cdc.gov/coronavirus

Evidence to Recommendation Framework: 

Moderna COVID-19 vaccine,

Spikevax

Sara Oliver, MD, MSPH

ACIP Meeting

February 4, 2022
Policy question

2

 Should vaccination with the Moderna COVID-19 vaccine (Spikevax, 

2-dose primary series) be recommended for persons 18 years of 

age and older? 

EUA= Emergency Use Authorization, BLA= Biologics License Application
Policy question

3

 Should vaccination with the Moderna COVID-19 vaccine (Spikevax, 

2-dose primary series) be recommended for persons 18 years of 

age and older? 

Moderna 

COVID-19 vaccine 

No

COVID-19 vaccine Compared to

Regulatory action, GRADE, Evidence to Recommendation Framework, Vote
Additional questions for discussion 

4

Moderna 

COVID-19 vaccine 

Pfizer-BioNTech

COVID-19 vaccine And

Implementation; 

Discussions around myocarditis and intervals 
Evidence to Recommendations (EtR) Framework:

PICO Question

5

Population People ages 18 years and older

Intervention Moderna COVID-19 vaccine mRNA-1273 

(100μg, 2 doses IM, 28 days apart) 

Comparison No vaccine

Outcomes

Symptomatic laboratory confirmed COVID-19 

Hospitalization due to COVID-19

Death due to COVID-19

Asymptomatic SARS-CoV-2 infection 

Serious adverse events 

Reactogenicity 
Evidence to Recommendations (EtR) Framework

EtR Domain Question(s)

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 outcome?

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 intervention” = Moderna COVID-19 vaccine, given to adults ages 18 years and older

“The problem” = COVID-19 
EtR Domain: Public Health Problem
Trends in daily number of COVID-19 cases in the United States

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#trends_dailycases Accessed February 3, 2022

January 23, 2020 – February 1, 2022

8
Trends in daily number of COVID-19 deaths in the United States

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#trends_dailydeaths Accessed February 3, 2022

January 23, 2020 – February 1, 2022

9
Rates of COVID-19 cases by vaccination status

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status Accessed January 24, 2022

In November, unvaccinated adults ages 18 years and older had:

compared to fully vaccinated adults 

4X

Risk of Testing Positive for COVID-19

April 04 – December 25, 2021 (28 U.S. Jurisdictions)

10
Rates of COVID-19 deaths by vaccination status

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status Accessed January 24, 2022

In November, unvaccinated adults ages 18 years and older had:

compared to fully vaccinated adults 

15X

Risk of Dying from COVID-19

April 04 – December 25, 2021 (28 U.S. Jurisdictions)

11
Rates of COVID-19 cases and deaths by vaccination status, 

August 29 – December 25, 2021 (25 U.S. Jurisdictions)

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status Accessed January 24, 2022 

In November, unvaccinated adults ages 18 years and older had:

compared to fully vaccinated adults with booster dose 

12

Cases Deaths
Weekly trends in COVID-19-associated hospitalization rates

in the United States

CDC COVID-NET. https://gis.cdc.gov/grasp/covidnet/covid19_3.html Accessed February 3, 2022 

March 7, 2020 – January 29, 2022

Mar 7 ‘20 Jul 18 ‘20 Nov 28 ‘20 Mar 20 ‘21 Jul 3 ‘21 Nov 6 ‘21 Jan 29 ‘22

13
Rates of COVID-19-associated hospitalizations by vaccination 

status in adults ages 18-49 years, January – December 2021

A population-based surveillance system (COVID-NET) collected data on laboratory-confirm ed COVID-19-associated hospitalizations am ong adults 

through a network of over 250 acute -care hospitals in 14 states.

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data -tracker/# covidnet-hospitalizations-vaccination Accessed January 31, 2022 14

In December, compared to fully vaccinated adults ages 18-49 years, monthly rates of COVID-19-associated 

hospitalizations were 12X higher in unvaccinated adults ages 18-49 years
Rates of COVID-19-associated hospitalizations by vaccination 

status in adults ages 50-64 years, January – December 2021

A population-based surveillance system (COVID-NET) collected data on laboratory-confirm ed COVID-19-associated hospitalizations am ong adults 

through a network of over 250 acute -care hospitals in 14 states.

