02 COVID Havers Galang Link Gelles 508

cdc.gov/coronavirus
Epidemiology of COVID -19-Associated Hospitalizations,
including in Pregnant Persons and Infants
Fiona Havers, MD, MHS, FIDSA
Team Lead, RESP -NET Hospitalization Surveillance Team
Commander, US Public Health Service
Coronavirus and Other Respiratory Viruses Division
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
Advisory Committee on Immunization Practices
June 23, 2023
COVID -19-associated hospitalizations
COVID -NET: March 2020 –June 2023
COVID -NET Hospitalizations
▪>250 acute -care hospitals
▪98 counties in 13 states
▪~10% of U.S. population
▪Positive SARS -CoV-2 within 14 days of or
during hospitalization
▪Screening or clinician -driven testing
▪Clinical data is from representative sample
of COVID -NET patients
3
Weekly COVID -19-associated hospitalization rates —COVID -NET, 14 U.S.
States
Rates highest in ≥75 years,
followed by infants <6 months and
those 65 –74 years020406080100120140March 1, 2020 –June 3, 2023
0-<6 months 6 months-4 years 5-11 years 12-17 years
18-49 years 50-64 years 65-74 years ≥ 75 years020406080100120140
7-Jan 7-Feb 7-Mar 7-Apr 7-MayJanuary 1 –June 3, 2023
4
COVID -19-associated hospitalization rates by race and ethnicity*  —
COVID -NET, 14 U.S. States, October 2022 –May 2023
* Black, White, American Indian/Alaska Native and Asian/Pacific Islander people
were categorized as non -Hispanic; Hispanic people could be of any race. Cumulative hospitalization rates
remain highest in American
Indian/Alaska Native and Black
persons050100150200250300Hospitalization Rate per 100,000Age adjusted cumulative rates
October 2022 –May 2023
0246810121416Rate per 100,000Age adjusted 3 -week moving average rate
January –May 2023
Hispanic American Indian/Alaska Native Asian/Pacific Islander Black White
5
COVID -19-associated hospitalizations in
pregnant persons
COVID -NET: January 2021 –April 2023
COVID -19-associated hospitalizations among pregnant persons aged 15 –
49 years —COVID -NET, 14 U.S. States, January 2021 –April 2023
Most pregnant people
hospitalized with a positive SARS -
CoV-2 test had no respiratory
symptoms
•363 of 1,651 (21%) had respiratory
symptoms recorded
•Proportion without respiratory
symptoms increased from 73% to 82%
Among symptomatic patients,
the proportion with underlying
medical conditions increasedJanuary –
November 2021
(pre-Omicron)
N (%)December 2021 –
June 2022
(early Omicron)
N (%)July 2022 –April
2023
(later Omicron)
N (%)
Total number 184 99 80
Age group
15-24 years 45 (16) 38 (31) 22 (21)
25-34 years 98 (60) 46 (54) 45 (59)
35-49 years 41 (25) 15 (15) 13 (20)
Any underlying
medical conditions72 (33) 32 (33) 46 (56)
Any pregnancy -
associated
complications*37 (20) 25 (31) 23 (29)Table 1. Characteristics of COVID -19-associated hospitalized pregnant
patients (15 –49 years) with respiratory symptoms
*Pregnancy -associated complications include hypertensive disorders of pregnancy,
gestational diabetes, intrauterine growth restrictions, and pre -eclampsia. Note that
percentages are weighted to account for sampling scheme.  7
January –
November 2021
(pre-Omicron)
N (%)*December 2021
–June 2022
(early Omicron)
N (%)*July 2022 –April
2023
(later Omicron)
N (%) *
Total Number 184 99 80
Interventions
High flow nasal
cannula20  (12) 2 (2) 0 (0)
BIPAP/CPAP 5 (2) 1 (1) 1 (3)
Mechanical
ventilation15 (7) 3 (2) 1 (2)
Vasopressor 26 (15) 3 (2) 3 (6)
Dialysis or RRT 1 (0.5) 1 (1) 0 (0)
Severe outcomes
ICU admission 31 (17) 7 (6) 2 (4)
In-hospital death 0 (0) 1 (1) 0 (0)Interventions and outcomes among pregnant patients with respiratory
symptoms and a positive SARS -CoV-2 test
The p roportion
requiring ICU
admission and
vasopressor support
decreased over time
*Note that percentages are weighted to account for sampling scheme.  8
0102030405060708090100
Unvaccinated Primary
series onlyPrimary
series + ≥ 1
boosterUnvaccinated Primary
series onlyPrimary
series + ≥ 1
boosterUnvaccinated Primary
series onlyPrimary
series + ≥ 1
booster
January-November 2021 (n=1,231) December 2021-June 2022 (n=279) July 2022-January 2023 (n=239)Weighted %
Respiratory symptoms No COVID-19 symptoms recordedVaccination status among pregnant patients hospitalized with
laboratory -confirmed SARS -CoV-2 infection by symptom status, COVID -
NET, January 2021 –April 2023
More asymptomatic
pregnant patients
received boosters
compared with
symptomatic
patients
Most pregnant
patients had not
received booster
doses
9
COVID -19-associated hospitalizations in
infants <6 months
COVID -NET: March 2020 –May 2023
Infants <6 months old had similar COVID -19–associated
hospitalization rates to adults aged 65 –74 years old
Source: COVID -NET: https://www.cdc.gov/coronavirus/2019 -ncov/covid -data/covid -net/purpose -methods.html . Data March 1, 2020 through March 31, 2023. Pre -Delta: March 1, 2020 –
June 19, 2021; Delta: June 20 –December 18, 2021; Omicron BA.1: December 19, 2021 –March 19, 2022; Omicron BA.2: March 20 –June 18, 2022; Omicron BA.5 (J une 19, 2022 –June 3, 2023)Pre-Delta DeltaOmicron
BA.1Omicron
BA.2Omicron BA.5 and later
11020406080100120140160Hospitalization rate per 100,000
0-<6 months 6 months-4 years 5-11 years 12-17 years 65-74 years ≥ 75 years
Hospitalization rates in infants, children and adolescents
aged 6 months through <18 years
Source: COVID -NET: https://www.cdc.gov/coronavirus/2019 -ncov/covid -data/covid -net/purpose -methods.html . Data March 1, 2020 through March 31, 2023. Pre -Delta: March 1, 2020 –June
19, 2021; Delta: June 20 –December 18, 2021; Omicron BA.1: December 19, 2021 –March 19, 2022; Omicron BA.2: March 20 –June 18, 2022; Omicron BA.5 (J une 19, 2022 –May 27, 2023)Pre-Delta DeltaOmicron
BA.1Omicron
BA.2Omicron BA.5 and later
02468101214161820
3/7/2020
4/7/2020
5/7/2020
6/7/2020
7/7/2020
8/7/2020
9/7/2020
10/7/2020
11/7/2020
12/7/2020
1/7/2021
2/7/2021
3/7/2021
4/7/2021
5/7/2021
6/7/2021
7/7/2021
8/7/2021
9/7/2021
10/7/2021
11/7/2021
12/7/2021
1/7/2022
2/7/2022
3/7/2022
4/7/2022
5/7/2022
6/7/2022
7/7/2022
8/7/2022
9/7/2022
10/7/2022
11/7/2022
12/7/2022
1/7/2023
2/7/2023
3/7/2023
4/7/2023
5/7/2023Rate per 100,000
6 months <2 years 2-4 years 5-11 years 12-17 years
12
On average, 15% of hospitalized infants <6 months with
COVID -19 were identified during their birth hospitalization*
*Birth hospitalization was defined as admission date within 1 day of birth. Source: COVID -NET: https://www.cdc.gov/coronavirus/2019 -ncov/covid -data/covid -net/purpose -methods.html . Data March 1, 2020
through March 31, 2023. Pre -Delta: March 1, 2020 –June 19, 2021; Delta: June 20 –December 18, 2021; Omicron BA.1: December 19, 2021 –March 19, 2022; Omicron BA.2: March 20 –June 18, 2022; Omicron
BA.5 (June 19, 2022 –March 31, 2023) . 18 16 1620
11
0%10%20%30%40%50%60%70%80%90%100%
Pre-Delta Delta Omicron BA.1 Omicron BA.2 Omicron BA.5 and later
Birth hospitalization Separate hospitalization
13
95% of infants <6 months old with a separate hospitalization
had COVID -19 symptoms during the Omicron BA.5 period
Source: COVID -NET: https://www.cdc.gov/coronavirus/2019 -ncov/covid -data/covid -net/purpose -methods.html . Data March 1, 2020 through March 31, 2023. Pre -Delta: March 1, 2020 –June 19,
2021; Delta: June 20 –December 18, 2021; Omicron BA.1: December 19, 2021 –March 19, 2022; Omicron BA.2: March 20 –June 18, 2022; Omicron BA.5 (J une 19, 2022 –March 31, 2023)93 94 94 97 95
0%10%20%30%40%50%60%70%80%90%100%
Pre-Delta Delta Omicron BA.1 Omicron BA.2 Omicron BA.5 and
later
Symptoms No symptoms
14
1 in 5 infants < 6 months old with COVID -19 were admitted to
the ICU (excluding birth hospitalizations)
Source: COVID -NET: https://www.cdc.gov/coronavirus/2019 -ncov/covid -data/covid -net/purpose -methods.html . Data March 1, 2020 through March 31, 2023. Pre -Delta: March 1, 2020 –June
19, 2021; Delta: June 20 –December 18, 2021; Omicron BA.1: December 19, 2021 –March 19, 2022; Omicron BA.2: March 20 –June 18, 2022; Omicron BA.5 (J une 19, 2022 –March 31, 2023)19%
5%
2% 2%
0.3%18%
14%
4%5%
0.0%24%
15%
8%
3%
1%21%
14%
5%4%
2%20%
19%
3%6%
0%
0%5%10%15%20%25%30%
ICU admission High flow nasal cannula Invasive mechanical
ventilationBiPAP or CPAP use In-hospital deathWEIGHTED %  OF COVID -19-ASSOCIATED HOSPITALIZATIONSPre-delta
Delta
Omicron BA.1
Omicron BA.2
Omicron BA.5 and later
15
•General : Hospitalization rates decreased in all age groups
•The age distribution of persons hospitalized with COVID -19 has shifted such that the highest
rates are in adults aged ≥75 years followed by those 65 -74 years and infants ages <6 months
•Pregnant persons:
•Most pregnant persons hospitalized with a positive SARS -CoV-2 test had no symptoms
recorded at admission and were likely identified through screening on admission
•Among those with respiratory symptoms, the proportion with underlying medical conditions
has increased and the proportion with severe outcomes has decreased
•Most hospitalized pregnant persons with a positive SARS -CoV-2 test, regardless of symptoms
or reason for testing, were not up to date with vaccinations
•Infants <6 months : Hospitalization rates increased in the Omicron period
•Most hospitalized with COVID -19-like symptoms
•Excluding birth hospitalizations, 20% admitted to the ICU since June 2022Trends in COVID -19-associated hospitalizations –COVID -NET, March 2020
–May 2023
16
Acknowledgments
Coronaviruses and Other Respiratory
Viruses Division (CORVD):
RESP -NET Team (COVID -NET/RSV -NET):
•Michael Whitaker
•Kadam Patel
•Christopher Taylor
•Huong Pham
•Onika Anglin
•Jenny Milucky
•Bhoomija Chatwani
•Michael Melgar
•Monica Patton
Many others in CORVD….▪State, Local, and Territorial
health Department partners
▪RESP -NET partners
Thank you.
