cdc.gov/coronavirus

Evidence to Recommendation Framework:

Moderna & Janssen

COVID-19 Vaccine Booster Dose

Kathleen Dooling, MD, MPH

ACIP Meeting, Oct 21, 2021
Evidence to Recommendations (EtR) Framework

2

EtR Domains

Public Health Problem

Benefits and Harms

Values

Acceptability

Feasibility

Resource Use

Equity
Booster doses of COVID-19 vaccines

3

 Policy on booster doses will be coordinated with FDA for regulatory 

allowance and ACIP/CDC for recommendations for use

Review 

data 

FDA

Regulatory 

allowance

ACIP/CDC

Recommendations 

for use
 The following recipients of Pfizer-BioNTech COVID-19 vaccine primary series 

should receive a single booster dose ≥6 months after completion of the primary series:

– ≥65 years 

– ≥18 years and reside in long-term care settings

– Aged 50-64 years with certain underlying medical conditions

 The following recipients of Pfizer-BioNTech COVID-19 vaccine primary series 

may receive a single booster dose ≥6 months after completion of the primary series 

based on their individual risks and benefits:

– Aged 18-49 years with certain underlying medical conditions

– Aged 18-64 years at increased risk for SARS-CoV-2 exposure and transmission because of occupational 

or institutional setting

CDC recommends the following groups for Pfizer-BioNTech 

COVID-19 vaccine boosters
1) Among risk groups for whom CDC recommends a Pfizer-BioNTech booster 

dose, should those who received a Moderna COVID-19 vaccine primary series 

be recommended to receive a single Moderna COVID-19 booster dose (50μg) 

≥6 months after completion of the primary series?

2) Among people aged ≥18 years who received Janssen COVID-19 vaccine for 

their primary COVID-19 vaccine, should a booster dose of Janssen COVID-19 

be recommended ≥2 months after receipt of the initial dose?

Evidence to Recommendations (EtR) Framework

Policy Questions

5
Number of people fully vaccinated in the U.S. by COVID-19 

vaccine series type

CDC. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total. Accessed October 20, 2021

189,487,793

Fully Vaccinated

6
Public 

Health

Problem

Evidence to Recommendations Framework

Booster doses of COVID-19 vaccines

7
Daily trends in number of COVID-19 cases in the United States

CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailycases. Accessed October 19, 2021

January 23, 2020 – October 17, 2021

44,857,861 total cases

8

Pfizer-BioNTech booster dose 

recommended
Daily trends in number of hospitalized COVID-19 cases in 

the United States 

CDC. COVID-19 Data Tracker. https://covid.cdc.gov/covid-data-tracker/#hospitalizations. Accessed 10.20.2021.

New Hospitalizations for COVID-19 with a 7-Day Moving Average, August 2020-October 2021

Number of New Hospitalizations with Confirmed COVID-19
18-49 years 50-64 years ≥65 years

*Data are preliminary and case counts and rates for recent hospital admissions are subject to lag. As data are received each week, prior case counts and rates are updated accordingly.

†Cumulative rate ratio from January 24 – August 28, 2021. 

COVID Data Tracker: https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination

Vaccinated vs. Unvaccinated †

14x higher 15x higher 9x higher

10

0

5

10

15

20

25

30

35

1/30/20212/13/20212/27/20213/13/20213/27/20214/10/20214/24/2021

5/8/2021

5/22/2021

6/5/2021

6/19/2021

7/3/2021

7/17/20217/31/20218/14/20218/28/2021

Rate per 100,000 population

0

10

20

30

40

50

60

70

80

90

100

1/30/20212/13/20212/27/20213/13/20213/27/20214/10/20214/24/2021

5/8/2021

5/22/2021

6/5/2021

6/19/2021

7/3/2021

7/17/20217/31/20218/14/20218/28/2021

Rate per 100,000 population

0

50

100

150

200

250

1/30/20212/13/20212/27/20213/13/20213/27/20214/10/20214/24/2021

5/8/2021

5/22/2021

6/5/2021

6/19/2021

7/3/2021

7/17/20217/31/20218/14/20218/28/2021

Rate per 100,000 population

Age-adjusted weekly COVID-19-associated hospitalization rates among adults by 

week of admission and age group*—COVID-NET, January 24–August 28, 2021
 Prevalence of post-COVID-19 conditions, among vaccinated and unvaccinated, 

reported from 5%–80%1

 Prevalence of long COVID-19 among fully vaccinated persons who develop COVID19 ranges from 5% (U.K. adults)2 to 19% (Israeli healthcare workers)3

