About
The Evidence to Recommendations (EtR) frameworks describe information considered in moving from evidence to ACIP vaccine recommendations.
Summary
Question: Should persons who are at continued risk* for occupational exposure to orthopoxviruses, and who received an ACAM2000 primary vaccination, receive a booster dose of JYNNEOS as an option to a booster dose of ACAM2000?
Population: Persons who are at risk for occupational exposure to orthopoxviruses
Intervention: Booster with JYNNEOS
Comparison(s): Booster with ACAM2000
Outcome: 1) Prevention of disease 2) Severity of disease 3) Severe adverse events 4) Myo-/peri-carditis
*Orthopoxvirus and healthcare worker response teams designated by appropriate public health and antiterrorism authorities are not at “continued risk” because they are vaccinated for the purposes of preparedness.
Background
The ACIP recommends booster doses of ACAM2000 every 3 years for persons at occupational risk for virulent replicating orthopoxviruses (e.g., variola virus and monkeypox) and at least every 10 years for persons at occupational risk for less virulent orthopoxviruses (e.g., cowpox and vaccinia virus). Vaccination with ACAM2000 has contraindications (e.g., being a household contact of a person with eczema), is believed to have more serious adverse events (including myopericarditis), and requires infection control measures because contact with the vaccination site can result in auto-inoculation or infection to others. Additionally, the vaccination technique can be painful and a smaller number of providers are willing to administer it compared to subcutaneous vaccines like JYNNEOS.
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) for booster vaccines even though they received ACAM2000 primary series.
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? | Large |
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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: Very 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? | 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? | Probably increasedt |
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Feasibility
Criteria | Work Group Judgements | Evidence | Additional Information |
---|---|---|---|
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.