Centers for Disease Control and Prevention
COVID -19 in pregnant people
Romeo Galang, MD MPH
Emergency Preparedness and Response Team
Field Support Branch
Division of Reproductive Health
National Center for Chronic Disease Prevention and Health Promotion
Disease burden and risks to
maternal and infant health
COVID -19 in Pregnant People
▪COVID -19 during pregnancy is associated with more severe maternal
health outcomes
▪COVID -19 during pregnancy is associated with adverse pregnancy
outcomes (e.g., preterm birth, stillbirth)
▪Adverse maternal, fetal, and infant outcomes differed according to the
circulating variant
Reported COVID -19 cases overall and among pregnant people in the US
(National COVID -19 Case Surveillance Data; Jan 22, 2020 –May 3, 2023)
Total among
pregnant people:
226,263 cases
738 ICU admissions
329 Deaths
050001000015000200002500030000
Overall Cases
Cases among
pregnant
peoplePre-Delta Delta Omicron
Among people with COVID -19, pregnancy increased the risk for ICU
admission and invasive ventilation
(Living Systematic Review with data from 1 Dec 2019 -27 Apr 2021)
Outcomes # Studies# with event/# in group (%)
Odds ratio (95% CI)
Pregnant with COVID -19Non -pregnant with
COVID -19
All cause mortality 11 242/122 222 (0.2) 5252/2 138 726 (0.2) 1.48 (0.62 to 3.49)
ICU admission 10 912/118 403 (0.8) 11 513/1 908 957 (0.6) 2.61 (1.84 to 3.71)
Invasive ventilation 8 310/116 458 (0.3) 3607/1 772 716 (0.2) 2.41 (2.13 to 2.71)
ECMO 5 19/30 694 (0.1) 122/432 623 (0.0) 3.71 (0.71 to 19.41)
ARDS 4 22/197 (11.2) 45/418 (10.8) 1.19 (0.24 to 5.95)
Major organ failure 4 5/197 (2.5) 28/418 (6.7) 0.39 (0.15 to 1.04)
Allotey, J  et al. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta -
analysis. BMJ . 2020. Final version 7 -May 2022 https://doi.org/10.1136/bmj.m3320ECMO: extracorporeal membrane oxygenation; ARDS: Acute respiratory distress syndrome
Among pregnant people , COVID -19 increased the risk for adverse
maternal, fetal, and infant outcomes
(Living Systematic Review with data from 1 Dec 2019 -27 Apr 2021)
Outcomes # Studies# with event/# in group (%)
Odds ratio (95% CI)Pregnant with COVID -19Pregnant without
COVID -19
Maternal outcomes:
All cause mortality 21 47/11 362 (0.4) 37/411 126 (0.0) 6.09 (1.82 to 20.38)
ICU admission 21 447/12 957 (3.4) 1962/459 359 (0.4) 5.41 (3.59 to 8.14)
Preterm birth <37 weeks 48 1306/12 076 (10.8) 26 068/436 964 (6.0) 1.57 (1.36 to 1.81)
Perinatal outcomes:
Stillbirth 25 76/9338 (0.8) 1397/414 139 (0.3) 1.81 (1.38 to 2.37)
Neonatal death 21 16/3153 (0.5) 28/9 263 (0.3) 2.35 (1.16 to 4.76)
Admission to neonatal unit 29 687/4072 (16.9) 6968/193 124 (3.6) 2.18 (1.46 to 3.26)
Fetal distress 6 131/1073 (12.2) 246/3933 (6.3) 2.22 (1.45 to 3.41)
Allotey, J  et al. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta -
analysis. BMJ . 2020. Final version 7 -May 2022 https://doi.org/10.1136/bmj.m3320
Pregnancy -related mortality increased rapidly in 2021 (pre -Omicron),
consistent with rising rates of COVID -19 associated mortality
Thoma , M. E., & Declercq , E. R. (2023). Changes in Pregnancy -Related Mortality Associated With the Coronavirus Disease 2019 (COVID -19) Pandemic in the U nited States. Obstetrics and gynecology ,141(5),
911–917. https://doi.org/10.1097/AOG.0000000000005182
Have risks evolved by COVID -19 variant?
Figure 1. Maternal deaths and maternal deaths mentioning
COVID -19, by count, US 2020 -2022
Pre-delta Delta Omicron
Note:  Data for 2020 -2021 are final and data for 2022 -2023. Death counts between 1 -9 are suppressed in accordance with NCHS conf identiality standards. Weeks with COVID -19 death counts 1 -9 are noted on the figure with
black and grey diagonal lines.
Source: CDC, National Center for Health Statistics. National Vital Statistics System, Provisional Mortality on CDC WONDER Onl ineDatabase. Accessed at http://wonder.cdc.gov/mcd -icd10 -provisional.html  020406080100120140160180200Number of Deaths
Date of DeathMaternal Deaths without COVID-19 Maternal Deaths with COVID-19 Counts 1-9
Updated Premier: Pregnant Person Complications Associated With a
Documented COVID -19 Diagnosis at Delivery Hospitalization —
United States, Pre -delta, Delta, and Omicron
Ko et al., 2021 (n = 489471)
June 2021 -December 2021 (n=505108 )
2022 (n = 782503)
*Data from Delta and
Omicron periods are
unpublished

Updated Premier: Pregnant Person Complications Associated With a
Documented COVID -19 Diagnosis at Delivery Hospitalization —
United States, Pre -delta, Delta, and Omicron
Ko et al., 2021 (n = 489471)
June 2021 -December 2021 (n=505108 )
2022 (n = 782503)Although less than Delta,
risks remain elevated
during Omicron
*Data from Delta and
Omicron periods are
unpublished
Updated Premier: Pregnant Person Complications Associated With a
Documented COVID -19 Diagnosis at Delivery Hospitalization —
United States, Pre -delta, Delta, and Omicron
*Data from Delta and
Omicron periods are
unpublished
Ko et al., 2021 (n = 489471)
June 2021 -December 2021 (n=505108 )
2022 (n = 782503)
Updated Premier: Pregnant Person Complications Associated With a
Documented COVID -19 Diagnosis at Delivery Hospitalization —
United States, Pre -delta, Delta, and Omicron
Ko et al., 2021 (n = 489471)
June 2021 -December 2021 (n=505108 )
2022 (n = 782503)
*Data from Delta and
Omicron periods are
unpublishedSimilar pattern: Although less than Delta,
increased risks persisted during Omicron
Updated Premier: Pregnant Person Complications Associated With a
Documented COVID -19 Diagnosis at Delivery Hospitalization —
United States, Pre -delta, Delta, and Omicron
Ko et al., 2021 (n = 489471)
June 2021 -December 2021 (n=505108 )
2022 (n = 782503)
*Data from Delta and
Omicron periods are
unpublished
Similar pattern: Although less than Delta,
increased risks persisted during Omicron
Adverse Pregnancy Outcomes Associated With a Documented COVID -
19 Diagnosis at Delivery Hospitalization —United States,
Pre-delta, Delta, and Omicron Periods, Premier
Ko et al., 2021 (n = 489471)
June 2021 -December 2021 (n=505108)
2022 (n = 782503)
*Data from Delta and
Omicron periods are
unpublished

Adverse Pregnancy Outcomes Associated With a Documented COVID -
19 Diagnosis at Delivery Hospitalization —United States,
Pre-delta, Delta, and Omicron Periods, Premier
Ko et al., 2021 (n = 489471)
June 2021 -December 2021 (n=509265)
2022 (n = 765425)
*Data from Delta and
Omicron periods are
unpublished•Although less than Delta, risks
for adverse pregnancy
outcomes and preterm delivery
remain elevated during Omicron
•Risk for stillbirth not
significantly elevated during
Omicron
Trends (%) in pregnancy outcomes by maternal COVID -19 status:
14 states and the District of Columbia (July 2020 -December 2022)
pre-Delta
July 2020 -June 2021Delta
July 2021 -December 2021Omicron
January 2022 -December 2022
COVID -191No COVID -19 COVID -191No COVID -19 COVID -191No COVID -19
ICU admission 0.6 0.1 1.2 0.2 0.2 0.2
NICU admission 10.3 8.7 10.9 8.5 9.0 8.7
Total preterm211.9 9.9 13.0 10.1 10.3 10.1
Early preterm 3.2 2.6 3.8 2.7 2.4 2.7
Late preterm 8.8 7.2 9.2 7.4 7.9 7.4
Total low birthweight38.8 7.9 9.8 8.1 7.9 8.2
Very low birthweight41.5 1.3 1.6 1.3 1.1 1.3
1 Confirmed or presumed COVID -19 during pregnancy. Confirmed cases only are included for California, Maryland, Ohio, North Dakota, and Tennessee.
