08 Srinivasan covid 508

Economic Analysis of
COVID -19 Vaccination
University of Michigan
COVID -19 Vaccination Modeling Team
Presentation to the Advisory Committee on Immunization Practices
September 19, 2025
1
Study team
•University of Michigan
•Wake Forest University
•Centers for Disease Control and Prevention
2Conflict of interest statement
No known conflicts of interest.
Economic Analysis of COVID -19 Vaccination: Objectives
Using an economic model of COVID -19 vaccination:
•Estimate  the annual population burden of disease in a cohort representing the US
population
oresource utilization (outpatient visits, hospitalizations )
ototal cases
ototal costs
odeaths
oquality -adjusted life years lost due to COVID -19
•Estimate events averted by COVID -19 vaccination
•Estimate incremental cost -effectiveness ratios for subgroups defined by age and risk
status
3Earlier analyses from this model were presented to ACIP in September 2023, February 2024, June 2024, and October 2024: Prosser , Lisa A. (2023). Economic Analysis
of Vaccination with mRNA Booster Dose against COVID -19 Among Adults; Prosser, Lisa A (2024). Economic analysis of an additional dose of COVID -19 vaccine; Prosser,
Lisa A. (2024). Economic analysis of COVID -19 vaccination; Prosser, Lisa A. (2024). Economic analysis of an additional dose of t he 2024 -2025 COVID -19 vaccine.
Methods
•Intervention strategies:
oVaccination against COVID -19 illness with an updated “generic” mRNA booster
oNo updated mRNA booster (vaccination against COVID -19 illness with primary series only or
primary series plus current booster)
•Target population: all US adults, stratified by age and risk status
o18-49 y, 50 -64 y, ≥65 y
oHigh risk or not at high risk for complications
oPediatric and adolescent age groups excluded  from current analysis, insufficient data to
incorporate into this first phase analysis
•Time horizon: 1 year*
•Perspective: Societal
•Costing year: 2024$
•Discount rate: 3%
*Costs and QALYs lost due to long -term sequelae and deaths beyond one year are included 4
Symptomatic
COVID -19
(non -hospitalized)
Hospitalized
COVID -19Non -medically
attended
Outpatient visit
No ICU
admission
ICU admissionAB
No
complications
Long COVID
No ventilator
VentilatorB
DDeathModel
schematic
No
COVID -19
COVID -19No long COVID
Long COVID
Long -term
sequelae C
No
complications
Long COVID
Death
5ED visit B
ED = emergency department; ICU = intensive care unit
Prosser et al. Cost -effectiveness of 2023 -2024 COVID -19 vaccination in US adults. JAMA Network Open. 2025 Aug 1;8(8):e2523688.No ventilator
Ventilator C
D
Updated COVID -
19 vaccinationNo side
effects
Systemic
reaction
Anaphylaxis
Severe
adverse eventA
A
ANo updated
COVID -19
vaccination
A
Epidemiological inputs
6Input Source
Probability of symptomatic illness HEROES -RECOVER
(2022 – 2023)
Probability of medically attended illness MarketScan
(2022)
Probability of hospitalization COVID -NET (2023 - 2024),
expert opinion
Probability of ICU stay and ventilator use COVID -NET
(2022 – 2023)
Probability of death COVID -NET
(2022 – 2023)
Probability of long -term sequalae Published literature
Probability of long COVID Published literature
020406080100120140
Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug SepMonthly hospitalizations per 100,000Weekly rates of
COVID -19–
associated
hospitalizations
by season, all
ages
72021 -2022
2020 -2021
2019 -20202022 -2023
2024 -2025
Source: COVID -NETBase case (2023 -2024)
Vaccination -related parameter inputs
8Input Source
Seasonality -adjusted vaccine impact (SAVI) VISION (2024 – 2025),
IVY (2024 – 2025),
COVID -NET (2023 – 2024),
expert opinion
Probabilities of adverse events
•Systemic reaction
•Anaphylaxis
•Myocarditis/pericarditisFDA product approval
information, published
literature, expert opinion
Costs
9Input Source
Illness -related
Direct medical costs
•Outpatient visits
•ED visits
•Hospitalizations
•Long -term sequalae
•Long COVIDMarketScan  2022 -2023,
published literature
Productivity lossesBLS, published literature, expert
opinion
Vaccination -related
Direct medical costs:
•Vaccine dose
•Administration
•Adverse eventsCDC vaccine price list
Physician fee schedule
Published literature, expert opinion
Time costs of vaccination Published literature
BLS = Bureau of Labor Statistics
Quality of life adjustments
10Input Source
Illness -related
•Symptomatic illness
•Hospitalization
•Long -term sequalae
•Long COVIDPublished literature
Vaccination -related
•Systemic reaction
•Anaphylaxis
•Myocarditis/pericarditisPublished literature
Methods: Analysis Plan
•Project health and economic outcomes stratified by intervention strategy, age (18-
49 y, 50 -64 y, ≥65 y) and risk subgroups (high risk, non -high risk)
oCases
oHospitalizations
oDeaths
oCosts
oQuality -Adjusted Life -Years  (QALYs)
oAdverse events
oNumber needed to vaccinate (NNV)
11
Methods: Analysis Plan
•Incremental cost -effectiveness ratio (ICER):
   CostsUpdated  Vaccination  – CostsNo Updated Vaccination
  QALYsUpdated  Vaccination  – QALYsNo Updated Vaccination
•Base case analysis
•Sensitivity analyses
•Probabilistic sensitivity analysis
•Univariate and multi -way sensitivity analyses
•Scenario analyses
1212
Results*
13*This presentation reports preliminary results of an ongoing analysis
Disaggregated results, per 100,000 simulated cohort,
societal perspective, 2025 -2026 vaccination
140500010000150002000025000300003500040000
18-49 NHR 50-64 NHR >65 NHR 18-49 HR 50-64 HR >65 HRCases
020040060080010001200
18-49 NHR 50-64 NHR >65 NHR 18-49 HR 50-64 HR >65 HRHospitalizations
020406080100120140160
18-49 NHR 50-64 NHR >65 NHR 18-49 HR 50-64 HR >65 HRICU Stays
0102030405060
18-49 NHR 50-64 NHR >65 NHR 18-49 HR 50-64 HR >65 HRDeaths - 100 200 300 400 500 600
18-49 NHR 50-64 NHR >65 NHR 18-49 HR 50-64 HR >65 HRCases of Long COVID
Remaining events with vaccination, NHR
          Events averted with vaccination, NHR
          Remaining events with vaccination, HR
          Events averted with vaccination, HR
          HR = high risk; NHR = non -high risk

Incremental cost -effectiveness ratios (ICERs), 2025 -2026
vaccination, per cohort of 1,000,000
15Age Strategy CostIncremental
costQALYsIncremental
QALYs$/QALY
Non -high -risk
18 - 49 yNo vaccination $121,084,319 - 20,208,352 - -
Vaccination $292,804,184 $171,719,865 20,208,697 345 $498,090
50 - 64 yNo vaccination $172,993,823 - 12,278,283 - -
Vaccination $329,875,771 $156,881,948 12,278,676 393 $398,809
>65 yNo vaccination $213,552,333 - 6,526,870 - -
Vaccination $345,570,759 $132,018,426 6,527,758 887 $148,811
High -risk
18 - 49 yNo vaccination $166,726,302 - 20,208,138 - -
Vaccination $323,381,110 $156,654,808 20,208,555 417 $375,399
50 - 64 yNo vaccination $295,589,269 - 12,277,500 - -
Vaccination $411,159,262 $115,569,993 12,278,163 663 $174,359
>65 yNo vaccination $395,948,683 - 6,524,593 - -
Vaccination $467,984,279 $72,035,596 6,526,248 1655 $43,537
QALY = quality -adjusted life year
Base -case and probabilistic sensitivity analyses, 2025 -2026
vaccination
AgeICER ($/QALY)
Base case 95% confidence interval
Non -high -risk
18 - 49 y $498,090 $309,220 - $913,905
50 - 64 y $398,809 $252,690 - $691,360
>65 y $148,811 $78,132 - $276,981
High -risk
18 - 49 y $375,399 $232,241 - $659,757
50 - 64 y $174,359 $66,920 - $388,115
>65 y $43,537 Cost -saving - $142,478
16ICER = incremental cost effectiveness ratio; QALY = quality -adjusted life year
Number needed to vaccinate (NNV), 2025 -2026 vaccination,
base case
AgeNNV to
avert a caseNNV to
avert a
hospitalization NNV to
avert a death
Non -high -risk
18 - 49 y 15 15,746 1,133,330
50 - 64 y 16 4,897 145,755
>65 y 12 778 14,818
High -risk
18 - 49 y 15 3,351 241,229
50 - 64 y 16 1,227 36,522
>65 y 12 296 5,642
17
Cost/outcome averted, 2025 -2026 vaccination, base case
Age $/Case averted$/Hospitalization
averted$/Death averted
Non -high -risk
18 - 49 y $2,504 $2,703,838 $194,615,325
50 - 64 y $2,474 $768,180 $22,866,393
>65 y $1,540 $102,729 $1,956,219
High -risk
18 - 49 y $2,282 $525,021 $37,789,676
50 - 64 y $1,817 $141,797 $4,220,853
>65 y $836 $21,344 $406,450
18
One-way sensitivity analysis, >65 years, non -high -risk
19$/QALY gained with variable at upper bound $/QALY gained with variable at lower bound$0 $100,000 $200,000 $300,000 $400,000Time to receive vaccine, pharmacyProbability, outpatient visit given symptomatic COVIDCost, vaccine administrationLifetime productivity costTime to receive vaccine, doctor's officeProbability, symptomatic illnessQuality adjustment, symptomatic COVIDCost, vaccine doseProbability, hospitalizationSAVI against symptomatic COVID, hospitalization, critical illness
$/QALY
Base case: $148,811/QALY
SAVI = seasonality -adjusted vaccine impact
One-way sensitivity analysis: probability of hospitalization
AgeICER ($/QALY)
Lower bound Base case Upper bound
Non -high -risk
18 - 49 y $526,249 $498,090 $466,186
50 - 64 y $501,595 $398,809 $306,095
>65 y $267,505 $148,811 $81,894
High -risk
18 - 49 y $477,426 $375,399 $284,883
50 - 64 y $368,234 $174,359 $68,386
>65 y $157,467 $43,537 Cost -saving
20ICER = incremental cost effectiveness ratio; QALY = quality -adjusted life year
Scenario analysis: vaccine dose cost, 2025 -2026 vaccination
AgeICER ($/QALY)
$30 $60 $90 $120 Base case $150
Non -high -risk
18 - 49 y $181,113 $268,131 $355,149 $442,166 $498,090 $529,184
50 - 64 y $121,009 $197,272 $273,535 $349,798 $398,809 $426,061
>65 y $25,631 $59,447 $93,262 $127,078 $148,811 $160,894
High -risk
18 - 49 y $113,526 $185,417 $257,307 $329,198 $375,399 $401,088
50 - 64 y $9,490 $54,750 $100,011 $145,272 $174,359 $190,532
>65 y Cost -saving Cost -saving $13,753 $31,885 $43,537 $50,016
21ICER = incremental cost effectiveness ratio; QALY = quality -adjusted life year
Base case: $139.28
Age >18 private sector prices: Moderna $141.80; Pfizer $136.75
Accounting for Vaccine Wastage in Cost -
effectiveness Analyses
22•Few CEAs include wastage as a separate cost in the analysis
•Conventional assumption is that any costs associated with wastage are
reflected in the price per dose (if returns are allowed) or the administration
fee (if provider bears the cost of unused doses)
•Scenario analysis on price per dose yields insights if wastage is not adequately
captured by base case assumptions
Limitations
23•Unpublished data used to derive key parameters in the model: vaccine
effectiveness, symptomatic illness, probabilities of hospitalization and
critical illness
•Data sources vary in representativeness, generalizability
•VE estimates derived from single prior season data
•Few seasons to date to estimate seasonality
•MarketScan  data for ages >65 y only includes those with supplemental
insurance
•Evidence base for long COVID is especially scarce
•Model does not include reduced transmission (conservative approach)
Summary
•Vaccination averts morbidity and mortality for all age and risk groups
•Substantial variation in impact by age and risk status
•Overall economic favorability has declined compared to estimates from earlier
seasons due to declining burden of illness
•ICERs for ≥65 y age group [HR: $44,000/QALY; NHR: $149,000/QALY] are robust to
changes in parameter inputs across plausible ranges [HR: Cost -saving -$142,000/QALY;
NHR: $78,000/QALY -$277,000/QALY]
•ICERs for 18 -49 y and 50 -64 y age groups are sensitive to changes in parameter
inputs and favorable only under certain conditions for high -risk 50 -64 y
24
Questions
25

