07 Mat Peds Jones 508

1
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.
Proposed clinical considerations for maternal RSVPreF
vaccine and nirsevimab
Jefferson Jones MD MPH FAAP
CDR USPHS
Co-Lead, Respiratory Syncytial Virus Vaccines -Pediatric/Maternal Work Group
Coronavirus and Other Respiratory Viruses Division
National Center for Immunization and Respiratory Diseases
September 22, 2023
2
Proposed clinical considerations
for use of maternal RSV vaccine
3▪Maternal vaccine recommended for pregnant people during 32 through 36
weeks gestation, with seasonal administration
–During September through January in most of the continental United States
–In jurisdictions with seasonality that differs from most of the continental United
States (e.g., Alaska, jurisdictions with tropical climates), providers should follow
state, local, or territorial guidance on timing of administration
▪Maternal RSVpreF vaccine may be simultaneously administered with
other indicated vaccinations 1Proposed clinical considerations for use of maternal RSV
vaccine
1 https://www.cdc.gov/vaccines/hcp/acip -recs/general -recs/index.html.
Work Group considerations for
use of both maternal RSV
vaccine and nirsevimab
5▪As proposed, maternal RSV vaccine recommendation is for administration
beginning at 32 weeks gestation
▪From time of maternal vaccination, 14 days or more likely needed for
development and transplacental transfer of maternal antibodies to
protect the infant,1 and nirsevimab is recommended for infants born
within 14 days of vaccination
▪Therefore, the earliest an infant can be born and have maternal vaccine -
induced protection is at 34 weeks gestation
▪Infants born <34 weeks gestation will be recommended to receive
nirsevimabMaternal vaccination and considerations for use of
nirsevimab in infants born <34 weeks gestation
1 https://www.cdc.gov/vaccines/pregnancy/vacc -during -after.html .
6▪Protection from maternal vaccination may begin to wane after 3 or more
months (e.g., influenza and COVID -19 vaccines) 1–3
–Work Group members initially concerned that , with a year -round recommendation, infants born prior to the RSV
season and born to vaccinated mothers would require nirsevimab to boost protection when entering RSV season
▪However, because maternal RSV vaccine administration is recommended
during September through January, most infants of vaccinated mothers
will be born during RSV season (i.e., born during October –March)
▪Mothers of most infants born outside of RSV season (i.e., born during April
through September) will not have been vaccinated, and nirsevimab will be
recommended for these infantsMaternal vaccination and considerations for use of
nirsevimab in infants born outside of the RSV season
1 Kampmann NEJM 2023 . 2Nunes F1000Res 2018 . 3 Zerbo Nat Commun 2023 .
7▪Two products are available to protect infants from RSV lower respiratory tract
infection
▪For infants born to vaccinated mothers, the addition of nirsevimab may
provide incremental protection, but this is unknown
–No safety data on use of nirsevimab in infants born to vaccinated mothers, but nirsevimab trials
included infants with maternal infection -induced antibodies and risk likely minimal
▪For most infants, administering both products is not needed and would not be
a reasonable and efficient allocation of resources
▪Documentation of maternal vaccination status may not be available to the
infant's healthcare providerWork Group considerations for use of both maternal RSV
vaccine and nirsevimab
8▪Most Work Group members felt that pregnant people should be aware that
both maternal vaccination and nirsevimab are options when deciding whether
to be vaccinated
–However, healthcare providers of pregnant people may not have time or feel
equipped to discuss nirsevimab when counselling
▪In rare situations flexibility is needed for providers to be able to provide
nirsevimab when clinically warranted to infants born to vaccinated mothers
–Conditions in pregnant people resulting in an inadequate immune response to vaccine or decrease
in transplacental antibody transfer1
–Infants who have undergone cardiopulmonary bypass, leading to loss of maternal antibodies2
–Infants with sufficiently increased risk for severe disease to warrant nirsevimab because of the
potential increased benefitWork Group considerations for use of both maternal RSV
vaccine and nirsevimab ( cont )
1Palmerira Clin Dev Immunol 2012 . 2 Feltes J Pediatr 2003 .
9
Proposed clinical considerations for use
of maternal RSV vaccine and
nirsevimab
10▪Either maternal vaccination or use of nirsevimab in the infant is
recommended to prevent RSV lower respiratory tract infection, but
administration of both products is not needed for most infants
▪Healthcare providers of pregnant people should provide
information onboth products and consider patient preferences when
determining whether to vaccinate the pregnant patient or to not
vaccinate and rely on administration of nirsevimab to the infant after birthProposed clinical considerations for maternal RSV vaccine
and nirsevimab
11Relative risks and benefits of maternal vaccination and
nirsevimab
Maternal RSV vaccine
Benefits
•Provides protection immediately after
birth
•May be more resistant to virus mutation
•Avoids injection of infant
Risks
•Protection reduced if fewer antibodies
produced or are transferred from mother
to baby (e.g., mother
immunocompromised or infant born soon
after vaccination)
•Potential risk of preterm birthNirsevimab
Benefits
•Studies of antibody levels suggest that
protection might wane more slowly
•Can provide antibodies directly if infant
receives less antibodies from mother
•No risk of adverse pregnancy outcomes
Risks
•Potentially limited availability during
2023 -2024 RSV seasonBoth products are safe and effective in preventing RSV lower respiratory infection in infants
12▪Nirsevimab is recommended for infants aged <8 months born
during or entering their first RSV season if
–Mother did not receive RSV vaccine or unknown if mother received RSV vaccine
–Mother vaccinated but infant born <14 days after vaccination
▪Nirsevimab is not needed for most infants born ≥14 days after
maternal vaccinationProposed recommendations for use of nirsevimab in setting of
an available maternal RSV vaccine
13▪Nirsevimab can be considered in rare circumstances when, per the
clinical judgment of the healthcare provider, the potential
incremental benefit of administration is warranted
–Infants born to pregnant people who may not mount an adequate immune response
to vaccination (e.g., people with immunocompromising conditions) or have
conditions associated with reduced transplacental antibody transfer (e.g., people
living with HIV infection)1
–Infants who have undergone cardiopulmonary bypass, leading to loss of maternal
antibodies2
–Infants with substantial increased risk for severe RSV disease (e.g.,
hemodynamically significant congenital heart disease, intensive care admission and
requiring oxygen at discharge)Circumstances for which nirsevimab can be considered when
mother has received RSV vaccine ≥14 days prior to birth
1Palmerira Clin Dev Immunol 2012 .2Feltes J Pediatr 2003 .
14Nirsevimab administration algorithm for children aged <8 months
on the day of administration
Nirsevimab
not neededNo
Any criteria not metMeet all 3 following criteria? (yes/no)
1.Either mother did not receive RSV vaccine during pregnancy ≥14
days prior to birth or maternal RSV vaccine status unknown1
2.Day of nirsevimab administration during October through March2
3.Never previously received dose of nirsevimab3
Nirsevimab
recommendedYes
All 3 criteria met
15Nirsevimab administration algorithm for children aged
<8 months on the day of administration footnotes
1For most infants age <8 months whose mother received RSV vaccine 14 or more days prior to birth,
nirsevimab is not needed. Nirsevimab can be considered in rare circumstances when, per the clinical
judgment of the healthcare provider, the potential incremental benefit of administration is warranted.
These situations include infants born to  pregnant people who may not mount an adequate immune
response to vaccination (e.g., people with immunocompromising conditions) or have conditions associated
with reduced transplacental antibody transfer (e.g., people living with HIV infection), infants who have
undergone cardiopulmonary bypass leading to loss of maternal antibodies, and infants with substantial
increased risk for severe RSV disease (e.g., hemodynamically significant congenital heart disease, intensive
care admission and requiring oxygen at discharge).
2While the timing of the onset and duration of RSV season may vary, nirsevimab may be administered
October through the end of March in the majority of the continental United States. Providers may adjust
timing of administration based on guidance from public health authorities (e.g., CDC, health departments)
or regional medical centers. Although optimal timing of administration is just before the start of the RSV
season, nirsevimab may also be administered during the RSV season to infants and children who are age -
eligible. Infants born shortly before or during RSV season should receive nirsevimab within one week of
birth. Nirsevimab administration can occur during the birth hospitalization or in the outpatient setting.
Infants with prolonged birth hospitalizations related to prematurity or other causes should receive
nirsevimab shortly before or promptly after hospital discharge.
16
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1-800 -CDC -INFO (232 -4636)
TTY:  1 -888 -232-6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention.
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.

