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In Response to Expanding Monkeypox Outbreak, FDA Approves Emergency Use of JYNNEOS Vaccine

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In response to the growing prevalence of monkeypox, the FDA granted Emergency Use Authorization (EUA) for the JYNNEOS vaccine by intradermal injection to individuals 18 years of age and older who are at high risk of monkeypox infection. This decision will alleviate the situation where the vaccine was running out due to the spread of the epidemic and, with the Emergency Use Authorization, will provide up to five times as many doses available for use.

The JYNNEOS vaccine is also authorized for emergency use in individuals younger than 18 years of age who are at high risk of monkeypox infection, provided that it is administered as a subcutaneous injection.

Related Article: Three Previously Approved Treatments Show Anti-monkeypox Activity

What We Should Know About JYNNEOS Vaccine

The JYNNEOS vaccine is a modified Vaccinia Ankara (MVA) vaccine approved for use in 2019 in individuals older than 18 years of age who are at high risk of smallpox or monkeypox infection. The vaccine consists of two doses given by intradermal injection 4 weeks apart. Currently, it has not been proved that long-term protection can be achieved with only one dose of vaccine.

FDA’s Justification for EUA

The reason for the FDA’s decision to grant emergency use was primarily based on data from the 2015 clinical study of the MVA vaccine, which compared two doses administered intradermally versus subcutaneously. Individuals who were vaccinated intradermally received less than one-fifth the amount of vaccine given subcutaneously. The results of this study suggest that intradermal administration produced similar immune responses to subcutaneous administration, meaning that both groups of individuals responded in the same way to vaccination. Intradermal administration may cause redness, itching and swelling at the injection site, but pain is relatively mild and these adverse effects are manageable. The FDA has determined that the benefits of using JYNNEOS outweigh the potential risks of using the vaccine.

In response to the ongoing spread of monkeypox virus, the U.S. Department of Health and Human Services Secretary Xavier Becerra declared it a Public Health Emergency last week, following the declaration of the monkeypox outbreak as a Public Health Emergency of International Concern by the WHO Director-General. These circumstances prompted the FDA to approve the emergency use of vaccines.

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