Summary: Economic Analysis of COVID -19 Vaccination University of Michigan  COVID -19 Vaccination Modeling Team Presentation to the Advisory Committee on Immunization Practices September 19, 2025 1 Study team •University of Michigan •Wake Forest University •Centers for Disease Control and Prevention 2Conflict of interest statement No known conflicts of interest.  Economic Analysis of COVID -19 Vaccination: Objectives Using an economic model of COVID -19 vaccination: •Estimate  the annual population…


10 levi COVID 508

ACIP Meeting, CDC
September 19, 2025COVID -19 Vaccine Discussion
Framing, 2025-2026
Professor Retsef Levi, PhD, MIT
ACIP Meeting, CDC
September 19, 2025WG Main Takeaways
•Assessments of the protection level provided by COVID -19 vaccines and especially
seasonal boosters against severe outcomes (hospitalization, ICU, death, long- covid)
are based on very low -quality data and analyses
•Vaccine injuries are demonstrably not recognized by current pharmacovigilance
systems, leaving vaccine injured individuals abandoned and without appropriate care
•Ample published research suggests serious safety uncertainties and concerns, including potential adulteration (mRNA vaccines), that are currently not appropriately addressed
ACIP Meeting, CDC
September 19, 2025WG Recommended Actions
•The risks and uncertainties related to the COVID -19 vaccine should be appropriately
communicated by CDC to patients and medical providers to enable appropriate informed
consent (WG recommendations regarding the Vaccine Information Statement)
•Development and enhancement of national efforts to appropriately diagnose the vaccine injured and care for them (WG will continue discussions in coming months)
•Development and enhancement of national safety surveillance systems to address safety uncertainties and assess impact (WG will continue discussions in the coming months)
ACIP Meeting, CDC
September 19, 2025COVID-19 Vaccine Benefits: Quality of Evidence
The WG could not receive reliable assessments of the Number Needed to Vaccinate
(NNV) related to different sub- groups and outcomes:
Presentation to COVID -19 Work Group September 12, 2025 by the University of Michigan
ACIP Meeting, CDC
September 19, 2025Quality of Evidence re COVID -19 Vaccine Benefits
Estimates from the UK greatly differ from the CDC estimates:
UK Health Security Agency (UKHSA) NVV estimates for the
2024- 2025 season
Appendix A: estimating the number needed to vaccinate to
prevent a COVID -19 hospitalisation  in autumn 2024 in
England - GOV.UK

ACIP Meeting, CDC
September 19, 2025Quality of Evidence re COVID -19 Vaccine Benefits
Estimates from the UK greatly differ from the CDC estimates:
UK Health Security Agency (UKHSA) NVV estimates for the 2024 -2025
season
Appendix A: estimating the number needed to vaccinate to prevent a
COVID -19 hospitalisation  in autumn 2024 in England - GOV.UK

ACIP Meeting, CDC
September 19, 2025Methodological Limitations
•WG members felt that the current working definition of the CDC regarding COVID -19
associated hospitals does not seem to meaningfully capture the clinical impact of
SARS- CoV-2 infections on severe COVID -19 outcomes
•Only 30% of patients under current definition have COVID as primary discharge diagnosis
Trends in COVID -19–Attributable Hospitalizations Among Adults With Laboratory -Confirmed SARS -CoV -2—COVID -NET, June
2020 to September 2023 - Taylor - 2024 - Influenza and Other Respiratory Viruses -  Wiley Online Library
ACIP Meeting, CDC
September 19, 2025Methodological Limitations
•WG members felt that the current methodology to assess vaccine efficacy (VE) is
prone to major biases:
“The design cannot be used for studying the mortality effects of vaccines and is
problematic for studies into the effect on hospitalization. The vaccine's effectiveness on the transmission of viruses is also potentially problematic, depending very much on the characteristics of the tests. The implication of our findings is that the test -negative
designs can, at best, be seen as an indication of effectiveness in highly idealized situations that are often far away from reality.”
https://onlinelibrary.wiley.com/doi/10.1111/jep.13888

ACIP Meeting, CDC
September 19, 2025Test-Negative- Design
N = population size= Nv + Nuv
Unknown number of vaccinated
(Nv) and unvaccinated (Nuv)
Cv = # of vaccinated
covid cases Cuv = # of unvaccinated
covid cases Ov = # of vaccinated
controlsOuv = # of unvaccinated
covid controls
ACIP Meeting, CDC
September 19, 2025NTD - Main Idea
•Ideally the relative risk would be calculated as 1- (Cv/Cuv)÷(Nv/Nuv), but Nv/Nuv not
observed!
•Approximate it with the observed Ov/Ouv assuming the control cases are not affected
by/correlated with vaccination status and therefore are drawn at random from the
population
•Attempt to mitigate biases because health- seeking behavior (people who arrived to
the hospital)
•Under assumptions provide an unbiased estimator of the relative risk reduction
ACIP Meeting, CDC
September 19, 2025Potential Biases of NTD
•The estimate of Ov/Ouv (for unobserved Nv/Nuv) is prone to many biases:
•Hospitalizations of controls (and cases) might be triggered by other (non-
respiratory) medical conditions
•Vaccinated test more when they have a cold
•Vaccine could make vaccinated more vulnerable to other cold infections
•Healthy vaccinee effect (HVE)
https://www.nejm.org/doi/full/10.1056/NEJMc2306683
ACIP Meeting, CDC
September 19, 2025Other VE Assessment Approaches
•Matched cases (exact on based on propensity scores)
•Use of negative controls to capture unobserved biases
•Randomized control clinical trials (RCTs)
Note:
RCTs of mRNA vaccines did not show benefits for all cause mortality & hospitalizations
https://pubmed.ncbi.nlm.nih.gov/37163200/
https://pubmed.ncbi.nlm.nih.gov/36055877/

ACIP Meeting, CDC
September 19, 2025Other Concerns regarding VE
•WG members were concerned that the boosters’ protection seems to be short -term
•WG members were concerned by published and unpublished research that suggest
negative efficacy or increased vulnerability to other respiratory viruses:
https://academic.oup.com/ofid/article/10/6/ofad209/7131292?login=false
https://www.nature.com/articles/s43856- 025-01046-8
https://www.medrxiv.org/content/10.1101/2023.12.07.23298573v3
ACIP Meeting, CDC
September 19, 2025COVID- 19 Burden Decreases
Presentation to COVID -19 Work Group September 12, 2025 by the University of Michigan

ACIP Meeting, CDC
September 19, 2025Safety Concerns and Uncertainties
WG members felt that CDC currently does not appropriately acknowledge several
safety concerns & uncertainties:
•Outcomes and prognosis of myocarditis and other cardiovascular adverse events
•Clinically documented prolonged vaccines injuries, specifically post vaccine syndrome (PVS)
•Multiple documented unintended mechanisms of action of the mRNA vaccines and seemingly regulatory violations
ACIP Meeting, CDC
September 19, 2025Deaths from Myocarditis
Autopsies of 2 teenage boys in the US who died in their sleep 3 & 4 days
post Pfizer Dose 2

