FDA Issues EUA for Monkeypox Vaccine for Under 18; IV Treatment on the Way

The EUA allows Jynneos to be used in children at high risk for monkeypox and as an intradermal injection, rather than subcutaneous, for adults.

The FDA issued an emergency use authorization (EUA) for the Bavarian Nordic’s Jynneos monkeypox vaccine intradermal injection for people, including those under the age of 18, who are at high risk for monkeypox infection. This will increase the total number of doses available for use by up to five-fold, FDA said in a news release.

“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, M.D. “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.”

U.S. monkeypox cases have soared to 10,392 as of Aug. 10, 2022, according to the CDC, and HHS Secretary Xavier Becerra declared the ongoing spread of monkeypox virus in the United States a Public Health Emergency (PHE).

Jynneos, the modified vaccinia ankara (MVA) vaccine, was approved as a subcutanous injection in 2019 for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.

While Jynneos is administered subcutaneously as two doses, four weeks (28 days) apart, the EUA now allows for a fraction of the Jynneos dose to be administered between the layers of the skin for adult patients.

Two doses of the vaccine given 4 weeks (28 days) apart will still be needed. There are no data available to indicate that one dose of Jynneos will provide long-lasting protection, which will be needed to control the current monkeypox outbreak, the FDA said.

Meanwhile, the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Administration for Strategic Preparedness and Response at the Department of Health and Human Services (HHS) is buying around $26 million worth of SIGA Technologies’ IV TPoxx treatment courses.

IV TPoxx, a treatment for both monkeypox and smallpox, is an important option for those who are unable to swallow, SIGA said in a statement. The manufacturer expects to deliver the product in 2023.