17Nirsevimab administration algorithm for children aged 8 through
19 months on day of administration1
No
Notall 3 criteria metMeet all 3 following criteria? (yes/no)
1.Child at increased risk for RSV disease2
2.Day of administration during October through March3
3.Has not received 1 dose of nirsevimab during current
RSV season and has not received 2 total doses4
Nirsevimab
recommendedNirsevimab not
neededYes
All 3 criteria met
18Nirsevimab administration algorithm for children aged 8 through 19 months on day of administration
footnotes
1Children at increased risk for severe disease aged <8 months of age and entering their second RSV season
should receive nirsevimab. For example, a child born in March should receive their first RSV dose shortly
after birth; they may be entering their second RSV season at 7 months of age in October and should not wait
until 8 months of age to receive nirsevimab.
2Children aged 8 –19 months recommended to receive nirsevimab during their second RSV season by ACIP:
-Children with chronic lung disease of prematurity who required medical support (chronic corticosteroid
therapy, diuretic therapy, or supplemental oxygen) any time during the 6 -month period before the start of
the second RSV season
-Children with severe immunocompromise
-Children with cystic fibrosis who have either 1) manifestations of severe lung disease (previous
hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that
persist when stable) or 2) weight -for-length <10th percentile
-American Indian and Alaska Native children
19Nirsevimab administration algorithm for children aged 8 through 19 months on day of administration
footnotes
3While the timing of the onset and duration of RSV season may vary, nirsevimab may be administered
October through the end of March in the majority of the continental United States. Providers may adjust
timing of administration based on guidance from public health authorities (e.g., CDC, health departments)
or regional medical centers. Although optimal timing of administration is just before the start of the RSV
season, nirsevimab may also be administered during the RSV season to infants and children who are age -
eligible. Infants born shortly before or during RSV season should receive nirsevimab within one week of
birth. Nirsevimab administration can occur during the birth hospitalization or in the outpatient setting.
Infants with prolonged birth hospitalizations related to prematurity or other causes should receive
nirsevimab shortly before or promptly after hospital discharge.
4Children at increased risk for severe disease should not receive more than two doses of nirsevimab (one
dose [50mg or 100 mg depending on weight] for the first RSV season and one dose [two 100 mg injections]
for the second RSV season). Only one dose of nirsevimab is recommended per season (with exception for
children who undergo cardiac surgery with cardiopulmonary bypass). Nirsevimab is recommended for
children at increased risk for severe disease (as defined in footnote 4) during their first RSV season, including
if aged 8 -11 months if the child has not received nirsevimab during that RSV season.

