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Monkeypox vaccine: Why does the U.S. government want five people to share one dose?

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Will less be more?

Officials with the U.S. Food and Drug Administration announced Thursday that they are reviewing plans to expand supplies of the monkeypox vaccine. Divided dose.

The announcement came on the heels of the announcement by Secretary of Health and Human Services Xavier Becerra. public health emergency A global virus that was once endemic only in Africa.

At a press conference Thursday, FDA Commissioner Dr. Robert Calif said the FDA is considering a process called “dose parsimony” to expand supplies. This prompts health care providers to split a single-dose vial of Jynneos, one of two smallpox vaccines approved against the fellow poxvirus monkeypox and far safer, into five doses to You will be able to administer to 5 patients.

Doses are administered intradermally or between layers of the skin rather than subcutaneously or under the skin. This approach improves the immune response without compromising safety or efficacy, Califf said.

Officials are likely to take a decision on dose savings “within the next few days,” Calif said Thursday, adding that the chances of moving forward with the plan “look good.” The vaccine is FDA-approved, but a change in dosage will require an Emergency Use Authorization.

“Safe and efficient mass vaccination”

‘Dose parsimony’ may sound like a desperate solution to an inadequate vaccine supply, but ‘it’s not happening at random’. There’s data behind the concept, said Dr. Lindsey Barden, an infectious disease specialist at Brigham and Women’s Hospital in Massachusetts and a professor at Harvard Medical School. luck.

Previous studies of dose-sparing, including the smallpox vaccine, have shown that one-fifth and sometimes one-tenth the dose produced immune responses comparable to full doses, Baden said. .

Intradermal administration of a small amount of smallpox vaccine “allows for safe and efficient mass vaccination, which is a prerequisite if vaccination of large populations in a short time is desired.” said the authors of a 2018 paper. study It was published in the magazine vaccination report.

Alexandra Brugler Yonts, Ph.D., an infectious disease specialist at the National Children’s Hospital in Washington, DC, who helped the FDA review Jynneos, said the approach “is worth considering.” luck.

However, “there is not much data available that is specific to Jynneos,” she warned.

“Research on this route of delivery was not evaluated as part of Jynneos’ initial approval in 2019, so intradermal injection is not included in the current package insert,” she said. “But if the FDA can review the data and find it convincing, it would be a reasonable temporary measure.”

She worries that lower doses may not be appropriate for people with HIV or those with compromised immune systems.

“Although some protection is better than nothing, people who are vaccinated should take other precautions to minimize physical or close contact with potentially infected individuals. They should be warned and advised to continue protective measures,” she said.

“As with COVID, vaccination, especially only one dose or a small dose, is not a free pass for blindly participating in high-risk behavior in the context of an active outbreak.”

Baden is concerned with the safety and efficacy of all treatments (including dose-sparing approaches to Jynneos) and believes more data is always better.

“We can always want more science,” he said. “But more than that doesn’t mean we haven’t demonstrated the point yet.”

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2/ https://fortune.com/2022/08/06/monkeypox-what-is-dose-sparing-jynneos-smallpox-one-dose-five-patients-outbreak-endemic-epidemic-poxvirus/

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