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data -tracker/# covidnet-hospitalizations-vaccination Accessed January 31, 2022 15

In December, compared to fully vaccinated adults ages 50-64 years, monthly rates of COVID-19-associated 

hospitalizations were 18X higher in unvaccinated adults ages 50-64 years
Rates of COVID-19-associated hospitalizations by vaccination 

status in adults ages ≥65 years, January – December 2021

A population-based surveillance system (COVID-NET) collected data on laboratory-confirm ed COVID-19-associated hospitalizations am ong adults 

through a network of over 250 acute -care hospitals in 14 states.

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data -tracker/# covidnet-hospitalizations-vaccination Accessed January 31, 2022 16

In December, compared to fully vaccinated adults ages ≥65 years, monthly rates of COVID-19-associated 

hospitalizations were 18X higher in unvaccinated adults ages ≥65 years
ICU utilization by state as of February 3, 2022

% of ICU Beds Occupied

3 states over 90% of ICU capacity

Data updated daily and provides the latest values reported by each facility within the last four days. No statistical analysis is applied to account for non-response and/or to account for 

m issing data.

HHS Protect Public Data Hub. https://protect-public.hhs.gov/pages/hospital-utilization Accessed February 3, 2022

29 states over 80% of ICU capacity

17
Omicron is the dominant circulating SARS-CoV-2 variant

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#variant-proportions Accessed February 3, 2022 18
Daily trends in doses of COVID-19 vaccine administered

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccination-trends Accessed February 3, 2022

December 14, 2020 – February 1, 2022

19
Daily trends in doses of COVID-19 vaccine administered

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total Accessed February 3, 2022

December 14, 2020 – February 1, 2022

20

~25.8% of people 18 years and older

are not fully vaccinated
U.S. COVID-19 vaccine administration by vaccine type

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total Accessed February 3, 2022

477,190

18,198,400

204,662,169

317,292,439

0 50,000,000 100,000,000 150,000,000 200,000,000 250,000,000 300,000,000 350,000,000

Other

J & J

Moderna

Pfizer-BioNTech

21
136,231

16,603,504

74,646,620

120,744,329

0 20,000,000 40,000,000 60,000,000 80,000,000 100,000,000 120,000,000 140,000,000

Other 2-dose

J&J/Janssen single dose

Moderna 2-dose

Pfizer-BioNTech 2-dose

Number of people fully vaccinated in the United States by 

COVID-19 vaccine series type 

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total Accessed February 3, 2022 22
0

10

20

30

40

50

60

70

80

90

100

Dec '20 Jan '21 Feb '21 Mar '21 Apr '21 May '21 Jun '21 Jul '21 Aug '21 Sep '21 Oct '21 Nov '21 Dec '21 Jan '22 Feb' 22

% Receiving ≥ 1 dose 

December 14, 2020 – February 2, 2022

Percent of COVID-19 vaccination coverage by age and date 

administered, United States 

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends Accessed February 3, 2022

Percent Receiving ≥1 dose

75+ years 95.0%

65-74 years 95.0%

50-64 years 91.5%

40-49 years 84.8%

25-39 years 77.6%

18-24 years 75.1%

23
People fully vaccinated with Moderna COVID-19 vaccine, by 

MMWR week and age group

CDC Data Analytics and Visualization Task Force; Data included through the end of January 2022

0

500,000

1,000,000

1,500,000

2,000,000

2,500,000

3,000,000

3,500,000

4,000,000

4,500,000

5,000,000

# of People Fully Vaccinated

Year, MMWR Week

18-49 yrs 50-64 yrs 65+ yrs

Underreporting

due to data lag 
Percent of population fully vaccinated ≥18 years of age 

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-fully-percent-pop18 Accessed February 3, 2022

No data

0-59.9%

60-69.9%

70-79.9%

80-89.9%

≥90%

25
 The Omicron variant is the dominant circulating variant of SARS-CoV-2 in the United

States

 As of January, COVID-19 cases, hospitalizations, and deaths have increased

– In November 2021, unvaccinated adults ages 18 years and older had 4X risk of testing 

positive and 15X risk of dying from COVID-19 compared to fully vaccinated adults 

 Increasing cases are taxing healthcare resources, with many states facing ICU bed 

shortages again

 Over 212 million people (63.9%) are fully vaccinated in the United States; however, 

vaccination coverage varies by age and geography

Summary

26
Public Health Problem

Work Group Interpretation

Is COVID-19 disease among adults aged 18 years and older of 

public health importance?

