Monkeypox vaccine: FDA authorizes change to how vaccine is given, to stretch supply


The U.S. Food and Drug Administration on Tuesday issued an emergency use authorization that allows healthcare providers to change how the Jynneos monkeypox vaccine is administered, expanding supply amid high demand. .

The vaccine can now be given to high-risk adults intradermally, i.e. between the layers of the skin, rather than subcutaneously or under the skin, as was the case until recently. here. This will allow providers to get five doses from a standard single-dose vial.

The new EUA also allows for subcutaneous vaccination in people under 18 at high risk of infection.

“Over the past few weeks, the monkeypox virus has continued to spread at a rate that has made it clear that our current vaccine supply will not meet current demand,” said FDA Commissioner Robert M. Califf, in a statement. statement. “The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all affected individuals. By increasing the number of doses available, more people wishing to be vaccinated against monkeypox will now be able to do so.

The move comes less than a week after the Biden administration declared monkeypox a public health emergency, giving the FDA and other government health agencies more flexibility to combat the spread of the virus.

Earlier Tuesday, US Department of Health and Human Services Secretary Xavier Becerra issued his decision to clear the way for the FDA’s decision.

“Last week, I declared monkeypox a public health emergency to unlock additional tools that will help us contain and end this outbreak and signal to the American people that we are taking our response to the next level. superior,” Becerra said in a statement. “Today’s action will allow the FDA to exercise additional powers that may increase the availability of vaccines to prevent monkeypox while continuing to ensure that the vaccine meets high standards of safety, d ‘efficiency and manufacturing quality.

On Monday, the US government shipped 617,693 doses of Jynneos to states and jurisdictions. The United States Centers for Disease Control and Prevention has estimated that at least 1.5 million people in the United States are eligible for the monkeypox vaccination.

As of Monday evening, the CDC reports 8,934 probable or confirmed cases of monkeypox in 49 states, Puerto Rico and the District of Columbia.

With an intradermal vaccination, “you basically stay in the skin; you don’t go through the skin,” said Dr. Daniel Griffin, an infectious disease specialist at Columbia University.

The use of a smaller dose with intradermal injection has been made with influenza and rabies vaccines, epidemiologist Dr Jay Varma told CNN in an email.

“The skin has special cells that are very good at helping a vaccine boost the body’s immune system,” he wrote.

These cells, called dendritic cells, are better able to mount an immune response, Griffin said.

“They live in the skin, and they’re better able to teach the immune system what to respond to,” he said.

“If you are able to administer the monkeypox vaccine intradermally, you can administer a lower dose. … They would just need to have some sort of demonstration that you get the same immune response,” he said.

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