2Gestational age in completed weeks; based on the obstetric estimate of gestation.
3 Less than 2,500 grams
4 Less than 1,500 grams
NOTES: Reporting area includes Alabama, Alaska, Arkansas, California, District of Columbia, Idaho, Maine, Maryland, New Hamps hire, North Dakota, Ohio, Oklahoma, Oregon, Tennessee, and West Virginia. District of Columbia did not report for October -December
2022.
SOURCE: National Center for Health Statistics, National Vital Statistics System, Natality.
https://www.cdc.gov/nchs/data/health_policy/trends -in-outcomes.pdf
Summary
▪Incidence of COVID -19 among pregnant people mirrors that of the general
population
▪Pregnancy remains a risk factor for severe maternal disease and adverse
pregnancy outcomes, even with new variants
▪Some maternal, fetal, and infant risks were lower with Omicron; cannot
disentangle the impact of prior infection/vaccination
Conclusion
COVID -19 vaccination improves outcomes for pregnant
people, their pregnancies and their infants; therefore
vaccination should continue to be recommended for maternal
and fetal benefit
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.
National Center for Immunization and Respiratory Diseases
Sascha Ellington
Katherine Fleming -Dutra
Sara Oliver
Regina Simeone
National Center for Health Statistics
Donna Hoyert
Joyce Martin
Michelle Osterman
Claudia ValenzuelaAcknowledgements
National Center on Birth Defects and Developmental Disorders
Jeffrey Carlson
Amanda Cohn
Dana Meaney -Delman
Suzanne Gilboa
Kara Polen
Emily Reeves
Van Tong
Kate Woodworth
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.COVID -19 vaccine effectiveness updates
23 June 2023
Ruth Link -Gelles, PhD, MPH
LCDR, US Public Health Service
COVID -19 Vaccine Effectiveness Program Lead
Centers for Disease Control and Prevention
Coverage / Age (years) <22–45–1112–1718–2424–4950–64>65
At least one dos e† 8.9 10.9 40.0 72.2 82.3 85.5 95.0 95.0
At least one bivalent dose 0.6 0.6 4.8 7.8 7.4 12.1 21.7 43.3
Unvaccinated 91.1 89.1 60.0 27.8 17.7 14.5 —†—†U.S. COVID -19 Vaccination Coverage (%) of Total Population by
Age Group —May 10, 2023
†Note: Coverage is capped at 95%
Source: https://covid.cdc.gov/covid -data -tracker/#vaccination -demographics -trends Updated June 1, 2023 39
▪Bivalent VE, by outcome and Omicron subvariant in adults
▪VE in special populations:
–Monovalent and bivalent VE in pregnant people
–Bivalent people with immunocompromising conditionsOrganization of vaccine effectiveness (VE) data
40
Monovalent and bivalent VE, against
hospitalization and critical illness by Omicron
subvariant in adults ≥18 years, VISION Network
VISION Multi -State Network of Electronic Health Records
▪Variant periods designated for analysis
based on time when novel sublineage
became predominant (>50%) at study
site
▪VE a djusted for age, sex, race and
ethnicity, geographic region, and
calendar time
▪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 SARS -CoV-2
42
VISION: Absolute VE of monovalent and bivalent booster doses against
hospitalization and critical illness among immuno competent adults aged
≥18 years –September 2022 –May 2023
Critical illness defined as admission to intensive care unit or death; case -patients were persons admitted to ICU or who experie nced death associated with COVID -19, and control patients were persons hospitalized without COVID -19.
VE estimates adjusted for age, sex, race and ethnicity, geographic region, and calendar time. Updated from: Link -Gelles et al., MMWR, https://www.cdc.gov/mmwr/volumes/72/wr/mm7221a3.htm43mRNA Dosage PatternTotal
testsSARS -CoV-2-
test-positive,
N (%)Median interval
since last dose,
days (IQR)Adjusted VE
(95% CI)
Hospitalization
Unvaccinated (ref) 16,219 1,835 (11) -- Ref
Monovalent doses only 38,843 4,086 (11) 381 (275 -513) 21 (16 -26)
Bivalent booster, 7 -59 days earlier 4,894 329 (7) 35 (21 -47) 62 (57 -67)
Bivalent booster, 60 -119 days earlier 5,283 491 (9) 87 (73 -103) 47 (41 -53)
Bivalent booster, 120 -179 days earlier 3,756 346 (9) 146 (132 -161) 24 (12 -33)
Critical illness
Unvaccinated (ref) 14,762 378 (3) -- Ref
Monovalent doses only 35,415 658 (2) 380 (275 -514) 31 (21 -40)
Bivalent booster, 7 -59 days earlier 4,614 49 (1) 34 (21 -47) 69 (58 -77)
Bivalent booster, 60 -119 days earlier 4,880 88 (2) 87 (73 -103) 45 (29 -58)
Bivalent booster, 120 -179 days earlier 3,445 35 (1) 146 (132 -161) 52 (30 -67)
-20 0 20 40 60 80 100
Vaccine Effectiveness (%)
VISION: Absolute VE of monovalent and bivalent booster doses against
hospitalization and critical illness among immuno competent adults aged ≥18 years,
during BA.4/5 predominance –September 2022 –January 2023
CDC unpublished data. VE estimates adjusted for age, sex, race and ethnicity, geographic region, and calendar time.
Variant predominance based on regional circulation: https://covid.cdc.gov/covid -data -tracker/#variant -proportions44mRNA Dosage PatternTotal
testsSARS -CoV-2-
test-positive,
N (%)Median interval
since last dose,
days (IQR)Adjusted VE
(95% CI)
Hospitalization
Unvaccinated (ref) 11,240 1,426 (13) -- Ref
Monovalent doses only 27,564 3,106 (11) 349 (238 -460) 25 (19 -30)
Bivalent booster, 7 -89 days earlier 6,723 524 (8) 47 (28 -67) 61 (56 -65)
Bivalent booster, ≥90 days earlier 1,511 163 (11) 105 (96 -115) 40 (28 -50)
Critical illness
Unvaccinated (ref) 10,110 296 (3) -- Ref
Monovalent doses only 24,976 518 (2) 347 (236 -460) 33 (21 -42)
Bivalent booster, 7 -89 days earlier 6,199 91 (1) 47 (28 -66) 61 (50 -70)
Bivalent booster, ≥90 days earlier 1,348 25 (2) 105 (96 -115) 49 (21 -67)
-20 0 20 40 60 80 100
Vaccine Effectiveness (%)
VISION: Absolute VE of monovalent and bivalent booster doses against
hospitalization and critical illness among immuno competent adults aged
≥18 years, during XBB predominance –January –May 2023
CDC unpublished data. VE estimates adjusted for age, sex, race and ethnicity, geographic region, and calendar time.
* These interim estimates are imprecise, which might be because of a relatively small number of persons in each level of vacc ination or case status. This imprecision indicates
the actual VE may be substantially different from the point estimate shown, and estimates should therefore be interpreted wit h caution. Additional data accrual should increase
precision and allow appropriate interpretation.
Variant predominance based on regional circulation: https://covid.cdc.gov/covid -data -tracker/#variant -proportions45mRNA Dosage PatternTotal
testsSARS -CoV-2-
test-positive,
N (%)Median interval
since last dose,
days (IQR)Adjusted VE
(95% CI)
Hospitalization
Unvaccinated (ref) 4,979 409 (8) -- Ref
Monovalent doses only 11,279 980 (9) 469 (375 -605) 9 (-4 to 20)
Bivalent booster, 7 -89 days earlier 1,045 60 (6) 65 (43 -79) 51 (35 to 63)
Bivalent booster, 90 -179 days earlier 4,654 419 (9) 139 (119 -157) 20 (7 to 32)
Critical illness
Unvaccinated (ref) 4,652 82 (2) -- Ref
Monovalent doses only 10,439 140 (1) 469 (375 -602) 28 (3 to 46)
Bivalent booster, 7 -89 days earlier 994 9 (1) 65 (43 -78) 58 (15 to 79)*
Bivalent booster, 90 -179 days earlier 4282 47 (1) 139 (119 -157) 48 (23 to 65)
-20 0 20 40 60 80 100
Vaccine Effectiveness (%)
Monovalent and bivalent VE against
hospitalization among adults aged ≥18 years ,
IVY Network
IVY Network —25 hospitals, 20 U.S. States
▪Design : Prospective, case -control
▪Population : Adults aged ≥18 years hospitalized with
Acute respiratory illness (ARI)*
–Cases: ARI and test positive for SARS -CoV-2 by NAAT or
antigen test within 10 days of illness
–Controls: ARI and test negative for SARS -CoV-2 and influenza
by NAAT within 10 days of illness
▪Vaccination data: Electronic medical records (EMR),
state and city registries, and self -report
▪Specimens: Upper respiratory specimens obtained
for central RT -qPCR testing and sequencing
*ARI is defined as presence of any one of the following: fever, cough, shortness of breath, chest imaging consistent with pne umo nia, hypoxemia
IVY Network: Absolute VE against COVID -19 hospitalization
among immuno competent adults aged ≥18 years —September 8,
2022 –May 29, 2023
Total Cases and
Controls Cases (%)Median time
since last dose,
days (IQR)Adjusted VE*,
% (95% CI)
Absolute VE
Unvaccinated (Ref) 1286 537 (42) -- Ref
Monovalent doses only 3511 1460 (42) 393 (282 –517) 16 (3 to 26)
Bivalent booster dose, 7 –59 days earlier 374 100 (27) 36 (21–49) 54 (39 to 65)
Bivalent booster dose, 60 –119 days earlier 443 160 (36) 89 (73–103) 34 (15 to 50)
Bivalent booster dose, 120 –179 days earlier 366 157 (43) 145 (133 –159) 6 (-27 to 30)*
-40 -20 0 20 40 60 80 100
Vaccine Effectiveness (%)
* These interim estimates are imprecise, which might be because of a relatively small number of persons in each level of vacc ination or case status. This imprecision indicates the actual VE may be substantially different
from the point estimate shown, and estimates should therefore be interpreted with caution. Additional data accrual should inc rease precision and allow appropriate interpretation.
