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Healthcare providers will be allowed to administer a fraction of the normal dose of monkeypox vaccine Jynneos to patients after the U.S. Food and Drug Administration green-lit the plan to stretch limited vaccine supply on Tuesday.
The emergency use authorization also allows for the vaccination of children who are at high risk of monkeypox, according to a news release issued by the agency.
Prior to the announcement, only those ages 18 and older could be vaccinated without express, patient-specific approval from the FDA, a process known as “single patient expanded access investigational new drug application.”
The FDA on Thursday announced its consideration of the supply-stretching plan, referred to as “dose sparing,” which would split each dose into five and involve injection intradermally, or between layers of the skin, versus subcutaneously, or under the skin.
The Thursday announcement came just moments after Department of Health and Human Services Secretary Xavier Becerra declared a public health emergency over the globally circulating virus, once endemic only to Africa.
On a Thursday press call, FDA Commissioner Dr. Robert Califf said the approach provides improved immune response and does not jeopardize safety or effectiveness.
Though Jynneos—one of two smallpox vaccines approved for fellow poxvirus monkeypox, and the safest by far—is authorized by the FDA for treatment of monkeypox in adults, an emergency use authorization was needed due to changes in dosing and administration, as well as to allow children to receive the vaccine.
‘Safe and efficient mass vaccination’
While “dose sparing” might sound like a desperate solution to inadequate vaccine supply, it’s “not being done randomly.” There are data behind the concept, Dr. Lindsey Baden, an infectious disease specialist at Brigham and Women’s Hospital in Massachusetts and a Harvard Medical School professor, told Fortune on Friday.
A prior study of dose sparing involving smallpox vaccine showed that a fifth of a dose—and perhaps even a tenth—produced an immune response comparable to a whole dose, Baden said.
Administering a small dose of smallpox vaccine intradermally allows for “safe and efficient mass vaccination, a prerequisite when vaccination of a large population at a short time is needed,” the authors of a 2018 study published in the journal Vaccines reported.
The approach is “definitely worth exploring,” Dr. Alexandra Brugler Yonts, an infectious disease specialist at Children’s National Hospital in Washington, D.C., who assisted in the FDA’s review of Jynneos, told Fortune on Friday.
But “there isn’t much available data specifically for Jynneos,” she cautioned.
“Any studies on this route of delivery were not evaluated as a part of the initial licensure of Jynneos in 2019, which is why intradermal injection is not included on the current package insert,” she said. “But if the FDA has that data now to review and find it convincing, it would be a reasonable temporizing measure.”
She said she was concerned that smaller doses may not be adequate for those with HIV or those who are immunocompromised.
“Some protection is better than none, but the people being vaccinated should be warned and advised to continue other protective measures to minimize physical or intense close contact with potentially infected individuals,” she said.
“Just like with COVID, receiving the vaccination—especially only a single dose or smaller doses—is not a free pass to blindly take part in high risk behavior in the context of an active outbreak.”
Baden said he’s concerned with the safety and efficacy of every treatment—a dose-sparing approach to Jynneos included—and thinks more data are always better.
“We can always want more science,” he said. “But more doesn’t mean you haven’t already demonstrated the point.”
This is a developing story and will be updated.
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