypox infection.

Now, the vaccine is authorized for a series of 2, 0.5 mL doses via subcutaneous injection administered 28 days apart in patients <18 years and patients of any age who have a history of developing keloid scars under the new EUA. Additionally, an alternative regimen of 2, 0.1 mL doses via intradermal injections administered 28 days apart is authorized for use in patients ≥18 years.

“In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand,” said FDA Commissioner Robert M. Califf, MD “The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals. By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so.”

Jynneos, a Modified Vaccinia Ankara (MVA) vaccine, was approved for the prevention of smallpox and monkeypox in adults 18 years and older in 2019.1

This article originally appeared on Contemporary Pediatrics.


1. Monkeypox update: FDA authorizes emergency use of Jynneos vaccine to increase vaccine supply. FDA. Published August 9, 2022. Accessed August 10, 2022. https://www.fda.gov/news-events/press-announcements/monkeypox-update-fda-authorizes-emergency-use-jynneos-vaccine-increase-vaccine-supply

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