Summary: 1 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. Proposed clinical considerations for maternal RSVPreF vaccine and nirsevimab Jefferson Jones MD MPH FAAP CDR USPHS Co-Lead, Respiratory Syncytial Virus Vaccines…


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National Center for Immunization and Respiratory Diseases
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use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.
Maternal RSV Vaccine Implementation
Considerations
Georgina Peacock, MD, MPH
Immunization Services Division
Centers for Disease Control and Prevention
▪Vaccine storage, handling, and administration
▪Cost of vaccine
▪Insurance coverage
▪Supply and availability
▪Complexity of immunization schedule
▪Vaccine demand and coverage in pregnant people
▪Obstetric and pediatric provider roles in vaccination decisions
▪Immunization information systems
▪Communication challengesMaternal RSV Implementation Considerations

▪Overall clinical implementation similar to other vaccines
–Stored at 2 ◦to 8◦C
–Administered as a single dose through intramuscular route
▪Additional steps required for dilution,
including reconstitution of the lyophilized antigen
component with the sterile water diluent componentPfizer RSV Vaccine Storage, Handling, and Administration
Package Insert -ABRYSVO (STN 125769/26) | FDA
▪Proposed recommendations to ACIP allow for simultaneous administration
with other recommended vaccines
▪Increasing number of vaccines could lead to concerns for limited storage spaceSupplied as a kit with the following components:
▪Cost of the Pfizer RSV vaccine is $295/dose, compared to ~$46 -52 for Tdap1
–Cost is lower than infant nirsevimab ($495 private sector cost)
▪Reimbursement and cost recovery challenges already identified by providers and
practices as an implementation barrier for maternal immunization2Cost of Maternal RSV Vaccine
1. Current CDC Vaccine Price List | CDC
2.Immunization Practices of U.S. Obstetrician/Gynecologists for Pregnant Patients | ScienceDirect
Provider Financial Concerns
are a Leading Barrier to
Maternal Immunization
Immunization Practices of U.S. Obstetrician/Gynecologists for Pregnant Patients |
ScienceDirect

▪Private insurance: 52% of pregnant people1
–The Affordable Care Act (ACA) requires insurers to cover all ACIP -routinely recommended
immunizations for plan years that begin on or after the date that is one year after the date of the
recommendation2
▪Medicaid: 41% of pregnant people1
–After 10/1/23, when the Inflation Reduction Act provisions become effective, state Medicaid agencies
will be required to cover vaccines and their administration without cost -sharing for nearly all full -
benefit adult beneficiaries covered under traditional Medicaid, if the CDC/ACIP recommendations
apply3
▪No insurance: 4% of pregnant people “self -pay” (likely uninsured)1
–If recommended, ACIP will vote on a Vaccines for Children resolution for maternal RSV vaccine in
people aged <19 years
–For people age 19+ years, limited availability (e.g., through 317 program)Insurance Coverage of Maternal RSV Vaccine
1.Products -Data Briefs -Number 468 -May 2023 (cdc.gov) ; insurance status refers to source of payment for delivery. Another ~3% used other types of coverage
2.42 U.S. Code §300gg –13 -Coverage of preventive health services | Cornell Law School
3.Anniversary of the Inflation Reduction Act: Update on CMS Implementation | CMS
▪ACIP has recommended nirsevimab as a routine immunization. Therefore, it will be
covered under the ACA without cost sharing by the patient starting in the effective
plan year1
▪Nirsevimab is included in the Vaccines for Children Program2
–Eligible children (~50% of U.S. children) will be able to access nirsevimab at no costInsurance Coverage for Infant Nirsevimab
1.42 U.S. Code §300gg –13 -Coverage of preventive health services | Cornell Law School
2.Advisory Committee on Immunization Practices, Vaccines for Children Program | CDC
▪No anticipated supply/demand mismatch
▪Because the Pfizer maternal RSV vaccine is the same product in use for adults aged
≥60 years, availability is expected shortly after ACIP recommendations
▪Nirsevimab will likely be available late September/early October, but may not be
available in all pediatric settings this season
–Efforts underway to increase number of birthing hospitals who will administer nirsevimabSupply and Availability of Maternal RSV Vaccine and
Nirsevimab During 2023 –2024 RSV Season
Increasing Complexity of Maternal Immunization Schedule
▪Increasingly complex maternal immunization schedule, with different timing of
vaccines based on season and/or gestational age (with seasonal timing varying in
some locations)
▪Limited window for RSV vaccine administration
▪Unclear willingness of pregnant people to accept multiple vaccines in pregnancy

In a survey of pregnant people, 12% said they would accept
no vaccines, and 49% said they would accept 1 -2 vaccines
CDC and University of Iowa/RAND survey, unpublished

Uptake of Vaccines among Pregnant People Has Declined
and Disparities Persist
Flu, Tdap, and COVID -19 Vaccination Coverage Among Pregnant Women –United States, April 2022 | CDC

