For more information: www.cdc.gov/COVID19

EtR Framework: 

Janssen COVID-19 vaccine

ACIP COVID-19 Vaccines

Sara Oliver MD, MSPH

ACIP Meeting

February 28, 2021
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

Evidence to Recommendations (EtR) Framework

3
 Should vaccination with the Janssen COVID-19 vaccine 

(1 dose) 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 Janssen COVID-19 vaccine (Ad26.COV2.S)

5 × 1010 viral particles, 0.5 ml single dose IM

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 problem” = COVID-19 disease

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

350000

Jan 22 2020 Mar 22 2020 May 21 2020 Jul 20 2020 Sep 18 2020 Nov 17 2020 Jan 16 2021

Number of COVID-19 Cases

Public Health Problem:

Review of the Available Evidence

January 21, 2020 – February 25, 2021

Feb 25 2021

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

1000

2000

3000

4000

5000

6000

7000

Jan 22 2020 Mar 22 2020 May 21 2020 Jul 20 2020 Sep 18 2020 Nov 17 2020 Jan 16 2021

Number of COVID-19 Cases

Public Health Problem:

Review of the Available Evidence

Feb 25 2021

January 21, 2020 – February 25, 2021

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

– Cumulative hospitalization rate between March 1 and February 20, 2021 was 

452.2 per 100,000 population

– Among those hospitalized, 25% required care in an intensive care unit and 11% died

 Mortality

– Cumulative mortality rate between January 22, 2020 and February 25, 2021 was 153

per 100,000 population

 Life expectancy

– Dropped full year for U.S. population overall in first half of 2020

– Black population declined 2.7 years, Hispanic population declined 1.9 years

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 . 

https://www.cdc.gov/nchs/data/vsrr/VSRR10-508.pdf
 Requires urgency 

with vaccination to 

build population 

immunity

Emerging Landscape of SARS-CoV-2 variants

https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant-cases.html ; As of Feb 17, 2021
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 (Janssen COVID-19 vaccine)

Favors comparison (no vaccine)

Favors both

Favors neither

Unclear
 The clinical trial demonstrated efficacy against symptomatic, laboratory-confirmed 

COVID-19. The overall efficacy was 66.3% (95% CI: 59.9%, 71.8%).

Moderate certainty of evidence

 For COVID-19 associated hospitalization, 31 events occurred, 29 in the placebo group, 

2 in the vaccine group. Vaccine efficacy against hospitalization was 93% (95% 

CI: 71%, 98%).

Moderate certainty of evidence

 For all-cause deaths, 5 occurred in the vaccine group and 20 in the placebo 

group. Vaccine efficacy against all-cause death was 75% (95% CI: 33%, 91%)

Moderate certainty of evidence

Benefits and Harms:

Summary of the Available Evidence: Benefits

19
 Preliminary data were available to assess vaccine efficacy against 

seroconversion between days 29 and 71, based on the first 7% of specimens 

tested.

 Analysis was based on detection of N-binding antibody among persons who 

remained asymptomatic and did not have a positive SARS-CoV-2 PCR at any 

time in the study.

 Between four and ten weeks after vaccination with the Janssen COVID-19 

vaccine, 10/1346 participants (0.7%) seroconverted, compared to 37/1304 

(2.8%) of those receiving placebo. Vaccine efficacy against seroconversion 

was 74% (95% CI: 48%, 87%).

Low certainty of evidence

Benefits and Harms:

Summary of the Available Evidence: Benefits

20
 Similar efficacy for across age, sex, race, and ethnicity categories, and those 

with underlying medical conditions at ≥14 days post-vaccination 

64.7

76.5

66.4

65.6

67.6

63.7

64.2

67.6

0 20 40 60 80 100

Vaccine Efficacy (%)

Benefits and Harms:

Summary of the Available Evidence: Benefits

21

Age 18-64 years 

Age ≥65 years 

Non-Hispanic/Latino

Hispanic/Latino 

White

Black

With comorbidities

Without comorbidities
Benefits and Harms:

Summary of the Available Evidence: Benefits

22

 Higher efficacy against severe outcomes than for any symptomatic COVID-19*

– VE against deaths due to COVID-19: 100%

 Efficacy estimates for severe outcomes assessed ≥28 days post vaccination 

were higher: 83.5% for severe disease†

, 100% for hospitalization

 Efficacy against severe disease† remained high across world regions (73-82%*), 

suggesting protection against severe illness with variant strains

†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

*Assessed ≥ 14 days post vaccination
 Serious adverse events were reported in a similar proportion among 

recipients of vaccine and placebo (0.4% vs 0.4%). 

