COVID 09 Wallace 508

CDC ACIP — Vaccine Advisory Committee

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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.Benefit and risk assessment for COVID -19 vaccines
Megan Wallace, DrPH, MPH
Benefit -risk assessment 
2Benefits of COVID- 19 vaccine by age for primary series 
Incremental benefits of COVID- 19 vaccine by age and time since last dose for 
bivalent booster dose
–Sensitivity analyses model high and low points in the pandemic
Benefit -risk assessment for bivalent booster dose
–Focused on ages 12 -17 years and 18- 49 years
Methods for benefit assessment
3Benefits –Calculated per 1 million primary series or bivalent booster doses
Hospitalization rates1: December 2022 COVID -19-associated hospitalization rate among persons 
aged 5 –11, 12–17, 18– 49, 50– 65, 65+ years, by vaccination status, from COVID-NET
–Sensitivity analyses model high and low points in the pandemic
Time horizon2: 6 months
Vaccine Effectiveness : VE estimates from VISION3with assumption of waning of effectiveness 
by 10% each month starting after month 2
–VE of primary series based on absolute VE for bivalent dose4
–VE of bivalent booster dose based on relative VE by interval from last monovalent dose to 
bivalent5
1https://covid.cdc.gov/covid -data -tracker/#covidnet- hospitalizations -vaccination. Rates among unvaccinated used for primary serie s assessment. Rates among those vaccinated with 
monovalent doses only used for bivalent booster dose assessment. 
2Period over which benefits of bivalent vaccination accrue 
3https://www.cdc.gov/mmwr/volumes/71/wr/mm715152e1.htm?s_cid=mm715152e1_w. 
4Absolute VE of bivalent booster dose (57%) used as the estimated primary series VE. Absolute VE from the bivalent booster was used as an estimate of primary series VE because current VE of 
monovalent primary series is unknown. 
5Relative VE of bivalent booster dose used in booster dose assessment (5 -7 month interval: 38%; 8- 10 month interval: 42%; 11+ mon th interval 45%). Relative VE for ED/UC visit was used for 2 -4 
month interval (31%) because VE against hospitalization was not available  
Monthly age-adjusted rates of COVID-19-associated hospitalization 
by vaccination status in patients ≥ 18 years, COVID-NET
https://covid.cdc.gov/covid -data -tracker/#covidnet- hospitalizations -vaccination
4Age group Rate per 100,000 
persons
5-11 Years 2.13
12-17 Years 2.66
18-49 Years 12.89
50-64 Years 27.48
≥ 65 Years 121.10December 2022 hospitalization rates per 
100,000 vaccinated persons with no 
bivalent booster by age group, COVID- NET

Estimated COVID -19-associated hospitalizations prevented over 6 
months for every million mRNA COVID-19 primary series given 
248
944
2465
5033
15978
0 2000 4000 6000 8000 10000 12000 14000 16000 18000COVID -19-associated hospitalizations p revented over 6 months per m illion doses by age group
Based on hospitalization rates from December 2022
12 –17 years
18 –49 years
50 –64 years
≥ 65 years
55 –11 years
Estimated COVID -19 hospitalizations prevented over 6 months for 
every million mRNA COVID -19 primary series and bivalent booster doses1
53
257
549
2419944
2465
5033
15978
0 2000 4000 6000 8000 10000 12000 14000 16000 18000COVID -19-associated hospitalizations p revented over 6 months per million
primary series or bivalent booster by age group
Based on hospitalization rates from December 2022
12 –17 years
18 –49 years
50 –64 years
≥ 65 years
1. Calculated assuming booster dose given ≥11 months from last monovalent vaccine dose 6
Estimated COVID -19 hospitalizations prevented over 6 months for 
every million bivalent mRNA COVID -19 booster doses, by age group and 
dose interval1
0 500 1000 1500 2000 2500 3000COVID -19-associated hospitalizations p revented over 6 months per million doses given in 
2 –4 month interval, 5 –7 month interval, 8 –10 month interval, ≥11 month interval
Based on hospitalization rates from December 2022
12 –17 years
18 –49 years
50 –64 years
≥ 65 years
7 1Interval refers to the time between the most recent monovalent dose and a bivalent dose. 
