For more information: www.cdc.gov/COVID19

EtR Framework: 

Moderna COVID-19 vaccine

ACIP COVID-19 Vaccines

Sara Oliver MD, MSPH

ACIP Meeting

December 19, 2020
Evidence to Recommendations Framework
 Structure to describe information considered in moving from evidence

to ACIP vaccine recommendations

 Provide transparency around the impact of additional factors on 

deliberations when considering a recommendation 

 Highlight updates based on the Moderna COVID-19 vaccine 

Evidence to Recommendations (EtR) Framework

3
 Should vaccination with the Moderna COVID-19 vaccine 

(2-doses, IM) be recommended for persons 18 years of age and 

older under an Emergency Use Authorization?

Evidence to Recommendations (EtR) Framework

Policy Question

4
Evidence to Recommendations (EtR) Framework:

PICO Question

5

Population Persons aged ≥18 years

Intervention Moderna COVID-19 vaccine (mRNA-1273)

100 μg, 2 doses IM, 28 days apart 

Comparison No COVID-19 vaccine

Outcomes

Symptomatic laboratory-confirmed COVID-19

Hospitalization due to COVID-19

All-cause death

SARS-CoV-2 seroconversion to a non-spike protein

Asymptomatic SARS-CoV-2 infection

Serious Adverse Events

Reactogenicity grade ≥3
Evidence to Recommendations (EtR) Framework

6

EtR DomainQuestion

Public Health Problem • Is the problem of public health importance?

Benefits and Harms

• How substantial are the desirable anticipated effects?

• How substantial are the undesirable anticipated effects?

• Do the desirable effects outweigh the undesirable effects?

Values

• Does the target population feel the desirable effects are large relative to the

_ undesirable effects?

• Is there important variability in how patients value the outcomes?

Acceptability • Is the intervention acceptable to key stakeholders?

Feasibility • Is the intervention feasible to implement?

Resource Use • Is the intervention a reasonable and efficient allocation of resources?

Equity • What would be the impact of the intervention on health equity?
Evidence to Recommendations (EtR) Framework

7

EtR DomainQuestion

Public Health Problem • Is the problem of public health importance?

Benefits and Harms

• How substantial are the desirable anticipated effects?

• How substantial are the undesirable anticipated effects?

• Do the desirable effects outweigh the undesirable effects?

Values

• Does the target population feel the desirable effects are large relative to the

_ undesirable effects?

• Is there important variability in how patients value the outcomes?

Acceptability • Is the intervention acceptable to key stakeholders?

Feasibility • Is the intervention feasible to implement?

Resource Use • Is the intervention a reasonable and efficient allocation of resources?

Equity • What would be the impact of the intervention on health equity?

“The vaccine” or “The intervention” = Moderna COVID-19 vaccine

“The problem” = COVID-19 disease
EtR Domain: Public Health Problem
Public Health Problem

Is COVID-19 disease of public health importance?

- Are the consequences of COVID-19 serious?

- Is COVID-19 urgent?

- Are a large number of people affected by COVID-19?

- Are there populations disproportionately affected by COVID-19? 

○ No ○ Probably no ○ Probably yes ○ Yes ○ Varies ○ Don't know
0

50000

100000

150000

200000

250000

300000

Jan 22 2020 Mar 7 2020 Apr 21 2020 Jun 5 2020 Jul 20 2020 Sep 3 2020 Oct 18 2020 Dec 2 2020

Number of COVID-19 Cases

Public Health Problem:

Review of the Available Evidence

January 21 – December 17

Dec 17 2020

https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases 10
0

1000

2000

3000

4000

5000

6000

7000

Jan 22 2020 Mar 7 2020 Apr 21 2020 Jun 5 2020 Jul 20 2020 Sep 3 2020 Oct 18 2020 Dec 2 2020

Number of COVID-19 Cases

Public Health Problem:

Review of the Available Evidence

January 21 – December 17

Dec 17 2020

https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases 11
 Hospitalization

–

–

Cumulative hospitalization rate between March 1 and December 12, 2020 was 

295.9 per 100,000 population

Among those hospitalized, 32% required care in an intensive care unit and 15% died

 Mortality

– Estimates of the SARS-CoV-2 infection fatality ratio range from 0.5% to 1.4%

12

Public Health Problem:

Summary of the Available Evidence

https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html . 

https://gis.cdc.gov/grasp/COVIDNet/COVID19_5.html . 