 Among COVID-19 cases in a U.K. study, odds of long COVID-19 were reduced by half 

among fully vaccinated compared to unvaccinated2

Long COVID-19 and risk in vaccinated people

1Cabrera Martimbianco AL, Pacheco RL, Bagattini ÂM, Riera R. Frequency, signs and symptoms, and criteria adopted for long COVID-19: a systematic review. Int J Clin Pract

2021;e14357. Epub May 11, 2021. PMID:33977626

2Antonelli, M et al. "Risk factors and disease profile of post-vaccination SARS-CoV-2 infection in UK users of the COVID Symptom Study app: a prospective, community-based, 

nested, case-control study." The Lancet Infectious Diseases (2021).

3Bergwerk, M et al. "Covid-19 breakthrough infections in vaccinated health care workers." New England Journal of Medicine (2021).
HEROESRECOVER 

(mRNA)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Pre-Delta Delta

Vaccine effectiveness (%)

SUPERNOVA 

(mRNA)

IVY ≥1 

underlying 

condtion (all 

products)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Pre-Delta Delta

Vaccine effectiveness (%)

Magnitude of vaccine effectiveness (VE) against infection or

hospitalization by Delta predominance and study, by risk group

NHSN: https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e3.htm

COVID-NET: CDC unpublished VISION: https://www.nejm.org/doi/10.1056/NEJMoa2110362/ https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e2.htm

IVY: CDC unpublished data SUPERNOVA: https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e3.htm

NYS: https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e1.htm HEROES-RECOVER: https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm 12

Underlying medical conditions Frontline workers

NHSN (mRNA)

COVID-NET (mRNA)

VISION (Pfizer)

VISION (Moderna)

NYS (all products) 

NYS (all products)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Pre-Delta Delta

Vaccine effectiveness (%)

≥ 65 years of age
0

10

20

30

40

50

60

70

80

90

100

February March April May June July

Vaccine Effectiveness (%)

Nanduri et al.*

Rosenberg, et al.

Puranik, et al.

(Pfizer)

Puranik, et al.

(Moderna)

Fowlkes et al. **

Keehner, et al.**

Vaccine effectiveness against infection over time

Adults ≥18 years of age

Rosenberg ES, Holtgrave DR, Dorabawila V, et al. New COVID-19 Cases and Hospitalizations Among Adults, by Vaccination Status — New York, May 3–July 25, 2021. MMWR Morb Mortal Wkly Rep. ePub: 18 August 2021.

Nanduri S. Effectiveness of Pfizer-BioNTech and Moderna Vaccines in Preventing SARS-CoV-2 Infection Among Nursing Home Residents Before and During Widespread Circulation of the SARS-CoV-2 B.1.617.2 (Delta) Variant 

— National Healthcare Safety Network, March 1–August 1, 2021. MMWR Morbidity and Mortality Weekly Report. 2021 2021;70. 

Fowlkes A, Gaglani M, Groover K, et al. Effectiveness of COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Frontline Workers Before and During B.1.617.2 (Delta) Variant Predominance — Eight U.S. Locations, 

December 2020–August 2021. MMWR Morb Mortal Wkly Rep. ePub: 24 August 2021. 

Puranik A, Lenehan PJ, Silvert E, et al. Comparison of two highly-effective mRNA vaccines for COVID-19 during periods of Alpha and Delta variant prevalence. medRxiv 2021.08.06.21261707. 

Keehner J, Horton LE, Binkin NJ et al. Resurgence of SARS-CoV-2 Infection in a Highly Vaccinated Health System Workforce. NEJM, September 1, 2021. DOI: 10.1056/NEJMc2112981

**HCWs, frontline workers

* Nursing Home Residents

**HCWs, first responders

13
0

10

20

30

40

50

60

70

80

90

100

February March April May June July

Vaccine Effectiveness (%)

Tenforde, et al.*

Rosenberg, et al.

Puranik, et al. (Pfizer)

Puranik, et al. (Moderna)

Bajema et al.

Vaccine effectiveness against hospitalization by month

Adults ≥18 years of age

Tenforde MW, Self WH, Naioti EA, et al. Sustained Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Associated Hospitalizations Among Adults — United States, March–July 2021. MMWR Morb Mortal Wkly

Rep. ePub: 18 August 2021.

Tenforde MW, Olson SM, Self WH, et al. Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021. MMWR Morb Mortal Wkly Rep 

2021;70:674–679.