oNo oProbably no oProbably yes oYes oVaries oDon’t know
EtR Domain: Benefits and Harms
Benefits and harms assessments

 GRADE

 Potential risk of myocarditis

 Potential benefit and harm balance

GRADE= Grading of Recommendations, Assessment, Development and Evaluation 29
Benefits and Harms

Summary of the Available Evidence: Benefits

The clinical trial demonstrated efficacy against symptomatic, laboratory-confirmed COVID-19, which was 

further supported by observational data. The overall efficacy was 92.7% (95% CI: 90.4%, 94.4%).

High certainty of evidence

The clinical trial demonstrated efficacy against hospitalization due to COVID-19, which was further 

supported by observational data. The overall efficacy was 95.9% (95% CI: 69.5%, 99.4%).

Moderate certainty of evidence

Deaths were uncommon in the clinical trial, however observational data demonstrated effectiveness 

against death due to COVID-19. The pooled vaccine effectiveness was 93.8% (95% CI: 91.5%, 95.4%).

Moderate certainty of evidence

The clinical trial demonstrated efficacy against asymptomatic SARS-CoV-2 infection. The overall efficacy 

was 57.4% (95% CI: 50.1%, 63.6%). 

High certainty of evidence 30
Benefits and Harms

Summary of the Available Evidence: Harms

Serious adverse events (SAEs) were reported in a similar proportion among recipients of vaccine and 

placebo (1.7% vs 1.9%). Two specific, rare SAEs have been associated with vaccination through safety 

surveillance.

Moderate certainty of evidence

Severe reactions were more common in vaccine recipients; any grade ≥3 reaction was reported by 21.3% 

of vaccinated versus 4.5% of placebo group. 

High certainty of evidence

31
Conclusion

GRADE

Policy question: Focuses on recommendation following licensure of Moderna COVID-19 

vaccine primary series that has been in use for a year under an emergency use authorization

Benefits: Supported by body of evidence from randomized controlled trials (RCTs) and 

observational studies

– RCT evidence demonstrated efficacy for all beneficial outcomes, including the 2 critical 

outcomes: symptomatic disease and hospitalization

– Efficacy data further supported by body of evidence from observational studies

Harms: 

– Grade 3 reactions were more common in vaccine than placebo recipients

– SAEs occurred at a similar frequency in vaccine and placebo groups

– Two specific, rare SAEs have been associated with vaccination through safety surveillance

32
Benefits and harms assessments

 GRADE

 Potential risk of myocarditis

 Potential benefit and harm balance

GRADE= Grading of Recommendations, Assessment, Development and Evaluation 33
Summary 

Myocarditis after Moderna COVID-19 vaccine: U.S. data

 VAERS demonstrates reporting rates of myocarditis greater than the 

background rates for males (18–49 years) and females (after dose 2, 18–29 

years)

 At least 90 day after myocarditis diagnosis, most patients reported no impact 

on their quality of life, and most did not report missing school or work

– Most (81%) healthcare providers indicated the patient was probably or fully 

recovered

34
Benefit and risk balance for Moderna COVID-19 vaccine 

in adults ages 18–39 years

Benefits

Moderna COVID-19 vaccine

Risks

Moderna COVID-19 vaccine

35
36

Methods for assessment of benefit-risk balance

Benefits — Calculated per 1 million people who are fully vaccinated

• Age group: 18 – 39 years

– Selected because this age group has the highest rates of myocarditis and lowest 

hospitalization rates among adults, and would therefore have the closest benefit/risk margin

• Age/sex specific hospitalization rates: COVID-NET (average of rates from Dec 11-Jan 1, 2022)1

• Pooled vaccine-specific VE estimates from two platforms2

• Time Horizon: 150-day period

Harms — Calculated per 1 million people who are fully vaccinated

• Vaccine-specific myocarditis rates from Vaccine Safety Datalink (VSD)

VE: Vaccine Effectiveness

1https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html

2https://covid.cdc.gov/covid-data-tracker/#vaccine-effectiveness
37

Vaccine-specific estimates of effectiveness against COVID-19 

hospitalization

VE against COVID-19 hospitalization1

IVY Network2, 

Oct – Nov, 2021 

% (95% CI)

