FDA Approves Emergency Use of Jynneos Vaccine for Monkeypox

As monkeypox infections continue to rise around the world, vaccine demand has greatly surpassed production capacity. Under these circumstances, US health regulators authorized the intradermal application of the Bavarian Nordic Jynneos monkeypox vaccine in individuals 18 years and older who are part of high-risk populations.

The US Food and Drug Administration’s (FDA) authorization will allow for the application of the monkeypox vaccine intradermally. By injecting the vaccine between layers of the skin rather than subcutaneously, it will be possible to increase the number of doses available up to fivefold. Individuals under 18 years old at high risk of a monkeypox infection will be able to get the intradermal vaccination.

The Jynneos vaccine was approved for preventing smallpox and monkeypox disease in adults 18 years of age and older back in 2019. However, demand for the vaccine skyrocketed following the recent outbreak. “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 Robert Califf, Commissioner, FDA. “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.”

On Aug. 4, 2022, the US declared that the monkeypox outbreak corresponds to a public health emergency, increasing the funding, data available and tools to fight the outbreak.  The authorization of the Jynneos vaccine was discussed then.

The current administration has made more than 1.1 million vaccine doses available to order, with over 620,000 doses already shipped. The Pan American Health Organization (PAHO) recently convened a session with member states to analyze equitable access to the vaccine for the most-at-risk populations in the region, as reported by MBN. During the session, the organization called for a coordinated response to take the required steps to gain access to the vaccine through the organization’s Revolving Fund.

Mexico has 147 confirmed monkeypox cases and a total of 390 probable cases, 107 are currently under study, according to the Institute for Epidemiological Diagnosis and Reference (InDRE) and reported by Forbes Mexico. The infections are distributed through 18 states, with Mexico City having 75 infections, followed by Jalisco with 33.  The Deputy Minister of Health Promotion Hugo López-Gatell highlighted the low lethality of the disease, which “occurs in small outbreaks and in key populations; transmission is mainly by skin contact with patients in the active phase, and disappears in 21 days. It generally causes little harm, except in severely immunosuppressed persons with low defenses,” as reported by MBN.