ACIP Meeting, CDC
September 19, 2025Deaths from Myocarditis
CDC response

ACIP Meeting, CDC
September 19, 2025Deaths from Myocarditis
Pathologist response

ACIP Meeting, CDC
September 19, 2025Subclinical myocarditis may occur in up to 3% post vaccination
Teenage boys post dose 2
Adult healthcare workers post booster
dose

ACIP Meeting, CDC
September 19, 2025Deaths from Subclinical Myocarditis
Korean study of 44 million vaccinated
•95 cases severe vaccine related myocarditis
•85 ICU admissions
•36 cases of fulminant myocarditis
•21 deaths (12 males & 9 females)
•8 of the deaths were sudden cardiac death
autopsy -found myocarditis without prodrome
(subclinical myocarditis)  all in <45 year olds who
had received mRNA vaccines
ACIP Meeting, CDC
September 19, 2025Long Term Prognosis of Myocarditis
Unknown if this will apply to COVID -19
vaccine associated myocarditisHigher risk (almost 2.5 fold) of CV death 10 years after a myocarditis diagnosis
ACIP Meeting, CDC
September 19, 2025Post Vaccine Syndrome (PVS)
•The injuries associated with PVS are prolonged, debilitating and involve diverse
symptoms and conditions, many overlapping with long COVID injuries
•Symptoms include among others dysautonomia (POTS), immune dysregulation, autoimmune disorders, severe neuropathy, cardiovascular & neurovascular injuries and severe clotting
ACIP Meeting, CDC
September 19, 2025Post Vaccine Syndrome (PVS)
•The frequency of PVS and related risk factors are currently not well understood
•Do not fit existing diagnosis codes and often have common post vaccination
symptoms but prolonged, therefore not likely to be captured by existing pharmacovigilance systems
Identification of Potential Adverse Events After COVID -19 mRNA Vaccines in Danish Children Using Healthcare Registries
ACIP Meeting, CDC
September 19, 2025mRNA Vaccines Don’t Work as Intended
•Wide biodistribution and prolonged persistent
of Spike, mRNA and nano-lipid particles
•Not understood prolonged immune response (e.g., IgG4 switch class and cytokine profile)
•Frame shift leading to production of unintended proteins and related immune
response
•DNA contamination (regulatory violation)

ACIP Meeting, CDC
September 19, 2025Vaccination in Pregnancy
Most WG members felt that the current data not only do not support recommendation
to vaccinate during pregnancy, but to the contrary support NOT to recommend:
•No appropriate randomized clinical trials to show efficacy and safety
•In the single (small) clinical trial (Pfizer) there was observed numerical imbalance of higher number of fetal anomalies among babies born to vaccinated women (8 vs. 2)
ACIP Meeting, CDC
September 19, 2025Vaccination in Pregnancy
•Observational studies are of very low -quality with structural biases, and some raise
concerns
https://pubmed.ncbi.nlm.nih.gov/36794918/
https://obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.17721
https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07784- w

ACIP Meeting, CDC
September 19, 2025Vaccine -Specific Recommendations
The WG felt that there weren’t sufficient data and time to arrive at recommendations specific to
a vendor or a platform, but this seems likely to be a plausible approach in the future:
•In RCTs adenovirus vaccines reduced all cause mortality vs. mRNA vaccines that didn’t
https://pubmed.ncbi.nlm.nih.gov/37163200/
•Studies show Moderna may have higher protection and lower AEs compared to Pfizer
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2793236
https://www.nejm.org/doi/full/10.1056/NEJMoa2115463
•Other vaccines, including not currently authorized in the US should be evaluated
ACIP Meeting, CDC
September 19, 2025Public Trust
Members in the WG felt that there a concerning gap between CDC ‘safe and effective’
narrative and public perception that erodes trust:
•In a recent poll over 56% suspect COVID -19 vaccines caused death:
https://www.rasmussenreports.com/public_content/politics/trump_administration_second_term/56_suspect_covid_19_vaccines_caused_deaths
•In another poll, 25% think they know someone who died from COVID -19 vaccines
https://issuu.com/indiabookofrecords/docs/chugalkhor_times_mar_2023_issue_4/s/20904385
ACIP Meeting, CDC
September 19, 2025Trust of Healthcare Workers

ACIP Meeting, CDC
September 19, 2025Discussion of the Recommendations
for ACIP Vote
ACIP Meeting, CDC
September 19, 2025Recommended Updates to the Vaccine Information Statement
Most of the WG members were concerned that the existing administration processes of the
COVID -19 vaccination products do not ensure a meaningful informed consent:

ACIP Meeting, CDC
September 19, 2025Recommended Updates to the Vaccine Information Statement
“To inform is not merely to provide written or verbal notification of risks and benefits.
Information disclosures, both in their content and mode of delivery, must spur earnest
contemplation and autonomous decision-making.”
“Each VIS must have a description of a vaccine’s 1) benefits, 2) risks, 3) a statement of
availability of the VICP, and 4) any other information deemed relevant. VISs must be presented
before every vaccine dose in all clinical settings, regardless of whether there is a learned intermediary present or not.”

ACIP Meeting, CDC
September 19, 2025Recommended Updates to the Vaccine Information Statement
The WG recommendation is that the CDC engages in effort to create more
consistent and comprehensive informed consent processes, and as part of that
considers adding language accessible to patients and medical providers to
describe the following risks and uncertainties:
ACIP Meeting, CDC
September 19, 2025Recommended Updates to the Vaccine Information Statement
1.Current assessments regarding the protection provided by COVID -19
vaccines and especially seasonal COVID -19 boosters against severe
outcomes (e.g., death, hospitalization and long COVID) are of low
quality. At best, the additional protection provided by a seasonal
booster is moderate and of short duration.
ACIP Meeting, CDC
September 19, 2025Recommended Updates to the Vaccine Information Statement
2.There is evidence that repeated seasonal mRNA boosters cause
acquired changes in the immune system and may be associated with
increased vulnerability to future infections, including SARS -CoV-2 and
other respiratory viruses. These risks, as well as potential risks of autoimmunity, chronic inflammation, immune tolerance and impaired
immune surveillance including immune fatigue or suppression, are
currently not well understood.
ACIP Meeting, CDC
September 19, 2025Recommended Updates to the Vaccine Information Statement
3.There are documented deaths from symptomatic and subclinical
myocarditis, pericarditis and potentially other cardiovascular conditions
post COVID -19 vaccination, including of healthy children, with probable
causal relationship to the mRNA vaccines. This risk is likely relatively small but currently not well understood.
ACIP Meeting, CDC
September 19, 2025Recommended Updates to the Vaccine Information Statement
4.Clinical reports demonstrate that in some cases COVID -19 vaccines can
cause prolonged and debilitating post vaccine syndrome (PVS).  The injuries
associated with PVS involve diverse symptoms and conditions, many overlapping with long COVID injuries. Some of the observed symptoms and conditions may include insomnia, chronic pain and fatigue, dysautonomia (e.g., POTS), immune dysregulation and deficiency, autoimmune disorders, severe neuropathy and other neurodegenerative conditions, cardiovascular and neurovascular injuries, and severe clotting. The frequency of PVS and related risk factors are currently not well understood.
ACIP Meeting, CDC
September 19, 2025Recommended Updates to the Vaccine Information Statement
5.There is evidence that in some individuals vaccinated with mRNA COVID -19
vaccines, the resulting spike protein, the mRNA and the nano- lipids
formulation components persist in different body organs, including lymph
nodes and the heart, for a prolonged period of months and possibly years in some patients. Prolonged and persistent exposure to spike, mRNA and nano- lipids particles is associated with post -vaccine syndrome (PVS) injuries
as well as potentially other side effects that are currently only partially understood.
ACIP Meeting, CDC
September 19, 2025Recommended Updates to the Vaccine Information Statement
6.The safety and the efficacy of COVID -19 vaccination during pregnancy have
never been tested in appropriately powered randomized clinical trials.  In
one randomized trial there was observed numerical imbalance of higher number of babies with congenital malformation among those born to vaccinated women.
ACIP Meeting, CDC
September 19, 2025Recommendations for 2025- 2026
Guiding principles:
•Access within the FDA authorized population
•Benefits, risks and uncertainties must be communicated as part of proper informed
consent
•Debated between Individual -based decisions to group recommendations

Summary: ACIP Meeting, CDC September 19, 2025COVID -19 Vaccine Discussion  Framing, 2025-2026 Professor Retsef Levi, PhD, MIT ACIP Meeting, CDC September 19, 2025WG Main Takeaways •Assessments of the protection level provided by COVID -19 vaccines and especially  seasonal boosters against severe outcomes (hospitalization, ICU, death, long- covid)  are based on very low -quality data and analyses •Vaccine injuries are demonstrably not recognized by current pharmacovigilance  systems, leaving vaccine…