Rosenberg ES, Holtgrave DR, Dorabawila V, et al. New COVID-19 Cases and Hospitalizations Among Adults, by Vaccination Status — New York, May 3–July 25, 2021. MMWR Morb Mortal Wkly Rep. ePub: 18 August 2021.

Puranik A, Lenehan PJ, Silvert E, et al. Comparison of two highly-effective mRNA vaccines for COVID-19 during periods of Alpha and Delta variant prevalence. medRxiv 2021.08.06.21261707. 

Bajema KL, Dahl RM, Prill MM, et al. Effectiveness of COVID-19 mRNA Vaccines Against COVID-19–Associated Hospitalization — Five Veterans Affairs Medical Centers, United States, February 1–August 6, 2021. MMWR Morb

Mortal Wkly Rep.

* February estimates from 

platform's May 2021 MMWR

14
Vaccine effectiveness against hospitalization over time

Adults ≥16 years of age 

Bajema KL, Dahl RM, Prill MM, et al. Effectiveness of COVID-19 mRNA Vaccines Against COVID-19–Associated Hospitalization — Five Veterans Affairs Medical Centers, United States, February 1–August 6, 2021. MMWR Morb Mortal Wkly Rep.

Thompson MG, Burgess JL, Naleway AL, et al. Prevention and attenuation of Covid-19 with the BNT162b2 and mRNA-1273 vaccines. N Engl J Med 2021;385:320–9.

Self WH, Tenforde MW, Rhoads JP, et al. Comparative Effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) Vaccines in Preventing COVID-19 Hospitalizations Among Adults Without Immunocompromising Conditions — United States, 

March–August 2021. MMWR Morb Mortal Wkly Rep. ePub: 17 September 2021.

Nunes et al. mRNA vaccines effectiveness against COVID-19 hospitalizations and deaths in older adults: a cohort study based on data-linkage of national health registries in Portugal. MedRXiv preprint.

Andrews et al. Vaccine effectiveness and duration of protection of Comirnaty, Vaxzevria and Spikevax against mild and severe COVID-19 in the UK. Preprint. 

Tartof SY, Slezak JM, Fischer H, Hong V, Ackerson BK, Ranasinghe ON, et al. Six-month effectiveness of BNT162b2 mRNA COVID-19 vaccine in a large US integrated health system: a retrospective cohort study. 

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3909743

0

20

40

60

80

100

5 weeks 10 weeks 15 weeks 20 weeks 25 weeks

Vaccine Effectivness

mRNA 16+ years

mRNA 50+ years

J&J/Janssen 16+ years

15

18+ years
Summary

 More than 189 million people in the U.S. are fully vaccinated (~57% total population)

 Hospitalization rates are ~9X-15X higher in unvaccinated as compared to vaccinated 

adults

 Moderna COVID-19 Vaccine (37% of fully vaccinated people)

– Infection: Declines in VE against infection over time and during Delta period

– Hospitalization: Minimal to no declines in VE against hospitalization in younger adults and mild declines 

observed in some for platforms among older adults

 Janssen COVID-19 Vaccine (8% of fully vaccinated people)

– Lower VE compared to mRNA vaccines, but most study platforms show persistent VE over time against 

infection and hospitalization, even among older adults

16
Benefits 

and 

Harms

Evidence to Recommendations Framework

Booster doses of COVID-19 vaccines

17
18

PICO Question

Moderna Janssen

Population Persons aged ≥18 years who 

completed a COVID-19 vaccine 

primary series ≥6 months ago

Persons aged ≥18 years who

completed a COVID-19 vaccine

primary series ≥2 months ago

Intervention Moderna COVID-19 Vaccine

booster dose (mRNA-1273, 50 μg, IM)

Janssen COVID-19 Vaccine

booster dose (Ad26.CoV2.S, 5X1010 VP, IM)

Comparison No booster dose

Outcomes Symptomatic laboratory-confirmed COVID-19*

Hospitalization due to COVID-19*

Death due to COVID-19

Transmission of SARS-CoV-2 infection

Serious adverse events*

Reactogenicity

* Critical outcomes
Evidence Retrieval

19

Records identified 

from WHO/IVAC 

literature review*

(n = 0)

Additional records 

identified through 

other sources**

(n = 2)

*See https://view-hub.org/resources** clinicaltrials.gov and Sponsor

Records excluded from 

initial review

(n = 0)

Records screened

(n = 2)

Records assessed for 

eligibility

(n = 2)