VE adjustments: Age, sex, race, ethnicity, admission date (biweekly), and HHS region
IVY Network: Absolute VE against COVID -19 hospitalization
among immuno competent adults aged ≥18 years by lineage
period —September 8, 2022 –May 24, 2023
Total Cases and
Controls Cases (%)Median time
since last dose,
days (IQR)Adjusted VE*,
% (95% CI)
BA.4/5 (September 8 –November 13, 2022)
Unvaccinated (Ref) 313 138 (44) -- Ref
Monovalent doses only 1003 398 (40) 304 (188 –386) 30 (8–47)
Bivalent booster dose, 7 –59 days earlier 83 26 (31) 25 (13–40) 59 (21–78)*
BQ.1 (November 14, 2022 –January 22, 2023)
Unvaccinated (Ref) 458 190 (41) -- Ref
Monovalent doses only 1262 504 (40) 386 (297 –518) 17 (-5 to 34)
Bivalent booster dose, 7 –59 days earlier 226 52 (23) 40 (25–52) 63 (44–75)
Bivalent booster dose, 60 –119 days earlier 225 68 (30) 83 (69–95) 49 (24–66)
XBB (January 23 –May 24, 2023)
Unvaccinated (Ref) 514 209 (41) -- Ref
Monovalent doses only 1246 558 (45) 464 (378 –590) -8 (-34 to 13)
Bivalent booster dose, 7 –89 days earlier 155 56 (36) 64 (46–78) 29 (-8 to 53)*
Bivalent booster dose, 90 –179 days earlier 478 208 (44) 137 (118 –154) -8 (-44 to 19)*
* These interim estimates are imprecise, which might be because of a relatively small number of persons in each level of vacc ination or case status. This imprecision indicates the actual VE may be
substantially different from the point estimate shown, and estimates should therefore be interpreted with caution. Additional data accrual should increase precision and allow appropriate interpretation.
VE adjustments: Age, sex, race, ethnicity, admission date (biweekly), and HHS region-55 -35 -15 5 25 45 65 85
Vaccine Effectiveness (%)
VE in special populations:
pregnant people
VISION Multi -State Network of Electronic Health Records
▪Cases : COVID -like illness (CLI) with positive PCR for
SARS -CoV-2 within 14 days before or 72 hours after the
encounter
▪Controls : CLI with negative PCR for SARS -CoV-2
51▪Among pregnant people 18 -45 years at time of
emergency department/urgent care encounter
▪VE adjusted for age, ethnicity, race, underlying
medical conditions, gestational age at
encounter, site, Medicaid status, day of
encounter, site facility urbanicity
▪Vaccination documented by electronic health
records and state and city registries
▪Separate results for COVID -19 vaccine
monovalent doses received prior to pregnancy
and bivalent doses received during pregnancy
due to timing of bivalent authorization/analysis
(Sept 2022 -May 2023)
VISION: Absolute VE of COVID -19 monovalent doses received prior to
pregnancy against ED/UC encounters among immuno competent pregnant
persons aged 18 -45 years –June 2022 –May 2023*
Adjusted for: Age, ethnicity, race, underlying medical conditions, gestational age at encounter, site, Medicaid status, day o f encounter, site facility urbanicity
*Unpublished CDC data.52Vaccine Dosage PatternTotal
testsSARS -CoV-2-
test-positive,
N (%)Median interval
since last dose,
days (IQR)Adjusted VE
(95% CI)
Absolute VE
Unvaccinated (ref) 2238 317 (14) -- Ref
Monovalent received:
<6 months before pregnancy 833 108 (13) 270 (216, 326) 27 (6, 44)
≥6 months before pregnancy 1986 264 (13) 454 (375, 544) 5 (-15, 22)
-20 0 20 40 60 80 100
Vaccine Effectiveness (%)
VISION: Absolute VE of COVID -19 bivalent doses received during pregnancy
against ED/UC encounters among immuno competent pregnant persons aged
18-45 years –September 2022 –May 2023*
Adjusted for: Age, ethnicity, race, underlying medical conditions, gestational age at encounter, site, Medicaid status, day o f encounter, site facility urbanicity
*Unpublished CDC data
**Doses received during pregnancy for bivalent group
***These interim estimates are imprecise, which might be because of a relatively small number of persons in each level of vac cination or case status. This imprecision
indicates the actual VE may be substantially different from the point estimate shown, and estimates should therefore be inter preted with caution. Additional data accrual
should increase precision and allow appropriate interpretation.53Vaccine Dosage PatternTotal
testsSARS -CoV-2-
test-positive,
N (%)Median
interval
since last dose,
days (IQR)Adjusted VE
(95% CI)
Absolute VE
Unvaccinated (ref) 1701 196 (12) -- Ref
Bivalent dose** 191 10 (5) 56 (29, 97) 61 (22, 81)***
0 20 40 60 80 100
Vaccine Effectiveness (%)
▪Cases infants : hospitalized with COVID -19 as the
primary reason for admission and with a positive
SARS -CoV-2 RT -PCR or antigen test result
▪Control infants : hospitalized with or without
COVID -19 symptoms and negative SARS -CoV-2
RT-PCR or antigen test result
–Matched to case -infants by site; hospitalized within 4
weeks of case -infant admission▪Case -control study to assess effectiveness of
maternal vaccination for COVID -19 in infants < 6
months of age
▪25 pediatric hospitals across 20 states
▪Infants admitted between March 9, 2022, and
May 9, 2023
▪Baseline demographic and clinical characteristics
obtained via parent interview
▪Maternal vaccination status verified using state
vaccination registries, electronic medical records,
or other sourcesOvercoming COVID -19 network
54

Overcoming COVID -19: Effectiveness of maternal vaccination in prevention
of hospitalization among infants –March 9, 2022 –May 9, 2023
CDC unpublished data. VE estimates adjusted for infant age, sex, race and ethnicity, census region, and month and year of hos pitalization. 55Vaccination during pregnancy* TotalCase infants,
N (%)Median interval
since last maternal
dose, days (IQR)Infant median age at
hospitalization, days
(IQR)Adjusted VE
(95% CI)Effectiveness of Maternal Vaccination against
Infant Covid -19 Hospitalization % (95% CI)†
Infants <3 months of age at hospitalization
Unvaccinated (ref) 310 174 (56) NA 44 (27 to 63) Ref
Vaccinated 101 43 (43) 222 (152 to 271) 41 (23 to 66) 56 (24 to 75)*
Infants < 6 months of age at hospitalization
Unvaccinated (ref) 498 281 (56) NA 68 (37 to 125) Ref
Vaccinated 163 78 (48) 236 (190 to 302) 74 (33 to 132) 38 (7 to 59)*
0 20 40 60 80 100
Vaccine Effectiveness (%)
*Last mRNA or viral vector vaccine dose received between the beginning of pregnancy and 14 days before delivery. 14 people re ceived a bivalent mRNA vaccine.
†These estimates are imprecise, which might be because of a relatively small number of persons in each level of vaccination o r case status. This imprecision indicates the actual VE may be
substantially different from the point estimate shown, and estimates should therefore be interpreted with caution. Additional data accrual should increase precision and allow appropriate
interpretation.
Bivalent VE in special populations:
people with immunocompromising conditions
VISION: Absolute VE of monovalent and bivalent booster doses against
hospitalization and critical illness among immuno compromised adults
aged ≥18 years –September 2022 –May 2023
* These interim estimates are imprecise, which might be because of a relatively small number of persons in each level of vacc ination or case status. This imprecision indicates
the actual VE may be substantially different from the point estimate shown, and estimates should therefore be interpreted wit h caution. Additional data accrual should increase
precision and allow appropriate interpretation.
Critical illness defined as admission to intensive care unit or death; case -patients were persons admitted to an ICU or who expe rienced death associated with COVID -19, and control patients were persons hospitalized
without COVID -19. VE estimates adjusted for age, sex, race and ethnicity, geographic region, and calendar time. Updated from: Li nk-Gelles et al., MMWR, https://www.cdc.gov/mmwr/volumes/72/wr/mm7221a3.htm57mRNA Dosage PatternTotal
testsSARS -CoV-2-
test-positive,
N (%)Median interval
since last dose,
days (IQR)Adjusted VE
(95% CI)
Hospitalization
Unvaccinated (ref) 3,240 322 (10) -- Ref
Monovalent doses only 11,623 1,169 (10) 359 (242 -481) 3 (-12-16)
Bivalent booster, 7 -59 days earlier 1,627 144 (9) 33 (19 -46) 27 (9 -41)
Bivalent booster, 60 -119 days earlier 1,862 144 (8) 88 (74 -104) 39 (24 -51)
Bivalent booster, 120 -179 days earlier 1,448 118 (8) 146 (133 -161) 11 (-13-31)
Critical illness
Unvaccinated (ref) 3,006 88 (3) -- Ref
Monovalent doses only 10,725 271 (3) 358 (241 -481) 16 (-10-35)
Bivalent booster, 7 -59 days earlier 1,515 32 (2) 33 (19 -46) 41 (8 -62)*
Bivalent booster, 60 -119 days earlier 1,755 37 (2) 88 (74 -104) 43 (13 -62)
Bivalent booster, 120 -179 days earlier 1,348 18 (1) 146 (133 -162) 51 (15 -72)*
-20 0 20 40 60 80 100
Vaccine Effectiveness (%)
Summary and conclusions
▪For estimates of absolute vaccine effectiveness, if unvaccinated are meaningfully
different from vaccinated individuals (e.g., by COVID -19 risk factors), estimates may
be biased.