Monthly age -adjusted rates of COVID -19-associated hospitalization 
by vaccination status in patients 12 – 17 years, COVID -NET
https://covid.cdc.gov/covid -data -tracker/#covidnet- hospitalizations -vaccinationHigh
LowRecent
8

Estimated COVID -19 hospitalizations prevented over 6 months for 
every million bivalent mRNA COVID -19 booster doses, 12 –17-year -olds
0 20 40 60 80 100 120 140 160COVID -19-associated hospitalizations p revented over 6 months per million
doses by low, recent , and high incidence1
2-5 month interval2
5-7 month interval2
8-10 month interval2
11+ month interval2
91Low incidence scenario uses hospitalization rate from March 2022, recent incidence scenario uses hospitalization rate from De cem ber 2022, and high incidence 
scenario uses hospitalization rate from July 2022
2Interval refers to the time between the most recent monovalent dose and a bivalent dose. 
Dosing intervals for monovalent booster and bivalent 
booster, by age group 
IZ Data Lake: Accessed 2/7/20230% 20% 40% 60% 80% 100%
12-17 year olds
18-49 year olds
2-4 month interval 5-7 month interval
8-10 month interval 11+ month interval0% 20% 40% 60% 80% 100%
12-17 year olds
18-49 year olds
2-4 month interval 5-7 month interval
8-10 month interval 11+ month intervalInterval between completion of the primary series 
and monovalent boosterInterval between completion of the most recent 
monovalent dose * and bivalent booster
* Primary series or monovalent boosterAmong adolescents who received a monovalent booster, nearly half received the 
monovalent booster at an interval <8 months after their primary series 
Over 90% of adolescents received a bivalent booster ≥8 months after their previous dose
Limited data to inform myocarditis risk after bivalent COVID- 19 vaccine booster dose 
–
–
–Preliminary VSD myocarditis rates following b ivalent booster dose in adolescent and young adult 
males lower than first monovalent boosters, but limited by small numbers of doses administered
Myocarditis risk lower wi th longer time between doses 
Rates of myocarditis lower with extended interval between dose 1 and dose 2 for primary series1
Longer interval between doses for bivalent boosters, compared to monovalent boosters, may 
also impact myocarditis rates
Most individuals with myocarditis/pericarditis have f ully recovered at follow-up2
The risk of adverse cardiac outcomes were 1 .8 –5.6 times higher after SARS -CoV-2 
infection than after mRNA COVID-19 vaccination among males ages 12- 17 years3Myocarditis and COVID-19 vaccines
111 https://www.cdc.gov/vaccines/acip/meetings/downloads/slides -2022-02-04/11-COVID -Moulia-508.pdf2https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-02-04/04-COVID -Kracalic-
508.pdf3https://www.cdc.gov/mmwr/volumes/71/wr/mm7114e1.htm?s_cid=mm7114e1_w
VSD incidence rates of verified myocarditis or pericarditis in the 0 -7 days 
after Pfizer-BioNTech vaccination in people 12 –39 years1
1Primary series and 1stmonovalent booster data through August 20, 2022, bivalent booster data through January 29, 2023; Source: Kristin Goddard, Kay laE. Hanson, Ned Lewis, 
et al. Incidence of Myocarditis/Pericarditis Following mRNA COVID -19 Vaccination Among Children and Younger Adults in the United States .Ann Intern Med. [Epub 4 October 
2022]. doi: 10.7326/M22- 2274Dose 2 Primary Series 
Pfizer -BioNTech1stMonovalent Booster Dose 
Pfizer -BioNTechBivalent Booster Dose
Pfizer -BioNTech
Age & Sex Cases Dose 2 
TotalIncidence rate/ million doses (95% CI)Cases 1
stBooster 
TotalIncidence rate/ million doses (95% CI)Cases Bivalent Booster TotalIncidence rate/ million doses(95% CI)
12-17 Years
MalesFemales456308,046311,247146.1 (106.6 – 195.5)
19.3 (7.1 – 42.0)142129,487139,118108.1 (59.1 –181.4)
14.4 (1.7 – 51.9)0048,06649,7250.0 (0.0 – 62.3)0.0 (0.0 – 60.2)
18-29 Years
MalesFemales272331,889400,32181.4 (53.6 –118.4)
5.0 (0.6 – 18.0)71166,973240,22641.9 (16.9 – 86.4)
4.2 (0.1 – 23.2)1050,68780,21119.7 (0.5 – 53.1)
0.0 (0.0 – 37.3)
30-39 Years
MalesFemales53341,527410,71314.6 (4.8 – 34.2)
7.3 (1.5 – 21.3)31197,554268,41215.2 (3.1 – 44.4)