Hauser, A. et al. Estimation of SARS-CoV-2 mortality during the early stages of an epidemic: a modeling study in Hubei, China, and six regions in Europe. PLoS medicine, 17(7), p.e1003189

Yang, W. et al. Estimating the infection-fatality risk of SARS-CoV-2 in New York City during the spring 2020 pandemic wave: a model-based analysis. Lancet Infect Dis. 2020 

DOI:https://doi.org/10.1016/S1473-3099(20)30769-6 
Public Health Problem:

Work Group Interpretation

Is COVID-19 disease of public health importance? 

○ No ○ Probably no ○ Probably yes ○ Yes ○ Varies ○ Don't know
EtR Domain: Benefits and Harms
Benefits and Harms

How substantial are the desirable anticipated effects?

- How substantial is the anticipated effect for each main outcome for which there is a 

_____desirable effect? 

○ Minimal ○ Small ○ Moderate ○ Large ○ Varies ○ Don't know
○

Benefits and Harms

How substantial are the undesirable anticipated effects?

- How substantial is the anticipated effect for each main outcome for which there is an 

_____undesirable effect? 

○ Minimal ○ Small ○ Moderate ○ Large ○ Varies Don't know
Benefits and Harms

Do the desirable effects outweigh the undesirable effects? 

- What is the balance between the desirable effects relative to the undesirable effects?

○

○

○

○

○

Favors intervention (Moderna COVID-19 vaccine)

Favors comparison (no vaccine)

Favors both

Favors neither

Unclear
 The clinical trial demonstrated very high efficacy against symptomatic, laboratoryconfirmed COVID-19. The overall efficacy was 94.1% (95% CI: 89.3%, 96.8%).

High certainty of evidence

 For COVID-19 associated hospitalization, 10 events occurred, 9 in the placebo group, 

1 in the vaccine group. Vaccine efficacy against hospitalization was 89% (95% 

CI: 13%, 99%).

Moderate certainty of evidence

 Deaths were uncommon, 6 in the vaccine group and 7 in the placebo group.

Very low certainty of evidence

Benefits and Harms:

Summary of the Available Evidence: Benefits

18
 The ability of the vaccine series to prevent asymptomatic SARS-CoV-2 

infection has not been assessed to date in a large, prospective clinical trial. 

However, it can be informed by PCR screening among trial participants 

returning for second dose. 

 Four weeks after the first dose of the Moderna COVID-19 vaccine, 14 

participants (0.1%) had a positive SARS-CoV-2 PCR without symptoms of 

COVID-19, compared to 38 (0.3%) of those receiving placebo. 

Very low certainty of evidence

Benefits and Harms:

Summary of the Available Evidence: Benefits

19
Benefits and Harms:

Summary of the Available Evidence: Benefits

20

 Primary efficacy endpoint: subjects without evidence of prior infection

–

–

–

–

Efficacy: 94.1% (89.3%, 96.8%)

 High efficacy for additional efficacy analysis, across age, sex, race, and 

ethnicity categories, and those with underlying medical conditions

Efficacy among adults 18-64 years of age: 95.6% (90.6%, 97.9%)

Efficacy among adults ≥65 years of age: 86.4% (61.4%, 95.5%)

• Efficacy among adults ≥75 years of age: 100%

 Most recipients received 2 doses of the Moderna COVID-19 vaccine

Efficacy of 69.5% (43.5%, 84.5%) noted between dose 1 and dose 2
Benefits and Harms:

Summary of the Available Evidence: Benefits

21

 30 cases of severe disease* noted in placebo group, 1 in vaccine group

–

–

–

VE estimate: 97% (76%, 100%)

 Numbers of observed COVID-19 associated hospitalization or death are low

Nine COVID-19 associated hospitalizations in placebo recipient, 1 in vaccine recipient

One COVID-19 associated death occurred in placebo recipient

*Definition: Respiratory Rate ≥ 30, Heart Rate ≥125, SpO2≤ 93% on room air at sea level or PaO2/FIO2< 300 mm Hg; OR respiratory failure

or Acute Respiratory Distress Syndrome (ARDS), defined as needing high-flow oxygen, non-invasive or mechanical ventilation, or ECMO; OR evidence 

of shock (systolic blood pressure <90mmHg, diastolic BP<60mmHg or requiring vasopressors); OR significant acute renal, hepatic or neurologic 

dysfunction; OR admission to an intensive care unit or death
 Serious adverse events were reported in a similar proportion among 

recipients of vaccine and placebo (1.0% vs 1.0%). 

Moderate certainty of evidence

 Severe reactions were more common in vaccine recipients; any grade ≥3 

reaction was reported by 21.5% of vaccinated versus 4.4% of placebo group. 