–For estimates of relative vaccine effectiveness, residual protection from prior doses is an important
consideration for interpretation.
▪Information on prior infection is limited, although we know rates of prior infection in
the U.S. population are high and vary by age.
▪VE against COVID -19-associated hospitalization may underestimate protection against
more severe COVID -19 disease.
▪Lack of statistical power to estimate VE for maternal vaccination by timing of doses
during pregnancy; could not separate monovalent and bivalent doses for protection
against infant hospitalizationLimitations of VE against severe disease
59
▪Bivalent boosters are helping provide additional protection against hospitalization, though evidence of waning
▪For most people who received monovalent doses and are eligible for a bivalent booster, more than a year has
elapsed since their last monovalent dose. Because of waning, they may have limited remaining protection against
hospitalization.
▪Effectiveness against the most critical illness (ICU admission and death) more sustained compared to less severe
illness
▪VE during XBB predominance may wane more quickly against hospitalization compared to early variant
predominant periods
▪Vaccination during pregnancy provides protection against hospitalization for infants <6 months; protection may be
highest in the first 3 months
▪CDC will continue ongoing monitoring of VE, including for all outcomes of interest and for all authorized COVID -19
vaccines in the U.S. with a focus on assessing new policy recommendations and VE in populations at higher risk of
severe COVID -19Conclusions: updates to VE of bivalent COVID -19 boosters
60
CDC COVID -19 Vaccine Effectiveness and
Policy Team
▪Amadea Britton
▪Allison Ciesla
▪Monica Godfrey
▪Eric Griggs
▪Katherine Fleming -Dutra
▪Dani Moulia
▪Morgan Najdowski
▪Erica OkwuaziVE platforms teams, including:
▪Sarah Ball
▪Angela Campbell
▪Jennifer DeCuir
▪Monica Dickerson
▪Margaret Dunne
▪Kiara Everett
▪Shikha Garg
▪Victoria Lazariu
▪Patrick Mitchell
▪Palak Patel
And many more!!!Acknowledgements
61▪Caitlin Ray
▪Sarah Reese
▪Elizabeth Rowley
▪Regina Simeone
▪Zach Smith
▪Diya Surie
▪Mark Tenforde
▪Zack Weber
▪Laura Zambrano▪Sara Oliver
▪Josephine Mac
▪Amanda Payne
▪Lauren Roper
▪Laura Steinhardt
▪Evelyn Twentyman
▪Megan Wallace
▪Ryan Wiegand
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.Questions?

Summary: cdc.gov/coronavirus Epidemiology of COVID -19-Associated Hospitalizations,  including in Pregnant Persons and Infants Fiona Havers, MD, MHS, FIDSA Team Lead, RESP -NET Hospitalization Surveillance Team Commander, US Public Health Service Coronavirus and Other Respiratory Viruses Division National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention Advisory Committee on Immunization Practices June 23, 2023 COVID -19-associated hospitalizations COVID -NET:…


03 COVID Jones 508

cdc.gov/coronavirusInfection -induced and hybrid immunity
Jefferson Jones, MD MPH FAAP
CDR, US Public Health Service

Shifts in vaccine -induced, infection -induced, and hybrid immunity against SARS -CoV-2
among blood donors aged ≥16 years —United States, Quarter 2 2021 –Quarter 3 2022
No infection or vaccination
Vaccine only -induced
antibodies
Infection only -induced
antibodies
Both infection and
vaccination -induced
antibodies (hybrid immunity)
Jones MMWR 2023: Data from a longitudinal, national cohort of
>70,000 blood donors. Vaccine history is from self report. Infection
history is based on presence of anti -nucleocapsid antibodies.
Shifts in vaccine -induced, infection -induced, and hybrid immunity against SARS -CoV-
2 among people aged ≥16 years by age group —United States, Q2 2021 –Q3 2022
No infection or vaccination
Vaccination without previous
infection
Previous infection without
vaccination
Both previous infection and
vaccination (hybrid
immunity)
16–29 years 30–49 years30–49 years
50–64 years ≥65 years
Jones MMWR 2023: Data from a longitudinal, national
cohort of >70,000 blood donors. Vaccine history is from
self report. Infection history is based on presence of anti-
nucleocapsid antibodies.
Quantitative anti -spike antibody titers by age group
and by infection and vaccine status, Jul -Oct 2022
Previous infection,
unvaccinatedPrevious infection,
vaccinatedVaccinated, no previous
infection
Spike antibody titers (BAU/ml)
16–29               30 –49            50 –64  ≥65
Age (years)
Source: CDC (unpublished). Data from nationwide blood donor cohort
Vaccine history is from self report. Infection history is based on presence of anti -nucleocapsid antibodies. N=2,553 N=15,437 N=27,130 N=26,034 N=3,711 N=44,486 N=21,281
63828993
0102030405060708090100
Mar-Apr May-Jun Jul-Aug Sep-Oct Nov-DecSeroprevalence (%)
Month7585929799
0102030405060708090100
Mar-Apr May-Jun Jul-Aug Sep-Oct Nov-DecSeroprevalence (%)
MonthPediatric infection -induced and combined (vaccine -and infection -induced)
Seroprevalence from U.S. commercial laboratories —March –December 2022
Source: https://covid.cdc.gov/covid -data -tracker/#pediatric -seroprevalence and unpublished data (CDC) Data from repeat, cross -sectional study on blood specimens collected by
commercial laboratories. Vaccine history is unknown in this study. Infection -induced seroprevalence estimated from blood specime ns tested for anti -nucleocapsid antibodies:
the number of specimens per 2 -month collection period were, by age group: 6 –11 months: 157; 12 –23 months: 724; 2 –4 years: 2,165; 5–11 years: 9,247; and 12 –17 years: 14,570.
Combined (vaccine -and infection -induced seroprevalence estimated from specimens tested for both spike and nucleocapsid antibodi es: >99% of samples tested for anti -
nucleocapsid antibodies were tested for anti -spike antibodies. 5Infection -induced Combined (vaccine -and infection -induced)

Antibody titers depend more on history of infection and
vaccination than age
6–23 month    2 –4 yrs 5– 11 yrs 12–17 yrs
Age group 10000
1000
100
10Spike antibody titers (BAU/ml)N=612 N=1,769 N=13,785 N=8,299Spike antibody titers (BAU/ml)
Previous infection,
unvaccinatedPrevious infection,
vaccinatedVaccinated, no
previous infection
*Does not include specimens with no detectable antibodies
Source: CDC (unpublished)National blood donor seroprevalence study
Ages ≥16 years, Jul –Oct 2022National pediatric commercial lab seroprevalence study
Ages 6 months –17 years, Nov –Dec 2022, among
specimens with antibodies*N=3,711 N=44,486 N=21,281
RBD Ab levels by history of infection and vaccination
status— children 6 mo—17+ yrs, PROTECT study
0.000.010.020.03RBD AUC6 months — 17+ years
1 infection only n=175
2 infections only n=201 dose only n=36
1 dose + infection only n=22
mRNA primary series only n=306
mRNA primary series + ³1 infection only n=251
Booster* only n=47
Booster+ ³1 infection only n=125
Antigen exposures
Blood draw within 6 months of immune modifying event, time between immune modifying events is <365 days.
RDB AUC:  area under the curve of receptor -binding domain antibodies, a quantitative measure of binding antibodies.
*Booster Bivalent and monovalent boosters grouped together.