Moderate certainty of evidence

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

reaction was reported by 2.5% of vaccinated versus 0.7% of placebo group. 

High certainty of evidence

Benefits and Harms:

Summary of the Available Evidence: Harms

23
Benefits and Harms:

Summary of the Available Evidence: Harms

24

 Local reactions within 7 days occurred in ~50% vaccine recipients

– Pain at the injection site most common

 Systemic reactions within 7 days occurred in ~55% vaccine recipients

– Headache, fatigue, and myalgia most common

 Most symptoms resolved after 1-2 days
Benefits and Harms: Reactogenicity

59.8% 58.6%

61.5%

12.8%

20.2%

17.4%

36.4%

0.7%

35.4%

33.3%

45.3%

3.1%

18.3%

15.6%

33.1%

0.5%

ANY PAIN ANY FEVER

LOCAL AE, ANY GRADE SYSTEMIC AE, ANY GRADE 

REACTOGENICITY BY AGE GROUP, 

PHASE III TRIAL DATA (N=3356 VACCINE, 3380 PLACEBO)

18-59 years, Vaccine 18-59 years, Placebo ≥60 years, Vaccine ≥60 years, Placebo

Abbreviations, AE= Adverse Events 25
Benefits and Harms: Reactogenicity

0.9%

0.4%

2.3%

0.3% 0.2%

0.0%

0.6%

0.0%

0.4%

0.2%

1.1%

0.1%

0.2% 0.2%

0.7%

0.0%

ANY PAIN ANY FEVER

LOCAL AE, GRADE 3 SYSTEMIC AE, GRADE 3

GRADE 3 REACTOGENICITY BY AGE GROUP, 

PHASE III TRIAL DATA (N=3356 VACCINE, 3380 PLACEBO)

18-59 years, Vaccine 18-59 years, Placebo ≥60 years, Vaccine ≥60 years, Placebo

Abbreviations, AE= Adverse Events 26
Benefits and Harms:

Summary of the Available Evidence: Harms

27

Adverse event imbalances of note: 

 Urticaria events: vaccine n=5; placebo n=1

– Possibly related to the vaccine*

 Tinnitus: vaccine n=6; placebo n=0

– Insufficient data to determine causal relationship*

 Thromboembolic events: vaccine n=15; placebo n=10

– Many of the participants had predisposing conditions. FDA determined contributory 

effect of vaccine not excluded, insufficient data to determine causal relationship*

– FDA recommends surveillance for further evaluation of thromboembolic events

*Causal determination per FDA
Benefits and Harms:

Summary of the Evidence: All authorized COVID-19 vaccines 

28

 No trials compared efficacy between vaccines in the same study at the same time

– All Phase 3 trials differed by calendar time and geography

– Vaccines were tested against different circulating variants and in settings with different 

background incidence

 All authorized COVID-19 vaccines demonstrated efficacy (range 65 to 95%) against 

symptomatic lab-confirmed COVID-19

 All authorized COVID-19 vaccines demonstrated high efficacy (≥89%) against 

COVID-19 severe enough to require hospitalization

 In the vaccine trials, no participants who received a COVID-19 vaccine died from 

COVID-19

– The Moderna and Janssen trials each had COVID-19 deaths in the placebo arm
Summary of GRADE

29

OutcomeImportance Design

(# of studies)

FindingsEvidence

type

Benefits

Symptomatic laboratoryconfirmed COVID-19

Critical RCT (1) Janssen COVID-19 vaccine is effective in preventing symptomatic COVID192

Hospitalization due to 

COVID-19

Critical RCT (1) Janssen COVID-19 vaccine prevents COVID-19-resulting in hospitalization 2