High certainty of evidence

Benefits and Harms:

Summary of the Available Evidence: Harms

22
Benefits and Harms:

Summary of the Available Evidence: Harms

23

 Local reactions occurring within 7 days were common

–

–

Pain at the injection site most common

 Systemic reactions within 7 days were common

Fatigue, headache, and myalgia most common

 Symptom onset was usually 1-2 days post-vaccine receipt

 Most symptoms resolved after 2-3 days (median duration)
Benefits and Harms: Reactogenicity (Local)

24

Dose 1 Dose 2

Moderna vaccine 

N=11401

Placebo

N=11404

Moderna vaccine

N=10357

Placebo

N=10317

Local Reaction

Any 9960 (87.4) 2432 (21.3) 9371 (90.5) 2134 (20.7)

Severe (Grade 3) 452 (4.0) 39 (0.3) 766 (7.4) 41 (0.4)

Pain at the injection site

Any 9908 (86.9) 2179 (19.1) 9335 (90.1) 1942 (18.8)

Severe (Grade 3) 367 (3.2) 23 (0.2) 479 (4.6) 21 (0.2)

Dose 1 Dose 2

Moderna Vaccine 

N=3762

Placebo

N=3746

Moderna Vaccine

N=3587

Placebo

N=3549

Local Reaction 

Any 2805 (74.6) 566 (15.1) 3010 (83.9) 473 (13.3)

Severe (Grade 3) 77 (2.0) 39 (1.0) 212 (5.9) 29 (0.8)

Pain at the injection site

Any 2782 (74.0) 481(12.8) 2990 (83.4) 421 (11.9)

Severe (Grade 3) 50 (1.3) 32 (0.9) 96 (2.7) 17 (0.5)

Select local reactions in persons aged 18-64 years

Select local reactions in persons aged ≥65 years
Benefits and Harms: Reactogenicity (Local)

25

Dose 1 Dose 2

Moderna vaccine 

N=11401

Placebo

N=11404

Moderna vaccine

N=10357

Placebo

N=10317

Local Reaction

Any 9960 (87.4) 2432 (21.3) 9371 (90.5) 2134 (20.7)

Severe (Grade 3) 452 (4.0) 39 (0.3) 766 (7.4) 41 (0.4)

Pain at the injection site

Any 9908 (86.9) 2179 (19.1) 9335 (90.1) 1942 (18.8)

Severe (Grade 3) 367 (3.2) 23 (0.2) 479 (4.6) 21 (0.2)

Dose 1 Dose 2

Moderna Vaccine 

N=3762

Placebo

N=3746

Moderna Vaccine

N=3587

Placebo

N=3549

Local Reaction 

Any 2805 (74.6) 566 (15.1) 3010 (83.9) 473 (13.3)

Severe (Grade 3) 77 (2.0) 39 (1.0) 212 (5.9) 29 (0.8)

Pain at the injection site

Any 2782 (74.0) 481(12.8) 2990 (83.4) 421 (11.9)

Severe (Grade 3) 50 (1.3) 32 (0.9) 96 (2.7) 17 (0.5)

Select local reactions in persons aged 18-64 years

Select local reactions in persons aged ≥65 years
Benefits and Harms: Reactogenicity (Systemic)

26

Dose 1 Dose 2

Moderna vaccine 

N=11401

Placebo

N=11404

Moderna vaccine

N=10357

Placebo

N=10317

Systemic Reaction

Any 6503 (57.0) 5063 (44.4) 8484 (81.9) 3967 (38.4)

Grade 3 or 4 368 (3.2) 252 (2.2) 1811 (17.4) 217 (2.1)

Fever

Any 105 (0.9) 39 (0.3) 1806 (17.4) 38 (0.4)

Grade 3 10 (<0.1) 1 (<0.1) 168 (1.6) 1 (<0.1)

Grade 4 4 (<0.1) 4 (<0.1) 10 (<0.1) 1 (<0.1)

Select systemic 

reactions in persons 

aged 18-64 years

Select systemic 

reactions in persons 

aged ≥65 years

Dose 1 Dose 2

Moderna vaccine 

N=3761

Placebo

N=3748

Moderna vaccine

N=3589

Placebo

N=10317

Systemic Reaction

Any 1818 (48.3) 1335 (35.6) 2580 (71.9) 1102 (31.1)

Grade 3 or 4 84 (2.2) 63 (1.7) 389 (10.8) 59 (1.6)

Fever

Any 10 (0.3) 7 (0.2) 366 (10.2) 5 (0.1)

Grade 3 1 (<0.1) 1 (<0.1) 18 (0.5) 0 (0)

Grade 4 0 (0) 2 (<0.1) 1 (<0.1) 1 (<0.1)

Grade 3 fever: 102.1–104.0oF

Grade 4 fever: >104.0oF
Benefits and Harms: Reactogenicity (Systemic)

