FDA plans to split Jynneos doses into fifths to increase vaccine supply

The Biden administration is considering splitting the doses of the smallpox vaccine, which is used to prevent monkeypox amid the current outbreak, into five smaller doses, the head of the Food and Drug Administration said Thursday ( FDA).

FDA Commissioner Robert Califf told a briefing that his agency was examining possible solutions to increase the number of available doses of the Jyenneos vaccine. One such proposed solution is to divide the current doses into fifths.

“We envision an approach for current doses of Jynneos that would allow healthcare providers to use an existing single-dose vial of the vaccine to deliver a total of up to five separate doses,” Califf said. “This approach, which we call dose saving, would change the way Jynneos is delivered, currently administered subcutaneously.”

According to Califf, this proposed change would involve injecting the reduced doses of Jynneos between the layers of skin, creating a “pocket” for the vaccine.

“Intradermal delivery has some advantages, including a better immune response to the vaccine,” Califf said. “It is important to note that the overall safety and efficacy profile will not be sacrificed with this approach.”

An FDA spokesperson told The Hill that this change in the monkeypox vaccination strategy was being considered because it had become “clear to all of us that we would not be meeting the current demand with the current supply. “.

“As we often do at the FDA, we began to explore other scientifically feasible options. The identification of a clinical study that demonstrates that this approach might work was particularly helpful in explaining how it might work without sacrificing the safety and efficacy of the vaccine,” the spokesperson said.

If pursued, this new strategy would still involve two doses administered approximately 28 days apart.

James Krellenstein, co-founder of LGBTQ+ healthcare advocacy group PrEP4All, noted on Twitter that the FDA’s decision appears to be based on a 2015 study that examined the immune response derived from a one-fifth dose of Jynneos administered intradermally versus a full dose administered subcutaneously, it is that is, when the vaccine is injected into the layer of fat under the skin.

The study, funded in part by the National Institute of Allergy and Infectious Diseases, found an “equivalent immune response” between the two different forms of Jynneos administration.

Krellenstein wrote that he was happy to see the decision taken into account, saying his organization had suggested this strategy to federal officials on several occasions.

Leave a Comment