About
- The Evidence to Recommendations (EtR) frameworks describe information considered in moving from evidence to ACIP vaccine recommendations.
Summary
Question: Should JYNNEOS® be recommended for research and clinical laboratory personnel performing diagnostic testing for orthopoxviruses* and for designated response teams# at risk for occupational exposure to orthopoxviruses?
Population: Clinical laboratory personnel performing diagnostic testing for orthopoxviruses and designated response teams
Intervention: Vaccination with JYNNEOS®
Comparison(s): Vaccination with ACAM2000
Outcome: 1) Prevention of disease 2) Severity of disease 3) Serious adverse events 4) Myo-/peri-carditis
*Clinical laboratory personnel who perform routine chemistry, hematology, and urinalysis testing, including for suspect patients with orthopoxvirus infections, are not included in this recommendation as their risk for exposure is very low
#Public health authorities, at their own discretion, may approve a cohort of healthcare and/or public health personnel to receive primary vaccination against orthopoxviruses for preparedness purposes (i.e., in the event of a smallpox or monkeypox outbreak)
[Note: Clinical laboratory personnel who perform routine chemistry, hematology, and urinalysis procedures are not recommended to be vaccinated with ACAM2000 or JYNNEOS because their risk of occupational exposure to orthopoxviruses is very low]
Background
In September 2019, FDA approved JYNNEOS®, a live replication-deficient modified vaccinia Ankara, 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. With the licensure of this vaccine, there are now 2 vaccines available in the United States for the prevention of orthopoxviruses; the other vaccine is ACAM2000, a live replicating vaccinia virus vaccine that is derived from a clonal isolate of Dryvax, the New York City Board of Health strain widely used during the smallpox eradication campaign. JYNNEOS® differs from ACAM2000 in several ways: JYNNEOS® is administered subcutaneously in 2 doses that are given 28 days apart, does not produce a cutaneous reaction or “take”, and does not carry risks for inadvertent inoculation or autoinoculation. Serious adverse events like progressive vaccinia and eczema vaccinatum are not expected to occur with JYNNEOS®; this is because the uncontrolled viral replication that occurred with previous orthopoxvirus vaccines (i.e., live, replicating vaccines) does not happen with JYNNEOS® (live, non-replicating vaccine). Cardiac adverse events like myopericarditis are believed to be fewer with JYNNEOS®. FDA assessed effectiveness by comparing its immunologic response to that of 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. Because of the favorable profile outlined above, there is specific interest in receiving doses of JYNNEOS® (instead of ACAM2000) as the recommended boosters even though ACAM2000 was the vaccination administered for the primary series for a vaccinee.
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 |
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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: Moderate |
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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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Some clinics have patients return for in-person clnic appointments on days 3, 7 etc. So there may be multiple clinical appointments for ACAM2000 even though only one appointment for the vaccine. |
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.