All-cause Death Important RCT (1) Janssen COVID-19 vaccine is associated with a lower risk of both allcause death and death due to COVID-19 2

SARS-CoV-2 

seroconversion Important RCT (1)

Data from day 71 serology indicates that Janssen COVID-19 vaccine 

prevents seroconversion during the available follow-up period; data 

support an effect on prevention of asymptomatic infection

3

Asymptomatic SARS-CoV-2 

infection Important No Studies No systematically collected PCR data are available to develop an 

estimate for this outcome ND

Harms

Serious adverse events

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

had SAEs judged by FDA as likely related to vaccination 2

Reactogenicity Important RCT (3) Severe reactions were about 3 times more common in vaccinated vs. 

placebo; any grade ≥3 reaction was reported by 2.5% 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 (Janssen 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 Janssen 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

36

 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: Societal Experts Action Network COVID-19 Survey Archive, Google

– Last search date: February 26, 2021

 Inclusion criteria

– Data collection in 2020 and 2021 related to COVID-19 vaccine beliefs, attitudes, and intentions

– Population: Adults in the U.S.
 Overall acceptability of a COVID-19 vaccine was moderate1

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

– February 2021: 46% get as soon as available, 27% wait and see, 18% definitely not get2

 Highest estimates of non-intent to receive COVID-19 vaccination3:

– Younger adults

– Women

– Non-Hispanic Black adults

– Adults living in nonmetropolitan areas

– Adults with less education and income, and without health insurance

Values:

Summary of the Available Evidence

37

1. APNORC; Harris; Fisher Ann Intern Med.; ICF; Kreps JAMA Netw Open.; Lazarus Nature Med.; Malik EClinicalMedicine.; Pogue Vaccines.; Reiter Vaccine.; Thunstrom SSRN. Szilagyi JAMA. Axios-IPSOS. Pew. KFF. ABC News-IPSOS. Quinnipiac. Monmouth.

2. KFF COVID-19 Vaccine Monitor: February 2021. February 26, 2021. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-february-2021/

3. Nguyen KH, Srivastav A, Razzaghi H, et al. COVID-19 Vaccination Intent, Perceptions, and Reasons for Not Vaccinating Among Groups Prioritized for Early Vaccination — United States, September and December 2020. MMWR Morb Mortal

Wkly Rep 2021;70:217–222. DOI: http://dx.doi.org/10.15585/mmwr.mm7006e3
COVID-19 Vaccination Intentions Vary by Survey Month†

†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.

*Positive vaccine intentions includes persons reporting definitely, probably, or somewhat likely to get vaccinated. Some surveys also included persons who 

already received vaccine.
Likelihood of Receiving a COVID-19 Vaccine Varies by State

U.S. Census Bureau, Household Pulse Survey, Week 24 Data, February 3-15

Percentage of adults who 

have not received a COVID19 vaccine but definitely 

will once available
COVID-19 Vaccination Intentions Vary by Race/ethnicity 

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

EUA granted for 

first COVID-19 

vaccine

1. Szilagyi PG, Thomas K, Shah MD, et al. National Trends in the US Public’s Likelihood of Getting a COVID-19 Vaccine—April 1 to December 8, 2020. JAMA. 2021;325(4):396–398. doi:10.1001/jama.2020.26419

1
41

 Vaccination intentions varied substantially by race/ethnicity and socioeconomic status

 Common reasons for positive intentions: protecting self, family, and community from 

COVID-19, belief that COVID-19 vaccines are safe, and ability to resume social activities

 Common concerns included vaccine side effects and uncertainty about vaccine safety

 Feb 2021 survey of 2-dose vs. 1-dose vaccines*: 58% would choose 2-dose vaccine, 7% 

would choose 1-dose vaccine, 21% would take either1

– Of those that chose 2-dose, 28% would get the 1-dose vaccine now rather than wait a month to get 2-dose

 Limitations:

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

– Convenience samples may not be representative

Values:

Summary of the Available Evidence

1. NORC AmeriSpeak, Feb 11-15, 2021. CDC unpublished data.

*Comparing a 2-dose vaccine that is 94% effective against getting COVID-19 and 97% effective against getting severe disease to a 1-dose vaccine that is 72% effective against getting 

COVID-19 and 85% effective against getting severe disease
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 Janssen 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)

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

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

 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

46
 No published provider knowledge, attitudes, and practices surveys

 State health officers, Oct 2020: concerns with rollout included vaccine 

hesitancy (53%), vaccine safety (32%), and communications (26%)1

 Concern from jurisdictions regarding vaccine supply and unmet demand

– National Governors Association Executive Committee Letter to the President2

Acceptability:

Summary of the Available Evidence

47 1. CDC COVID-19 Response Team.