VISION2, Aug –

Dec, 2021, % 

(95% CI)

Pooled VE 

Estimate

Moderna 91 (89-93) 92 (91-93) 92

1. https://covid.cdc.gov/covid-data-tracker/#vaccine-effectiveness

2. VE estimate for 17-179 days after 2nd dose 

VE= vaccine effectiveness; VE reported for 2 doses of mRNA COVID-19 vaccines
38

Reporting rates of myocarditis following Moderna COVID-19 

vaccination (per million 2nd doses administered) among persons ages 

18-39 years1

Vaccine Sex

Rate per 1M 2nd Doses in 7-

day risk period 

among persons ages 18–39 

years2

Moderna Males 67.5

All 33.0

1. Data from the Vaccine Safety Datalink (VSD): https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html

2. Data through Jan 15, 2022
39

33

0 100 200 300 400 500

Benefits and risks after mRNA COVID-19 vaccines among persons ages 

18-39 years

18-39

Age group 

(years)

Cases of Myocarditis Expected per Million 2nd 

Doses of Moderna Vaccine

COVID-19-Associated Hospitalizations Prevented per 

Million 2nd Doses of Moderna Vaccine

. 

per million 2nd doses

• COVID-19-associated hospitalizations prevented by Moderna COVID-19 vaccine compared with myocarditis cases expected

2982

3000 2500 2000 1500 1000 500 0
40

68

0 100 200 300 400 500

Benefits and risks after mRNA COVID-19 vaccines among males ages 

18-39 years

18-39

Age group 

(years)

Cases of Myocarditis Expected per Million 2nd 

Doses of Moderna Vaccine

COVID-19-Associated Hospitalizations Prevented per 

Million 2nd Doses of Moderna Vaccine

. 

per million 2nd doses

• COVID-19-associated hospitalizations prevented by Moderna COVID-19 vaccines compared with myocarditis cases expected

1903

2000 1500 1000 500 0
 Benefit-risk analysis considers direct benefits and risk over a 180-

day period comparing vaccine vs. no vaccine

 VE assumptions used in the model do not yet include Omicron-specific 

VE estimates

 The model assumes static hospitalization rate over 5 months

– Benefit/risk profile might change as hospitalization rates change

 Model does not account for booster doses or prior infection

Limitations

41
Benefits and Harms

Summary

 Clinical trial and observational studies demonstrated Moderna COVID-19 

vaccine is effective in the prevention of COVID-19 in persons ages 18 years 

and older

 Risk of myocarditis/pericarditis noted after mRNA COVID-19 vaccines

– The highest risk was seen after the second dose among younger males

 Benefits for the Moderna COVID-19 vaccine far outweigh any possible 

vaccine-associated risks

42
Benefits and Harms

How substantial are the desirable anticipated effects?

• How substantial are the anticipated effect for each main outcome for which 

there is a desirable effect?

o Minimal o Small o Moderate o Large o Varies o Don’t know
Benefits and Harms

How substantial are the undesirable anticipated effects?

• How substantial are the anticipated effect for each main outcome for which 

there is an undesirable effect?

o Minimal o Small o Moderate o Large o Varies o 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?

oFavors intervention (Moderna COVID-19 vaccine)

oFavors comparison (no vaccine)

oFavors both

oFavors neither

oUnclear
EtR Domain: Values
Positive COVID-19 vaccination intent† among adults 

ages 18 years and older

† Positive vaccine intent includes persons already vaccinated or reporting definitely, probably, or somewhat likely to get vaccinated 

*Surveys with multiple time points are shown with the same color bubble for each time point. Surveys with only one time point are shown in gray.

