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FDA Authorizes Emergency Use Of JYNNEOS Vaccine For Monkeypox

monkeypox aug10 lt

The U.S. Food and Drug Administration issued an emergency use authorization or EUA for the JYNNEOS vaccine for use in individuals 18 years of age and older who are determined to be at high risk for monkeypox infection.

JYNNEOS, the Modified Vaccinia Ankara or MVA vaccine, was developed by Denmark's Bavarian Nordic.

The FDA expects the authorization would increase the total number of doses available for use by up to five-fold. The approval comes as the U.S. government last week declared the monkeypox outbreak a Public Health Emergency.

Now, healthcare providers can use the vaccine in adults by intradermal injection, meaning, administered within the layers of the skin. The approval also allows to use the vaccine in individuals younger than 18 years of age determined to be at high risk of monkeypox infection. However, in these individuals, JYNNEOS is administered by subcutaneous injection, which is applied under the skin.

The vaccine is generally administered as two doses, four weeks apart. The vaccine was approved 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.

Health and Human Services or HHS last week said it has already shipped more than 602,000 doses of the JYNNEOS vaccine to states and jurisdictions. HHS had allocated 1.1 million doses to states and jurisdictions in total and was making more doses available as jurisdictions use their current supply.

Since the first U.S. case of monkeypox was confirmed on May 18, the United States reported more than 5,000 cases. However, no monkeypox-related death has been reported in the country so far.

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