On August 9, 2022, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the JYNNEOS monkeypox/smallpox vaccine. The EUA will allow for the administration of the vaccine—via intradermal injection—to individuals 18 years of age and older who are deemed to be at high risk of monkeypox infection. As the monkeypox virus has spread over the past several weeks there has been growing concern that the current vaccine supply will fail to meet demand.
The JYNNEOS vaccine was approved in 2019 for use in adults 18 years of age and older to help prevent smallpox and monkeypox. That approval, however, was for subcutaneous administration. The EUA now allows for intradermal injection, which uses much less of the vaccine, increasing the total number of available doses by 500 percent. Additionally, the recent EUA allows for the subcutaneous injection of the vaccine in people younger than 18 year of age who are at high risk of infection.
“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,” says FDA commissioner Robert M. Califf MD.