Lyski, Z and Porter, C. Unpublished data from the PROTECT cohort. PROTECT protocol: https://www.ncbi.nlm.nih.gov/pmc/articles /PM C9377426/
RBD Ab levels by history of infection and vaccination status
by age group —children 6 mo—17+ yrs, PROTECT study
Immune -modifying events (in any order)
0.000.010.020.03RBD AUC6 months — <5 years
1 Infection only n=33
2 infections only n=61 Dose+ infection only n=4
mRNA primary series only n=13
mRNA primary series + ³1 infection only n=17
Booster+ infection n=1
Antigen exposures1 dose only n=1
Booster* only n=1
0.000.010.020.03RBD AUC6 months — <5 years
1 Infection only n=33
2 infections only n=61 Dose+ infection only n=4
mRNA primary series only n=13
mRNA primary series + ³1 infection only n=17
Booster+ infection n=1
Antigen exposures1 dose only n=1
Booster* only n=1
0.000.010.020.0312-17+RBD AUC
Antigen exposures1 infection only n=41
2 infections only n=91 dose only n=12
1 dose + infection only n=5
mRNA primary series only n=125
mRNA primary series + ³ 1infection only n=64
Booster* only n=16
Booster*+ ³ 1 infection only n=65
0.000.010.020.0312-17+RBD AUC
Antigen exposures1 infection only n=41
2 infections only n=91 dose only n=12
1 dose + infection only n=5
mRNA primary series only n=125
mRNA primary series + ³ 1infection only n=64
Booster* only n=16
Booster*+ ³ 1 infection only n=65
0.000.010.020.03RBD AUC5-11
1 infection only n=71
dose 1 only n=23
1 dose + infection only n=15
mRNA primary series only n=169
mRNA primary series + ³1 infection only n=172
Monovalent booster only n=31
Booster+ infection ³1 infection only n=61
Antigen exposures2 infections only n=10
0.000.010.020.03RBD AUC5-11
1 infection only n=71
dose 1 only n=23
1 dose + infection only n=15
mRNA primary series only n=169
mRNA primary series + ³1 infection only n=172
Monovalent booster only n=31
Booster+ infection ³1 infection only n=61
Antigen exposures2 infections only n=10n= 72 n= 552 n= 337
SARS -CoV-2 neutralizing antibody ( nAb) studies
▪In unvaccinated persons, infection -induced nAb titers highest against variants
similar to the variant that infected the person1
▪nAb titers in people with hybrid immunity may wane slower than in
people vaccinated without infection2
–Infection after vaccination may be moderated by imprinting3
▪Omicron
–Omicron variants demonstrate greater escape from neutralization than older
variants1–2,4–6
–Additional vaccine doses beyond primary series increase Omicron nAb titers4,5
–Hybrid immunity results in higher Omicron nAb titers than immunity from
infection or vaccination alone, including to recent Omicron subvariants4
1 Rössler 2022 NEJM ; 2 Qu 2022 NEJM ; 3 Wheatley Trends Immunol 2021 ; 4 Kurhade 2023 Nat Med ;
5 Gaebler 2022 OFID ; 6 Barateau 2023 Sci Transl Med
Other SARS -CoV-2 immunity laboratory study highlights
▪Hybrid immunity appears to result in stronger more robust immune response
using other measures as well, including
–
–
–Infection -induced and hybrid immunity result in higher IgA titers than
vaccine -induced immunity1,2
Hybrid immunity may result in higher proportion of anti -spike memory
B cells than vaccination alone3
Hybrid immunity induces T cells and antibodies directed against non -
spike viral antigens4
▪T-cell immunity from both infection and vaccination well preserved against
Omicron4
–Cellular immunity likely important in preventing severe disease5
1 Barateau 2023 Sci Transl Med ; 2 Sheikh -Mohamed Immunol Rev 2022 ;
3 Bednarski 2022 mBio ; 4 Naranbhai 2022 Cell ; 5 Moss 2022 Nature
Systematic review of protection against Omicron from infection, hybrid with
monovalent primary series, and hybrid with first monovalent booster
Bobrovitz 2023 Lancet
Conclusions
▪SARS -CoV-2 infection can cause severe disease, death, and long -term morbidity, whereas COVID -19
vaccination is safe and effective at preventing severe COVID -19 disease
▪The proportion of people with immunity from infection or hybrid immunity has increased
▪Immunity following vaccination and infection wanes over time, and both monovalent primary series
vaccination and history of pre -Omicron infection provided much lower protection during Omicron than
during prior COVID -19 waves
▪Compared with protection from infection or vaccination alone, hybrid immunity likely better protects
against infection and severe disease with Omicron
▪Stronger protection is likely provided when the infecting variant is similar to the circulating variant, but this
may be complicated by imprinting
▪Current protection likely influenced by both cumulative number of vaccine doses, number of times
infected, and timing of most recent vaccination or infection, and how closely the circulating variant
matches the vaccine or prior infection
▪Conclusions apply to both children and adults
Acknowledgments
▪Tarayn Fairlie
▪Melissa Briggs -Hagen
▪Melissa Coughlin
▪Natalie Thornburg
▪Claire Midgley▪Ian Plumb
▪Amadea Britton
▪Ruth Link -Gelles
▪Amanda Payne
▪PROTECT team
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.

Summary: cdc.gov/coronavirusInfection -induced and hybrid immunity Jefferson Jones, MD MPH FAAP CDR, US Public Health Service  Shifts in vaccine -induced, infection -induced, and hybrid immunity against SARS -CoV-2  among blood donors aged ≥16 years —United States, Quarter 2 2021 –Quarter 3 2022 No infection or vaccination Vaccine only -induced  antibodies Infection only -induced  antibodies Both infection and  vaccination -induced  antibodies (hybrid immunity) Jones MMWR 2023: Data from a…


03 Meningococcal Ortega Sanchez 508

Economics of Potential Pentavalent Meningococcal
Conjugate Vaccine (MenABCWY) versus the Current
MenACWY and MenB vaccines for US Adolescents
A SUMMARY REPORT COMPARING MODELS FROM:
Pfizer AND CDC
Ismael R. Ortega-Sanchez, PhD
NCIRD/CDC
Meningococcal ACIP Meeting, October 25, 2023
Disclaimer : The findings and conclusions in this report are t hose of the authors and do not necessarily represen t the views of
the Centers for Disease Control and Prevention.
National Center for Immunization & Respiratory Dise ases
1
Conflict of interest Conflict of interest Conflict of interest Conflict of interest
•Pfizer model : Shannon Sullivan et al., [complete authors list a nd
affiliations, upon request ]
•Pfizer manufactures pentavalent (MenABCWY) vaccine
•Evidera Inc. (France, USA, Hungary) was funded by Pfizer
•CDC model : Ismael R Ortega-Sanchez et al. from CDC [complete
authors list and affiliations, upon request ]
•All authors: No conflicts of interest
2
3 Policy questions for economic modeling 3 Policy questions for economic modeling 3 Policy questions for economic modeling 3 Policy questions for economic modeling •Should the pentavalent vaccine (MenABCWY) be consid ered as an
option for MenACWY/MenB vaccination in people curren tly
recommended to receive both vaccines?  (PICO 1)
•Should the pentavalent vaccine (MenABCWY) be include d as an
option for people currently recommended to receive MenACWY only?
(PICO 2)
•Should the pentavalent vaccine (MenABCWY) be includ ed as an
option for people currently recommended to receive MenB only?
(PICO 3)
3
Economic analysis Economic analysis Economic analysis Economic analysis Question : Is vaccinating adolescents 11-16 years old with P entavalent (MenABCWY)
vaccine series to prevent Invasive Meningococcal Di sease in adolescents cost-effective ?
Comparator Interventions
Base-case scenario: What is the incremental cost-effectiveness of vaccinating healthy
adolescents 11-12 and 16 years old with Pentavalent  vaccine relative to using MenACWY
and MenB vaccines ? MenACWY vaccine: one dose at 11-12 years and one dose at 16 years. (
Q-Q)
MenB vaccines: two doses at 16 years. (
B-B)Use of Pentavalent
MenABCWY vaccine
combined either as
Q-P-B
P-P-N
or  Q-P-P
4
Description of Current and Hypothetical Description of Current and Hypothetical Description of Current and Hypothetical Description of Current and Hypothetical
Vaccines and Vaccination Strategies Vaccines and Vaccination Strategies Vaccines and Vaccination Strategies Vaccines and Vaccination Strategies
Standard of Care (SoC) Potential vaccination strategies
First dose Second dose Key Label First dose Second dose Third dose Key Label
At 11-12 yrs
old with
MenACWY At 16 yrs old
with MenACWY Q-QAt 11-12 yrs old
with MenACWY At 16 yrs old with
MenABCWY At 16.5 yrs old with
MenB Q-P-B
At 11-12 yrs old
with MenABCWY At 16 yrs old with
MenABCWY None (N) P-P-N
At 16 yrs old
with MenB At 16.5 yrs old
with MenB B-BAt 11-12 yrs old
with MenACWY At 16 yrs old with
MenABCWY At 16.5 yrs old with
MenABCWY Q-P-P
SoC= Standard of care (current vaccination programs: Q-Qand B-B)
MenABCWY = Potential pentavalent vaccine ( P) with serogroups A, B, C W Y
MenACWY = currently recommended quadrivalent vaccine ( Q) for serogroups A, C, W, Y,
MenB =currently recommended monovalent vaccine for serogro up B5
Pfizer Pfizer Pfizer Pfizer and and and and CDC CDC CDC CDC : incremental cost : incremental cost : incremental cost : incremental cost- - --effectiveness effectiveness effectiveness effectiveness
analyses of vaccination strategies with pentavalentanalyses of vaccination strategies with pentavalentanalyses of vaccination strategies with pentavalentanalyses of vaccination strategies with pentavalent
Policy
question Incremental
analysis Pfizer CDC Vaccine Price
used for
Pentavalent **
PICO #1 Q- P-B vs SoC Included* Included $250 (private) /
$187.5 (public)
PICO #2 P-P-N vs Q-Q Included Included $210 (private) /
$157.5 (public)
PICO #3 Q- P-Pvs SoC Included Included $210 (private) /
$157.5 (public)
SoC = Standard of care (current vaccination programs: Q-Q and B-B)
* Included in Pfizer technical report updates until August 2023, not inc luded in the Pfizer technical report update of October 2023
** The price of $250 (private) / $187.5 (public) is for strategies using a single dose of pentavalent and the price of   $210 (private) / $157.5
(public) for strategies using ≥2 doses of pentavale nt 6
Focus on key features for model comparison Focus on key features for model comparison Focus on key features for model comparison Focus on key features for model comparison •Modeling approach
•Targeted population(s)
•Perspective (healthcare vs. societal)
•Intervention strategies and comparators
•Inputs for IMD burden, vaccine efficacy, and costs
•Incidence of IMD rates and sequelae outcomes
•Direct and indirect costs of IMD
•Intervention: efficacy, duration of protection, saf ety and program costs
•Assumptions
•Strong, influential assumptions
7
Modeling design and assumptions Modeling design and assumptions Modeling design and assumptions Modeling design and assumptions
Pfizer CDC
Static analytical decision-making models ✔ ✔
Sensitivity analyses (and probabilistic simulation) ✔(✔)✔(✔)
Hypothetical population: US cohort of adolescents ≥ 11 years of age ✔ ✔
Time Frame: 15 years (from 11-25 years) ✔ ✔
Analytic Horizon: Temporary disability (acute witho ut sequelae) and
Life Expectancy (permanent sequalae or premature mo rtality) ✔
✔✔
✔
Discount rate: 3% ✔ ✔
Year of health and economic outcomes measured: 2022 ✔ ✔
Societal perspective (and healthcare perspective) ✔(✔)✔(✔)
8
Inputs and main outcomes Inputs and main outcomes Inputs and main outcomes Inputs and main outcomes
Prevention of: •IMD cases
•IMD-associated sequelae
•IMD-associated deaths
QALYs saved $/QALY saved Number needed to vaccinate (NNV) to avert an: •IMD case
•IMD death Pfizer CDC
/uni2714 /uni2714/uni2714 /uni2714/uni2714 /uni2714 /uni2714 /uni2714/uni2714 /uni2714
/uni2714/uni2714
IMD = invasive meningococcal disease HCRU = healthcare resource utilization QALY= quality-adjusted life year
9
Pfizer Pfizer Pfizer Pfizer and and and and CDC CDC CDC CDC models comparison: models comparison: models comparison: models comparison:
Selected inputs Selected inputs Selected inputs Selected inputs
•Cost of vaccine and vaccine administration
•IMD incidence for pre vaccine and vaccine era
•Initial vaccine effectiveness and waning over time
•IMD associated permanent sequalae
•Age and serogroup specific Case Fatality Rate (CFR)
•Acute IMD: QALY scores and unitary direct costs
IMD = Invasive meningococcal disease QALY= Quality-adjusted life years
Note : Starting this slide and forward, to specifically identify changes and updates from those presented l ast June 2023, the
text will appear either highlighted, or with the wor d updated at the top of the slide or table. 10
Pfizer Pfizer Pfizer Pfizer vaccine price for a dose of Pentavalent
11 Vaccination
Strategies March to June
2023* August 2023** October 2023***
With one dose
Private $240
($230-$250) $250.0 $250.0
Public -- 187.5 187.5
With ≥ 2 doses
Private $240
($230-$250) $250.0 $210.0
Public -- 187.5 $157.5
* From March to June 2023, Pfizer submitted various technical reports using the pentavalent vaccine prices of $240 (range $230 to $250) per dose
** In August 2023, Pfizer submitted a new technical report updating the penta valent prices to $250 (private) / $187.5 (public) per dose
*** In October 2023, Pfizer submitted a newer technical report updating the pen tavalent prices to $210 (private) / $157.5 (public) per dose for strat egies using ≥2 doses
of pentavalent
Pfizer Pfizer Pfizer Pfizer and and and and CDC CDC CDC CDC : Vaccine cost per vaccine type, : Vaccine cost per vaccine type, : Vaccine cost per vaccine type, : Vaccine cost per vaccine type,
and vaccine administration costs and vaccine administration costs and vaccine administration costs and vaccine administration costs
* 2023 public and private sector cost per dose; VFC  Current CDC Vaccine Price List, CDC.
