At a glance
The Evidence to Recommendations (EtR) frameworks describe information considered in moving from evidence to ACIP vaccine recommendations.
Summary
Question: Should JYNNEOS be recommended, based on shared clinical decision-making, for persons who are at risk for occupational exposure to orthopoxviruses*?
Population: Persons who are at risk for occupational exposure to orthopoxviruses
Intervention: Vaccination with JYNNEOS
Comparison(s): Vaccination with ACAM2000
Outcome: 1) Prevention of disease 2) Severity of disease 3) Severe adverse events 4) Myo-/peri-carditis
*For some populations, a subset of persons may benefit from receiving the vaccine but the entire population would not. For those persons, ACAM2000 is currently offered permissively as needed but not for the entire population. Examples of persons for whom this shared clinical decision-making may apply are persons who administer ACAM2000 to a large number of persons, persons who currently treat ACAM2000 clinical trial participants or investigate monkeypox outbreaks
Background
In September 2019, FDA approved JYNNEOS Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. Licensure of this vaccine means that there are now 2 vaccines for prevention of smallpox that are licensed in the US, the other vaccine being ACAM2000. JYNNEOS is the only currently FDA-approved vaccine with an indication that explicitly includes prevention of monkeypox disease. It is a replication-deficient modified vaccinia Ankara, administered subcutaneously in 2 doses that are given 28 days apart, does not produce a cutaneous reaction or “take” and there is no risk of inadvertent inoculation or autoinoculation. Serious adverse events like progressive vaccinia and eczema vaccinatum are not expected to occur with JYNNEOS; this is because these have occurred with previous orthopoxvirus vaccines secondary to uncontrolled viral replication and there is no risk for that with JYNNEOS. Cardiac adverse events like myopericarditis are believed to be fewer and FDA assessed effectiveness by comparing the immunologic response to ACAM2000 and deemed it non-inferior.
CDC has received multiple inquiries from federal agencies, occupational health clinics, and vaccinees inquiring about when JYNNEOS will be available specifically because they would like to receive JYNNEOS (instead of ACAM2000) because of the favorable profile outlined above.
Problem
Criteria | Work Group Judgements | Evidence | Additional Information |
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Is the problem of public health importance? | Yes |
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Benefits and Harms
Criteria | Work Group Judgements | Evidence | Additional Information |
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How substantial are the desirable anticipated effects? | Small |
Small benefit of JYNNEOS compared to aCAM per GRADE table. |
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How substantial are the undesirable anticipated effects? | Minimal |
No known harms; however, the Evidence table could not adequately assess adverse events given the low number of subjects and other study limitations |
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Do the desirable effects outweigh the undesirable effects? | Favors interventional |
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What is the overall certainty of this evidence for the critical outcomes? | Effectiveness of the intervention: Low |
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Values
Criteria | Work Group Judgements | Evidence | Additional Information |
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Does the target population feel that the desirable effects are large relative to undesirable effects? | Probably yes |
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Is there important uncertainty about or variability in how much people value the main outcomes? | Probably not important uncertainty or variability |
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Acceptability
Criteria | Work Group Judgements | Evidence | Additional Information |
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Is the intervention acceptable to key stakeholders? | Yes |
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Resource Use
Criteria | Work Group Judgements | Evidence | Additional Information |
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Is the intervention a reasonable and efficient allocation of resources? | Yes |
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Equity
Criteria | Work Group Judgements | Evidence | Additional Information |
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What would be the impact on health equity? | Increased |
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Feasibility
Criteria | Work Group Judgements | Evidence | Additional Information |
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Is the intervention feasible to implement? | Yes |
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Balance of consequences
Desirable consequences probably outweigh undesirable consequences in most settings
Is there sufficient information to move forward with a recommendation? Yes.