27

Dose 1 Dose 2

Moderna vaccine 

N=11401

Placebo

N=11404

Moderna vaccine

N=10357

Placebo

N=10317

Systemic Reaction

Any 6503 (57.0) 5063 (44.4) 8484 (81.9) 3967 (38.4)

Grade 3 or 4 368 (3.2) 252 (2.2) 1811 (17.4) 217 (2.1)

Fever

Any 105 (0.9) 39 (0.3) 1806 (17.4) 38 (0.4)

Grade 3 10 (<0.1) 1 (<0.1) 168 (1.6) 1 (<0.1)

Grade 4 4 (<0.1) 4 (<0.1) 10 (<0.1) 1 (<0.1)

Select systemic 

reactions in persons 

aged 18-64 years

Select systemic 

reactions in persons 

aged ≥65 years

Dose 1 Dose 2

Moderna vaccine 

N=3761

Placebo

N=3748

Moderna vaccine

N=3589

Placebo

N=10317

Systemic Reaction

Any 1818 (48.3) 1335 (35.6) 2580 (71.9) 1102 (31.1)

Grade 3 or 4 84 (2.2) 63 (1.7) 389 (10.8) 59 (1.6)

Fever

Any 10 (0.3) 7 (0.2) 366 (10.2) 5 (0.1)

Grade 3 1 (<0.1) 1 (<0.1) 18 (0.5) 0 (0)

Grade 4 0 (0) 2 (<0.1) 1 (<0.1) 1 (<0.1)

Grade 3 fever: 102.1–104.0oF

Grade 4 fever: >104.0oF
Benefits and Harms:

Summary of the Available Evidence: Harms

28

 Lymphadenopathy

–

–

–

–

Ipsilateral (same side) axillary swelling and tenderness was a solicited adverse event

More common among vaccine recipients <65 years of age 

Grade 3 axillary lymphadenopathy rare, but more common after second dose

Duration after first dose: 1 day. Duration after second dose: 2 days

Moderna vaccine Placebo

Adults 18-64 years of age 21.4% 7.5%

Adults ≥65 years of age 12.4% 5.8%

Moderna vaccine Placebo

Dose 1 0.3% 0.2%

Dose 2 0.5% 0.1%

Grade 3 lymphadenopathy: Any use of prescription (narcotic) pain reliever or prevents daily activity
Benefits and Harms:

Summary of the Available Evidence: Harms

29

 Bell’s palsy 

–

–

–

Small imbalance between vaccine group (n=3) and placebo (n=1)

Currently available information is insufficient to determine a causal relationship with 

the vaccine 

Post-authorization surveillance will help determine any possible causal relationship

 Serious adverse events similar between vaccine (1.0%) and placebo (1.0%)
Summary of GRADE

30

OutcomeImportance Design

(# of studies)

FindingsEvidence

type

Benefits

Symptomatic laboratoryconfirmed COVID-19

Critical RCT (1) Moderna COVID-19 vaccine prevents symptomatic COVID-191

Hospitalization due to 

COVID-19

Critical RCT (1) Moderna COVID-19 vaccine prevents COVID-19-resulting in 

hospitalization 2

All-cause Death Important RCT (1) Moderna COVID-19 vaccine may or may not prevent death; certainty is 

very low because this is a rare outcome 4

SARS-CoV-2 

seroconversion Important No studies Data not yet available from any studies ND

Asymptomatic SARS-CoV-2 

infection Important RCT (1) Preliminary data consistent with a lower incidence of asymptomatic 

SARS-CoV-2 infection among vaccinated compared with placebo 4

Harms

Serious adverse events

Critical RCT (2) SAEs were balanced between vaccine and placebo arms. 3 SAEs were 

judged by FDA to be related to vaccination 2

Reactogenicity Important RCT (2) Severe reactions were almost 5 times more common in vaccinated vs. 

placebo; any grade ≥3 reaction was reported by 21.5% of vaccinated 1

Evidence type: 1=high; 2=moderate; 3=low; 4=very low; ND, no data. 
○ ○ ○ ○ ○ ○

Benefits and Harms

How substantial are the desirable anticipated effects?

- How substantial is the anticipated effect for each main outcome for which there is a 

_____desirable effect? 

Minimal Small Moderate Large Varies Don't know
○ ○ ○ ○ ○ ○

Benefits and Harms

How substantial are the undesirable anticipated effects?

- How substantial is the anticipated effect for each main outcome for which there is an 

_____undesirable effect? 

Minimal Small Moderate Large Varies Don't know
Benefits and Harms

Do the desirable effects outweigh the undesirable effects? 

- What is the balance between the desirable effects relative to the undesirable effects?

