FDA Considers “Dose-Saving” Approach to Increase Jynneos Vaccine Availability

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The Food and Drug Administration is considering splitting doses of the Jynneos vaccine into fifths to increase supply during the growing monkeypox outbreak, FDA Commissioner Robert Califf said this week.

Send the news: Under the “dose-sparing” approach, health care providers could use one vial of the vaccine to deliver up to five doses without impacting safety or efficacy, Califf said.

  • As the Department of Health and Human Services is working with the manufacturer of Jynneos to increase vaccine availability, Califf said “dose-sparing” could provide a potential solution in the meantime.
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Between the lines: The new approach requires a different method of delivery or injection into the skin, Califf said at a briefing Thursday.

  • The Jynneos vaccine is currently administered via a subcutaneous injection, which goes into the fat layer under the skin.
  • The new “dose sparing” approach would require intradermal administration going into the dermis. The dermis lies just below the top layer of skin known as the epidermis.
  • Califf noted that there are some benefits to this approach, such as an improved immune response to the vaccine.
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What he says: “It is important to note that the overall safety and efficacy profile will not be sacrificed with this approach,” Califf said. “Please know that we have explored all scientifically viable options, and we believe this could be a promising approach.”

  • “It is important to note that we will not compromise on the high quality standards that Americans are used to,” he added.
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