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FDA: Children to receive monkeypox vaccine subcutaneously while adults have new intradermal option

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Health officials have authorized an alternative way to administer a monkeypox vaccine that will help boost the limited supply, but this intradermal regimen applies only to adults. Children will continue to receive the vaccine subcutaneously.

Robert Fenton, White House national monkeypox response coordinator, said the new regimen is a “game changer when it comes to our response and our ability to get ahead of the virus.”

“It’s safe, it’s effective and it will significantly scale the volume of vaccine doses available for communities across the country,” he said at a press briefing Tuesday.

The new dosing regimen comes as case counts have reached 9,493 and continue to climb, leading to last week’s declaration of a public health emergency. To address the increasing case counts and demand for limited vaccines, the Food and Drug Administration (FDA) granted emergency use authorization of the JYNNEOS vaccine as an intradermal injection for adults using one-fifth of the dose used when given subcutaneously. That means the 441,000 vials in the Strategic National Stockpile could be used for up to 2.2 million doses.

FDA Commissioner Robert Califf, M.D., said a 2015 clinical study that evaluated this regimen found it has a similar immune response to the subcutaneous regimen, although the intradermal group had more redness, itchiness and swelling at the injection site.

JYNNEOS still will be given as a two-dose series 28 days apart. People who received their first dose subcutaneously can receive their second dose intradermally.

Children under 18 should receive the traditional dose as a subcutaneous injection.

“We want to make sure we get it right. We don’t have the data in children that we have in adults,” said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. He added intradermal injections can be challenging in very young children.

The Centers for Disease Control and Prevention (CDC) is providing clinical guidance, educational materials, videos and webinars to help educate vaccine providers about the new approach.




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