▪Decisions for whether to administer maternal RSV vaccine or infant nirsevimab will
need to be made during pregnancy
▪Studies continue to demonstrate healthcare providers as pregnant people’s most
trusted source of information on vaccines, and provider recommendation is a strong
predictor of vaccination1
▪However, one survey showed that 2/3 of obstetricians did not feel providing
information about routine childhood immunizations was part of their role2Obstetric Provider Role in Immunization Decisions
1.Lutz C, et al. Understanding barriers and predictors of maternal immunization: Identifying gaps through an exploratory litera ture review. Vaccine 36 (2018): 7445 -7455
2.Missed Opportunities: A National Survey of Obstetricians About Attitudes on Maternal and Infant Immunization | SpringerLink
▪Recommendations for nirsevimab that are contingent upon knowledge of maternal
vaccination status could be challenging if the pediatric provider does not receive the
maternal record
▪Verbal report of vaccines received during pregnancy may not be reliable1
▪Pediatric providers may need to make decisions on nirsevimab administration with
incomplete information on maternal vaccination statusPediatric Provider Role in Immunization Decisions
1.Tdap Vaccination Coverage During Pregnancy —Selected Sites, United States, 2006 –2015 | CDC
▪State IIS vary in adult immunization capture
▪Pregnancy status not identified in IIS, though could potentially consider RSV vaccine
administrations in adult women (<age 60 years) as a proxy
▪Unable to link maternal and infant immunization records in the IIS
–Clinical Decision Support for immunization unable to take into account maternal
vaccination history for forecasting for infant nirsevimab immunization
–Some state IIS policies limit ability of pediatric providers to review adult records, or
records for individuals who are not their patientsImmunization Information Systems (IIS)
▪Terminology: Vaccine (maternal product) vs.
Immunization (infant product)
▪Conveying potential risks and benefits of each
approach, and helping the pregnant person make an
informed decision
–Including potential but undetermined risk of preterm birth with
maternal immunization
▪Discussing financial implications to patient in setting of
uncertainties about coverage during the first year of
implementationCommunications Challenges

▪Formative Research and Message Testing:
–Focus groups and in -depth interviews with pregnant people and prenatal health
providers (in progress)
–Surveys with parents of young children and pregnant and recently pregnant people
▪Patient and provider education materials
▪Digital partnerships with healthcare provider organizations
▪Partnerships with organizations that serve pregnant people
▪Social media across CDC’s platformsCommunications Activities

Thank You

Summary: 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. Maternal RSV Vaccine Implementation  Considerations Georgina Peacock, MD, MPH Immunization Services Division Centers for Disease Control and Prevention ▪Vaccine storage,…


09 Mat Peds Schillie 508

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.Addition of an Addendum to the
2023 Immunization Schedules for Children/Adolescents and Adults
Sarah Schillie, MD, MPH, MBA
CAPT, US Public Health Service
Team Lead, Professional Education and Training, Immunization Services Division
Centers for Disease Control and Prevention
Advisory Committee on Immunization Practices
September 22, 2023
Atlanta, GA
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 pre sentation use. No
rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.
Immunization Schedules: Overview
▪Two separate schedules
–Child and adolescent schedule (age
birth through 18 years)
–Adult schedule (age 19 years or older)
▪Multiple sections that summarize
and aid in implementation of
approved ACIP policy
–Cover Page
–Tables
–Notes
–Appendix
2 of 23 Immunization Schedules | CDC
www.cdc.gov/vaccines/schedules/index.html

Immunization Schedules: Overview, cont.
▪Published in 3 formats:
–PDF, webpage, app
▪Multiple professional organizations partner with CDC to approve schedules
–American College of Physicians ( www.acponline.org )
–American Academy of Family Physicians ( www.aafp.org )
–American College of Obstetricians and Gynecologists ( www.acog.org )
–American College of Nurse -Midwives ( www.midwife.org )
–American Academy of Physician Associates ( www.aapa.org )
–American Pharmacists Association ( www.pharmacist.com )
–Society for Healthcare Epidemiology of America ( www.shea -online.org )
–American Academy of Pediatrics ( www.aap.org )
–National Association of Pediatric Nurse Practitioners ( www.napnap.org )
▪Some professional organizations publish the schedules
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Traditional Publication Timeline
October November December January February
ACIP vote approves the
immunization schedulesProfessional organizations
approve schedules
Draft and clear MMWR reports (both
schedules) and Annals of Internal
Medicine report (adult schedule only)Schedules (3 formats),
MMWR Notice to Readers, &
Annals of Internal Medicine
report published
8 of 23
▪Insurance reimbursement
▪The ability of certain health care providers to administer
immunizations
–Some states link pharmacists’ immunization authority to the schedule
▪Health care provider knowledge and practices related to
immunization recommendationsImpacts of Timeliness of Schedule Publication
9 of 23
▪Must provide coverage for and must not impose any cost -sharing requirements
(such as a copayment, coinsurance, or a deductible) for —
“Immunizations for routine use in children, adolescents, and adults that have in
effect a recommendation from the Advisory Committee on Immunization
Practices of the Centers for Disease Control and Prevention…” “…considered in
effect after it has been adopted by the Director of the Centers for Disease
Control and Prevention, and a recommendation is considered to be for routine
use if it is listed on the Immunization Schedules of the Centers for Disease
Control and Prevention)”
▪ACA does not specify what defines the Immunization Schedule
–Legally, CDC has discretion regarding what constitutes the immunization scheduleAffordable Care Act: Immunization Coverage
10 of 23
3-Pronged Approach to Address Schedule Timeliness,
Maximize Utility
Immediate
Strategy
Addition of
Addenda will help
bring the schedule
up-to-dateShort -term
Strategy
Publish entirety of
schedule soon after
October ACIP voteLonger -term
Strategy
Consider sustainable approach to ensure
schedule remains dynamic/responsive
and current (proposal in early in CY24)
Ensure partner engagement in
planning process
11 of 23
Addition of Addenda to 2023 Immunization Schedules
▪Contain ACIP recommendations that occurred after the 2023
schedule was published
▪Plan to release 2023 Immunization Schedules with Addenda next
week
▪With this addition, all ACIP recommendations will formally be part of
the CDC Immunization Schedules
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▪Anticipate release of 2023 Immunization Schedules with
Addenda next week
–Formally incorporate all ACIP recommendations into 2023 CDC
Immunization Schedule
▪Plan for short -and long -term sustainable strategies to address
schedule timeliness
–Ensure partner engagementSummary
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Acknowledgements
Immunization Services Division and
Health Education and Communication Branch staff, especially:
•Neil Murthy
•Patricia Wodi
•Rosa Herrera
•Richard Quartarone
•Akiko Wilson
23 of 23
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the
official position of the Centers for Disease Control and Prevention.Questions?
Additional Slides
▪Adult Vaccine Assessment Tool
▪Child and Adolescent Vaccine Assessment Tool
▪Parent Friendly CDC Resources based off the Immunization Schedules