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan

% Reporting Positive Vaccine Intentions*
Vaccination status and intent among all adults ages 18 years 

and older, United States

CDC COVID Data Tracker. Trends in COVID-19 Vaccine Confidence in the US. https://covid.cdc.gov/covid-data-tracker/#vaccine-confidence. Accessed January 21, 2022

 Data collection period: January 2 – January 8, 2022 (N = 19,115)

– 84.7% are Vaccinated (83.5%) or Definitely Will Get Vaccinated (1.2%)

– 4.5% Probably Will Get Vaccinated or Are Unsure

– 10.8% Probably or Definitely Will Not Get Vaccinated 

83.5 1.2 4.5 10.8

75% 80% 85% 90% 95% 100%

Overall

All Adults Ages 18 Years & Older

Vaccinated Definitely Will Get Vaccinated Probably Will Get Vaccinated or Are Unsure Probably or Definitely Will Not Get Vaccinated
 A survey of the American general population (N = 1,094) was conducted on 

individuals ≥ 18 years between January 7 – 10, 2022

– Unvaccinated survey respondents were asked, “Does the discovery of the Omicron variant 

make you more likely or less likely to get the COVID-19 vaccine? 

13%

13%

72%

0% 10% 20% 30% 40% 50% 60% 70% 80%

More likely

Less likely

Makes no difference

Vaccination intent among unvaccinated adults ages 18 years 

and older

Axios/Ipsos Poll. January 2022. https://www.ipsos.com/en-us/news-polls/axios-ipsos-coronavirus-index Accessed January 19, 2022
 Among unvaccinated adults: “What, if anything, will convince you to get vaccinated 

for COVID-19?”

About half of unvaccinated adults say nothing will convince 

them to get a COVID-19 vaccine

KFF COVID-19 Vaccine Monitor: Early Omicron Update (Dec 15 – 20, 2021). https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-earlyomicron-update/. Accessed January 19, 2022

3%

3%

5%

6%

12%

48%

0% 10% 20% 30% 40% 50% 60%

If it prevented 100% of infections

If a doctor recommended it

Money/large sum of money

If it were required for work/if it were mandatory

More research/transparency

Nothing
 Initial data indicated that following the FDA’s full approval of the Pfizer-BioNTech 

COVID-19 vaccine, the United States saw a slight uptick (17%) in the average number 

of Americans getting their first COVID-19 vaccine dose 

– In the week prior to full approval, an average of about 404,000 Americans were initiating 

vaccination each day 

– Following approval, approximately 473,000 Americans were getting their first dose each 

day

 Although not a rapid surge in vaccinations in the days immediately following 

approval, full approval may have been enough to convince some to finally get 

immunized

Rise in COVID-19 vaccinations following full FDA approval

ABC news. August 31, 2021. More Americans getting vaccinated following full FDA approval of Pfizer COVID vaccine. https://abcnews.go.com/Health/americans-vaccinatedfull-fda-approval-pfizer-covid-vaccine/story?id=79750505. 
 Ongoing survey designed to assess vaccination intention of unvaccinated Americans 

in response to FDA BLA for Moderna COVID-19 vaccine

 Data collection period: January 27 – January 31, 2022

 Current unvaccinated sample (N = 507)

Survey of vaccination intent among unvaccinated adults

Data collection is ongoing until sample target is reached, consisting of 1200 partial or unvaccinated US adults

CDC and University of Iowa/RAND survey, unpublished

Partial or Unvaccinated 

Sample

58% Female

42% Male or Other Gender 

Identity

41% 18-39 Years

34% 40-59 Years

25% 60+ Years

40% Non-Hispanic White

41% Non-Hispanic Black

19% Hispanic

GENDER AGE RACE/ETHNICITY
Reasons for remaining unvaccinated 

CDC and University of Iowa/RAND survey, unpublished

Concerns about vaccine side effects or general mistrust of COVID-19 vaccines were the 

top reasons given for continuing to be unvaccinated

43.6%

41.4%

33.1%

20.7%

18.9%

18.3%

15.0%

13.0%

10.8%

10.1%

8.5%

8.5%

5.3%

4.7%

4.5%

3.9%

3.0%

3.0%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Concerned about long-term side effects

I don't trust COVID-19 vaccines

Concerned about short-term side effects

Don't know if COVID-19 vaccines work

Concerned about allergic reaction

Wait to see if vaccine is safe

Don't trust healthcare system

Not worried about COVID-19

Fear of needles

I already had COVID-19

Not mandated

Against religious beliefs

Other

HCP said not to get vaccinated

None of these

Obstacles (lack of transportation, no time off work)

Community not getting vaccinated

Cost concerns

% of non-vaccinated respondents (n=507)
CDC and University of Iowa/RAND survey, unpublished