Full-text articles 

excluded 

(n = 0) Records included in evidence 

synthesis (n = 2)

2 clinical trial records

0 vaccine effectiveness studies

Records identified 

from WHO/IVAC 

literature review*

(n = 0)

Additional records 

identified through 

other sources**

(n = 2)

Records excluded from 

initial review

(n = 0)

Records screened

(n = 2)

Records assessed for 

eligibility

(n = 2)

Full-text articles 

excluded 

(n = 0) Records included in evidence 

synthesis (n = 2)

2 clinical trial records

0 vaccine effectiveness studies

Janssen booster Moderna booster
Moderna booster ≥6 months after primary series

Summary of GRADE

20

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

OutcomeImportance Design

(# of studies)

FindingsEvidence

type

Benefits (prevention of outcome)

Symptomatic 

laboratory-confirmed 

COVID-19

Critical RCT (0)

OBS (2)

Moderna COVID-19 booster dose (50 μg) induced immune response 

(GMR) noninferior to that following dose 2 of the 100 μg primary series 4

Hospitalization due to 

COVID-19

Critical RCT (0)

OBS (0) No data available ND

Death due to COVID-19 Important RCT (0)

OBS (0) No data available ND

Transmission of SARSCoV-2 infection Important RCT (0)

OBS (0) No data available ND

Harms

Serious adverse eventsCritical RCT (0)

OBS (2)

No SAEs were attributed to Moderna COVID-19 booster dose (50 

μg) during follow-up. No imbalance between booster and comparison 

group

4

Reactogenicity Important RCT (0)

OBS (2)

Grade ≥3 reactogenicity occurred in 10.8% of Moderna COVID-19 

booster dose (50 μg) recipients vs 19.7% primary series (100ug)

4
Janssen booster ≥2 months after primary dose

Summary of GRADE

Evidence type: 1=high; 2=moderate; 3=low; 4=very low; ND=no data 21

OutcomeImportance Design

(# of studies)

FindingsEvidence

type

Benefits (prevention of outcome)

Symptomatic 

laboratory-confirmed 

COVID-19

Critical RCT (0)

OBS (2)

Janssen COVID-19 booster dose is more effective at preventing 

symptomatic laboratory-confirmed COVID-19 than the primary dose 4

Hospitalization due to 

COVID-19

Critical RCT (0)

OBS (2)

Janssen COVID-19 booster dose may be more effective at preventing 

hospitalization due to COVID-19 (severe COVID-19) than the primary 

dose

4

Death due to COVID-19 Important RCT (0)

OBS (2)

Janssen COVID-19 booster dose may be more effective at preventing 

death due to COVID-19 than the primary dose 4

Transmission of SARSCoV-2 infection Important RCT (0)

OBS (0) No data available ND

Harms

Serious adverse eventsCritical RCT (1)

OBS (0)

3 SAEs were attributed to Janssen COVID-19 booster dose (facial paresis, 

pulmonary embolism, and cerebrovascular accident). SAE were balanced 

between booster and placebo arms

4

Reactogenicity Important RCT (1)

OBS (0)

Grade ≥3 systemic adverse events occurred in 2.1% of Janssen COVID-19 

booster dose recipients- similar or less than after the primary dose 4
22

Number of people needed to vaccinate with a booster dose 

to prevent one hospitalization over 6 months

**

** Not estimable due to pre-booster efficacy estimated at >95%

Methods for calculations included in backup slides
 Myocarditis and Pericarditis

– Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 

7 days following the second dose. The observed risk is higher among males under 40 years of age 

than among females and older males. The observed risk is highest in males 18 through 24 years of 

age. Although some cases required intensive care support, available data from short-term follow-up 

suggest that most individuals have had resolution of symptoms with conservative management. 

Information is not yet available about potential long-term sequelae.1

– Highest reporting rate in 18-24yo males (0-7 days post dose 2)= 39 cases/1M doses administered2