Summary: 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…


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use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.
ACIP COVID -19 Vaccines Work Group
Dr. Matthew F. Daley, Work Group Chair
Sept 12, 2023
▪September 11, 2023:
–FDA updated COVID -19 vaccine emergency use authorizations (EUAs)
•Use of 2023 –2024 mRNA vaccines for all doses/indications administered to
individuals ages 6 months –11 years
–FDA approved supplemental biologics license applications (BLAs)
•Use of 2023 –2024 mRNA vaccines for all doses/indications administered to
individuals ages ≥ 12 yearsCOVID -19 vaccine update:
FDA authorizations and approvals
▪Updates to COVID -19 epidemiology and vaccine effectiveness, including in pregnant persons and
infants
▪Infection -induced and hybrid immunity
▪Summary and Work Group considerations
–COVID -19 and pregnancy:
•Pregnancy remains a risk factor for severe COVID -19 disease
•COVID -19 vaccination improves outcomes for pregnant people and their infants
–Infection -induced and h ybrid immunity:
•Hybrid immunity likely provides better protection than either infection or vaccination alone.
•Protection likely influenced by multiple factors (e.g., prior vaccine doses, infection, time since
vaccination or infection)
•Protection wanes over time after both infection and vaccinationJune ACIP Meeting Review
June 23, 2023
▪Manufacturer data to inform monovalent XBB.1.5 containing vaccine update
▪Modeling of pandemic outcomes in varied scenarios, demonstrating potential impact
of new variants and varying vaccine/booster coverage
▪Comprehensive review of COVID -19 vaccine safety
▪Updated data on COVID -19 epidemiology, vaccine effectiveness, and benefit -risk
assessment
▪Epidemiology of post -COVID conditions
▪COVID -19 vaccine cost -effectiveness analysis
▪Evidence to Recommendations Framework
–Work group discussed universal vs. risk -based strategies, reviewed additional data
on burden (by age group, presence of underlying condition)ACIP COVID -19 Work Group Meeting Review
July –September 2023
▪Current landscape of SARS -CoV -2 lineages Dr. Natalie Thornburg
▪COVID -19 epidemiology Dr. Fiona Havers
▪Post -COVID conditions Dr. Sharon Saydah
▪COVID -19 Vaccine Effectiveness Update Dr. Ruth Link -Gelles
▪Economic analysis of COVID -19 vaccination Dr. Lisa Prosser
▪COVID -19 vaccine safety surveillance Dr. Nicola Klein
▪Break
▪Moderna 2023 –2024 COVID -19 vaccine Dr. Fran Priddy
▪Novavax 2023 –2024 COVID -19 vaccine Dr. Filip Dubovsky
▪Pfizer -BioNTech 2023 –2024 COVID -19 vaccine Dr. Kayvon ModjarradAgenda
September 12, 2023
Break
▪Evidence to Recommendations Dr. Megan Wallace
▪Overview of COVID -19 vaccine implementation Dr. Georgina Peacock
▪Bridge access program Dr. Evelyn Twentyman
▪Discussion
Break
PUBLIC COMMENT
Break
Vote:
2023 –2024 COVID -19 vaccines in persons ages 6 months and olderAgenda
September 12, 2023
Work Group members
ACIP members
▪Matthew Daley (chair)
▪Beth Bell
▪Grace Lee
▪Keipp Talbot
▪Oliver Brooks
Ex-officio/government members
▪FDA: Rachel Zhang, Lucia Lee, Anuja Rastogi
▪NIH: Chris Roberts, Michael Ison
▪IHS: Uzo Chukwuma
▪CMS: Jeff Kelman
▪BARDA: Christine Oshansky
▪HHS: Valerie Marshall
▪CDC: Alan Lam
CDC Leads
▪Megan Wallace
▪Joanna Regan
7Liaisons
▪AAFP: Jonathan Temte
▪AAP: Sean O’Leary
▪ACOG: Denise Jamieson (primary),
Laura Riley (alternate)
▪ACP: Jason Goldman
▪ADS: Emily Kahn
▪AGS: Ken Schmader
▪AMA: Sandra Fryhofer
▪ANA: Ruth Francis (alternate)
▪APA: Richard Dang
▪ASTHO: Marcus Plescia
▪CSTE: Paul Cieslak, Christine HahnLiaisons, cont’d
▪NACCHO: Matt Zahn (primary),
Jeff Duchin (alternate)
▪NACI: Matthew Tunis (primary),
Eva Wong (alternate)
▪NFID: Rob Schechter (primary),
Bill Schaffner (alternate)
▪NMA: Patricia Whitley -Williams
▪SHEA: Preeti Mehrotra,
Marci Drees (alternate)
Consultants
▪Ed Belongia
▪Hank Bernstein
▪Kathy Edwards
▪Robert Hopkins
▪Lisa Jackson
▪Kathy Kinlaw
▪Dayna Matthew ▪Jennifer Nelson
▪Kathleen Neuzil
▪Stanley Perlman
▪Peter Szilagyi
▪Sarah Meyer
▪Elisha Hall
▪Danielle Moulia
▪Monica Godfrey
▪Hannah Rosenblum
▪Katherine Fleming -Dutra
▪Ruth Link -Gelles
▪Lauren Roper
▪Mary Chamberland
▪Susan Goldstein
▪Stephen Hadler
▪JoEllen Wolicki
▪Melinda Wharton
▪Jessica MacNeil
▪Amanda Cohn
▪Brooke Aspinwall
▪Latifa Boyce CDC participants
8▪Amadea Britton
▪Karen Broder
▪Carolyn Bridges
▪Allison Ciesla
▪Nicole Dowling
▪Daniel Drapeau
▪Tarayn Fairlie
▪Ashley Fowlkes
▪Julianne Gee
▪Samuel Graitcer
▪Lisa Grohskopf
▪Katherine Grusich
▪Aaron Hall
▪Demorah Hayes
▪Rita Helfand
▪Terri Hyde
▪Jefferson Jones ▪Melisa Shah
▪Tom Shimabukuro
▪Jordan Singleton
▪Laura Steinhardt
▪John Su
▪Natalie Thornburg
▪Evelyn Twentyman
▪Dennis Wang
▪Raigan Wheeler
▪Ryan Wiegand
▪Patricia Yu
▪Yon Yu▪Andrew Kroger
▪Josephine Mak
▪Lauri Markowitz
▪Michael McNeil
▪Michael Melgar
▪Noelle -Angelique Molinari
▪Morgan Najdowski
▪Kristen Nordlund
▪Sara Oliver
▪Ismael Ortega -Sanchez
▪Manisha Patel
▪Pragna Patel
▪Amanda Payne
▪Georgina Peacock
▪Jamison Pike
▪Derrell Powers
▪Sierra Scarbrough
For more information, contact CDC
1-800 -CDC -INFO (232 -4636)
TTY:  1 -888 -232-6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention.
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

