cdc.gov/coronavirus

COVID-19 vaccine coverage & 

effectiveness during Omicron for

children and adolescents

Ruth Link-Gelles, PhD, MPH

LCDR, US Public Health Service

Program Lead, COVID-19 Vaccine Effectiveness

Epidemiology Task Force, CDC

VRBPAC

June 14, 2022
Pediatric Research Observing Trends and Exposures in 

COVID-19 Timelines (PROTECT)

Update to: Fowlkes AL, Yoon SK, Lutrick K, et al. Effectiveness of 2-Dose BNT162b2 (Pfizer BioNTech) mRNA Vaccine in Preventing SARS-CoV-2 Infection Among Children Aged 5–11 Years 

and Adolescents Aged 12–15 Years — PROTECT Cohort, July 2021–February 2022. MMWR Morb Mortal Wkly Rep 2022;71:422–428. DOI: http://dx.doi.org/10.15585/mmwr.mm7111e1 2

 Design: Prospective cohort study

 Population: Children ages 4 months – 17 years

 Methods: Weekly surveillance and self-swab

– SARS-CoV-2 testing by RT-PCR and whole genome 

sequencing

– Electronic surveys during and after SARS-CoV-2 infection

– Multi-method vaccination documentation

 Analysis: Cox proportional hazards model 

adjusted by propensity to be vaccinated, site, SARSCoV-2 circulation, and community mask use

– Timeframe for analysis during local Omicron predominance

• December 14, 2021 – April 23, 2022

Recruitment includes children of 

adult participants in a similar 

study (HEROES-RECOVER) of 

frontline workers and from the 

local community
Persondays

SARSCoV-2

positive

Median (IQR) 

time from last 

dose end of 

observation

Adjusted

VE

% (95% 

CI)

5 – 11 years

2 doses (≥14 days) 60,290 212 130 (59-142) 31 (10-48)

2 doses (14-59 days) 26,411 156 59 (59-59) 43 (24-57)

12 – 17 years

2 doses (≥14 days) 14,501 59 218 (184-252) 49 (23-67)

2 doses (14-149 days) 4,022 20 141 (119-149) 57 (22-76)

2 doses (≥150 days) 13,716 39 218 (185-252) 43 (4-67)

3 doses (≥7 days) 8,340 8 101 (92-107) 83 (62-93)

PROTECT: VE against SARS-CoV-2 infection by age group 

during Omicron variant predominance, mid-Dec 2021-Apr 2022

3

0 20 40 60 80 100

Vaccine Effectiveness (%)

CDC preliminary unpublished. Based on methods in: Fowlkes AL, Yoon SK, Lutrick K, et al. Effectiveness of 2-Dose BNT162b2 (Pfizer BioNTech) mRNA Vaccine in Preventing SARS-CoV-2 

Infection Among Children Aged 5–11 Years and Adolescents Aged 12–15 Years — PROTECT Cohort, July 2021–February 2022. MMWR Morb Mortal Wkly Rep 2022;71:422–428. DOI: 

http://dx.doi.org/10.15585/mmwr.mm7111e1
 Nationwide community-based drive-through COVID-19 testing via pharmacies

 Self-reported vaccine history at time of registration for COVID-19 testing; excluded 

those who did not report vaccination status

 Design: Test-negative, case-control analysis

 Population: Persons with ≥1 COVID-like symptom and nucleic acid amplification 

testing (NAAT)

 Adjusted for: – Calendar day, race, ethnicity, gender, site’s HHS region, site census tract’s social vulnerability index (SVI)

 Period for Omicron analysis:

– Adults: Tested December 10, 2021 – January 1, 2022, also adjusted for number of underlying conditions and 

tests, excluded if prior positive test within 90 days (Omicron defined by s-gene target failure)

– Children: Tested March 11-May 31, 2022 (mix of BA1, BA2, and BA2.12.2)

Increasing Community Access to Testing (ICATT) 

Partnership: VE analysis for symptomatic infection
ICATT: Pfizer-BioNTech 2-dose VE against symptomatic infection by variant and 

time since 2nd dose receipt, adults ages ≥18 years, Dec 10, 2021–Jan 1, 2022

*Vaccination dose dates are collected as month and year. Month 0 represents tests in the same month as 2nd dose (at least 2 weeks after 2nd dose). For all months greater than or equal to 1 the 

value represents the difference between calendar month of test and calendar month of 2nd dose receipt (at least 2 weeks after 2nd dose).

Accorsi EK, Britton A, Fleming-Dutra KE, et al. Association Between 3 Doses of mRNA COVID-19 Vaccine and Symptomatic Infection Caused by the SARS-CoV-2 Omicron and Delta Variants. 