○ Favors intervention (Moderna COVID-19 vaccine)

○ Favors comparison (no vaccine)

○ Favors both

○ Favors neither

○ Unclear
EtR Domain: Values
○ ○ ○ ○ ○ ○

Values

Criteria 1: 

Does the target population feel that the desirable 

effects are large relative to undesirable effects? 

-How does the target population view the balance of desirable versus undesirable effects?

-Would patients feel that the benefits outweigh the harms and burden?

-Does the population appreciate and value the Moderna COVID-19 vaccine? 

No Probably no Probably yes Yes Varies Don't know
Values

Criteria 2: 

Is there important uncertainty about, or variability in, 

how much people value the main outcomes? 

-How much do individuals value each outcomes in relation to the other outcomes?

-Is there evidence to support those value judgments? 

-Is there evidence that the variability is large enough to lead to different decisions? 

○ Important uncertainty or variability

○ Probably important uncertainty or variability 

○ Probably not important uncertainty or variability 

○ No important uncertainty or variability 

○ No known undesirable outcomes 
Values:

Review of the Available Evidence

37

 Review of scientific literature, news media, and reports

– Databases: Medline, Embase, Psycinfo, Global Health Ovid, CINAHL, ProQuest Coronavirus Research, 

Scopus, WHO COVID-19

– Search terms: SARS-CoV-2/COVID-19 string; vaccine string; intent, confidence, hesitancy, attitude, 

belief, accept, choice, decision, refusal

– News media and reports: SEAN COVID-19 Survey Archive, Google 

– Last search date: December 18, 2020

 Inclusion criteria

– Data collection in 2020 related to COVID-19 vaccine beliefs, attitudes, and intentions

– Population: Adults in the U.S. 

 Preliminary findings from CDC vaccine intent survey and focus group discussions
 Overall acceptability of a COVID-19 vaccine was moderate1

– Proportion intending to receive vaccine ranged across surveys: 42-86%

– Attitudes towards Pfizer-BioNTech COVID-19 vaccine with news reports of 90% efficacy:

71% believed effective, 68% safe

– November survey: 70% likely if proven safe and effective by public health officials

– December survey: 40% will get as soon as available, 44% wait a bit, 15% never get

Values:

Summary of the Available Evidence

38 1. APNORC; Harris; Fisher Ann Intern Med.; ICF; Kreps JAMA Netw Open.; Lazarus Nature Med.; Malik EClinicalMedicine.; Pogue Vaccines.; Reiter Vaccine.; Thunstrom SSRN. 

Axios-IPSOS. Pew. KFF. ABC News-IPSOS.
COVID-19 Vaccination Intentions Varied by Survey Month

*Positive vaccine intentions includes persons reporting definitely, probably, or somewhat likely to get vaccinated. 

Reference Date N % Intent

Romer Mar 1,050 82%

Fisher Apr 991 58%

Earnshaw Apr 845 86%

Southwell Apr 2,279 75%

Roozenbeek Apr 700 75%

Hogan Apr 101 74%

Malik May 672 67%

Taylor May 1,772 75%

Reiter May 2,006 69%

APNORC May 1,056 49%

ICF May 1,000 63%

Pew May 10,957 72%

CUNY May 1,999 74%

Head May 3,159 66%

Lazarus Jun 773 75%

ICF Jun 1,000 63%

Perlis Jul 19,027 66%

Romer Jul 840 72%

Pogues Aug 316 69%

KFF Sep 1,199 42%

Pew Sep 10,093 51%

Harris Sep 1,971 54%

Gallup Oct 2,985 58%

IPSOS Oct 3,541 62%

USC Nov 2,703 63%

Harris Nov 1,963 60%

Pew Nov 12.948 60%

Axios-Ipsos Nov 1,002 51%

Axios-Ipsos Dec 1,101 53%

APNORC Dec 1,117 47%

Quinnipiac Dec 978 61%

KFF Dec 1,676 71%

ABC News/IPSOS Dec 621 84%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Mar Apr May Jun Jul Aug Sep Oct Nov Dec

% Reporting Positive Vaccine Intentions*
40

 Many adults reported intentions to receive COVID-19 vaccine

– Common desirable effects included protecting self, family, community from SARS-CoV-2 

infection and severe illness and return to normalcy 

– Common concerns included vaccine side effects, uncertainty of vaccine efficacy, and speed of 

vaccine approval process

 Vaccination intentions varied substantially by race or ethnicity and socioeconomic 

status of respondents

 Limitations:

– Most surveys conducted prior to availability of information on Moderna COVID-19 vaccine

– Convenience samples may not be representative

Values:

Summary of the Available Evidence
Values: Work Group Interpretation

Criteria 1: 

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
Values: Work Group Interpretation

Criteria 2: 

Is there important uncertainty about, or variability in, 

how much people value the main outcomes? 