2. National Governors Association. Executive Committee Letter To President Regarding Vaccine Distribution Process. https://www.nga.org/advocacy-communications/executive-committee-letter-to-president-regarding-vaccine-distribution-process/
48

 Logistics regarding implementation may be more accessible to a wide 

variety of stakeholders

– Single dose

– More convenient storage (3 months at 2-8oC )

– Does not require dilution

Acceptability:

Summary of the Available Evidence
 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

 As of February 27th, 2021, >72 million doses have been administered1

– >48 million people have initiated a series

– >7 million doses administered in LTCFs

Acceptability:

Summary of the Available Evidence

1. COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccinations.
Acceptability:

Work Group Interpretation 

Is the Janssen COVID-19 vaccine acceptable to key 

__stakeholders? 

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

Is the Janssen COVID-19 vaccine feasible to 

__implement? 

- Is the Janssen COVID-19 vaccine program sustainable? 

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

_____COVID-19 vaccine or require consideration when implementing it? 

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

_

○ No ○ Probably no ○ Probably yes ○ Yes ○ Varies ○ Don't know
53

 Vaccine shipment and storage (3 months) at refrigerator temperatures (2-8oC)*

 Single-dose series

Feasibility:

Summary of the Available Evidence

1) Janssen vaccine characteristics

* Long-term storage at standard freezer temperatures (-20oC)
54

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

 Health systems or health departments could incur costs for vaccine 

implementation or clinics

 Personal investments in time and travel to obtain vaccine may be a barrier 

for some groups

– Janssen: Cost related to one dose presumably less than for two vaccine doses

Feasibility:

Summary of the Available Evidence

2) Financial barriers
55

Feasibility:

Summary of the Available Evidence

3) Complexity of recommendations

 One adenoviral vector vaccine and two mRNA vaccines under an EUA with 

different numbers of doses, dosing intervals, storage and handling 

requirements may make vaccine recommendations more complex

 Potential for emerging challenges related to managing choice/preferences of 

providers and consumers for different products
4) Access to vaccines

 Adding a third vaccine will increase access, in terms of vaccine doses available

 Access to vaccine could be limited for people who are underserved or live in 

rural or other hard-to-reach areas

– Consider differential access when planning vaccination locations, communicating vaccine 

information, and scheduling appointments4

 Federal Retail Pharmacy Program1, Federally Qualified Health Center Program2, 

and FEMA Community Vaccination Centers3 should further expand access

 Vaccine without freezer requirements could be used in individual provider 

offices, once supply allows 

Feasibility:

Summary of the Available Evidence

1 CDC. Understanding the Federal Retail Pharmacy Program for COVID-19 Vaccination. https://www.cdc.gov/vaccines/covid-19/retail-pharmacy-program/index.html

2 CDC. Ensuring Equity in COVID-19 Vaccine Distribution. https://www.cdc.gov/vaccines/covid-19/planning/health-center-program.html

3 FEMA. https://www.fema.gov/press-release/20210216/fema-supports-vaccine-distribution-amid-winter-weather-response

4 COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. October 29, 2020: https://www.cdc.gov/vaccines/covid-19/covid19-vaccination-guidance.html
Feasibility: 

Work Group Interpretation

Is the Janssen COVID-19 vaccine feasible to 

__implement? 

_

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

Is the Janssen COVID-19 vaccine a reasonable and 

_efficient allocation of resources? 