11 perlman bernstein miglis covid 508

Additional Workgroup
Considerations in COVID-19
Vaccination Policy and Practice
Evolution of a vaccine program. Chen RT, Orenstein WA. Epidemiologic methods in immunization programs. Epidemiol Rev.
1996;18(2):102. Copyright © 1996 by the Oxford University Press.
Edwards K, Hackell  J, Committee on Infectious Diseases, Committee on Practice and Ambulatory Medicine
Pediatrics  Sep 2016, 138 (3) e20162146; DOI: 10.1542/peds.2016- 2146Simple, stable recommendations
can increase vaccine coverage
VAERS does not identify causality; rather it is a signal detection tool
•Vaccination provided additional protection against COVID -19-associated:
ER and UC visits among children; protection generally similar across
age groups
ER and UC visits and hospitalizations compared to no vaccine dose
among adults
critical illness among older adults; protection appeared to be more
durable against critical illness compared to less severe outcomes
•VE should be interpreted as the added benefit of COVID -19 vaccination in
a population with high levels of infection- induced immunity, vaccine-
induced immunity, or both Effectiveness of COVID -19 vaccination
EthicsScience
ImplementationThree Pillars of the ACIP:
Science and Much More
Lee G, Bell B, Romero J. The Advisory Committee on Immunization Practices and
Its Role in the Pandemic Vaccine Response. JAMA Published Online J uly 22,
2020. doi:10.1001/jama.2020.13167
•Healthcare providers always discuss vaccination pros/cons with patients.
•In principle, clear recommendations and SCDM reach the same goal.
•With routine, age - or risk -based recommendations, the default
decision is to vaccinate all patients that consent
•However, recommendations with SCDM are perceived differently.
SCDM has no default – vaccination is often interpreted as optional
•Plus, the need for a provider prescription creates an unnecessary step to
receiving a vaccine and does not effectively target those at high riskShared clinical decision -making (SCDM)
and a need for provider prescription
create barriers to COVID -19 vaccination
25%
17% 18%39%2023 CHILD POPULATION BY AGE GROUP IN US
(CHILDREN < 5 MORE LIKELY TO BE INFECTION NAÏVE)
Data from the U.S. Census Bureau, Population Division
Annie E. Casey Foundation tracks the well -being of children, youth, and families in US
< 6 months
6-23 months
Antepartum Vaccination Protects
Newborns and Young Infants

“Immunosenescence” means older
people do not have as good an
immune response as when younger

Key Messages for Consideration
•The ACIP pillars are not driven by science alone; implementation
and ethics are additional important considerations for vaccine accessibility
•Simple, stable recommendations can increase vaccine coverage
•COVID -19 vaccines are highly safe and effective
•Shared clinical decision -making and the need for a provider
prescription create unnecessary steps to receiving a vaccine
and do not effectively target those at high risk
Key Messages for Consideration
•COVID -19 vaccination rates in the younger pediatric population
are very low: the primary COVID -19 vaccination series is needed
•Antepartum vaccination especially helps protect infection -naïve
newborns and young infants under 6 months of age
•Older people do not make as good an immune response as
when younger (“ Immunosenescence”)
•COVID -19 vaccination matters for pregnant women, pediatric
patients especially < 2 years of age, people 65 years and older, those of any age with a weakened immune system or chronic medical conditions, and anyone who feels they want
protection for themselves or their family !

Summary: Additional Workgroup  Considerations in COVID-19  Vaccination Policy and Practice Evolution of a vaccine program. Chen RT, Orenstein WA. Epidemiologic methods in immunization programs. Epidemiol Rev.  1996;18(2):102. Copyright © 1996 by the Oxford University Press. Edwards K, Hackell  J, Committee on Infectious Diseases, Committee on Practice and Ambulatory Medicine  Pediatrics  Sep 2016, 138 (3) e20162146; DOI: 10.1542/peds.2016- 2146Simple, stable recommendations  can increase vaccine…


01 MacNeil COVID 508

Advisory Committee on Immunization Practices
COVID -19 Session
Coronavirus and Other Respiratory Viruses Division
June 25, 2025National Center for Immunization and Respiratory Diseases
1
 Introduction  Dr. Adam MacNeil (CDC/NCIRD)
COVID -19 epidemiology Dr. Adam MacNeil (CDC/NCIRD)
COVID -19 vaccine effectiveness update Dr. Adam MacNeil (CDC/NCIRD)
COVID -19 vaccine safety update Dr. Sarah Meyer (CDC/NCEZID)
COVID -19 vaccine coverage and
implementation Dr. Georgina Peacock (CDC/NCIRD)
Evidence to recommendations (partial) Dr. Adam MacNeil (CDC/NCIRD)Agenda COVID -19 session: June 25, 2025
•June 2024: ACIP recommended 2024 –2025 COVID -19 vaccination for all people ages 6 months and older (published in
September 2024 MMWR1).
•August 2024: FDA approved or authorized the Novavax, Moderna, and Pfizer -BioNTech 2024 –2025 COVID -19 vaccines.
•October 2024: ACIP recommended additional doses for adults ages 65 years and older and people ages 6 months and
older with moderate or severe immunocompromise (published December 2024 MMWR2).
•August, September, October 2024: The Interim Clinical Considerations for Use of COVID -19 vaccines was updated with
detailed guidance.3
•May 2025:
-Per HHS directive, CDC updated COVID -19 vaccine recommendations to shared clinical decision -making for healthy
children ages 6 months –17 years and no guidance/not applicable for pregnant women.
-FDA approved Novavax’s NUVAXOVID (2024 –2025 Formula) and Moderna’s MNEXSPIKE (2024 –2025 Formula) for
people ages 12 –64 years at high risk for severe COVID -19 and all adults ages 65 years and older.
-FDA’s Vaccines and Related Biological Products Advisory Committee met to discuss strain selection for the 2025 –
2026 COVID -19 vaccines. FDA advised manufacturers that 2025 –2026 Formula COVID -19 vaccines should be
monovalent JN.1 -lineage -based, preferentially using the LP .8.1 strain.4Federal COVID -19 vaccine updates, June 2024 –May 2025
1. Panagiotakopoulos L, et al. Use of COVID -19 Vaccines for Persons Aged ≥6 Months: Recommendations of the Advisory Committee on Im munization Practices — United States, 2024 –2025. MMWR Morb  Mortal Wkly  Rep 2024;73:819 –824. DOI:
10.15585/mmwr.mm7337e2 .
2. Roper LE, et al. Use of Additional Doses of 2024 –2025 COVID -19 Vaccine for Adults Aged ≥65 Years and Persons Aged ≥6 Months with  Moderate or Severe Immunocompromise: Recommendations of the Advisory Committee on Immunization
Practices — United States, 2024. MMWR Morb  Mortal Wkly  Rep 2024;73:1118 –1123. DOI: 10.15585/mmwr.mm7349a2 .
3. https://www.cdc.gov/covid/hcp/vaccine -considerations/index.html
4. https://www.fda.gov/vaccines -blood -biologics/industry -biologics/covid -19-vaccines -2025 -2026 -formula -use-united -states -beginning -fall-2025
ACIP: Advisory Committee on Immunization Practices | FDA: Food and Drug Administration | MMWR: Morbidity and Mortality Weekly  Report3
•Children ages 6 months –4 years
-Unvaccinated: May receive a multidose initial series with a 2024 –2025 mRNA vaccine using shared
clinical decision -making
-Previously completed an initial series: May receive 1 dose of a 2024 –2025 mRNA vaccine from the same
manufacturer as the initial series using shared clinical decision -making
•People ages 5 –17 years:
-May receive 1 dose of an age -appropriate 2024 –2025 COVID -19 vaccine using shared clinical decision -
making
•Adults ages 18 –64 years:
-Should receive 1 dose of any 2024 –2025 COVID -19 vaccine
•Adults ages 65 years and older:
-Should receive 2 doses of any 2024 –2025 COVID -19 vaccine, spaced 6 months apart (minimum interval 2
months)Overview of the current COVID -19 vaccination schedule:
Routine vaccination
https://www.cdc.gov/covid/hcp/vaccine -considerations/routine -guidance.html  4
•Unvaccinated:
-Should receive a multidose initial vaccination series with an age -appropriate
2024 –2025 vaccine and receive 1 dose of 2024 –2025 vaccine 6 months after
completing the initial series (minimum interval 2 months)
•Previously completed an initial series:
-Should receive 2 doses of an age -appropriate 2024 –2025 COVID -19 vaccine,
spaced 6 months apart (minimum interval 2 months)
•May receive additional age -appropriate 2024 –2025 COVID -19 vaccine
doses under shared clinical decision -making (minimum interval 2
months) Overview of the current COVID -19 vaccination schedule:
Moderate or severe immunocompromise
5 https://www.cdc.gov/covid/hcp/vaccine -considerations/immunocompromised.html
September 20231June 20242April 20253June 2025Previous Work Group considerations of COVID -19 vaccine
non-universal recommendations
1 September 12, 2023. ACIP presentation, slide 124. https://www.cdc.gov/acip/downloads/slides -2023 -09-12/11 -COVID -Wallace -508.pdf
2 June 27, 2024. ACIP presentation, slide 83. https://www.cdc.gov/acip/downloads/slides -2024 -06-26-28/06 -COVID -Panagiotakopoulos -508.pdf
3 April 15, 2025. ACIP presentation, slide 65. https://www.cdc.gov/acip/downloads/slides -2025 -04-15-16/05 -Panagiotakopoulos -COVID -508.pdf
 6
•Age-appropriate 2025 –2026 COVID -19 vaccines* for all infants and children
ages 6–23 months
•Age-appropriate 2025 –2026 COVID -19 vaccine for persons ages 2–64 years  for
the following groups:
•Persons at high risk of severe COVID -19, including p regnant women (for infant and maternal
protection)
•Persons at high risk of exposure to SARS -CoV-2
•Shared clinical decision -making for persons desiring additional protection from COVID -19
•2 doses of 2025 –2026 COVID -19 vaccine for all adults ages ≥65 years and
persons ages ≥6 months with moderate or severe immunocompromise **Summary of recent COVID -19 Work Group discussions
*Number of doses depends on age, vaccine manufacturer, and vaccine history.
** Persons with immunocompromise who are unvaccinated or did not complete an initial series with 2024 -2025 vaccine should comple te the initial series followed by 1 dose of
2025 -2026 vaccine 6 months after the initial series. 7