Myocarditis/pericarditis following Moderna

1. Moderna COVID-19 Vaccine Fact Sheet for Health Care Providers (fda.gov) 

2. VAERS 23
 Thrombosis with thrombocytopenia syndrome (TTS)

– Blood clots involving blood vessels in the brain, lungs, abdomen, and legs along with low levels of 

platelets (blood cells that help your body stop bleeding), have occurred in some people who have 

received the Janssen COVID-19 Vaccine. In people who developed these blood clots and low levels of 

platelets, symptoms began approximately one to two weeks after vaccination. Reporting of these 

blood clots and low levels of platelets has been highest in females ages 18 through 49 years. The 

chance of having this occur is remote.1

– Highest reporting rate in 30-39 year old females (0-21 days post dose)= 10 cases/1M doses 

administered2

TTS following Janssen

1. Janssen COVID-19 Vaccine Fact Sheet for Recipients and Caregivers (fda.gov)

2. VAERS 24
 Guillain Barré syndrome (GBS)

– ...has occurred in some people who have received the Janssen COVID-19 Vaccine. In most of these 

people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The 

chance of having this occur is very low. 1

– Highest reporting rate in 50-64 year old males (1-42d post dose)= 16 cases/1M doses administered 2

GBS following Janssen

1. Janssen COVID-19 Vaccine Fact Sheet for Recipients and Caregivers (fda.gov)

2. Rosenblum et al. MMWR, Volume 70, Issue 32 — August 13, 2021 (cdc.gov) 25
 Use of Moderna, Janssen, and Pfizer-BioNTech COVID-19 vaccines as boosters led to 

strong serologic responses in groups primed by all three vaccines

 For a given primary COVID-19 vaccine, heterologous boosts elicited similar or higher 

serologic responses as compared to their respective homologous booster reponses

 mRNA vaccines resulted in higher antibody titers in the first 28 days after the boost

 The study arms were small (n=49-53), but no safety concerns were identified

Heterologous Boosting (Mix and Match)

https://www.medrxiv.org/content/10.1101/2021.10.10.21264827v1.full.pdf

26
27

Values and 

Acceptability

Evidence to Recommendations Framework

Booster dose of COVID-19 vaccines
Values and Acceptability

 In published surveys completed in August (n=5), 76%-87% of vaccinated adults 

reported they would get a booster dose, if available1-5

– In one survey, this increased to 93% of surveyed adults if it was recommended by their 

primary care provider

1. Axios Ipsos Poll. August 2, 2021.

2. Axios Ipsos Poll. August 30, 2021.

3. Marist Poll. September 3, 2021. https://maristpoll.marist.edu/polls/npr-pbs-newshour-marist-national-poll-covid-september-3-2021/

4. Morning Consult Poll. August 25, 2021. https://morningconsult.com/2021/08/25/covid-booster-shot-poll/

5. Reuters/Ipsos Poll. September 1, 2021. https://www.reuters.com/business/healthcare-pharmaceuticals/most-vaccinated-americans-want-covid-19-booster-shots-reutersipsos-poll-2021-09-01/ 28
Cumulative Number of COVID-19 Vaccine Booster/Additional Doses

Source: Immunization Data Lake. Data as of October 19, 2021.

Potential underreporting

due to reporting lag

Number of booster doses administered

Total booster/additional doses administered: 10.9M

0

2,000,000

4,000,000

6,000,000

8,000,000

10,000,000

12,000,000

13-Aug14-Aug15-Aug16-Aug17-Aug18-Aug19-Aug20-Aug21-Aug22-Aug23-Aug24-Aug25-Aug26-Aug27-Aug28-Aug29-Aug30-Aug31-Aug

1-Sep2-Sep3-Sep4-Sep5-Sep6-Sep7-Sep8-Sep9-Sep

10-Sep11-Sep12-Sep13-Sep14-Sep15-Sep16-Sep17-Sep18-Sep19-Sep20-Sep21-Sep22-Sep23-Sep24-Sep25-Sep26-Sep27-Sep28-Sep29-Sep30-Sep

1-Oct2-Oct3-Oct4-Oct5-Oct6-Oct7-Oct8-Oct9-Oct

10-Oct11-Oct12-Oct13-Oct14-Oct15-Oct16-Oct17-Oct18-Oct

Booster dose 

recommendation

All adults, 18+

65+ years

50-64 years

18-49 years
30

Feasibility 

and 

Implementation

Evidence to Recommendations Framework

Booster doses of COVID-19 vaccines
Completed primary vaccination regime, by week 

0

2

4

6

8

10

12

14

12/19/2020 1/19/2021 2/19/2021 3/19/2021 4/19/2021 5/19/2021 6/19/2021 7/19/2021 8/19/2021

Millions

J&J Moderna Pfizer

31 CDC Immunization Data Lake. Data as of September 9, 2021
Completed primary vaccination regime, by week 

0

2

4

6

8

10

12

14

12/19/2020 1/19/2021 2/19/2021 3/19/2021 4/19/2021 5/19/2021 6/19/2021 7/19/2021 8/19/2021