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

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

________response to changes in context, assumptions, etc? 

○ No ○ Probably no ○ Probably yes ○ Yes ○ Varies ○ Don't know
 Health-related costs (including premature deaths, long-term health impairment and 

mental health impairment) have been estimated at $8.5 trillion1

 U.S. Government has committed over $10 billion to provision of vaccines2

 A recent study estimated COVID-19 vaccinations to range between “cost-saving” and 

$94,000 per quality-adjusted life-year (QALY), depending on target population3

– Hypothetical vaccine; vaccine not provided free of charge

– Did not consider societal costs, e.g., productivity, individual costs associated with pandemic

 Modeling study concluded only limited situations favor foregoing currently available 

vaccine(s) for substantially higher efficacy vaccines available later in pandemic4

Resource Use:

Summary of the Available Evidence

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

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

3 Kohli M, Maschio M, Becker D, Weinstein M. "The Potential Public Health and Economic Value of a Hypothetical COVID-19 Vaccine in the United States: Use of Cost-Effectiveness 

Modeling to Inform Vaccination Prioritization." Vaccine 2021 Feb 12; 39(7): 1157–1164.

4 Bartsch SM, O'Shea KJ, Wedlock PT, et al. The Benefits of Vaccinating With the First Available COVID-19 Coronavirus Vaccine. American Journal of Preventive Medicine. 2021 Jan 19.
 Precise cost-effectiveness analysis and economic impact of vaccination 

depend on number of factors that are currently unknown:

– Real-world vaccine effectiveness and duration of vaccine protection

– Vaccination coverage levels and speed of vaccination

– Implementation costs associated with large vaccination program

 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, including post BLA

 During pandemic, best utilization of resources is to employ all vaccines with 

acceptable VE – save cost and lives

61

Resource Use:

Work Group Interpretation
Resource Use:

Work Group Interpretation

Is the Janssen 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 Janssen 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 Janssen COVID-19 vaccine?

- Are there considerations that should be made when implementing the Janssen 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
65

Equity: Groups that have experienced disproportionate COVID-19 morbidity 

and mortality or decreased uptake of COVID-19 vaccines

 Racial and ethnic minority populations and tribal communities

 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, 

correctional/detention facilities, homeless shelters, and group homes

 People with disabilities

 People with substance abuse disorders

 Sexual and gender minorities (social or structural inequities leading 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 
 Only 19 (38%) states used a social vulnerability index to deliver vaccines more equitably 

in initial vaccine allocation plans 1

 National survey (n=67,000) in first half of Jan. 2021, showed Black persons 52% less 

likely than White persons to be vaccinated or definitely plan to get vaccinated 2

Equity: Data on equitable provision of COVID-19 vaccine

1 Schmidt et al. Equitable Allocation of COVID-19 Vaccines. 2020: https://scholarship.law.georgetown.edu/facpub/2333/

2 Kim et al. https://www.medrxiv.org/content/10.1101/2021.02.16.21251769v1

3 CDC. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic as of Feb 17 2021 , and US Census Bureau 10-year July 2019 National Population Estimates

 As of February 26, lower % 

of Black & Hispanic persons

0 10 20 30 40 50 60 70

White, Non-Hispanic

Hispanic

Black, Non-Hispanic

Asian, Non-Hispanic

AIAN, Non-Hispanic

NHOPI, Non-Hispanic

Multiple/other, Non-Hispanic

% of total

Overall population

One dose vaccine

received ≥1 vaccine dose vs

% of overall population 3
 Storage, handling and administration requirements

– Refrigerator-stable vaccine will facilitate the availability of the Janssen COVID-19 vaccine in most 

community settings and mobile sites, once supply allows

 Single dose schedule; increased vaccine options and more doses available

 Easier to reach some disproportionately affected groups such as: homeless, rural 

residents, justice-involved, disabled, homebound, or with no/limited access to 

healthcare

 Community engagement and education will be important as new vaccines are utilized

67

Equity: Characteristics of the Janssen COVID-19 vaccine that 

could impact health equity 
 Equity and vaccination program implementation are closely linked

 Advancing health equity, particularly in populations who experience 

disproportionate COVID-19-related morbidity and mortality, requires 

community engagement and focused efforts to identify and remove barriers 

for COVID-19 vaccines, including issues related to access or vaccine hesitancy1

 Whenever possible, consider extending choice for COVID-19 vaccines

68

Equity:

Additional Considerations 

1 CDC. COVID-19 Vaccination Program Interim Playbook for Jurisdictions Operations Annex: Considerations for Increasing COVID-19 Vaccination, Reaching and Increasing 

Uptake in Priority Populations (January 2021 Version 1.0). https://www.cdc.gov/vaccines/covid-19/downloads/COVID-19-vaccination-program-playbook-annex.pdf
Equity: 

Work Group Interpretation 

What would be the impact of the Janssen 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 Janssen 

COVID-19 vaccine

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

2 (moderate) 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?