JAMA. 2022;327(7):639–651. doi:10.1001/jama.2022.0470 5

-40%

-20%

0%

20%

40%

60%

80%

100%

0 1 2 3 4 5 6 7 8 9 10 11

Vaccine Effectiveness

*Months since second dose

 VE against symptomatic Omicron 

compared to Delta variant over time 

since 2nd dose: – Baseline is lower

– No longer significant by 3 months

Delta 

Omicron

95% CI for Delta

VE for Delta

VE for Omicron

95% CI for Omicron
ICATT: Pfizer-BioNTech 2-dose VE against symptomatic 

infection, by age group and variant

6

*Vaccination dose dates are collected as month and year. Month 0 represents tests in the same month as 2nd dose (at least 2 weeks after 2nd dose). For all months greater than or 

equal to 1 the value represents the difference between calendar month of test and calendar month of 2nd dose receipt (at least 2 weeks after 2nd dose).

-40%

-20%

0%

20%

40%

60%

80%

100%

0 1 2 3 4 5 6 7 8

Vaccine effectiveness

*Months since second dose

Delta, adults ≥18 years

Omicron, adults ≥18 years

Omicron, adolescents 12–15 years

Omicron, children 5–11 years

95% CIs

CDC preliminary unpublished data. Prior infection excluded, other methods based on: Fleming-Dutra KE, Britton A, Shang N, et al. Association of Prior BNT162b2 COVID-19 Vaccination With 

Symptomatic SARS-CoV-2 Infection in Children and Adolescents During Omicron Predominance. JAMA. Published online May 13, 2022. doi:10.1001/jama.2022.7493

Adults: Tested Dec 10, 2021 – Jan 1, 2022

Children: Tested Mar 11, 2022 – May 31, 2022
ICATT: Pfizer-BioNTech 3 vs. 2-dose relative VE against 

symptomatic infection, age 12-15 years

7

*Vaccination dose dates are collected as month and year. Month 0 represents tests in the same month as 2nd dose (at least 2 weeks after 2nd dose). For all months greater 

than or equal to 1 the value represents the difference between calendar month of test and calendar month of 2nd dose receipt (at least 2 weeks after 2nd dose).

-40%

-20%

0%

20%

40%

60%

80%

100%

0 1 2 3 4 5 6 7 8

Vaccine effectiveness

*Months since last dose

2 vs. 0 doses

3 vs. 2 doses

95% CIs

CDC preliminary unpublished data. Prior infection excluded, other methods based on: Fleming-Dutra KE, Britton A, Shang N, et al. Association of Prior BNT162b2 COVID-19 Vaccination With 

Symptomatic SARS-CoV-2 Infection in Children and Adolescents During Omicron Predominance. JAMA. Published online May 13, 2022. doi:10.1001/jama.2022.7493
VISION Multi-State Network of Electronic Health Records

 Delta vs. Omicron determined by 

time when Omicron predominated in 

study site (mid-December 2021)

 VE adjusted by propensity to be 

vaccinated weights, calendar time, 

region, local virus circulation, and 

age

 Vaccination documented by 

electronic health records and state 

and city registries

 Cases: COVID-like illness (CLI) with positive 

PCR for SARS-CoV-2 within 14 days before 

or 72 hours after the admission or encounter

 Controls: CLI with negative PCR for SARSCoV-2
VISION: mRNA VE for ED/UC visits by number of doses and time since last dose 

receipt for children and adolescents during Omicron, mid-Dec 2021–mid-May 2022

CDC, preliminary unpublished data. Individuals with prior infections excluded. Adjusted for calendar time, geographic region, age, sex, race, ethnicity, local virus circulation, respiratory or nonrespiratory underlying medical conditions, and propensity to be vaccinated

COVID-like illness: included acute respiratory illness (e.g., COVID-19, respiratory failure, or pneumonia) or related signs or symptoms (cough, fever, dyspnea, vomiting, or diarrhea) 9

Total

Median day

from last dose

to ED/UC

encounter (IQR)

SARS-CoV-2

positive, N (%)

Adjusted

VE (95% CI)

5-11 years

Unvaccinated 18,223 2719 (14.9) Ref

2 doses 14-59 days 1,705 36 (26-46) 239 (14.0) 50 (40-58)

12-15 years

Unvaccinated 5,242 1182 (22.6) Ref

2 doses 14-59 days 196 40 (28-52) 24 (12.2) 56 (28-74)

2 doses ≥60 days 3,132 195 (143-226) 635 (20.3) 22 (10-32)

3 doses ≥7 days 554 58 (35-79) 16 (2.9) 73 (50-85)

-40 -20 0 20 40 60 80 100

Vaccine Effectiveness (%)
VISION: mRNA VE against hospitalization, all 

variants, ages 5-15 years, Apr 9, 2021-Jan 29, 2022

Klein NP, Stockwell MS, Demarco M, et al. Effectiveness of COVID-19 Pfizer-BioNTech BNT162b2 mRNA Vaccination in Preventing COVID-19–Associated Emergency Department and Urgent 

Care Encounters and Hospitalizations Among Nonimmunocompromised Children and Adolescents Aged 5–17 Years — VISION Network, 10 States, April 2021–January 2022. MMWR Morb

Mortal Wkly Rep 2022;71:352–358. DOI: http://dx.doi.org/10.15585/mmwr.mm7109e3 10

Total

SARS-CoV-2

positive, no. 

