ACIP Evidence to Recommendations Framework

Question: Overarching policy question to be answered by the guideline panel (ACIP) using the Evidence to Recommendations (EtR) framework. 

The question should be precise and identify the specific intervention, comparison, and outcome, as well as the target population and the setting 

(specific subpopulations) in PICO format.

Population: Target population for vaccine (e.g., age range, sex, immune status, pregnancy) 

Intervention: Vaccination (if applicable, dosage and schedule) 

Comparison(s): No Vaccination/Standard of care/An existing vaccine/Other prevention option 

Outcome: Outcome(s) associated with vaccination (e.g., prevention outcomes or adverse effects)

Background: The addressed PICO question should be described in detail, and important background information for understanding the question 

and why a recommendation or decision is needed should be briefly provided. If a recommendation is preferential or represents off-label use, 

this should be indicated. 

Include sample language: Additional background information supporting the ACIP recommendations on the use of xxx vaccine can be found in 

the relevant publication of the recommendation referenced on the ACIP website. 

WORK GROUP JUDGMENTS EVIDENCE ADDITIONAL INFORMATION

PROBLEM

Is the problem of public health importance?

○ No

○ Probably no

○ Probably yes

○ Yes

○ Varies

○ Don't know

Provide available scientific evidence on 

burden of disease, preferably within the

target population for the

recommendation.

If no published evidence is available,

provide expert judgment on the public 

health priority considerations.

Identify any additional public health

priority considerations, including 

consideration of disparities.
WORK GROUP JUDGMENTS EVIDENCE ADDITIONAL INFORMATION

BENEFITS & HARMS

How substantial are the desirable 

anticipated effects?

○ Minimal

○ Small

○ Moderate

○ Large

○ Varies

○ Don't know

Describe the magnitude of the beneficial

effects of vaccination on individual 

(vaccine effectiveness, duration of 

protection) and population (herd 

immunity) levels. 

Take into consideration:

Is the baseline benefit similar across 

subgroups (by age, gender, pregnancy or 

lactation status, occupation [i.e., healthcare 

workers], immune status, race, SES, and 

other groups)?

Are there indirect effects that should be 

considered (e.g., herd immunity)?

How substantial are the undesirable 

anticipated effects?

○ Minimal

○ Small

○ Moderate

○ Large

○ Varies

○ Don't know

Are there undesirable effects of the 

vaccine, either on the individual (e.g., 

adverse events following immunization) 

or population (e.g., age-shift of disease, 

serotype replacement) levels? 

Take into consideration: 

Is the baseline risk for harm similar across 

subgroups (see above)? 

Should there be separate recommendations 

for subgroups based on harms? 

Do the desirable effects outweigh the 

undesirable effects?

○ Favors interventionl

○ Favors comparison

○ Favors both

○ Favors neither

○ Varies

○ Don't know

Describe the balance of benefits of the 

vaccine with possible harms (individual and 

population level). 
WORK GROUP JUDGMENTS EVIDENCE ADDITIONAL INFORMATION

What is the overall certainty of this 

evidence for the critical outcomes? 

Effectiveness of the intervention

○ No studies found

○ 4 (very low)

○ 3 (low)

○ 2 (moderate)

○ 1 (high)

Safety of the intervention

○ No studies found

○ 4 (very low)

○ 3 (low)

○ 2 (moderate)

○ 1 (high)

Please refer to GRADE evidence profiles for 

detailed assessment of the certainty of the 

evidence. For more information, please see 

the ACIP Handbook for Developing EvidenceBased Recommendations.

If GRADE was not used to evaluate the 

certainty of evidence, please provide 

justification and the method and outcome of 

any other tools used to evaluate the body of 

evidence relevant to the critical outcomes.

VALUES

Does the target population feel that the 

desirable effects are large relative to 

undesirable effects?

○ No

○ Probably no

○ Probably yes

○ Yes

○ Varies

○ Don't know

Provide any available evidence on target 

population values & preferences related to 

vaccination and comparative health benefits 

and risks. Describe the source of these 

estimates.

Are values and preferences for relevant 

outcomes measured? Are the benefits, 

harms and costs of vaccination valued 

differently by different subgroups? 

 

If the target group doesn’t value the 

intervention, or attributes little value to the 

harms and benefits, consider whether 

potential education measures are needed. 
WORK GROUP JUDGMENTS EVIDENCE ADDITIONAL INFORMATION

Is there important uncertainty about or 

variability in how much people value the 

main outcomes?