Yes

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

Acceptability

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

Yes

Feasibility

Is the Janssen COVID-19 vaccine feasible to implement?

Yes

Resource Use

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

resources?

Yes

Equity

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

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
Old extra slides
Benefits and Harms:

Summary of the Available Evidence: Benefits

78

 Primary efficacy endpoint: subjects without evidence of prior infection

– Efficacy: 66.3% (59.9%, 71.8%)

 Variable efficacy by world region, possibly reflecting impact of variants

– United States: 74.4% (65.0%, 81.6%)

– South Africa: 52.0% (30.3%, 67.4%)

– Brazil: 66.2% (51.0%, 77.1%)
Benefits and Harms:

Summary of the Available Evidence: Benefits

79

 Higher efficacy against severe outcomes than for any symptomatic COVID-19*

– VE against hospitalization due to COVID-19: 90% (95% CI: 66%, 97%)

– VE against all-cause death: 81% (95% CI: 36%, 95%)

– VE against deaths due to COVID-19: 100%

 Efficacy estimates for severe outcomes assessed ≥28 days post vaccination 

were higher: 83.5% for severe disease†, 100% for hospitalization

 Efficacy against severe illness* remained high across world regions (78-82%), 

suggesting protection against severe illness with variant strains

*Assessed ≥ 14 days post vaccination
Benefits and Harms: Reactogenicity (Local)*

80

Janssen vaccine 

N=2036

Placebo

N=2049

Local Reaction

Any 1218 (59.8) 413 (20.2)

Severe (Grade 3) 18 (0.9) 4 (0.2)

Pain at the injection site

Any 1193 (58.6) 357 (17.4)

Severe (Grade 3) 8 (0.4) 0 (0.0)

Janssen Vaccine 

N=1320

Placebo

N=1331

Local Reaction 

Any 467 (35.4) 244 (18.3)

Severe (Grade 3) 5 (0.4) 2 (0.2)

Pain at the injection site

Any 439 (33.3) 207 (15.6)

Severe (Grade 3) 3 (0.2) 2 (0.2)

Select local reactions in persons aged 18-59 years

Select local reactions in persons aged ≥60 years

*Based on phase III trial data 
Benefits and Harms: Reactogenicity (Systemic)*

81

Janssen vaccine 

N=2593

Placebo

N=2594

Systemic Reaction

Any

Grade 3 or 4 52 (2.0) 12 (0.5)

Fever

Any 284 (11.0) 16 (0.6)

Grade 3 7 (0.3) 0 (0.0)

Select systemic 

reactions in persons 

aged 18-64 years

Select systemic 

reactions in persons 

aged ≥65 years

Janssen vaccine 

N=763

Placebo

N=786

Systemic Reaction

Any

Grade 3 or 4 9 (1.2) 9 (1.1)

Fever

Any 18 (2.4) 4 (0.5)

Grade 3 1 (0.1) 0 (0.0) Grade 3 fever: 102.1–104.0oF

Grade 4 fever: >104.0oF *Based on phase III trial data 
Benefits and Harms:

Summary of the Available Evidence: Benefits

82

 Primary efficacy endpoint: subjects without evidence of prior infection

– Efficacy: 66.3% (59.9%, 71.8%)

 Similar efficacy analysis across age, sex, race*, and ethnicity categories, and 

those with underlying medical conditions

– Efficacy among adults 18-64 years of age: 64.7% (57.6%, 70.8%)

– Efficacy among adults ≥65 years of age: 76.5% (59.1%, 87.3%)

*Defined as White or Black race; other racial groups had numbers too small for analysis.