Summary: 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. ACIP COVID -19 Vaccines Work Group Dr. Matthew F. Daley, Work Group Chair Sept 12, 2023 ▪September 11, 2023:  –FDA updated COVID -19 vaccine emergency use authorizations…


02 COVID Thornburg 508

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.
Current landscape of SARS -CoV-2 lineages
September 2023
Natalie J. Thornburg, PhD
Chief, Laboratory Branch
Coronaviruses and Other Respiratory Viruses Division
Trends in weighted lineage proportion estimates & Nowcast
United States, May 27 –September 2, 2023
https://covid.cdc.gov/covid -data-tracker/#variant -proportions Accessed 9/1/2023
Two-week period ending
Convergent Evolution of Different Omicron Sub -lineages:
Key changes in the spike receptor binding domain (RBD) detected since September 2022
LineageSpike RBD (residues 333 -527) amino acid substitutions
339
§346
§,¶368 444
§,¶445
¶446
§,¶452
§,¶460
§,¶478 486
§,¶490
§,¶521
Reference sequence: BA.4/BA.5 D R L K V G R N K V F P
BA.4.6, BA.5.2.6, BF.7, BF.11 — T——————————
BQ.1 ——— T——— K————
BQ.1.1 — T— T——— K————
BA.2.75 H———— S L K— F——
BN.1 H T——— S L K— F S—
CH.1.1 H T— T— S— K— S——
XBB, XBB.1 H T I— P S L K— S S—
XBB.1.5, XBB.1.5.1, FD.2, XBB.1.9.1,
XBB.1.9.2H T I— P S L K— P S—
XBB.1.16, XBB.1.16.1 H T I— P S L K R P S—
XBB.2.3 H T I— P S L K— P S S
Ma et al. MMWR to be published on June 15, 2023
§Indicates sites of independent substitutions in at least two different evolutionary lineages.
¶Indicates sites identified in a previous study associated with in vitro reductions in binding by monoclonal antibodies that were previously FDA -authorized.
Bolded sub -lineages are expanding in the United States as of June 10, 2023
More than 90% of circulating viruses have similar Spike receptor
binding domain sequences
LineageSpike RBD (residues 333 -527) amino acid substitutions
452 455 456 460 478 486 521
Reference sequence: XBB.1.5 L L F K K P P
XBB.1.9 — — — — — S —
XBB.1.5.70 — F L — — — —
XBB.1.16 — — — — R — —
EG, FL — — L — — — —
EG.5 , EG.5.1.6 , FL.1.5 — — L — — — —
XBB.1.16.6, XBB.1.16.9, FL.1.5.1, HN.1 — — L — R — —
HV.1 R — L — — — —
HK.3 — F L — — — —
XBB.2.3 — — — — — — S
XBB.1.16, XBB.1.16.1 — — — — R — —
XBB.1.5 and XBB.1.16 Spike substitutions relative to
BA.5
Receptor
binding motif
Receptor
binding domain
N-terminal
domain
Remainder of
S1
S2ACE2
ACE2XBB.1.5 XBB.1.16
BA.2.86 is a descendent of BA.2
Nexstrain (Roemer / Neher )•Most closely related
to BA.2
•BA.2 and its lineages
circulated in spring
2022 before BA.5
viruses