**2023 Proportions of vaccine purchased at private sector and procurement from either private or priva te providers were based on different sources (i.e.,
https://www.cdc.gov/nchs/data/nhis/earlyrelease/ins ur202305_1.pdf , Glazner et al., Pediatrics 2009)
*** Calculated using a hypothetical range of prices  for public and private as reported by Pfizer Inc. for MenABCWY .
¶  Assumption considers wastage from either open vi al, mishandling or outdated shelf life.
Note: CDC model : rates and associated costs of hypothetical vaccin e associated adverse events, non shown here, were a pplied to all vaccines.
Trotter et al., BMJ 2002 https://pubmed.ncbi.nlm.nih.gov/11934772/ ; Ortega-Sanchez et al., CID 2008. https://pubmed.ncbi.nlm.nih.gov/18171206/ Quadrivalent (Q)* Men B (B)* Pentavalent (P)
Q-P-B
(single dose) P-P-N & Q- P-P
(≥2 doses)
public sector cost for vaccine $105.6 $141.84 $187.5 $157.5
public sector admin cost $15.0 $15.0 $15.0 $15.0
private sector cost for vaccine $156.0 $211.32 $250.0 $210.0
private sector admin cost $30.0 $30.0 $30.0 $30.0
% vaccine purchased at public sector price ** 53.75% 53.75% 53.75% 53.75%
% vaccinations obtained from private sector provide rs ** 78% 78% 78% 78%
Pfizer : weighted cost per dose + administration $155.61 $ 200.67 $243.11*** $208.48***
% vaccine waste¶ 4.5% 4.5% 4.5% 4.5%
CDC : weighted cost per dose + administration $162.61
($128 - $191) $ 209.70
($155 - $250) $254.05***
($205 - $290) $217.86***
($192 - $250)
12
Pfizer Pfizer Pfizer Pfizer and and and and CDC CDC CDC CDC : Average Annual Incidence in Vaccine : Average Annual Incidence in Vaccine : Average Annual Incidence in Vaccine : Average Annual Incidence in Vaccine
Serogroups BCYW by Age per 100,000 used in the mode ls Serogroups BCYW by Age per 100,000 used in the mode ls Serogroups BCYW by Age per 100,000 used in the mode ls Serogroups BCYW by Age per 100,000 used in the mode ls
Source: CDC Model : Age-by-year-specific data from ABC Core Surveilla nce and NNDSS for PreVaxs and Vax eras
Pfizer model : Pre Vax Era : Mbaeyi et al. Incidence of Meningococcal Disease B efore and After Implementation of Quadrivalent Meni ngococcal Conjugate Vaccine in
the United States.  JAMA Pediatr. 2020;174(9):843-8 51. doi:10.1001/jamapediatrics.2020
Vax Era : US CDC Enhanced Meningococcal Disease Surveillanc e Report, 2017. Enhanced Meningococcal Disease Surveillance Report,  2017 (cdc.gov)
Note: Trend and variability across years were used for range of uncertainties and sensitivity analyses  •Rates of IMD disease remain relatively higher in late adolescence, but in general rates have been declining for all age groups.
•Overall, IMD incidence rates are
one fifth to
one sixth of those
from recent pre-vaccine era
13
Pfizer Pfizer Pfizer Pfizer and and and and CDC CDC CDC CDC : : : : Initial vaccine effectiveness Initial vaccine effectiveness Initial vaccine effectiveness Initial vaccine effectiveness by by by by
vaccine and serogroup vaccine and serogroup vaccine and serogroup vaccine and serogroup
QUADRIVALENT MEN B PENTAVALENT
Base-case Low High Base-case Low High Base-case Low High
First DOSE MenACWY 93% 73% 98% 93% 73% 98%
2nd + DOSE MenACWY 97% 73% 98% 97% 73% 98%
First DOSE MenB* 60% 18% 74% 60% 18% 74%
2nd + DOSE MenB 85% 50% 99% 85% 50% 99%
Values and assumptions on initial protection are ba sed on various sources:
Phase 3 noninferiority initial vaccine efficacy by single dose (at 11-12yrs) and second-dose (16yrs) o f pentavalent (Men ABCWY) vaccine as reported by Pf izer (data on file).
Updated Pfizer Technical reports on Cost-effectivene ss of the Pentavalent Meningococcal Vaccine (MenABC WY) in the US
Cohn AC, MacNeil JR, Harrison LH, et al. Active Bac terial Core Surveillance (ABCs) Team and MeningNet S urveillance Partners. Effectiveness and Duration of  Protection of
One Dose of a Meningococcal Conjugate Vaccine. Pedi atrics. 2017 Feb;139(2):e20162193. doi: 10.1542/ped s.2016-2193. PMID: 28100689; PMCID: PMC8353579.
*The range for VE efficacy for first dose of MenB i s from Castilla et al. NEJM 2023 https://www.nejm.org/doi/full/10.1056/nejmoa2206433
14
Pfizer CDC Pfizer Pfizer Pfizer Pfizer and and and and CDC CDC CDC CDC : : : : Assumption about residual Assumption about residual Assumption about residual Assumption about residual
protection by vaccine and serogroup protection by vaccine and serogroup protection by vaccine and serogroup protection by vaccine and serogroup
Assumptions on residual protection are based on var ious sources:
•Sero-protection is assumed to persist 4-5 years for  a single dose of MenACWY and MenABCWY (based on hSBA sero bactericidal assay from Pfizer’s clinical trial s report)
•Pfizer Technical report on Cost-effectiveness of th e Pentavalent Meningococcal Vaccine (MenABCWY) in t he US.
•The pink-shaded areas denote a higher level of unce rtainty of the waning assumption beyond available s urveillance or Phase 3 data
CYW
BB
CYW CYW B
15
Pfizer CDC Pfizer Pfizer Pfizer Pfizer and and and and CDC CDC CDC CDC : : : : Long Long Long Long- - --term sequalae and CFR term sequalae and CFR term sequalae and CFR term sequalae and CFR
included in the models included in the models included in the models included in the models
*  Range is a +/- 20% of base-case ** In addition to CFR, it is assumed an increased r isk of excess mortality of
1.21 (1.06-1.37); i.e., reduced life expectancy amo ng survivors with sequalae Long-term sequelae Probability (range for SA)
Skin scarring 7.6
(0 - 19)
Single amputation 1.9
(0.5 - 10)
Multiple amputations 1.2
(0.02 - 6)
Hearing loss 8.8
(2 - 20)
Significant long term neurologic disability 2.1
(0.02 - 11)
28.5% (24.2 - 34.3)* 21.6%
Case Fatality Rate (CFR) For serogroups BCWY Case Fat ality Rate (CFR) For serogroups BCWY
CFR in 11-25 years ** 12.5% (10 to <15yrs)
8% (15 to <25yrs) CFR in 11-25 years*** 12.3%
(8.9 – 15.5)
*** Weighted average by age and serogroup proportio ns (Lower value in
range is from serogroup B, high value is from serog roups CWY).