Millions

J&J Moderna Pfizer

Completed primary series 6 months prior 

32 CDC Immunization Data Lake. Data as of September 9, 2021
Number of U.S. persons potentially eligible (in millions) 

for a booster dose on October 22, 2021

Age group Pfizer-BioNTech

≥6m 

Moderna

≥6m 

Janssen

≥2m Total

18-29 years old 4.7 3.0 2.4 10.1

30-49 years old 11.9 8.3 4.5 24.7

50-64 years old 13.2 10.1 4.0 27.3

65+ years old 17.3 17.7 1.9 36.9

Total 47.1 39.1 12.9 99.1

CDC Immunization Data Lake. Data as of September 9, 2021 33
34

 CDC’s federal pharmacy program provides vaccination support to LTC settings, including 

on-site vaccination clinics where needed, to help residents access vaccine in local 

community

 8.1 million doses administered during original LTC program (December 2020-March 

2021): 6.2M (76%) were Pfizer-BioNTech, 1.9M (24%) were Moderna

 Thus far, the support for booster doses has been restricted to Pfizer-BioNTech recipients 

based on current FDA and CDC guidance

Implementation

Long-term care (LTC) facility residents
35

Resource 

Use

Evidence to Recommendations Framework

Booster doses of COVID-19 vaccines
 All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. 

population

– Health systems or health departments incur costs for vaccination program planning and 

implementation

– Fees for administration of COVID-19 vaccines recommended by ACIP/CDC are reimbursable by 

insurance or other federal programs

 Cost effectiveness analyses will take on increased importance in the future, when public 

health emergency is over

Summary - Resource Use

36
37

Equity

Evidence to Recommendations Framework

Booster doses of COVID-19 vaccines
Percentage of Booster Dose Administrations by Race/Ethnicity

Source: Immunization Data Lake Aggregate Dataset (includes TX). Data reported as of 19OCT2021 0600.

Notes: Census populations used to calculate Group Percentage of U.S. Population are from the Census 2019 Vintage files. The Multiple/Other category includes vaccine 

recipients that were identified as Multiple Race or Other Race. The Census populations used to calculate the Group Percentage of U.S. Population for this group represent the 

non-Hispanic Two or More Race population only, since Other is not a Census-recognized group.

Unknown

10.4%

Known

89.6%

Completeness of 

Race/Ethnicity 

Reporting for Booster 

Dose Administrations

Data shown for 9.8M people with a booster/additional dose administration and known race/ethnicity, vaccinated since August 13, 2021

59.5%

0.3%

2.2%

19.2%

12.4%

5.7%

0.7%

70.9%

0.2%

7.2%

9.1%

6.4%

5.4%

0.8%

0.0% 25.0% 50.0% 75.0% 100.0%

White, non-Hispanic

Native Hawaiian/Pacific Islander, non-Hispanic

Multiple/Other, non-Hispanic

Hispanic/Latino

Black, non-Hispanic

Asian, non-Hispanic

American Indian/Alaska Native, non-Hispanic

Group Percentage of Booster Dose Group Percentage of U.S. Population
Summary - Equity

 COVID-19 disease and COVID-19 vaccination varies by socioeconomic and 

sociodemographic groups

– However, vaccine effectiveness does not vary by race and ethnicity

 At present, only recipients of Pfizer-BioNTech COVID-19 vaccine have been recommended 

to receive a booster, thus creating inequity for recipients of Moderna or Janssen COVID19 vaccine

– Janssen COVID-19 vaccine may have been used more commonly for outreach to homeless 

or medically underserved communities because it is a single dose regime

39
Summary 
Work Group interpretation

 Top priority should be continued vaccination of unvaccinated individuals

 Goals of booster program:

– Prevention of severe disease, including hospitalization and death

– Other considerations are important, such as maintaining workforce and 

healthcare capacity, prevention of transmission, individual benefit/risk balance

 Balance of benefits and risks varies by age

– Adults ≥65 years have the clearest benefit>risk

– Moderna: Benefits are incrementally smaller with decreasing age, given high effectiveness 

maintained from primary series. Myocarditis risk higher in young adults.

– Janssen: Benefits may be smaller across age groups compared with mRNA vaccines. TTS 

risk higher in young females.