BA.2.86 has >30 amino acid substitions in spike in
comparison to XBB.1.5
▪>30 amino acid substitutions in Spike in comparison to XBB.1.5
–Variation between sequences due to missing data and sequencing artifacts
▪First detected in specimen collected in late July, 2023
▪As of 9/6 detected in 7 clinical specimens in 7 US states and 1 additional state in
waste water
▪Detected in 10 countries
▪Small number of sequences

Reduction in pseudovirus neutralization is not detected
using sera from people infected with XBB lineage
viruses
Qian Wang
Dr. David D. Ho lab

No reduction in BA.2.86 pseudovirus neutralization
is observed after bivalent vaccination, or after 6
months with or without XBB infection
Lasrado et al. Neutralization Escape by SARS -CoV-2 Omicron Subvariant BA.2.86 | bioRxiv

Data generation with authentic viruses
▪More than 90% of currently circulating viruses are XBB lineage viruses with 1 -2
additional substitutions in RBD in comparison to XBB.1.5
▪BA.2.86 is a newly detected lineage with > 30 amino acid substitutions in spike
–Thus far, the number of viruses detected is still low
–Sequence numbers are too low to calculate proportion (<0.05%)
▪Preliminary pseudovirus neutralization data generated by multiple labs do not
indicate a large reduction in neutralizing activity against BA.2.86
▪CDC has generated a BA.2.86 isolates, is currently working on titrations before
neutralization and will distribute to external laboratories for further examination
▪More than 90% of currently circulating viruses are XBB lineage viruses with 1 -2
additional substitutions in RBD in comparison to XBB.1.5
▪BA.2.86 is a newly detected lineage with > 30 amino acid substitutions in spike
–Thus far, the number of viruses detected is still low
–Sequence numbers are too low to calculate proportion (<0.05%)
▪Preliminary pseudovirus neutralization data generated by multiple labs do not
indicate a large reduction in neutralizing activity against BA.2.86
▪CDC has generated a BA.2.86 isolate, is currently working on titrations before
neutralization and has begun distribution to external laboratories for further
examinationSummary
For more information, contact CDC
1-800 -CDC -INFO (232 -4636)
TTY:  1 -888 -232-6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention.
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.

Summary: 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. Current landscape of SARS -CoV-2 lineages September 2023 Natalie J. Thornburg, PhD Chief, Laboratory Branch Coronaviruses and Other Respiratory Viruses Division Trends in…