3.7 (0.1 – 20.8)0082,191115,0140.0 (0.0 – 36.4)0.0 (0.0 – 26.0)
12
VSD incidence rates of verified myocarditis or pericarditis in the 0 –7 days 
after Moderna vaccination in people ages 18 –39 years1
1Primary series and 1st monovalent booster data through August 20, 2022, bivalent booster data through January 29, 2023; sourc e: Goddard K, et al. Incidence of Myocarditis/Pericarditis 
Following mRNA COVID -19 Vaccination Among Children and Younger Adults in the United States .Ann Intern Med. 2022;175:1169- 1771.Dose 2 primary series 
Moderna1stmonovalent booster dose 
ModernaBivalent booster dose
Moderna
Age/sex CasesDose 2
totalIncidence rate/
million doses
(95% CI)Cases1stbooster
totalIncidence rate/
million doses
(95% CI)CasesBivalent
booster
totalIncidence rate/
million doses
(95% CI)
18–29 years
MalesFemales19
0195,809
243,56097.0 (58.4 – 151.5)
0.0 (0.0 – 12.3)71109,337156,70764.0 (25.7 – 131.9)
6.4 (0.2 – 35.6)0
018,49929,5610.0 (0.0 –161.9)
0.0 (0.0 –101.3)
30–39 yearsMalesFemales8
1216,583259,78036.9 (15.9 – 72.8)
3.9 (0.1 – 21.4)12149,468191,7656.7 (0.2 – 37.3)
10.4 (1.3 – 37.7)0
035,31847,6200.0 (0.0 –84.8)
0.0 (0.0 –62.9)
31 –136 hospitalizations prevented
9 –40 ICU admissions prevented
0 –1 death preventedEstimated COVID -19 hospitalizations prevented vs. potential myocarditis 
cases for every million bivalent mRNA COVID -19 booster doses: 
12 –17-year -olds
Per million doses in 12 –17-year -olds over 6 months1
140 myocarditis2cases in 48,066 males with a bivalent booster 
0 myocarditis2cases in 49,725 females with a bivalent booster 
1Ranges presented for benefits are based on the high and low incidence scenarios presented on slides 7 and 8
2Based on preliminary Pfizer- BioNTech bivalent booster safety data from VSD (incident rate/million doses): 0 (95% CI: 0- 62) in males and 0 (95% CI: 0- 60) in females  
17–75 hospitalizations prevented
5 –22 ICU admissions prevented
0 – 1death preventedEstimated COVID -19 hospitalizations prevented vs. potential myocarditis cases for 
every million bivalent mRNA COVID -19 booster doses: 12 –17-year -olds 
Accounting for potential incidental SARS-CoV- 2 infections among hospitalized patients1
Per million doses in 12 –17-year -olds over 6 months2
150 myocarditis3cases in 48,066 males with a bivalent booster 
0 myocarditis3cases in 49,725 females with a bivalent booster 
1 Results were adjusted to account for potential incidental findings of SARS -CoV- 2 infection by multiplying the estimated hospital izations, ICU admissions, and deaths prevented by the estimated 
percent of COVID -NET hospitalizations that are likely due to COVID- 19 among 12 –17-year -olds during on Omicron BA.5 predominant period (55%)
2 Ranges presented for benefits are based on the high and low incidence scenarios presented on slides 7 and 8
3Based on preliminary Pfizer- BioNTech bivalent booster safety data from VSD (incident rate/million doses): 0 (95% CI: 0- 62) in males and 0 (95% CI: 0- 60) in females  
117 –376 hospitalizations prevented
21 –69 ICU admissions prevented
4 –11 deaths preventedEstimated COVID -19 hospitalizations prevented vs. potential myocarditis 
cases for every million bivalent mRNA COVID -19 booster doses: 
18 –49-year -olds
Per million doses in 18 –49-year -olds over 6 months1
161 myocarditis2case in 186,695 males with a bivalent booster 
0 myocarditis2cases in 272,406 females with a bivalent booster 
1Ranges presented for benefits are based on the high and low incidence scenarios presented on slide 7
2Based on preliminary bivalent booster safety data from VSD among persons ages 18 -39 years. Among Pfizer -BioNTech recipients, rates per million doses were: 20 (95% CI: 1– 53) in males 
ages 18 –29 years; 0 (95% CI: 0– 37) in females ages 18 –29 years; 0 (95% CI: 0– 36) in males ages 30 –39 years and 0 (95% CI: 0– 26) in females ages 30 –39 years. Among Moderna 
recipients, rates per million doses were: 0 (95% CI: 0– 162) in males ages 18 –29 years; 0 (95% CI: 0– 101) in females ages 18 –29 years; 0 (95% CI: 0– 85) in males ages 30 –39 years and 
0 (95% CI: 0– 63) in females ages 30 –39 years. 
