FDA Approves Use of Jynneos Vaccine Against Monkeypox for the First Time

Monkeypox, a viral disease affecting rodents and primates, has already become a global outbreak, affecting thousands of people in several dozens of countries as of Wednesday, August 10. Majority of these countries have no historical record of the pathogenic infection, with only a few nations to have a reoccurrence of monkeypox cases.

The zoonotic disease was recently declared by the World Health Organization (WHO) as a public health emergency of international concern (PHEIC) in late July and the United States declared it as a public health emergency within its domain. Such designation to the monkeypox virus has paved the way for increased priority and allocation of funds, especially for vaccine development, to combat it.

In the latest developments, the US Food and Drug Administration (US FDA) on Tuesday, August 9, authorized the "intradermal use" of Jynneos vaccine against monkeypox. The approval means the vaccine can be administered within or between the layers of the skin, a common injection method used in other types of diseases, against novel coronavirus disease 2019 (COVID-19).

The process has been approved primarily for high-risk patients. In addition, it will serve for emergency use and an alternative vaccine supply. The approval comes amid the very limited supply of monkeypox vaccines worldwide, wherein most supplies have been reported to be in the US and Europe.

Jynneos Monkeypox Vaccine

The US FDA approval of the Jynneos monkeypox vaccine is under the Biden Administration's Emergency Use Authorization, which follows the decision of the US Department of Health and Human Services on August 4 to announce monkeypox as a public health emergency, according to Medscape.

The intradermal administration will allow vaccine providers to receive five does out of a one-dose vial.

The Jynneos vaccine, manufactured by the Bavarian Nordic biotechnology company, aims to prevent the monkeypox disease for individuals aged 18 years and above, determined by health authorities to be a high-risk group.

Prior to the recent monkeypox global outbreak in May 2022, the vaccine was approved in 2019 for the prevention of smallpox as well. It also goes by the name of Modified Vaccinia Ankara (MVA) vaccine before.

Monkeypox Vaccine Supply Boost

The so-called emergency use authorization for Bavarian Nordic's vaccine will allow the increase in available doses of the Jynneos monkeypox vaccine, according to health officials during a White House briefing, as cited by Reuters.

During its first approval, Jynneos was originally administered beneath the skin or subcutaneously, the London-based news media outlet adds.

Monkeypox Outbreak Development

The Centers for Disease Control and Prevention (CDC) considers monkeypox to be a rare disease caused by the monkeypox virus, which is part of the same family of viruses like the variola virus, the pathogen the causes smallpox.

The CDC adds monkeypox symptoms is similar to smallpox symptoms, but are less severe and rarely fatal.

Monkeypox was first identified back in 1958, when two outbreaks of a pox-like disease transpired monkey colonies established for research purposes.