FDA Issues EUA for Monkeypox Vaccine

The FDA has issued an Emergency Use Authorization (EUA) for Bavarian Nordic’s Jynneos vaccine for individuals who are at high risk of monkeypox infection.

The EUA allows the vaccine to be administered through intradermal injection, meaning a shallow injection into the dermis, for individuals 18 years and older, but it requires subcutaneous injections for those who are younger than 18.

FDA Commissioner Robert Califf noted that the current vaccine supply “will not meet the current demand.” So the agency has authorized a one-fifth dose to increase the number of doses available.

The agency said the vaccine should be given in two doses 28 days apart, noting that there is no evidence to support a one-dose regimen.