41
 For people who received Moderna COVID-19 vaccine as a primary series, the Work Group 

supports using a single booster dose ≥ 6 months following the primary series in certain 

populations (consistent with CDC recommended populations for Pfizer-BioNTech COVID-19 

booster)

 For people who received Janssen COVID-19 vaccine as primary vaccination, the Work Group 

supports using a single booster ≥ 2 months following the initial dose in all people aged ≥ 18 

years and older

 A single dose of Janssen COVID-19 vaccine results in lower VE and antibody levels compared 

to mRNA vaccine primary series- data demonstrate that a single dose of Janssen or mRNA 

COVID-19 vaccines boost immune response in these individuals

Work Group interpretation
 Monica Godfrey

 Jack Gersten

 Amy Blain

 Heidi Moline

 Danielle Moulia

 Kathleen Dooling 

 Megan Wallace

 Jennifer Collins

 Jefferson Jones

 Julia Gargano

 Eddie Shanley

 Stephen Hadler

 Hannah Rosenblum

 Heather Scobie

 Ian Plumb

 Amy Blain

 Neela Goswami

 Mary Chamberland

 CDC/University of Iowa

 VTF ACIP WG Team

 ACIP COVID-19 Vaccines Work Group

 Vaccine Task Force

 Epi Task Force

 Respiratory Viruses Branch

Acknowledgments
Clinical Considerations 
45

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 assessment of 

benefits and risks

We recommend the 

intervention 

Used when the risks

clearly outweigh the 

benefits

in a population

Used when the 

benefits clearly 

outweigh the risks 

in a population

Used when there is 

diversity of the 

benefits and risks 

in a population

Can allow flexibility

across a population
Policy question #1

Among risk groups for whom CDC recommends a Pfizer-BioNTech 

booster dose, should those who received a Moderna COVID-19 vaccine 

primary series be recommended to receive a single Moderna COVID-19 

booster dose (50ug) ≥6 months after completion of the primary series?

Policy question #2

Among people aged ≥18 years who received Janssen COVID-19 vaccine 

for their primary COVID-19 vaccine, should a booster dose of Janssen 

COVID-19 be recommended ≥2 months after receipt of the initial dose?

46
ACIP Vote #1

Interim Recommendation

A single Moderna COVID-19 vaccine booster dose (50ug) is recommended at 

least 6 months after completion of the Moderna primary series, in the same 

risk groups for whom CDC recommended a booster dose of Pfizer-BioNTech, 

under the FDA’s Emergency Use Authorization

47
ACIP Vote #2

Interim Recommendation

A single Janssen COVID-19 vaccine booster dose is recommended for persons 

aged ≥18 years, at least 2 months after receipt of the initial Janssen dose, under 

the FDA’s Emergency Use Authorization

48
 The following recipients of Pfizer-BioNTech COVID-19 vaccine primary series 

should receive a single booster dose ≥6 months after completion of the primary series:

– ≥65 years 

– ≥18 years and reside in long-term care settings

– Aged 50-64 years with certain underlying medical conditions

 The following recipients of Pfizer-BioNTech COVID-19 vaccine primary series 

may receive a single booster dose ≥6 months after completion of the primary series 

based on their individual risks and benefits:

– Aged 18-49 years with certain underlying medical conditions

– Aged 18-64 years at increased risk for SARS-CoV-2 exposure and transmission because of occupational 

or institutional setting

CDC recommends the following groups for Pfizer-BioNTech 

COVID-19 vaccine boosters
ACIP Vote #3

Interim Recommendation

Among groups recommended to receive booster vaccination after a PfizerBioNTech, Moderna, or Janssen COVID-19 vaccine primary series, a single 

booster dose of any of the authorized or approved COVID-19 vaccines may be 

administered as a heterologous booster dose, under FDA’s Emergency Use 

Authorization.

50
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
0

0.02

0.04

0.06

0.08

0.1

0.12

Weekly COVID

May June July

-19 hospitalizations per 

1000 population

Week

18-49 50-64 65+ 60+ (Israel)*

For Israel, vaccine received in

Apr-May

Mar

Feb

Jan

Incidence among vaccinated people, for hospitalization by month in 

United States and for severe disease by time since 2nd dose in Israel

Scobie HM, Johnson AG, Suthar AB, et al. Monitoring Incidence of COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination Status — 13 U.S. Jurisdictions, April 4–July 17, 2021. MMWR Morb Mortal Wkly Rep 2021;70:1284–1290. 

Goldberg et al. Waning immunity of the BNT162b2 vaccine: A nationwide study from Israel. https://www.medrxiv.org/content/10.1101/2021.08.24.21262423v1.full-text

*Israel estimates were derived from rate of severe COVID-19 (per 1,000 persons) from July 11, 2021 to July 31, 2021. 