Summary: Advisory Committee on Immunization Practices COVID -19 Session Coronavirus and Other Respiratory Viruses Division June 25, 2025National Center for Immunization and Respiratory Diseases 1  Introduction  Dr. Adam MacNeil (CDC/NCIRD) COVID -19 epidemiology Dr. Adam MacNeil (CDC/NCIRD) COVID -19 vaccine effectiveness update Dr. Adam MacNeil (CDC/NCIRD) COVID -19 vaccine safety update Dr. Sarah Meyer (CDC/NCEZID) COVID -19 vaccine coverage and  implementation Dr. Georgina Peacock (CDC/NCIRD)…


02 MacNeil COVID 508

Current Epidemiology of COVID -19
Coronavirus and Other Respiratory Viruses Division
Advisory Committee on Immunization Practices (ACIP)
June 25, 2025National Center for Immunization and Respiratory Diseases
1
COVID- 19 continues to impact Americans’ health.
* Based on data from September 29, 2024 through June 7, 2025.
Source: https://www.cdc.gov/covid/php/surveillance/burden- estimates.html  2

Among adults aged ≥18 years, 3.6%
reported Long COVID
symptoms, and 8.4% reported ever
having Long COVID1
More than 3 in 5 adults with Long
COVID reported activity limitations1
Among children aged 0 -17
years, 0.4% reported Long COVID
symptoms, and 1.4% reported ever
having Long COVID2Long COVID is a significant public health threat.
1.Vahratian , et al . Prevalence of Post –COVID -19 Condition and Activity -Limiting Post –COVID -19 Condition Among Adults. doi:10.1001/jamanetworkopen.2024.51151
2.Ford, et al. Long COVID Prevalence and Associated Activity Limitation in US Children. doi:10.1001/jamapediatrics.2024.6206National surveys in 2023 estimated approximately 9.2 million adults and 0.3 million
children in the U.S. had Long COVID.

Almost 4 in 5 children with Long
COVID reported activity limitations2
3
COVID- NET is a population -based hospitalization
surveillance platform.
•RESP -NET includes COVID -NET, RSV -NET, FluSurv -NET
•>300 acute -care hospitals
•185 counties in 13 states (population- based rates)
•~10% of the U.S. population
•Positive SARS -CoV-2 test ≤14 days before admission or during hospitalization
•Screening or clinician -driven testing
•Clinical data: age - and site -stratified random sample of hospitalized patients
•Seasons defined in this presentation as July –June for rates.
-Most recent 12 months of sampled data
COVID -NET: https://www.cdc.gov/covid/php/covid- net/index.html   Some slides display data from 90 counties in 12 states due to incomplete data.4

010203040
20
2020
21202220
2320242025Rates of COVID -19, influenza, and RSV hospitalization — RESP -NET, 2020– 2025
2020 2021 2022 2023 2024 2025Weekly COVID- 19-associated hospitalization rates have
peaked in both winter and summer.
50246810121416Hospitalizations per 100,000 population
Month and YearWeekly Rates of COVID -19–, Influenza -, and RSV -Associated
Hospitalizations — RESP- NET, July 2023– April 2025
COVID-19 Influenza RSV
Figures displays weekly Rates of COVID -19–, Influenza -, and RSV -Associated Hospitalizations — RESP -NET, July 2023 –May 2025.
Rates for all three pathogens (COVID -19, influenza, and respiratory syncytial virus [RSV]) are laboratory -confirmed. Data source : https://www.cdc.gov/resp -net/dashboard/
Note that rates are not adjusted for testing. Rates are not limited to admissions where the respiratory infection is the like ly primary reason for admission.
Cumulative COVID- 19–associated hospitalization rates for the
July 2024–May 2025 period were higher during summer and fall
2024 and lower during the winter months compared to July
2023–June 2024.
6020406080100120140160180200
Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May JuneHospitalizations per 100,000 population
MonthCumulative Rates of COVID -19–, Influenza- , and RSV -Associated Hospitalizations, by Surveillance Season* —
RESP- NET, July 2023– May 2025
COVID 2023– 2024 Influenza 2023– 2024 RSV 2023– 2024
COVID 2024– 2025 Influenza 2024– 2025 RSV 2024– 2025
* Seasons are defined as July through June. The 2024 –2025 season shows data from July 2024– May 2025 and is ongoing. Influenza surveillance is conducted October – April.
Rates for all three pathogens (SARS- CoV-2, influenza, and respiratory syncytial virus [RSV]) are laboratory -confirmed. Data sour ce: https://www.cdc.gov/resp -net/dashboard/
Note that rates are not adjusted for testing. Rates are not limited to admissions where the respiratory infection is the like ly primary reason for admission.
From July 2024 – April 2025, a period that included a high
severity influenza season1, more infants <1 and adults ≥75 had
hospitalizations associated with COVID -19 than influenza.
701002003004005006007008009001000
<1 1–4 5–11 12–17 18–49 50–64 65–74 ≥75Hospitalizations per 100,000 population
Age group (years)Cumulative hospitalization rates of laboratory -confirmed COVID-19 and influenza hospitalizations —
RESP-NET, July 2024–April 2025
COVID-19 Influenza
Cumulative hospitalization rates with laboratory -confirmed SARS -CoV-2 and influenza hospitalizations — RESP -NET, July 2024 –April  2025. Note that influenza surveillance is conducted
from October –April annually. Data source: https://www.cdc.gov/resp -net/dashboard/ . Note that rates are not adjusted for testing nor limited to admissions where the respiratory
infection is the likely primary reason for admission.  1https://www.cdc.gov/flu/php/surveillance/in- season -severity.html
Cumulative COVID- 19-associated hospitalization rates are highest
among adults aged ≥75 years, followed by adults aged 65–74 years
and infants aged <6 months.
Weekly rates of COVID -19–associated hospitalizations per 100,000 population by age group— COVID- NET, July 2024– May 2025
Note that rates are not adjusted for testing. Rates are not limited to admissions where the respiratory infection is the like ly primary reason for admission. 8050100150200250300
Jul 2024 Aug 2024 Sep 2024 Oct 2024 Nov 2024 Dec 2024 Jan 2025 Feb 2025 Mar 2025 Apr 2025 May 2025Rate per 100,000 population
Surveillance week end date
<6 months 6–23 months 2–4 years 5–11 years
12–17 years 18–49 years 50–64 years 65–74 years50–64 years: 101
18–49 years: 36
2–4 years:  22
12–17 years: 12
5–11 years: 10<6 months: 268
65–74 years: 266
50–64 years: 103
6–23 months: 10002505007501000Rate per 100,000≥75 years: 884
COVID -19 Mortality
9
Weekly number of COVID- 19-associated deaths reported
to CDC, United States, June 8, 2024 –  June 7, 2025
The most recent 3 weeks of mortality counts are shaded grey because NVSS reporting is  <95% during this period.
Provisional data are non -final counts of deaths based on reported mortality data in NVSS. Deaths include those with COVID- 19, coded as ICD– 10 code U07.1, on the death certificate.
Death data are displayed by date of death (event). Data include underlying and contributing causes of death.CDC COVID Data Tracker. National Center for Health Statistics (NCHS) National Vital Statistics System (NVSS).
https://covid.cdc.gov/covid- data -tracker/#trends_weeklydeaths_select_00
Accessed June 18, 202502004006008001,0001,2001,4001,600
6/8/2024 8/8/2024 10/8/2024 12/8/2024 2/8/2025 4/8/2025Weekly Deaths
10
Total number of deaths with COVID -19listed as the underlying
cause1,2 in July 2024–June 2025, by age group, United States
1. Provisional data
2. Underlying cause of death Source: Centers for Disease Control and Prevention, National Center for Health Statistics. Natio nal Vital Statistics System, Provisional Mortality on CDC
WONDER Online Database. Data are from the final Underlying Cause of Death Files, provisional data for  2024 and provisional and partial data from 2025 , as compiled from data provided
by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. Number of deaths includes COVID- 19 code (U07.1) as the underlying cause of death.
http://wonder.cdc.gov/mcd -icd10 -provisional.html, accessed June 20 , 2025 45 16 294761,7684,00916,375
020004000600080001000012000140001600018000
<2 years 2-4 years 5-17 years 18-49 years 50-64 years 65-74 years ≥75 yearsNumber of Deaths
1
11
Death certificate data likely underestimate COVID -19-associated
deaths.
Figure displays the weighted percentage of COVID -19-associated hospitalizations with COVID -19 listed as an underlying or contributing cause of death,* by surveillance period** — COVID -NET, March 2020–
September 2023
* COVID -19 as a cause of death was defined as the inclusion of International Classification of Diseases, Tenth Edition (ICD- 10) code U07.1 on the death certificate as an underlying or contributing cause of death.
**Surveillance periods are defined as October –September, except for 2020, which was defined as March 2020– September 2020.
12Among in- hospital
deaths in patients
with laboratory -
confirmed SARS -
CoV- 2, the proportion
with a COVID- 19
cause of death listed decreased from 95%
in 2020 to 60% in
2022– 2023.95
89
77
60
0102030405060708090100
Category 1Percent of in -hospital deaths with COVID -
19 cause of death on the death certificate
2020 2020 –2021 2021 –2022 2022 –2023
COVID -19 continues to contribute to a large number of deaths in
the United States.
* COVID -19 as a cause of death was defined as the inclusion of International Classification of Diseases, Tenth Edition (ICD- 10) code U07.1 on the death certificate (October 2024- May 2025) as underlying or
contributing cause of death. Provisional death certificate data from the National Center for Health statistics
† Based on data from September 29, 2024 through June 7, 2025. Source: https://www.cdc.gov/covid/php/surveillance/burden- estimates.html . Accessed June 20, 2025
13Data sourceEstimated COVID -19
deaths since October
2024
Death certificate data* 20,800
Modeled estimates based on
multiple data sources†32,000– 51,000