Full approval

EUA

Don’t know/Unsure

Awareness of FDA status of Moderna COVID-19 vaccine

29% of unvaccinated respondents thought the Moderna COVID-19 vaccine 

had already received full approval from the FDA 
Vaccination intentions in response to a Moderna FDA BLA

CDC and University of Iowa/RAND survey, unpublished

Only 5% of unvaccinated respondents said they would get a COVID vaccine as 

soon as they could if the Moderna vaccine received full approval from the FDA
Vaccination intentions in response to a Moderna FDA BLA

CDC and University of Iowa/RAND survey, unpublished

20% of unvaccinated respondents said they would continue waiting to see if 

COVID vaccines were effective or safe
Vaccination intentions in response to a Moderna FDA BLA

CDC and University of Iowa/RAND survey, unpublished

52% of unvaccinated respondents said they would definitely not get vaccinated or 

would only do so if it were required
Time to vaccination in response to a Moderna FDA BLA

CDC and University of Iowa/RAND survey, unpublished

11% of unvaccinated respondents who were open or unsure about getting 

vaccinated (n=236) said they would wait a few more weeks to get a COVID vaccine 

after the Moderna vaccine received full FDA approval
Time to vaccination in response to a Moderna FDA BLA

CDC and University of Iowa/RAND survey, unpublished

11% of unvaccinated respondents who were open or unsure about getting 

vaccinated (n=236) said they would wait more than a year to get a COVID vaccine 

after the Moderna vaccine received full FDA approval
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/caregivers feel that the benefits outweigh the harms and burden?

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

o Minimal o Small o Moderate o Large o Varies o Don’t know
Values

oImportant uncertainty or variability

oProbably important uncertainty or variability

oProbably not important uncertainty or variability

oNo important uncertainty or variability

oNo known undesirable outcomes

Criteria 2:

Is there important uncertainty about, or variability in, how much people value 

the main outcomes?

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

• Is there evidence to support those value judgements?

• Is there evidence that the variability is large enough to lead to different decisions?
EtR Domain: Acceptability
 As of February 2, 2022, >204 million doses of Moderna COVID-19 vaccine have been 

administered1

 COVID-19 vaccination has been implemented in a variety of settings

– State and local health departments

– Healthcare sites/hospitals

– Mass vaccination clinics

– Long Term Care Facilities (LTCF)

– Retail pharmacies

Vaccine administration 

1. CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total Accessed February 3, 2022. 
 Vaccination with Moderna COVID-19 vaccine was already highly acceptable to 

stakeholders under FDA emergency use authorization and ACIP interim 

recommendation

 Vaccination may be more acceptable to stakeholders under full FDA approval and 

standard ACIP recommendation

Vaccine acceptability among stakeholders
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?

oNo oProbably no oProbably yes oYes oVaries oDon’t know
EtR Domain: Feasibility
 Barriers to implementation may include:

- Complexity of recommendations

- Vaccine storage and handling requirements

- Financial barriers

- Supply barriers

Feasibility of vaccine implementation 

67
 The Moderna COVID-19 vaccine will be the second COVID-19 vaccine with a BLA

 BLA only been issued for some indications, which may add complexity

– BLA:

• Primary series for those ages 18 years and older

– EUA: 

• Additional dose in immunocompromised people for those ages 18 years and older

• Booster dose in persons ≥18 years who completed a primary series ≥5 months ago

 Recommendations made under EUI only allowed for vaccines with a BLA

– Will allow these recommendations to extend to Moderna COVID-19 vaccine as well

– Include recommendations for additional/booster vaccination of people who received their 

primary series overseas or as a part of a clinical trial

Complexity of recommendations
 Moderna COVID-19 vaccine multiple-dose vials are stored frozen: -50oC to -15oC (-58o

to 5oF)

– The vaccine should not be stored on dry ice or below -50oC (-58oF)

– The vaccine must be stored in the original carton to protect from light

 Vials can be refrigerated between 2o to 8oC (36o to 46oF) for up to 30 days prior to first 

use

 After the first dose has been withdrawn, the vial should be held between 2o to 25oC 

(36o to 77oF)

– Vials should be discarded 12 hours after the first puncture 

Vaccine storage and handling requirements 

Moderna. Storage & Handling. Storage & Handling | Moderna COVID-19 Vaccine (EUA) (modernatx.com). Accessed January 18, 2022
70