○ Important uncertainty or variability

○ Probably important uncertainty or variability 

○ Probably not important uncertainty or variability 

○ No important uncertainty or variability 

○ No known undesirable outcomes 
EtR Domain: Acceptability
Acceptability

Is the Moderna COVID-19 vaccine acceptable to key 

__stakeholders? 

- Are there key stakeholders that would not accept the distribution of benefits and harms? 

_ - Are there key stakeholders that would not accept the undesirable effects in the short term 

_ for the desirable effects (benefits) in the future? 

○ No ○ Probably no ○ Probably yes ○ Yes ○ Varies ○ Don't know
 Review of scientific literature

 Preliminary findings from CDC evaluations of COVID-19 vaccine attitudes

– Survey with State Health Officers (n=34)

– Focus group discussions with nurses (7 focus groups)

– National online survey: sub-group analysis for healthcare providers (n=216)

 Review of news media, professional society and workers’ unions websites

– AAFP, AFT, AFSCME, AGS, ANA, AMA, IDSA, SEIU

– American Nurses Foundation (ANF) survey (n=12,939)

 Consideration of programmatic, financial, and ethical aspects

– State/jurisdiction and partner planning for vaccine implementation

– Anticipated out-of-pocket costs

Acceptability:

Review of the Available Evidence

45
 No published provider knowledge, attitudes, and practices surveys

 CDC evaluations

– State health officers, Oct: concerns with rollout included vaccine hesitancy (53%), vaccine safety 

(32%), and communications (26%)1

– Focus groups with nurses (n=7 groups), Jun-Aug: most supported prioritizing nurses, some reluctant 

to get vaccinated, and many do not want to get it right away2

– Vaccine intent survey, Sep-Oct: 63% healthcare providers would get COVID-19 vaccine3

 ANF nurses survey, Oct: moderate acceptability of COVID-19 vaccine4

– 63% somewhat or very confident vaccine will be safe and effective

– 57% comfortable discussing COVID-19 vaccines with patients

Acceptability:

Summary of the Available Evidence

4. ANF, 16 Nov 2020. https://www.nursingworld.org/practice-policy/work-environment/health-safety/disaster-preparedness/coronavirus/what-you-need-to-know/covid-19-vaccine-survey/46

1. CDC COVID-19 Response Team. 2. Jorgenson. CDC Presentation to ACIP Working Group. 3 Sep 2020. 3. Lindley et al, CDC COVID-19 Response Team: Report in progress.
Acceptability

Goldstein J, NYTimes, 18 Dec 2020. https://www.nytimes.com/2020/12/18/nyregion/coronavirus-vaccine-new-york.html 47

“At Northwell Health, New York state’s largest hospital 

system, more than 1,600 people had been vaccinated by 

midday Thursday. Only two people had declined or 

deferred, said Joe Kemp, a spokesman for the hospital.”

Petrona Ennis-Welch, a nurse, was the first person from 

Mount Sinai Hospital to receive a vaccine. 

Kirsten Luce for The New York Times
48

 Jurisdictions implementing COVID-19 vaccine implementation plans

 Large and small pharmacy chains working to launch COVID-19 

vaccination program in long-term care facilities

Acceptability:

Summary of the Available Evidence
Acceptability:

Work Group Interpretation 

Is the Moderna COVID-19 vaccine acceptable to key 

__stakeholders? 

○ No ○ Probably no ○ Probably yes ○ Yes ○ Varies ○ Don't know
EtR Domain: Feasibility 
Feasibility 

Is the Moderna COVID-19 vaccine feasible to 

__implement? 

- Is the Moderna COVID-19 vaccine program sustainable? 

- Are there barriers that are likely to limit the feasibility of implementing the Moderna 

_____COVID-19 vaccine or require consideration when implementing it? 

- Is access to the Moderna COVID-19 vaccine an important concern? 

_

○ No ○ Probably no ○ Probably yes ○ Yes ○ Varies ○ Don't know
 Barriers to implementation may include: 

1) Financial barriers

2) Complexity of recommendations

3) Vaccine storage and handling requirements 

Feasibility:

Summary of the Available Evidence

52
53

 All COVID-19 vaccines will be provided to U.S. population free of charge

 Health systems or health departments could incur costs for vaccine 

implementation or clinics 

Feasibility:

Summary of the Available Evidence

1) Financial barriers
54

Feasibility:

Summary of the Available Evidence

2) Complexity of recommendations

 Two mRNA vaccines under an EUA with different dosing intervals, 

storage and handling requirements may make vaccine 

recommendations more complex
55

 Vaccine must be maintained at standard freezer temperatures (-25oC to -15oC) 

for shipping and long-term storage

 Vaccine is stable up to 30 days at refrigerator temperatures

 Minimum size of orders (currently 100 doses)

 Requirements for two-dose series

Feasibility:

Summary of the Available Evidence

3) Vaccine storage and handling requirements
Feasibility: 

Work Group Interpretation

Is the Moderna COVID-19 vaccine feasible to 

__implement? 

_

○ No ○ Probably no ○ Probably yes ○ Yes ○ Varies ○ Don't know
EtR Domain: Resource Use
Resource Use

Is the Moderna COVID-19 vaccine a reasonable and 

_efficient allocation of resources? 

