Concerns about the rollout of the new monkeypox vaccine strategy

State and local public health authorities are receiving less supply following the move to intradermal administration

It’s becoming clear that the move to intradermal administration was not what it seemed. One health official, in describing the plan to me, called it an “accounting trick.” Rather than sending state and local health authorities the same number of vials with the option to use each one to vaccinate up to five people--which is what health departments were planning for--the administration is keeping the dose allocation the same.

In other words, when the pivot to intradermal administration was announced, a jurisdiction that ordered 1,000 vials thought they would be able to deliver 5,000 vaccinations. Instead, the administration is sending 200 vials. (More on this from the Washington Post.)

That’s not all. I have now heard multiple reports from my state and local colleagues that it is very difficult to extract five doses from a single vaccine vial. Average yield is more like 3 or 4 doses. That is, unless the stopper on the vial fails or some other hiccup arises from accessing a single use vial five different times, which does sometimes happen. In that event, the vial must be thrown away, and the remaining doses it contains are lost. Taken together, state and local health authorities now have up to one-third fewer doses for use in their communities than they were before the move to intradermal administration.

Supply constraints have complicated the vaccination campaign from the beginning. When the outbreak began, the Strategic National Stockpile held only a small number of doses. This is not surprising, as the vaccine was only licensed in 2019 and ACIP, the CDC committee that evaluates new vaccines for use in clinical practice, convened in November of 2021. I do not fault the administration for not having more Jynneos on the shelf.

To address shortages, officials made a bold move to stretch supply by pivoting from subcutaneous to intradermal administration. The new strategy allows one vial of vaccine to be split into up to five doses. There is scant data (in the public domain, at least) to support the effectiveness of this strategy in preventing monkeypox. According to an FDA decision memo, the primary evidence is a 2015 study that compares antibody response in a small number of study participants who received either lyophilized, subcutaneous or intradermal administration, and found them to be comparable. As far as I can tell, that’s it.

This decision was made in a data-thin environment, but there were not many good alternatives. Leaving people unprotected does not appeal, nor does using ACAM2000, an older vaccine stockpiled for smallpox that has a history of causing severe side effects. Adopting an intradermal dosing strategy is a gamble, but one that I think was worth making.

Officials went further out on a limb by issuing the Emergency Use Authorization for intradermal dosing before convening the expert advisory committee, VRBPAC, that customarily recommends whether to go forward with a new vaccine or new use of an existing vaccine. Consultation with that committee is not required in this instance, but there is a reason they are normally called upon. The independent review by outside experts, who conduct their discussion in a public forum, is integral for transparency and credibility of the process.

It is too late to call upon VRBPAC to review intradermal administration. That ship has sailed. But it’s not too late to restore the original allocations—by vial, not dose—to state and local health authorities so that their jurisdictions benefit from the increase in supply, which was the point of taking a chance on intradermal administration.

The plan for the “extra” vials is not clear. At least some are being reserved for large gatherings attended by men who have sex with men, like Pride events, and clinics that serve people living with HIV. State and local health authorities can still concentrate doses in those places if that makes sense for their local context. National authorities can even recommend that they do so. But the final decision about how to allocate doses should be made at the state and local level, in keeping with how most decisions about implementation of public health strategies are made.

Going forward, federal health officials must find a happier medium when balancing speed with transparency. Trust in public health has weakened over the course of the pandemic. A laggard response risks jeopardizing it further, but so too do inconsistent and opaque decisions. Federal officials must also take more pains to honor the role of state and local health officials as the front lines of public health practice. Further fracturing our already fragmented public health system will erode our ability to respond to serious health events even more.