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

 Health systems or health departments incur costs for vaccine implementation, clinics, 

outreach, and education

 Financial hardship may arise if vaccine recipients need to take time off to receive the 

vaccine or experience post-vaccination reactogenicity that prevents them from 

working

Financial barriers
 Vaccine supply in the United States is sufficient for implementation of the 

intervention

 As of February 2, 2022, over 204 million doses of Moderna COVID-19 vaccine have 

been administered in the United States, demonstrating that the vaccine is feasible to 

implement broadly1

Supply barriers

1. CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total Accessed February 3, 2022.
Feasibility

Is the Moderna COVID-19 vaccine feasible to

implement among people ≥18 years?

• 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 considerations when implementing it? 

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

oNo oProbably no oProbably yes oYes oVaries oDon’t know
EtR Domain: Resource Use
$0.7B

$1.5B

$4B

$3.5B

$2.2B

$2B

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

Jun '21 Jul '21 Aug '21 Sep '21 Oct '21 Nov '21

June to November total: $13.9 Billion

Estimated cost of preventable COVID-19 hospitalizations among 

unvaccinated adults in the United States, June – November 2021

Peterson-KFF Health System Tracker. https://www.healthsystemtracker.org/brief/unvaccinated-covid-patients-cost-the-u-s-health-system-billions-of-dollars/ Accessed January 

25, 2022 74
 Vaccine doses purchased with U.S. taxpayer funds will be given to people living in the 

United States at no cost1

 Several published modeling studies have found that COVID-19 vaccinations are likely 

to be of a reasonable economic value and may also be cost-saving under many 

circumstances2-5

Costs & benefits associated with COVID-19 vaccines

1. CDC COVID-19. COVID-19 Vaccines Are Free to the Public. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/no-cost.html

2. Padula et al. 2021. J Med Econ; 3. Bartsch et al. 2021 J Inf Dis; 4. Gupta et al. 2021 Health Aff; 5. Kohli et al 2021 Vaccine 75
Resource Use

Is the Moderna COVID-19 vaccine among adults 18 years and 

older 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.?

o No o Probably no o Probably yes o Yes o Varies o Don’t know
EtR Domain: Equity
Cumulative COVID-19 associated hospitalizations in the United 

States by race/ethnicity, March 7, 2020 – January 22, 2022 

CDC. https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalization-network Accessed February 3, 2022

American Indian/Alaska Native: 1736.8

Black: 1289.3

Hispanic: 1013

Overall: 878.5

White: 691.1

Asian/Pacific Islander: 423.3
What percentage of people ages 18 years and older in each race 

or ethnic group received at least one dose of COVID-19 vaccine? 

CDC. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends Accessed February 3, 2022

45.9%

52.4%

59.3%

63.1%

64.4%

69.3%

0% 10% 20% 30% 40% 50% 60% 70% 80%

Black

White

Hispanic

NH/PI

Asian

AI/AN

79
Percentage of people ages 18 years and older who have received at 

least one dose of the COVID-19 vaccine by race/ethnicity over time 

CDC. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends as of February 2, 2022, and US Census Bureau National Population Estimates

0

10

20

30

40

50

60

70

80

Dec-20 Jan-21 Feb-21 Mar-21 Apr-21 May-21 Jun-21 Jul-21 Aug-21 Sep-21 Oct-21 Nov-21 Dec-21 Jan-22 Feb-22

AI/AN

Asian

Black

Hispanic/Latino

NHOPI

White

80
COVID-19 vaccination coverage varies by geography

CDC COVID-19 County Integrated County View. https://covid.cdc.gov/covid-data-tracker/#vaccinations-county-view Accessed January 20, 2022

Percent of population ages 18 years and older fully vaccinated

% of population 

≥18 years of age 

fully vaccinated

% of U.S. 

counties at 

this level

0-29.9% 1%

30-39.9% 4%

40-49.9% 18%

50-69.9% 58%

70%+ 20%

No Data --
 Vaccine uptake lags in adults living in rural and suburban areas compared with urban 

 As of November 2021, eight in ten urban residents (79%) say they have received at 

least one dose of a COVID-19 vaccine, compared to seven in ten suburban adults and 