- What is the cost-effectiveness of the Moderna COVID-19 vaccine?

- How does the cost-effectiveness of the Moderna COVID-19 vaccine change in 

________response to changes in context, assumptions, etc? 

○ No ○ Probably no ○ Probably yes ○ Yes ○ Varies ○ Don't know
59

Resource Use:

Summary of the Available Evidence

 If 20% of the U.S. population is infected with COVID-19, the direct medical costs 

could be $163 billion1

 Health-related costs (including premature deaths, long-term health impairment 

and mental health impairment) have been estimated at $8.5 trillion2

Costs associated with COVID-19 disease

1. Bartsch et al. 2020. Health Affairs “The Potential Health Care Costs And Resource Use Associated With COVID-19 In The United States”.

2. Cutler and Summers. 2020. JAMA. “The COVID-19 pandemic and the $16 trillion virus.”
60

Resource Use:

Summary of the Available Evidence

 If 20% of the U.S. population is infected with COVID-19, the direct medical costs 

could be $163 billion 

 Health-related costs (including premature deaths, long-term health impairment 

and mental health impairment) have been estimated at $8.5 trillion

Costs associated with COVID-19 disease

Costs associated with COVID-19 vaccines

 U.S. Government has committed $10 billion to Operation Warp Speed for the 

provision of vaccines1

 Vaccine doses purchased with U.S. taxpayer dollars will be given to the American 

people at no cost2

1. https://www.hhs.gov/about/news/2020/05/15/trump-administration-announces-framework-and-leadership-for-operation-warp-speed.html

2. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html
 No published cost-effectiveness analyses currently available

 Precise cost-effectiveness analysis and economic impact of vaccination 

depend on number of factors that are currently unknown:

– Duration of vaccine protection

– Vaccination coverage levels

– Implementation costs associated with large vaccination program

 The Work Group concluded that cost-effectiveness may not be a primary 

driver for decision-making during a pandemic and for vaccine used under EUA 

– Will need to be reassessed for future recommendations

61

Resource Use:

Work Group Interpretation
Resource Use:

Work Group Interpretation

Is the Moderna COVID-19 vaccine a reasonable and 

__efficient allocation of resources?

○ No ○ Probably no ○ Probably yes ○ Yes ○ Varies ○ Don't know
EtR Domain: Equity 
Equity 

What would be the impact of the Moderna COVID-19 

__vaccine on health equity?

- Are there groups or settings that might be disadvantaged in relation to COVID-19 disease 

_____burden or receipt of the Moderna COVID-19 vaccine?

- Are there considerations that should be made when implementing the Moderna COVID-19 

_____vaccine program to ensure that inequities are reduced whenever possible, and that 

_____they are not increased?

○ Reduced ○ Probably reduced ○ Probably no impact

○ Probably increased ○ Increased ○ Varies ○ Don't know
Equity:

Review of the Available Evidence

65

 Identification of groups that might be disadvantaged in relation to COVID-19 

disease burden or receipt of the Moderna COVID-19 vaccine

– PROGRESS-Plus Framework:1 place of residence, race or ethnicity, occupation, gender or sex, 

religion, education, socioeconomic status, social capital, disability, other

 Review of the scientific and gray literature

 Review of CDC COVID-19 response data and resources

– CDC COVID Data Tracker & COVID-19-Associated Hospitalization Surveillance Network (COVID-NET)

– National Center for Health Statistics

– COVID-19 Disproportionately Affected Populations Team critical populations review

1 PROGRESS-Plus is an acronym to identify factors associated with unfair differences in disease burden and the potential for interventions to reduce these differential effects. 