Pediatric COVID -19–Associated
Hospitalizations
14
The highest rates for COVID- 19 in the New Vaccine Surveillance
Network were observed in infants <6 months of age.
Pediatric COVID- 19 and influenza hospitalization rates among children <18 years, New Vaccine Surveillance Network (NVSN), July 2024-  March 2025. Rate estimates with standard error >30 due to few
detections are not presented. Annual rates presented July – June of each season, with exception of 2024 -2025, which represents J uly 2024 – March 2025.
NVSN, unpublished data209.8
83.0
17.07.4149.4
82.9
58.5
39.6
11.1
0100200300
<6m 6-23m 2-4y 5-11y 12-17yHospitalization rate , No./100000 children
AgeSARS-CoV-2
Influenza
15
More than half of pediatric COVID- 19-associated
hospitalizations occur in children aged <2 years.
160%10%20%30%40%50%60%70%80%90%100%Percent of COVID -19–associated hospitalizations
Surveillance week end datePercent of weekly COVID -19–associated hospitalizations among children and adolescents, by age group
—
COVID -NET, July 2024– April 2025
<6 months 6–23 months 2–4 years 5–11 years 12–17 years
Figure displays percent of weekly COVID -19–associated hospitalizations among children and adolescents, by age group — COVID -NET,  July 2024– May 2025.≤6 months = 27%6–23 months = 30%
<2 years = 57%2–17 years = 43%
COVID- 19 causes severe disease in infants ages <6 months.
Data reported from July 2024– May 2025. Excludes newborns who were admitted during the same hospitalizations as their birth. Note  that rates are not adjusted for testing. Rates are not
limited to admissions where the respiratory infection is the likely primary reason for admission. •Highest rate of COVID -19-
associated hospitalization
among all pediatric age groups
-Rates comparable to adults ages
65–74 years
050100150200250300
Jul
2024Aug
2024Sep
2024Oct
2024Nov
2024Dec
2024Jan
2025Feb
2025Mar
2025Apr
2025May
2025Rate per 100,000 population
Surveillance week end dateCumulative rates of COVID -19–associated hospitalizations among
children and adolescents ages <18 years —
COVID -NET, July 2024– May 2025
<6 months 6–23 months 2–4 years
5–11 years 12–17 years 50–64 years
65–74 yearsCumulative rate per 100,000:
<6 months: 268
65–74 years: 266
17
Infants <6 months experience high rates of severe COVID-
19 disease.
18No COVID -19 vaccine products are approved for infants ages <6 months.
Any protection must come from transfer of maternal antibodies, either from
vaccination during pregnancy or prior infectionAmong infants <6 months hospitalized recently for COVID -19:
22% were admitted to the ICU
71% had no underlying medical conditions
3.5% had any record of maternal COVID -19 vaccination during pregnancy
Data reported from April 2024 –March 2025. Hospitalizations are limited to those with COVID -19 as the likely reason for admission . Excludes newborns who were admitted during the
same hospitalizations as their birth.
190%10%20%30%40%50%60%70%80%90%100%Percent of COVID -19–associated
hospitalizations
Surveillance week end datePercent of weekly COVID -19–associated hospitalizations among children and adolescents, by age group
—
COVID -NET, October 2024– April 2025
6–23 months 2–4 years 5–11 years 12–17 years
Figure displays the percent of weekly COVID -19–associated hospitalizations among children and adolescents, by age group — COVID -NET, October 2024– May 2025.Among vaccine -eligible children and adolescents ages 6
months –17 years, 41% of COVID- 19-associated hospitalizations
occurred among children ages 6–23 months.
During July 2024– May
2025:

•6–23 months = 41%
•2–4 years = 18%
•5–11 years = 20%
•12–17 years = 21%
COVID -19-associated cumulative hospitalization rates are
highest among the youngest age groups.
Note that rates are not adjusted for testing. Rates are not limited to admissions where the respiratory infection is the like ly primary reason for admission. 20050100150200250300
Jul 2024 Aug 2024 Sep 2024 Oct 2024 Nov 2024 Dec 2024 Jan 2025 Feb 2025 Mar 2025 Apr 2025 May 2025Rate per 100,000 population
Surveillance week end dateCumulative rates of COVID -19–associated hospitalizations among children and adolescents ages ≤17 years —
COVID -NET, July 2024– May 2025
<6 months 6–23 months 2–4 years ≤4 years 5–11 years 12–17 years65–74 years: 258
50–64 years: 101
18–49 years: 36
12–17 years: 12
5–11 years: 10≤4 years: 68257Rates for 100K population,
by age group:
<6 months: 268
6–23 months: 100
2–4 years:  22
The youngest age groups have comparable rates of cumulative
COVID -19-associated hospitalization to some adult age groups, but
direct comparisons are challenging.
Note that rates are not adjusted for testing. Rates are not limited to admissions where the respiratory infection is the like ly primary reason for admission. 21050100150200250300
Jul 2024 Aug 2024 Sep 2024 Oct 2024 Nov 2024 Dec 2024 Jan 2025 Feb 2025 Mar 2025 Apr 2025 May 2025Rate per 100,000 population
Surveillance week end dateCumulative rates of COVID -19–associated hospitalizations among children and adolescents ages ≤17 years —
COVID -NET, July 2024– May 2025
<6 months 6–23 months 2–4 years 5–11 years65–74 years: 258
50–64 years: 101
18–49 years: 36
12–17 years: 12
5–11 years: 10Rates for 100K population,
by age group:
<6 months: 268
65–74 years: 266
50–64 years: 103
6–23 months: 100
2–4 years:  22
The youngest age groups have comparable rates of cumulative
COVID -19-associated hospitalization to some adult age groups, but
direct comparisons are challenging.
Note that rates are not adjusted for testing. Rates are not limited to admissions where the respiratory infection is the like ly primary reason for admission. 22050100150200250300
Jul 2024 Aug 2024 Sep 2024 Oct 2024 Nov 2024 Dec 2024 Jan 2025 Feb 2025 Mar 2025 Apr 2025 May 2025Rate per 100,000 population
Surveillance week end dateCumulative rates of COVID -19–associated hospitalizations among children and adolescents ages ≤17 years —
COVID -NET, July 2024– May 2025
<6 months 6–23 months 2–4 years 5–11 years65–74 years: 258
50–64 years: 101
18–49 years: 36
12–17 years: 12
5–11 years: 10Rates for 100K population,
by age group:
<6 months: 268
65–74 years: 266
50–64 years: 103
6–23 months: 100
2–4 years:  22% with ≥1 underlying medical conditions
among those hospitalized for COVID -19:
Adults aged 50 -64: 94%
Infants and children 6 -23 months: 46%
Proportion of children hospitalized for COVID- 19 who
had no underlying medical conditions
Figure displays the weighted percent of children and adolescents hospitalized for COVID -19 with no underlying medical conditions, by age group —  COVID -NET, April 2024 –March 2025.
Hospitalizations are limited to those with COVID -19 as the presenting complaint upon admission. Pregnant adolescents ages 15 –17 years are excluded from proportions
presented. 2371
54
29
24 23
01020304050607080
<6 months 6–23 months 2–4 years 5–11 years 12–17 yearsPercentage of pediatric patients hospitalized
who have no underlying medical conditions
Age Group<2 years
2–17 yearsMost hospitalized
children ages <2
years did not have
any underlying
medical condition.
Percent of children and adolescents for COVID -19 who were admitted to the ICU, by age group — COVID -NET, April 2024 –March 2025
Hospitalizations are limited to those with COVID -19 as the likely reason for admission. Pregnant adolescents ages 15 –17 years are excluded from proportions presented. 2225
2128
26
051015202530
<6 months 6–23 months 2–4 years 5–11 years 12–17 yearsPercent of pediatric  hospitalizations
requiring ICU admission
Age group~1 in 4 children ages <18 years in all age groups
hospitalized for COVID- 19 required ICU admission.
2424%
Percent of children and adolescents for COVID -19 who were admitted to the ICU, by age group — COVID -NET, April 2024 –March 2025
Hospitalizations are limited to those with COVID -19 as the likely reason for admission. Pregnant adolescents ages 15 –17 years are excluded from proportions presented. 2225
2128
26
051015202530
<6 months 6–23 months 2–4 years 5–11 years 12–17 yearsPercent of pediatric  hospitalizations
requiring ICU admission
Age groupAmong children <2
years admitted to
ICU, most (53%) did
not have underlying
medical conditions.
25~1 in 4 children ages <18 years in all age groups
hospitalized for COVID- 19 required ICU admission.
23%
89% of COVID -19 vaccine-eligible children and adolescents who were
hospitalized with COVID -19 had no record of receiving the most recently
recommended COVID -19 vaccines.
No record of COVID -19 vaccine since July 1, 2023: No recorded doses of any COVID -19 vaccine dose since July 1, 2023. ≥1 vaccine dose since July 1, 2023, but
no 2024– 2025 dose:  Received at least one COVID -19 vaccination since July 1, 2023, but no record of receiving 2024- 2025 vaccine dose. Receipt of ≥1 24- 25 formula
dose: Received at least 1 dose of the 2024- 2025 vaccine dose. Persons with unknown vaccination status (6.4%) are excluded. Hospitaliza tions are limited to those with
COVID -19 as the presenting complaint upon admission.908589 89
1 2 311013
810
0102030405060708090100
6 months –4 years 5–11 years 12–17 years 6 months –17 yearsWeighted percent of hospitalizationsVaccination status among children and adolescents with COVID-19 –associated hospitalizations,
by age group — COVID -NET, October 2024 –March 2025
No record of COVID-19 vaccine since July 1, 2023
≥1 vaccine dose since July 1, 2023, but no record of receiving 24- 25 formula dose
Receipt of ≥1 24- 25 formula dose
26
Pediatric COVID -19 mortality
27
Total number of COVID -19- and Influenza -associated
deaths1,2, among ages 0 –17 years in July 2024 –June 2025,
United States
45
162944 42142
020406080100120140160
<2 year 2–4 years 5–17 yearsNumber of Deaths
COVID-19 Influenza
1. Provisional data
2. Underlying cause of death Source: Centers for Disease Control and Prevention, National Center for Health Statistics. National Vital Statistics System, Provisional Mortality on CDC WONDER Online
Database. Data are from the final Underlying Cause of Death Files, provisional data for 2024 and provisional and partial data from 2025 , as compiled from data provided by the 57 vital statistics jurisdictions
through the Vital Statistics Cooperative Program. Number of deaths includes influenza codes (J09 -J11) or COVID -19 code (U07.1) as the underlying cause of death. http://wonder.cdc.gov/mcd -icd10 -
provisional.html , accessed June 20, 2025
Note: Estimates of pediatric influenza deaths reported to CDC can be found here: https://www.cdc.gov/fluview/surveillance/2025 -week -15.html . Estimates will vary due to differences in reporting methods
and timeframes used. 28
Deaths among children with COVID- 19-associated
hospitalizations within COVID- NET catchment area
29Since March
2020July 2022–
June 2023July 2023–
March 2025
In-hospital and out- of-hospital deaths 128 32 25 (including 10*
since April 2024)
•Among 25 pediatric deaths since July 2023:
•13 (52%) were aged <2 years:  9 aged <6 months; 4 aged 6 –23 months
•18 (72%) had ≥1 underlying medical condition
•Of the 16 who were age- eligible for COVID -19 vaccination, 14 had no record of COVID -19 vaccination
and none were up to date.
•Death certificate data alone may underestimate COVID -19-associated pediatric deaths
-Among the 25 deaths** for whom we have death certificate data with ICD -10 codes, 7 (28%) had COVID -19 listed
as a cause of death (COD)
-Additional 9 (36%) had CODs related to other respiratory or circulatory causesCOVID -NET
represents 10% of
the U.S. population
* In-hospital deaths only; complete death certificate data not yet available.
** Deaths occurred during July 2022 and August 2023.
Summary
COVID -19 Epidemiology in Infants, Children, and Adolescents
30
Summary of COVID- 19 Epidemiology for Infants, Children, and
Adolescents
•Most (57%) pediatric hospitalizations occur in children ages <2 years .
-Most hospitalized children in these age groups have no underlying medical conditions, including 71%
of infants ages <6 months and 54% of children ages 6 –23 months.
•Rates of COVID -19–associated hospitalizations are highest among infants ages <6 months,  followed by
those ages 6 –23 months.
-Rates of COVID -19-associated hospitalizations among infants ages <6 months are comparable to rates
among adults ages 65 –74 years
-No COVID -19 vaccine products are approved for infants ages <6 months. Any protection must come
from transfer of maternal antibodies, either through vaccination during pregnancy or prior infection
•Outcomes among hospitalized children can be severe, with  1 in 4 admitted to ICU .
-Deaths from COVID -19 continue to occur among infants and children; death certificate data might
undercount these.
•The majority (89%) of COVID -19 vaccine -eligible children and adolescents who were hospitalized with
COVID -19 had no record of receiving the most recently recommended COVID -19 vaccine.
31
COVID -19–Associated Hospitalizations
Among Adults Ages ≥18 Years
32
Adults ages ≥65 years comprise more than 2/3 of all
COVID- 19–associated hospitalizations among adults.
Figure displays the percent of weekly COVID -19–associated hospitalizations among adults ages ≥18 years, by age group — COVID -NET, March 2020– May 2025.
During this same period of January 2024 through March 2025, children and adolescents ages 17 years and younger comprised 4.1%  of all COVID -19-associated hospitalizations. 330%10%20%30%40%50%60%70%80%90%100%Percent of adults hospitalized with COVID -19
Surveillance week end datePercent of weekly COVID -19–associated hospitalizations among adults ages ≥18 years, by age group —
COVID -NET, March 2020– April 2025
18–49 years 50–64 years 65–74 years ≥75 years≥75 years=50%
≥65 years=72%
50–64 years=16%
Most adults hospitalized for COVID- 19 have ≥1
underlying medical condition; a majority have ≥2.
34Prevalence of underlying medical conditions among adults ages ≥18 years, by age group — COVID -NET, April 2024 –March 2025.
Pregnant women ages 18 –49 years are excluded from proportions presented. Data are limited to hospitalizations with COVID -19 as t he likely reason for admission.1486
61
694
75
397
85
298
84
0102030405060708090100
0 conditions ≥1 condition ≥2 conditionsWeighted percent of hospitalizations
Underlying medical conditionsPrevalence of underlying medical conditions among adults ages ≥18 years, by age group —
COVID -NET, April 2024 –March 2025
18–49 years 50–64 years
Among adults hospitalized for COVID- 19, 15% were
admitted to the intensive care unit (ICU).
3517 17
14
6 6
4
145
02468101214161820
18–49 years 50–64 years ≥65 yearsWeighted percent of hospitalizationsAge groupProportion of adults hospitalized with COVID -19 with interventions and outcomes,
by age group — COVID -NET, April 2024 –March 2025
ICU admission Invasive mechical ventilation In-hospital death
The figure displays the proportion of adults hospitalized for COVID -19 with interventions and outcomes, by age group — COVID -NET, April 2024 –March 2025.
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission. Deaths do not include other COVID -19-related deaths that might occur after a patient is
discharged to hospice or deaths that occur soon after hospital discharge that could be attributable to COVID -19-related illness.  Pregnant women ages 18 –49 years are excluded from
proportions presented. During this period, 85% of all adults hospitalized with COVID- 19 who died in -hospital were ages ≥65 years.
Most adults hospitalized for COVID- 19 had received no
COVID -19 vaccine since July 2023.
Figure displays the COVID- 19 vaccination status among adults hospitalized for COVID -19, by age group — COVID -NET, October 2024– March 2025.
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission. 3687
746862 65
2 1 1 1 11125313734
122117
0102030405060708090100
18–49 50–64 65–74 ≥75 ≥65Weighted percent of hospitalizations Age group in yearsVaccination status among adults hospitalized with COVID -19, by age group —
COVID -NET, October 2024– March 2025
No record of vaccination since 7/1/2023
Record of ≥1 COVID dose since 7/1/2023, but no record of receiving the 24- 25
formula dose
COVID -19-Associated Hospitalizations
among Pregnant Women
37
Pregnant women with COVID- 19–associated
hospitalizations, April 2024 –March 2025
•Pregnancy status collected from
hospitalized women ages 15 –49
years
•28.5% of women ages 15 –49
years hospitalized with
laboratory- confirmed SARS-
CoV- 2 infection were pregnant
-50% of those had COVID -19-
related signs or symptoms
Source: COVID -NET, unpublished data.38