SA=Sensitivity analysis 16
Pfizer Pfizer Pfizer Pfizer and and and and CDC CDC CDC CDC : Direct costs and QALY scores : Direct costs and QALY scores : Direct costs and QALY scores : Direct costs and QALY scores
used in modeling acute phase of IMD used in modeling acute phase of IMD used in modeling acute phase of IMD used in modeling acute phase of IMD
CDC Pfizer
Direct cost: Medical unitary costs Public health response Medical cost for an IMD acute phase
only  $48,983 a
Public response per isolated case
$13,547 Medical cost of IMD acute phase by type d
Meningitis $81,782
Septicemia $115,899
Unspecified $101, 320
IMD cases without permanent  sequelae during acute phase Disutility: 0.12 for a year b
Equivalent QALDs:  46.24 days Disutility: 0.4 to 0.51 for a year e
Equivalent QALDs: 146 to 186 days
IMD cases without permanent sequelae after acute phase Disutility: 0.083 for a year c
Equivalent QALDs:  14.8 days Disutility: 0.03 (range +/- 20%) f
Duration: 9 years
Equivalent QALDs: 100 days
a. Medical costs were adjusted to 2022 using the GDP  implicit deflator index.  Public response costs we re based per hour wage of public health worker, hour s of work
per case, cost of chemoprophylaxis, average number of contacts per case.
b. QALD = quality-adjusted life days lost c. Assumption after acute phase based on 2/3 of disu tility during acute phase for patients without perm anent sequelae
d. Unitary cost per type of IMD based on  Davis et a l
https://pubmed.ncbi.nlm.nih.gov/21278486/
e. Derived from Lecocq et al. Vaccine 2016 https://pubmed.ncbi.nlm.nih.gov/27002504/
f. Koomen et al.  Qual Life Res. 2005  https://pubmed.ncbi.nlm.nih.gov/16110936/ and Schmand et al  J Infect. 2010 https://pubmed.ncbi.nlm.nih.gov/20659499/
17
*Updated from Monte Carlo Simulation using a sample  of 1000 iterations.  Preliminary estimates.                                            ICER = Increme ntal cost-effectiveness ratio
** Both total net costs estimates relied on $250 (p rivate)/$187.5 (public) cost per dose of pentavalen t vaccine
-10.54 -1.21
5.0% 5.0% 90.0%
0.0 0.2 0.4 0.6 0.8 1.0
-20 -15 -10
-5
05
10
Values in Millions ($) CDC : Cumulative probability of ICER per QALY saved: Q- P-B vs SoC Policy question 1: Policy question 1: Policy question 1: Policy question 1: Pfizer Pfizer Pfizer Pfizer and and and and CDC*: CDC*: CDC*: CDC*: Pentavalent Pentavalent Pentavalent Pentavalent
vaccine price vaccine price vaccine price vaccine price $250 $250 $250 $250 (private)/ (private)/ (private)/ (private)/$187.5 $187.5 $187.5 $187.5 (public)** (public)** (public)** (public)**
Pfizer
Q-P-B vs SoC CDC
Q-P-B vs SoC
IMD cases saved 0 <0 – 5
IMD deaths saved 0 0 – 3
LY saved 0 <0 – 28
QALYs saved 0 <0 – 42
Total Net Costs (millions) ($426)** ($564)**
$/QALY saved Cost savings
($/QALY <0) Cost savings
($/QALY <0) What is the incremental effectiveness and cost-effec tiveness of vaccinating healthy adolescents 11-12 and 16
years old with Pentavalent vaccine relative to using MenACWY and MenB vaccines ?
Baseline: -$3,050,277
18
Policy question 2: Policy question 2: Policy question 2: Policy question 2: Pfizer:  Pfizer:  Pfizer:  Pfizer:  Pentavalent Pentavalent Pentavalent Pentavalent vaccine price vaccine price vaccine price vaccine price
$$ $$210 (private)/$157.5 (public)* 210 (private)/$157.5 (public)* 210 (private)/$157.5 (public)* 210 (private)/$157.5 (public)*
P-P-N vs Q-Q
IMD cases saved 41 IMD deaths saved 4 LY saved 86 QALYs saved 164 Total Net Costs (millions)
$319
$/QALY saved $1.94 Million What is the incremental effectiveness and cost-effec tiveness of vaccinating healthy adolescents 11-12 and 16
years old with Pentavalent vaccine relative to using MenACWY only?
ICER = incremental cost-effectiveness ratio LTS = Long-term sequelae
* Updated Pfizer estimates with  pentavalent vaccin e price $210 (private)/ $157.5 (Public) and
tornado figure 19
1.73 9.15
5.0% 4.8% 90.2%
0.0 0.2 0.4 0.6 0.8 1.0
0369
12 15
Values in Millions ($) CDC : Cumulative probability of ICER per QALY saved: P- P-N vs Q-QPolicy question 2: Policy question 2: Policy question 2: Policy question 2: CDC*: CDC*: CDC*: CDC*: Pentavalent vaccine price Pentavalent vaccine price Pentavalent vaccine price Pentavalent vaccine price
$210 (private)/$157.5 (public) $210 (private)/$157.5 (public) $210 (private)/$157.5 (public) $210 (private)/$157.5 (public) ** ** ** **
P-P-N vs Q-Q
IMD cases saved 12
IMD deaths saved 1
LY saved 27
QALYs saved 58
Total Net Costs (millions) $270
$/QALY saved $4.7 Million What is the incremental effectiveness and cost-effec tiveness of vaccinating healthy adolescents 11-12 and 16
years old with Pentavalent vaccine relative to using MenACWY only?
Baseline: $4,693,778
*Updated from Monte Carlo Simulation using a sample of 1000 iterations.  Preliminary estimates
** Updated Pfizer estimates with  pentavalent vacci ne price $210 (private)/ $157.5 (Public) ICER = Inc remental cost-effectiveness ratio  20
Policy question 3: Policy question 3: Policy question 3: Policy question 3: Pfizer Pfizer Pfizer Pfizer and and and and CDC: CDC: CDC: CDC: Pentavalent Pentavalent Pentavalent Pentavalent
vaccine price $210 (private)/$157.5 (public)* vaccine price $210 (private)/$157.5 (public)* vaccine price $210 (private)/$157.5 (public)* vaccine price $210 (private)/$157.5 (public)*
What is the incremental effectiveness and cost-effec tiveness of vaccinating healthy adolescents ≥16 years old
with Pentavalent vaccine relative to using MenB vaccine only ?
Pfizer
Q-P-P vs SoC CDC**
Q-P-P vs SoC
IMD cases saved 4
5
IMD deaths saved 0
0 - 2
LY saved 9 26
QALYs saved 17 39
Total Net Costs (millions) ($528) ($639)
$/QALY saved Cost savings
($/QALY <0) Cost savings
($/QALY <0)
* Updated Pfizer estimates using $210 (private)/$15 7.5 (public) cost per dose of pentavalent vaccine
** Updated from Monte Carlo Simulation using a samp le of 1000 iterations.  Preliminary estimates                         ICER = Incremental cost-effectiv eness ratio
-15.95 -0.58
5.0% 5.0% 90.0%
0.0 0.2 0.4 0.6 0.8 1.0
-20 -15 -10
-5
05
10
Values in Millions ($) CDC : Cumulative probability of ICER per QALY saved: Q- P-P vs SoC
Baseline: -$3,063,131
21
Limitations Limitations Limitations Limitations
•Factors not considered in Pfizer and CDC models that may result in overestimating the ICER
(underestimating the cost-effectiveness) of MenABCW Y
•In base-case: both models assumed
•No protection against non-IMD
•No indirect protection against IMD of unvaccinated individuals
•Productivity losses incurred by caregivers for long -term specific sequelae are based on
assumptions and partially included
•Differences in key inputs among Pfizer and CDC models and the uncertainty in inputs data may expla in
some differences in results:
•Duration of vaccine protection
•Medical costs
•Variability in IMD incidence and CFR data
•Inclusion of different sequalae
•QALY score for IMD cases without permanent sequelae
•Pentavalent price for Q-P-B is uncertain: price used  here is the minimum expected. Higher prices will
increase total net cost & ICERs 22
Conclusion Conclusion Conclusion Conclusion
•In both Pfizer and CDC models , MenABCWY vaccine would reduce the IMD burden in adol escents
•In both models, strategies with one or more doses o f the MenABCWY vaccine would save more or equal
number of IMD cases.
•PICO #1 : Q-P-B could be incrementally cost-saving (ICER QALY saved <0) rela tive to SoC
•Q-P-B includes one dose of MenABCWY in substitution o f the second dose of MenACWY and first dose
of MenB
•PICO #2: P-P-N is incrementally costly (not cost saving) relative to Q-Q.
•P-P-N included two doses of MenABCWY in substitution of the two doses of MenACWY ,
•PICO #3: Q-P-P is likely cost saving (ICER QALY saved <0) relative to SoC
•About 96% percent of iterations in the CDC model simulations have an ICER<0
•Q-P-P included two doses of MenABCWY in substitution  of the second dose of MenACWY and the first
and second dose of MenB
•Reasonable pentavalent price and duration of protec tion combined with careful design of
vaccination interventions with MenABCWY would determ ine the cost or cost-saving value of the
pentavalent vaccine among adolescents ≥11 year of ag e
23
Acknowledgements Acknowledgements Acknowledgements Acknowledgements
From NCIRD/CDC •Lucy Alexandra McNamara
•Jennifer Collins
•Andrew Leidner
Also: •ACIP Meningococcal working group members
24
End of Summary

Summary: Economics of Potential Pentavalent Meningococcal  Conjugate Vaccine (MenABCWY) versus the Current  MenACWY and MenB vaccines for US Adolescents  A SUMMARY REPORT COMPARING MODELS FROM:  Pfizer AND CDC  Ismael R. Ortega-Sanchez, PhD  NCIRD/CDC  Meningococcal ACIP Meeting, October 25, 2023  Disclaimer : The findings and conclusions in this report are t hose of the authors and do not necessarily represen t the views of  the Centers for Disease Control and Prevention.  National Center for…