SeeO'Neill J, Tabish H, Welch V, et al. Applying an equity lens to interventions: using PROGRESS ensures consideration of socially stratifying factors to illuminate inequities in 

health. J Clin Epi. 2014;67: 56-64; Welch VA, Akl EA, Guyatt G, et al. GRADE equity guidelines 1: considering health equity in GRADE guideline development: introduction and 

rationale. J Clin Epidemiol. 2017;90:59-67.
66

Equity: Groups who might be unfairly disadvantaged in relation to COVID-19 

disease burden or receipt of the Moderna COVID-19 vaccine

 Racial and ethnic minority populations

 People living in poverty or with high social vulnerability

 Essential workers

– Some racial/ethnic minority populations disproportionately represented in subsets of essential 

workers, e.g., public transit, building cleaning services, construction, food and agriculture1-3

– Almost one quarter live in low-income families1

 Residents in congregate settings, such as long-term care facilities, prisons, homeless 

shelters, and group homes for people with intellectual/developmental disabilities

 People with substance abuse disorders 

 Sexual and gender minorities

– Face social or structural inequities that can lead to health disparities

1Rho HJ, Brown H, Fremstad S. A basic demographic profile of workers in frontline industries. April 2020. Washington, DC: Center for Economic and Policy Research;2020. https://cepr.net/abasic-demographic-profile-of-workers-in-frontline-industries 2Bui DP, McCaffrey K, Friedrichs M, et al. Racial and ethnic disparities among COVID-19 Cases in workplace outbreaks by industry sector — Utah, March 6–June 5, 2020. MMWR Morb Mortal 

Wkly Rep 2020;69:1133–8. DOI: http://dx.doi.org/10.15585/mmwr.mm6933e3

3Waltenburg MA, Rose CE, Victoroff T, et al. Coronavirus disease among workers in food processing, food manufacturing, and agriculture workplaces Emerg Infect Dis. 2021 Jan. 

https://wwwnc.cdc.gov/eid/article/27/1/20-3821_article 
 Storage, handling and administration requirements

– Refrigerator-stable vaccine will facilitate the availability of the Moderna COVID-19 

vaccine in most community settings, once supply allows

 Need for 2-dose series 

– Follow-up may be challenging for some disadvantaged groups, e.g., those who are 

homeless, live in rural locations, have no/limited access to healthcare 

– Will likely reduce access of the Moderna COVID-19 vaccine to some groups who 

bear an unfair burden of COVID-19-related morbidity and mortality

67

Equity: Characteristics of the Moderna COVID-19 vaccine that 

could impact health equity 
 Although COVID-19 vaccines will be provided at no cost, personal investments 

in time and travel to obtain vaccine may be a barrier for some groups

 Equity and vaccination program implementation are closely linked

 Advancing health equity will require efforts to identify and reduce accessrelated barriers to vaccination among groups who experience disproportionate 

COVID-19-related morbidity and mortality 

68

Equity:

Additional Considerations 
Equity: 

Work Group Interpretation 

What would be the impact of the Moderna COVID-19 

__vaccine on health equity? 

○ Reduced ○ Probably reduced ○ Probably no impact ○ Probably increased

○ Increased ○ Varies ○ Don't know
Summary 
71

EtR DomainQuestion

Work Group Judgments

Public Health 

Problem

Is COVID-19 disease of public health importance?

Yes

Benefits and 

Harms

How substantial are the desirable anticipated effects? Large

How substantial are the undesirable anticipated effects? Small

Do the desirable effects outweigh the undesirable effects? Favors Moderna 

COVID-19 vaccine

What is the overall certainty of the evidence for the critical outcomes?

1 (high) for prevention of 

symptomatic COVID-19

2 (moderate) for hospitalization

2 (moderate) for safety

Values

Does the target population feel the desirable effects are large relative to 

the undesirable effects?

Probably yes

Is there important variability in how patients value the outcomes? Probably important uncertainty

Acceptability

Is the Moderna COVID-19 vaccine acceptable to key stakeholders?

Probably yes

Feasibility

Is the Moderna COVID-19 vaccine feasible to implement?

Yes

Resource Use

Is the Moderna COVID-19 vaccine a reasonable and efficient allocation of 

resources?

Yes

Equity

What would be the impact of the intervention on health equity?

Probably increased
72

Evidence to Recommendations Framework

Summary: Work Group Interpretations

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
73

Evidence to Recommendations Framework

Summary: Work Group Interpretations

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
74

Evidence to Recommendations Framework

Summary: Work Group Interpretations

Type of 

recommendation

We do not recommend 

the intervention

We recommend the 

intervention for individuals 

based on shared clinical 

decision-making

We recommend the 

intervention 
75

Evidence to Recommendations Framework

Summary: Work Group Interpretations

Type of 

recommendation

We do not recommend 

the intervention

We recommend the 

intervention for individuals 

based on shared clinical 

decision-making

We recommend the 

intervention 
For more information, contact CDC

1-800-CDC-INFO (232-4636)

TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the 

official position of the Centers for Disease Control and Prevention.

Thank you