67% of rural adults 

 One in five (21%) of those living in rural areas and one in six (16%) of those living in 

suburban areas say they will “definitely not” get a COVID-19 vaccine, at least twice 

the share of urban residents who say the same (8%)

Disparities in vaccine intent by geographic location

KFF COVID-19 Vaccine Monitor: Differences in Vaccine Attitudes Between Rural, Suburban and Urban Areas. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid19-vaccine-monitor-vaccine-attitudes-rural-suburban-urban/. Accessed January 18, 2022
 During August 29-October 30, 2021, data from the National Immunization Survey 

Adult COVID Module (NIS-ACM) were analyzed to assess COVID-19 vaccination 

coverage in COVID-19 vaccines among lesbian, gay, bisexual, and transgender (LGBT) 

adults ages 18 years and older

 By sexual orientation, gay or lesbian adults reported higher vaccination coverage 

overall (85.4%) than heterosexual adults (76.3%)

– Among gay or lesbian adults and bisexual adults, vaccination coverage was lower among women 

(80.5% and 74.2%, respectively) than among men (88.9% and 81.7%, respectively)

 There were no significant differences in vaccination coverage among persons based 

on gender identity

 Vaccination coverage was lowest among non-Hispanic Black LGBT persons across all 

categories of sexual orientation and gender identity 

COVID-19 vaccination coverage by sexual orientation and 

gender identity – United States, August 29-October 30, 2021

McNaghten A, Brewer NT, Hung M, et al. COVID-19 Vaccination Coverage and Vaccine Confidence by Sexual Orientation and Gender Identity — United States, August 29–

October 30, 2021. MMWR Morb Mortal Wkly Rep 2022;71:171–176. DOI: http://dx.doi.org/10.15585/mmwr.mm7105a3
Equity

What would be the impact of the Moderna COVID-19 vaccine 

among people ages 18 years and older 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?

o Reduced o Probably reduced o Probably no impact

o Probably increased o Increased o Varies o Don’t know
Summary 
86

EtR DomainQuestionWork Group Judgments

Public Health 

Problem

Is COVID-19 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 intervention 

(Moderna COVID-19 vaccine)

What is the overall certainty of the evidence for the critical 

outcomes? High to Moderate

Values

Does the target population feel the desirable effects are large 

relative to the undesirable effects?

Large

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

or variability

Acceptability

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

Feasibility

Is the Moderna COVID-19 vaccine feasible to implement?Yes

Resource Use

Is 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 no impact
EUA 

≥16 years of age

Pfizer-BioNTech COVID-19 vaccine

BLA

≥16 years of age

EUA 

≥18 years of age

BLA

≥18 years of age

Moderna COVID-19 vaccine

Janssen COVID-19 vaccine

EUA 

≥18 years of age

EUA 

5-15 years of age

Primary series Additional/Booster doses

EUA 

≥18 years of age

EUA 

≥18 years of age

Additional dose

EUA 

≥5 years of age

Booster dose

EUA 

≥12 years of age
 COVID-19 vaccines have been a critical tool in this pandemic, preventing 

millions of COVID-19 associated hospitalizations and deaths

 To date, hundreds of millions of doses of the Moderna COVID-19 vaccine have 

been given with over a year of closely monitored real-world safety and 

effectiveness data

 Vaccinating the unvaccinated with a primary series continues to be important 

– Additional protection from all recommended COVID-19 vaccine doses important in 

evolving pandemic

Work Group Interpretation 
89

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
90

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
91

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 
92

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 
 Monica Godfrey

 Megan Wallace

 Amy Blain

 Amimah Asif

 Danielle Moulia

 Katie Curran

 Sarah Mbaeyi

 Evelyn Twentyman

 Tara Jatloui

 Susan Goldstein

 Jack Gersten

 Jefferson Jones

 Eddie Shanley

 Anthony Fiore

 Stephen Hadler 

 Valerie Morelli

 JoEllen Wolicki

 Elisha Hall

 Erin Ricketts

 Faisal Minhaj

 Heather Scobie

 VTF ACIP WG Team

 ACIP COVID-19 Vaccines Work Group

 Vaccine Task Force

 Epi Task Force

 Data Analytics and Visualization Task Force

 Respiratory Viruses Branch

Acknowledgments
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