○ Important uncertainty or variability

○ Probably important uncertainty or variability

○ Probabl not important uncertainty or variability

○ No important uncertainty or variability

○ No known undesireable outcomes

Please provide available data used to 

determine the relative importance that the 

target population attributes to the desirable 

and the undesirable outcomes related to the 

intervention as well as the comparison.

Describe the source of variability, if any.

Are there methods for determining values 

satisfactory for this recommendation? 

If not, systematic assessment of values and 

preferences of target group may be 

considered. 

ACCEPTABILITY

Is the intervention acceptable to key 

stakeholders?

○ No

○ Probably no

○ Probably yes

○ Yes

○ Varies

○ Don't know

Provide assessment of whether intervention 

would be acceptable to stakeholders 

(ethically, programmatically, financially, etc.) 

RESOURCE USE

Is the intervention a reasonable and 

efficient allocation of resources?

○ No

○ Probably no

○ Probably yes

○ Yes

○ Varies

○ Don't know

Provide summary of cost-effectiveness 

analyses (CEAs) of the vaccine in the target 

population. Include base case results and a 

sensitivity range. Include any other notable 

findings, for example, specific policyrelevant scenarios. 

Overall findings: Summarize the findings 

from available CEAs, including major 

differences in baseline assumptions.

Uncertainty: Does the analysis capture the 

full range of uncertainty? For example, are 

the findings from the uncertainty of 

evidence analysis, identified earlier in this 

document (the EtR Framework), 

appropriately represented in the methods of 

the CEAs?

Multiple assessments: Are there multiple 

CEAs? If so, what are the major differences 

in methods and results?
WORK GROUP JUDGMENTS EVIDENCE ADDITIONAL INFORMATION

EQUITY

What would be the impact on health 

equity?

○ Reduced

○ Probably reduced

○ Probably no impact

○ Probably increased

○ Increased

○ Varies

○ Don't know

Summarize the findings from a review of the 

literature addressing issues of health 

inequities or groups who may be 

disadvantaged.

Consider from the evidence or guideline 

panel:

• Are there any groups or settings that 

might be disadvantaged in relation to 

the problem or options that are 

considered?

• Are there plausible reasons for 

anticipating differences in the relative 

effectiveness of the option for 

disadvantaged groups or settings?

• Are there different baseline conditions 

across groups or settings that affect the 

absolute effectiveness of the option or 

the importance of the problem for 

disadvantaged groups or settings?

• Are there important considerations 

that should be made when 

implementing the intervention 

(option) in order to ensure that 

inequities are reduced, if possible, 

and that they are not increased?

FEASIBILITY

Is the intervention feasible to implement?

○ No

○ Probably no

○ Probably yes

○ Yes

○ Varies

○ Don't know

Are there any barriers to implementation? Please refer to the Implementation 

Considerations checklist.
Balance of 

consequences

Undesirable 

consequences 

clearly outweigh 

desirable 

consequences

in most settings

Undesirable 

consequences 

probably outweigh 

desirable 

consequences

in most settings

The balance 

between 

desirable and 

undesirable 

consequences 

is closely balanced 

or uncertain

Desirable 

consequences 

probably outweigh 

undesirable 

consequences

in most settings

Desirable 

consequences 

clearly outweigh 

undesirable 

consequences

in most settings

There is 

insufficient 

evidence to 

determine the 

balance of 

consequences

○ ○ ○ ○ ○ ○

Is there sufficient information to move forward with a recommendation?

Yes ○ No ○ 

Policy options for 

ACIP consideration

ACIP does not recommend the 

intervention* 

*Intervention may be used within 

FDA licensed indications

ACIP recommends the intervention 

for individuals based on shared 

clinical decision-making

ACIP recommends the intervention

○ ○ ○

Draft 

recommendation 

(text)

Please provide the draft recommendations proposed to ACIP. 

Additional 

considerations

(optional)

Please outline any significant additional considerations (e.g., aspects related to implementation, monitoring and 

evaluation, research priorities, etc.). 
Final deliberation and decision by the ACIP

Final ACIP 

recommendation

ACIP does not recommend the 

intervention*

*Intervention may be used within FDA 

licensed indications

ACIP recommends the intervention for 

individuals based on shared clinical 

decision-making 

ACIP recommends the intervention

○ ○ ○

Additional ACIP 

considerations

Wording as accepted in the guide