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FDA considering “dose-sparing” method of increase option of Jynneos vaccine

THE MEALS and Drug Administration is considering splitting doses of the Jynneos vaccine into fifths to improve supply amid the expanding monkeypox outbreak, FDA Commissioner Robert Califf said this week.

Driving the news headlines: Beneath the “dose-sparing” approach, healthcare providers might use one vial of the vaccine to manage around five doses lacking any effect on safety or efficacy, Califf said.

  • Because the Department of Health insurance and Human Services works together with Jynneos’ manufacturer to improve the option of the vaccine, Califf said “dose-sparing” could give a potential solution in the interim.

Between your lines: The brand new approach would need a different approach to administration, or injection in to the skin, Califf said at a briefing on Thursday.

  • The Jynneos vaccine currently is administered with a subcutaneous injection, which switches into the fat layer within the skin.
  • The brand new “dose-sparing” approach would require intradermal administration, which switches into the dermis. The dermis lies just within the top layer of skin referred to as the skin.
  • Califf noted there are some benefits to this approach, such as for example a better immune reaction to the vaccine.

What he’s saying: “It is critical to note that the entire safety and efficacy profile will never be sacrificed with this particular approach,” Califf said. “Please know we have been exploring all scientifically feasible options, and we believe this may be a promising approach.”

  • “It is critical to note that we shall not be sacrificing the high-quality regulatory standards that Americans attended to anticipate,” he added.

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