(%)

Adjusted VE

% (95% CI)

5–11 years

Unvaccinated 262 59 (22.5) Ref

2 doses, 14–59 days earlier 23 2 (8.7) 74 (-35–95)

12–15 years

Unvaccinated 496 149 (30) Ref

2 doses, 14–149 days earlier 182 7 (3.8) 92 (79–97)

2 doses, ≥150 days earlier 63 13 (20.6) 73 (43–88)

Note: estimates include all variants.

- 5–11 years: 190 (67%) due to Omicron

- 12–15 years: 111 (15%) due to Omicron

-40 -20 0 20 40 60 80 100

Vaccine Effectiveness (%)
 Design: Case-control test-negative design

 Population: Children and adolescents hospitalized at 31 pediatric medical centers in 23 U.S. 

states

 Case status (RT-PCR or antigen) – Cases tested SARS-CoV-2 positive – Controls tested SARS-CoV-2 negative 

 Vaccination status (documented or plausible self-report) – Fully vaccinated with Pfizer-BioNTech vaccine (dose 2 is ≥14 days prior to illness onset) – Or unvaccinated by illness onset

 Logistic regression to estimate VE against hospitalization (VEs) – Comparing odds of being fully vaccinated vs unvaccinated in COVID-19 cases and controls – VEs = 100 × (1 – adjusted odds ratio) • Adjusting for admission date, hospital region, age, sex, race/ethnicity 

Overcoming COVID-19 Methods
CDC preliminary unpublished data. Methods from: Price AM, Olson SM, Newhams MM, Halasa NB, Boom JA, Sahni LC, Pannaraj PS, Irby K, Bline KE, Maddux AB, Nofziger RA, Cameron 

MA, Walker TC, Schwartz SP, Mack EH, Smallcomb L, Schuster JE, Hobbs CV, Kamidani S, Tarquinio KM, Bradford TT, Levy ER, Chiotos K, Bhumbra SS, Cvijanovich NZ, Heidemann SM, 

Cullimore ML, Gertz SJ, Coates BM, Staat MA, Zinter MS, Kong M, Chatani BM, Hume JR, Typpo KV, Maamari M, Flori HR, Tenforde MW, Zambrano LD, Campbell AP, Patel MM, Randolph 

AG; Overcoming Covid-19 Investigators. BNT162b2 Protection against the Omicron Variant in Children and Adolescents. N Engl J Med. 2022 Mar 30. doi: 10.1056/NEJMoa2202826. Epub

ahead of print. PMID: 35353976.

Overcoming COVID-19 platform: VE for 2 doses of Pfizer-BioNTech 

vaccine against hospitalization, Dec 19, 2021-Apr 27, 2022

No. vaccinated 

COVID-19 

patients/Total no. 

COVID-19 patients (%)

Adjusted 

VE

% (95% CI)

5–11 years* 25/325 (8) 68 (48-81)

12–18 years 109/286 (38) 51 (31-65)

2–22 weeks since vaccination 42/219 (19) 58 (34-74)

23–45 weeks since vaccination 67/244 (27) 42 (14-61)

0 20 40 60 80 100

Vaccine Effectiveness (%)

*median time from vaccination to hospitalization is 37 days
Overcoming COVID-19 platform: VE for 2 doses of PfizerBioNTech vaccine against MIS-C, Jul 1, 2021-Apr 7, 2022

CDC preliminary unpublished data 13

No. vaccinated MIS-C

patients/Total no.

MIS-C patients (%)

Median (IQR)

days from 2nd

dose to MIS-C

Adjusted VE

(95% CI)

5–11 years 10/144 (7) 44 (32-56) 78 (48-90)

12–18 years 14/160 (9) 120 (57-169) 90 (81-95)

28-120 days since vaccination 7/153 (5) 60 (42-89) 90 (75-96)

≥121 days since vaccination 7/131 (5) 172 (138-215) 92 (78-97)

0 20 40 60 80 100

Vaccine Effectiveness (%)
 Infection

– 2-dose VE declines quickly in children and adolescents, following similar pattern to adults during 

Omicron predominance

– A booster dose in adolescents significantly improved VE initially, although there was waning

 Emergency department/urgent care visits

– 2-dose VE was higher for ED/UC visits compared to infection.

• Declined ≥60 days after the 2nd dose for adolescents

– A booster dose in ages 12-15 years significantly improved VE

 Severe disease: hospitalization and MIS-C – 2-doses provided protection for both age groups, with some waning for hospitalization in adolescents

– High VE in both age groups against MIS-C

– Not enough data to assess waning in 5-11 or impact of booster dose in 12-15

Summary

14
 Tamara Pilishvili

 Sara Oliver

 Allison Ciesla

 Monica Godfrey

 Lauren Roper

 Zach Smith

 Evelyn Twentyman

 Ryan Wiegand

 Site PIs and study staff for ICATT, 

PROTECT, VISION, and Overcoming 

COVID

– Emma Accorsi

– Amadea Britton

– Alexandra Dalton

– Katherine Fleming-Dutra

– Ashley Fowlkes

– Samantha Olson

– Manish Patel

– Mark Tenforde

– Mark Thompson

– Laura Zambrano

Acknowledgements

15
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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.