81 –259 hospitalizations prevented
15 –48 ICU admissions prevented
3 –8 deaths preventedEstimated COVID -19 hospitalizations prevented vs. potential myocarditis cases for 
every million bivalent mRNA COVID -19 booster doses: 18 –49-year -olds
Accounting for potential incidental SARS-CoV- 2 infections among hospitalized patients1
Per million doses in 18 –49-year -olds over 6 months2
171 myocarditis3case in 186,695 males with a bivalent booster 
0 myocarditis3cases in 272,406 females with a bivalent booster 
1 Results were adjusted to account for potential incidental findings of SARS -CoV- 2 infection by multiplying the estimated hospital izations, ICU admissions, and deaths prevented by the 
estimated percent of COVID- NET hospitalizations that are likely due to COVID- 19 among 18 –49-year -olds during on Omicron BA.5 p redominant period (69%)
2 Ranges presented for benefits are based on the high and low incidence scenarios presented on slides 7 and 8
3Based on preliminary bivalent booster safety data from VSD among persons ages 18 -39 years. Among Pfizer -BioNTech recipients, rates per million doses were: 20 (95% CI: 1– 53) in males ages 
18–29 years; 0 (95% CI: 0– 37) in females ages 18 –29 years; 0 (95% CI: 0– 36) in males ages 30 –39 years and 0 (95% CI: 0– 26) in females ages 30 –39 years. Among Moderna recipients, rates 
per million doses were: 0 (95% CI: 0– 162) in males ages 18 –29 years; 0 (95% CI: 0– 101) in females ages 18 –29 years; 0 (95% CI: 0– 85) in males ages 30 –39 years and 
0 (95% CI: 0– 63) in females ages 30 –39 years. 
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Benefits of vaccination may continue to accrue beyond time horizon used
Stable hospitalization rates were assumed for the duration of the time horizon
Unde
rlying complexity of vaccine histories and previous infections could not be 
accounted forCOVID -NET hospitalization rates include hospitalizations for which COVID- 19 was not a 
primary reason for admission
Current COVID -19 epidemiology, including hospitalization rates used in assessment,  
reflects impact of both prior vaccination and prior infection
–Cannot account for possible future increases in COVID -19 hospitalization rates or new variant
My ocarditis rates following bivalent booster dose are uncertain. Studies are underway 
to assess the long- term impact of vaccine- associated myocarditisLimitations
Benefits c ontinue to outweigh risks for primary series vaccination in all age groups
Benefits of bivalent booster dose vary by age, time since last dose, and COVID- 1 9 incidence
Risk of myocarditis after COVID- 1 9 vaccines likely reduced by longer interval since last dose
–Additional data can better define risk after bivalent vaccines, but current data encouraging
Changes in COVID-19 hos pitalization rates would impact the benefit assessment
Additional b enefits of COVID-19 vaccines unable to be quantified in benefit- risk assessment
–Likely prevention of post- COVID conditions, possible reduction in transmission, increased confidence 
in social interactions
Benefit risk assessment will continue to be monitored as new data are available 
Receipt of primary series c ontinues to be important in all ages 
Boosters r emain an important option to improve protection against severe COVID- 19, 
especially for higher -risk populations
19Summary of benefit-risk balance for bivalent mRNA COVID -19 vaccination
VEaP Team
–
–
–––Da
ni Moulia
Sara OliverEvelyn TwentymanKatherine Fleming -Dutra
R
uth Link-Gelles
C
OVID -NET
–Chris Taylor
ISO––Eric WeintraubTom ShimabukuroAcknowledgements
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 o f the Centers for Disease Control and Prevention.
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.
 Thank you