Monkeypox: FDA authorizes emergency use of intradermal vaccine for treatment

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The United States Food and Drug Administration (FDA), has issued an emergency use authorization for Jynneos vaccine to increase the existing monkeypox vaccine supply.

The FDA said the approved vaccine will enable healthcare providers to use the intradermal injection and this will increase the total number of doses available for use by up to five-fold.

It stated that the emergency use authorization allows for use of the vaccine in people who are 18 years and older, and in people seen to be at high risk of monkeypox infection.

Jynneos vaccine was approved in 2019 for the prevention of smallpox and monkeypox disease in individuals 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.

The FDA explained that the Jynneos monkeypox vaccine is administered under the skin (subcutaneously) in two doses, given 28 days apart, and also for individuals 18 years of age and older determined to be at high risk of monkeypox infection.

The vaccine is administered between the layers of the skin (intradermally) and two doses of the vaccine given 28 days apart will still be required.

“There are no data available to indicate that one dose of JYNNEOS will provide long-lasting protection, which will be needed to control the current monkeypox outbreak,” it said.

The FDA Commissioner, Robert M. Califf said, “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.

“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.”

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