Pregnant women with COVID- 19–associated
hospitalization, April 2024– March 2025
Among 131 hospitalized pregnant women with a laboratory- confirmed
SARS -CoV- 2-positive test result and COVID -19-related signs or symptoms:
•50% had no underlying conditions
•68% were no longer pregnant at discharge, among whom:
-83% had a healthy newborn, 11% had a pre -term infant, 1% had an ill infant, and
5% had pregnancy loss*
•92% have no record of vaccination since July 1, 2023
-5.8% received recommended 2024- 25 COVID -19 vaccine dose**
* Includes spontaneous miscarriage and abortion.
** Vaccination might have occurred before the pregnancy period and is not necessarily indicative of maternal vaccination stat us.
Source: COVID -NET, unpublished data.39
Summary
Adults
40
Summary of COVID- 19 Epidemiology for Adults
•Rates of COVID -19– associated hospitalization are highest among oldest adult age groups
-Adults aged ≥65 years comprise 72% of adult COVID -19– associated hospitalizations
-Ages ≥75 years: 50% of adult hospitalizations
•COVID -19-associated hospitalization rates have decreased over time, but cumulative rates among
adults aged ≥75 years remain high
•Risk of hospitalization with COVID -19 continues year -round, peaking in the winter and summer.
•65% of adults ages ≥65 years hospitalized with COVID -19 had no record of receiving ≥1 dose of the
recommended 2024 -25 COVID -19 vaccine prior to hospitalization.
•Most adults with COVID -19-associated hospitalization have ≥1 underlying condition.
•Among SARS -CoV -2-positive pregnant women admitted during April 2024 –March 2025 with COVID -
19-related symptoms on admission, half had no underlying conditions and most (92%) have no
record of COVID -19 vaccination since July 1, 2023
41
Genomics
42
Subsampled SARS -CoV-2 sequences by lineage group, date of specimen collection, and number of
spike protein amino acid differences relative to Wuhan -Hu-1 reference
United States, January 1, 2021–March 29, 2025
* LF.7 includes LF.7, LF.7.2.1, LF7.7.1, and LF7.7.2.
Sequences were subsampled (100 per month) for analysis from an initial dataset of >1 million sequences spanning January 1, 20 21–March 29, 2025. Only lineages circulating at >5% prevalence nationally during at least one 2 -week period are displayed. Sequences are reported to CDC through the National
SARS -CoV-2 Strain Surveillance program, contract laboratories, public health laboratories, and other U.S. institutions.  Lineages were ordered by date of first appearance on CDC’s COVID data tracker ( https://covid.cdc.gov/covid -data -tracker/#variant -proportions ). Lineages with identical spike receptor binding
domain amino acid sequences (residues 332 to 527) were grouped with a representative lineage and denoted as “representative l ineage-like.” Vaccine availability for a given composition was defined by the estimated date of earliest possible administration.Vaccine strain composition : original Bivalent (original, BA.4/5) XBB.1.5 JN.1/KP.2
Variant
43
In winter 2023-2024, we observed a strain replacement
of XBB.1.5 -like viruses to JN.1- like viruses.
JN.1-likeHV.1FL.1.5.1 -
likeEG.5 -likeXBB.1.5 -
like
Genomic Surveillance for SARS -CoV -2 Variants: Circulation of Omicron XBB and JN.1 Lineages — United
States, May 2023– September 2024 | MMWR44
Weighted SARS -CoV-2 Variant Proportion Estimates: XBB and JN.1 Lineages
United States, October 1, 2023– March 29, 2025
* LF.7 includes LF.7, LF.7.2.1, LF7.7.1, and LF7.7.2.
† “Other” represents aggregated  lineages circulating at <1% prevalence nationally during all 2 -week periods displayed.
Lineages were ordered  by date of first appearance on CDC’s COVID data tracker ( https://covid.cdc.gov/covid- data -tracker/#variant- proportions ). Lineages with identical spike receptor binding domain amino acid sequences (residues 332 to 527) were
grouped with a representative lineage and denoted as “representative lineage -like.”†JN.1-likeKP.3.1.1-likeXEC
LP.8.1LB.1-like
45
Viruses that have predominated since January 2025
are all JN.1 descendants.
CDC COVID Data Tracker: Variant Proportions
Weighted and Nowcast Estimates in the United States
for 2 -week Periods, 2/16/2025 – 6/7/2025
CDC COVID Data Tracker: Variant
Proportions
As of June 15, 2025Due to low numbers of sequences being reported to CDC, precision for the most recent reporting periods is low
47
Convergent Evolution of Different Omicron JN.1 Lineages
Key changes in the spike receptor binding domain (RBD)* detected relative to KP.2
* Lineages or lineage groups with ≥1% prevalence in at least one 2 -week period and substitutions present in ≥50% of sequences bel onging to a lineage were included.
† The KP .2 spike protein sequence was used as a reference because of its inclusion in updated mRNA -based 2024– 2025 COVID -19 vaccin es. Substitutions compared to Wuhan- Hu-1 are
underlined.
§ Indicates sites of independent substitution or deletion in at least two different evolutionary lineages.
Bolded sub- lineages are expanding in the United States as of June 7, 2025.Lineage N-terminal domain Receptor binding domain S2
22 31 59 146 182 183 184 186 190 346 435 444 445 456 478 493 572 679 748 929 1086 1104 1235
KP.2
Reference
† T S F H K Q G F R T A K H L T Q T K E S K L C
KP.3 R E
KP.3.1.1 ∆ R E
KP.3.3 R E
KP.2.3 ∆ Q I
JN.1 R F V
JN.1.16 Q R V
JN.1.18.6 N S
KP.2.15 ∆
LB.1 ∆ H V
LF.7 N P R S R I V
LP.8.1 ∆ L S R E R
MC.10.1 ∆ R S E
MC.28.1 ∆ S E F
XEC N S R E
XEC.4 N S R E I
XEK N S R E Q
XFC N P R S R E R R
NB.1.8.1 N S G S H I E
48
Human sera collected after 2024- 2025 COVID -19
vaccination neutralizes LP.8.1 pseudoviruses and XEC
virus.
Mellis  et al. bioRxiv : Do Existing
COVID -19 Vaccines Need to Be
Updated in 2025?
Suthar et al. The Lancet Infectious Diseases: The KP.2- adapted
COVID -19 vaccine improves neutralising activity against the XEC
variant -  ScienceDirect*Geometric mean titer (GMT)
49
Antigenic cartography with hamster and human sera
indicate that JN.1 lineage viruses group together.
Wu-1 BA.2BA.5
XBB.1.5
JN.1KP.3.1.1ProVac
Hamster sera
Live virus assay
+0.5 log2 unit reactivity
adjustment for the XEC
antigen
XEC LP.8.1 - H445R + L441I
Francis Crick Institute
MRC University of Glasgow Centre for Virus Research
Center for Pathogen Evolution, University of Cambridge
   Antigenic and Virological Characteristics of
SARS -CoV-2 Variant BA.3.2, XFG, and
NB.1.8.1
•Current viruses are JN.1 descendants with 2 -3 substitutions in the spike receptor
binding domain in comparison to KP .2 spike
•Current viruses are neutralized with sera from participants who received the 2024 -
2025 COVID -19 vaccine
•Antigenic cartography indicates JN.1 viruses are antigenically similar
•FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC)
reviewed genomic and phenotypic data in May and voted unanimously to recommend a monovalent JN.1 -lineage vaccine composition.
-FDA has advised manufacturers to use JN.1 -lineage based COVID -19 vaccines, preferentially
using the LP .8.1 strain, for the 2025- 2026 COVID -19 vaccinesSummary of COVID- 19 Genomics
Back -up
Among all age groups, weekly rates of COVID -19–associated
hospitalizations are highest among adults ages ≥75 years.
Figure displays the w eekly rates of COVID -19–associated hospitalizations — COVID -NET, March 2020 –May 2025 .
Note that rates are not adjusted for testing. Rates are not limited to admissions where the respiratory infection is the like ly primary reason for admission. 53010203040506070Rate per 100,000 population
Surveillance week end dateWeekly rates of COVID -19–associated hospitalizations — COVID -NET, July 2023– April 2025
<6 months 6–23 months 2–4 years 5–11 years 12–17 years
18–49 years 50–64 years 65–74 years ≥75 years
Among all children and adolescents, rates of COVID -19-associated
hospitalizations are highest among infants and children ages <2 years.
Figure displays weekly rates of COVID -19–associated hospitalizations among children and adolescents ages ≤17 years — COVID -NET, July 2023– May 2025.
Note that rates are not adjusted for testing. Rates are not limited to admissions where the respiratory infection is the like ly primary reason for admission. 540510152025
Jul
2023Aug
2023Sep
2023Oct
2023Nov
2023Dec
2023Jan
2024Feb
2024Mar
2024Apr
2024May
2024Jun
2024Jul
2024Aug
2024Sep
2024Oct
2024Nov
2024Dec
2024Jan
2025Feb
2025Mar
2025Apr
2025May
2025Jun
2025Hospitalizations per 100,000 population
Surveillance periodWeekly rates of COVID -19–associated hospitalizations among children and adolescents ages ≤17 years — COVID -NET, July 2023–
May 2025
<6 months 6–23 months 2–4 years
Structure of XBB.1.5 vs. JN.1 spike
Blue – NTD
Red – RBD
Green – RBM
Purple – S1
Gold – FCS
Brown – S2Red sphere – deletions in one chain (labeled)
Magenta sphere – substitutions in one chain (labeled)
Raspberry sphere – deletions in rest 2 chains
Cyan sphere – substitutions in rest 2 chains
Schrodinger homology model of JN.1, starting with 7YR2 (BA.2.75)
Prepared by CDC: Megha Aggarwal, PhD 55
LP.8.1, the lineage that predominated this spring, has
limited spike substitutions in comparison to KP.2
Red sphere – deletions in one chain (labeled)
Magenta sphere – substitutions in one chain (labeled)
Raspberry sphere – deletions in rest 2 chains
Cyan sphere – substitutions in rest 2 chainsBlue – NTD
Red – RBD
Green – RBM
Purple – S1
Gold – FCS
Brown – S2ACE-2
Structure of JN.1 in complex with ACE -2 (PDB ID: 8YZE) Structure of JN.1 (PDB ID: 8Y5J)
56
COVID- NET Summary
•COVID -19 is estimated to have resulted in more than 250,000 hospitalizations since October 2024.
•Among children, rates of COVID -19–associated hospitalizations are highest among children ages <2 years.
-89% of children ages 6 months –17 years admitted for COVID -19 had no record of recent COVID -19 vaccination
-1 in 5 children aged <2 years admitted for COVID -19 are admitted to the ICU
•Of those ages <2 years admitted to the ICU, 53% had no underlying medical conditions
•Among adults, rates of COVID -19–associated hospitalizations are highest among adults ages ≥75 years.
•65% of adults ages ≥65 years hospitalized with COVID -19 had no record of receiving ≥1 dose of the
recommended 2024 -25 COVID -19 vaccine prior to hospitalization.
•Most adults ages ≥18 years hospitalized for COVID -19 have ≥1 underlying medical condition.
•Among SARS -CoV-2-positive pregnant women admitted during April 2024– March 2025 with COVID -19-
related symptoms on admission
-50% had no underlying medical condition
-92% have no record of COVID -19 vaccination since July 1, 2023
57
~1 in 4 children and adolescents hospitalized for COVID- 19 are
admitted to the intensive care unit (ICU)
Hospitalizations are limited to those with COVID -19 as the presenting complaint upon admission. Pregnant adolescents ages 15 –17 years are excluded from proportions
presented. 2225
2128
26
051015202530
<6 months 6 months –<2
years2–4 years 5–11 years 12–17 yearsPercent of hospitalizationsPercent of children and adolescents with COVID-19 –
associated hospitalizations admitted to the ICU,
by age group — COVID -NET, April 2024 –March 2025
During this period, 7 children with COVID -19–associated
hospitalization died in -hospital in the COVID -NET
catchment area. Age categoryAmong those
admitted to
ICU, % with no
underlying
conditions
<6 months 62%
6–23 months 48%
2–4 years 23%
5–11 years 19%
12–17 years 16%
Among children <2 years admitted to
ICU, most did not have underlying
medical conditions
58

Summary: Current Epidemiology of COVID -19  Coronavirus and Other Respiratory Viruses Division Advisory Committee on Immunization Practices (ACIP) June 25, 2025National Center for Immunization and Respiratory Diseases 1 COVID- 19 continues to impact Americans’ health. * Based on data from September 29, 2024 through June 7, 2025. Source: https://www.cdc.gov/covid/php/surveillance/burden- estimates.html  2  Among adults aged ≥18 years, 3.6%   reported Long COVID  symptoms, and 8.4% reported ever  having…