Each data point represents all person stratified by when second dose of COVID-19 vaccine received.

52

(United States)
Summary of GRADE- Pfizer-BioNTech

OutcomeImportance Design

(# of studies)

FindingsEvidence

type

Benefits

Symptomatic 

laboratory-confirmed 

COVID-19

Critical RCT (2)

OBS (1)

Pfizer-BioNTech COVID-19 booster dose induced immune responses 

(GMR, seroresponse) noninferior to those following dose 

2. Observational data suggest increased protective effect against any 

SARS-CoV-2 infection.

4

Hospitalization due to 

COVID-19

Critical RCT (0)

OBS (1)

Observational data suggest increased protective effect against severe 

COVID-19. 4

Death due to COVID-19 Important RCT (0)

OBS (0) No data available. ND

Transmission of SARSCoV-2 infection Important OBS (0) No data available. ND

Harms

Serious adverse eventsCritical RCT (1) No SAEs were attributed to booster dose. 4

Reactogenicity Important RCT (1) Grade ≥3 reactogenicity was reported by 6.6% of booster dose 

recipients.

4

Evidence type: 1=high; 2=moderate; 3=low; 4=very low; ND, no data 53
54

Methods for number needed to vaccinate

Calculated per 1 million booster doses using current COVID-19 vaccine and disease data to estimate 

number of cases and hospitalizations occurring among vaccinated

• Age groups: 18 – 29 years, 30 – 49 years, 50 – 64 years, ≥65 years

• Time Horizon: 180-day period, with stable incidence and VE

Input Source

Number fully vaccinated CDC Data Tracker (Sept 10, 2021)1

Case Incidence CDC Data Tracker (Sept 9, 2021)2

Hospitalization Incidence COVID-NET (Aug 21, 2021)3

Vaccine Effectiveness (primary series) Averaged VE estimates from four platforms

Vaccine Effectiveness booster Assumption (VE post-booster is unknown)

95% VE for hospitalization

VE: Vaccine Effectiveness

1https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic

2https://covid.cdc.gov/covid-data-tracker/#trends_dailycases

3https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html
0.7%

12.5%

25.0%

6.1%

40.0%

9.4%

6.2%

0% 5% 10% 15% 20% 25% 30% 35% 40% 45%

Refuse to answer

Don't know

Much less likely

Less likely

No impact

More likely

Much more likely

% of respondents

Around 1/3 of unvaccinated respondents said that COVID-19 booster 

vaccines would make them less likely to get vaccinated at all 

CDC/University of Iowa unpublished data, August 2021 55
Cumulative COVID-19 associated hospitalizations in the United 

States by race/ethnicity, March 7, 2020 – September 11, 2021

CDC. https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalization-network. Accessed September 21, 2021

American Indian/Alaska Native: 1273.8

Black: 1.009.5

Hispanic: 816.5

Overall: 654

White: 486

Asian/Pacific Islander: 346

56
Vaccine effectiveness by race and ethnicity

M Thompson et al. NEJM https://www.nejm.org/doi/pdf/10.1056/NEJMoa2110362?articleTools=true

 Among VE platforms able to provide specific estimates for vaccine 

effectiveness by race or ethnicity, no differences noted 

 VE against hospitalization among adults ≥50 years of age: 

– Overall: 89% (95% CI: 87-91%)

– Black individuals: 86% (95% CI: 75-92%)

– Hispanic individuals: 90% (95% CI: 85-93%)

 VE against hospitalization among VA centers: 

– Black individuals: 86% (95% CI: 77-93%)

– White individuals: 88% (95% CI: 77-94%)

57
Percentage of people 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 October 14, 2021, and US Census Bureau National Population Estimates

0

10

20

30

40

50

60

70

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

AI/AN

Asian

Black

Hispanic/Latino

NHOPI

White

58
59

 For public health purposes, people who have completed a primary vaccine series (i.e., 

2-dose mRNA vaccine series or a single dose of the Janssen vaccine) are considered 

fully vaccinated ≥2 weeks after completion of the primary series

 The above definition applies to all people including those recommended to receive an 

additional single dose due to moderate to severe immunocompromise and those 

recommended to receive a booster dose

 People who have received a booster dose should continue to follow guidance for fully 

vaccinated persons to minimize spread of SARS-CoV-2

Implications for public health recommendations 

Definition of ‘fully vaccinated’

https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html