03 COVID Havers 508

Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation
use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.
COVID -19–Associated Hospitalizations among
Infants, Children and Adults —COVID -NET, January –
August 2023
ACIP , September 12, 2023
Fiona P . Havers, MD, MHS
Team Lead, RESP -NET Hospitalization Surveillance Team
Surveillance and Prevention Branch
Coronavirus and Other Respiratory Viruses Division
▪RESP -NET: COVID -NET, RSV -NET, FluSurv -NET
▪>300 acute -care hospitals
▪98 counties in 13 states
▪In 9 of 10 HHS regions
▪~10% of U.S. population
▪Positive SARS -CoV-2 within 14 days of or
during hospitalization
▪Screening or clinician -driven testing
▪Clinical data: representative sample of
COVID -NET patientsCOVID -NET: A RESP -NET population -based hospitalization
surveillance platform
2
Weekly Population -Based Rates of COVID -19-Associated
Hospitalizations —COVID -NET, March 2020 –August 26,
2023
020406080100120140
3/7/2020
5/7/2020
7/7/2020
9/7/2020
11/7/2020
1/7/2021
3/7/2021
5/7/2021
7/7/2021
9/7/2021
11/7/2021
1/7/2022
3/7/2022
5/7/2022
7/7/2022
9/7/2022
11/7/2022
1/7/2023
3/7/2023
5/7/2023
7/7/2023Rate per 100,000 population
Week Ending DateMarch 1, 2020 –August 26, 2023
<6 months 6 months –4 years 5–11 years 12–17 years
18–49 years 50–64 years 65–74 years ≥75 years020406080100120140Rate per 100,000 population
Week Ending DateJanuary 1 –August 26, 2023
Gray boxes indicate potential reporting delays. Interpretation of trends should be excluded from these weeks. Rates highest in ≥75 years, followed by
infants <6 months and adults 65 –74 years
3
Epidemiology of COVID -19–associated
hospitalization among children
01020304050607080Rate per 100,000 population
Week Ending Date
<6 months 6 months –4 years 5–11 years 12–17 years
Gray boxes indicate potential reporting delays. Interpretation of trends should be excluded from these weeks. Weekly Population -Based Rates of COVID -19-Associated
Hospitalizations among Infants, Children, and Adolescents
≤17 Years —COVID -NET, March 2020 –August 26, 2023
5
Gray boxes indicate potential reporting delays. Interpretation of trends should be excluded from these weeks. 02468101214161820
3/7/2020 6/7/2020 9/7/2020 12/7/2020 3/7/2021 6/7/2021 9/7/2021 12/7/2021 3/7/2022 6/7/2022 9/7/2022 12/7/2022 3/7/2023 6/7/2023Rate per 100,000 population
Week Ending Date
6-23 months 2-4 years 5–11 years 12–17 yearsFocus on 6 months -17 years of ageWeekly COVID -19-Associated Hospitalization Rates among
Infants, Children and Adolescents Ages 6 months –≤17 Years
—COVID -NET, March 2020 –August 26, 2023
6
Percent of COVID -19-Associated Hospitalizations with Underlying
Medical Conditions among Children and Adolescents Ages 5 –17 Years
by Age Group —COVID -NET, January –June 2023
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission. Figure displays underlying medical conditions present in ≥5% in ≥1 age group.•54% of hospitalized
infants, children, and
adolescents ages
≤17 years have no
underlying medical
conditions .
•Hospitalizations
children and
adolescents ages ≥5
years are more
likely to have
underlying medical
conditions relative
to children and
infants ages ≤4
years.0510152025303540
<6 months 6–<2 years 2–4 years 5–11 years 12–17 yearsWeighted % of COVID -19 associated
hospitalizations
Prematurity Asthma
Neurologic disorders Obesity
Immunocompromising condition Cardiovascular disease
Feeding tube dependence Chronic lung disease, not including asthma
Blood disorders Chronic metabolic diseases, including diabetes34% with no
underlying
conditions59% with no
underlying
conditions42% with no
underlying
conditions23% with no
underlying
conditions75% with no
underlying
conditions
7
050100150200250
10/9/2021 1/9/2022 4/9/2022 7/9/2022Rate per 100,000 population
Week Ending Date
≤4 years (COVID -19) ≤4 years (Influenza)
5–11 years (COVID -19) 5–11 years (Influenza)
12–17 years (COVID -19) 12–17 years (Influenza)050100150200250
10/8/2022 11/26/2022 1/14/2023 3/4/2023 4/22/2023 6/10/2023Rate per 100,000 population
Week Ending Date
≤4 years (COVID -19) ≤4 years (Influenza)
5–11 years (COVID -19) 5–11 years (Influenza)
12–17 years (COVID -19) 12–17 years (Influenza)Cumulative Weekly Rates of COVID -19-and Influenza -Associated
Hospitalizations among Infants, Children, and Adolescents Ages
≤17 Years —COVID -NET and FluSurv -NET*, October 2021 —July 2023
October 2022 –July 2023 October 2021 –September 2022
* Influenza Hospitalization Surveillance Network. Seasonal FluSurv -NET surveillance was extended into June for the 2021 -2022 season. Surveillance ended on April 30, 2023, for the 2022 –2023
season. Hospitalization rates are among those with laboratory -confirmed influenza and SARS -CoV-2 and are not adjusted for likely reason for admission. 8
212726 2532
1619
17 1723
05101520253035
<6 months 6 months –<2 years 2–4 years 5–11 years 12–17 yearsPercent of Hospitalizations
COVID-19 InfluenzaPercent of COVID -19-and Influenza -Associated Hospitalizations
with ICU Admission among Infants, Children, and Adolescents
by Age Group —COVID -NET and FluSurv -NET*, October 2022 –
April 2023
•Influenza Hospitalization Surveillance Network
Limited to COVID -NET hospitalizations with COVID -19-related illness as likely reason for admission9
Vaccination Status by Age Group among Infants, Children and
Adolescents Ages ≤17 Years Hospitalized for COVID -19 —
COVID -NET, January –June 2023
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission. Unvaccinated : No recorded doses of COVID -19 vaccine. Vaccinated, but no bivalent booster :
Completed a primary series with or without ≥1 booster dose but did not receive an updated bivalent booster dose. Updated bivalent booster : Received updated bivalent booster dose.
Partially vaccinated : Received at least one dose of COVID -19 but was not considered fully vaccinated at the time of a positive SARS -CoV-2 test. Pers ons with unknown vaccination status
are excluded. 86
63
268
28
634 6
0%10%20%30%40%50%60%70%80%90%100%
6 months –4 years 5–11 years 12–17 yearsPercent of COVID -19-asssoicated
hospitalizations
Unvaccinated Vaccinated, but no bivalent booster Updated bivalent booster Partially vaccinated
10
Epidemiology of COVID -19–associated
hospitalizations among adults
Weekly Population -Based Rates of COVID -19-Associated
Hospitalizations among Adults Ages ≥18 Years —COVID -NET,
March 2020 –August 2023
020406080100120140Rate per 100,000 population
Week Ending DateMarch 1, 2020 –August 26, 2023 (entire pandemic period)
18–49 years 50–64 years 65–74 years ≥75 years020406080100120140Rate per 100,000 population
Week Ending DateJanuary 1 –August 26, 2023
Gray boxes indicate potential reporting delays. Interpretation of trends should be excluded from these weeks. 12
Underlying Medical Conditions among Adults Ages ≥18 Years Hospitalized
for COVID -19, by Age Group  —COVID -NET, January –June 2023
274966
2238 39
31
263640 41
29
23
17
102133 33
141716
814
614
7525 413 1224
92528
010203040506070
18–49 years 50–64 years ≥65 yearsWeighted % of hospitalizations
Cardiovascular disease Diabetes
Neurologic disorders Obesity
Asthma Chronic lung disease, not including asthma
Immunocompromising condition Gastrointenstinal/liver Disease
Blood disorders Autoimmune/inflammatory disease
Chronic metabolic disease, not including diabetes Renal disease
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission.18–49 years:
58% with ≥3 underlying
conditions50–64 years:
72% with ≥3 underlying
conditions≥65 years:
81% with ≥3 underlying
conditions
13
Cumulative Weekly Rates of COVID -19-and Influenza -
Associated Hospitalizations among Adults Ages ≥18 Years —
COVID -NET and FluSurv -NET*, October 2022 –July 2023
050100150200250
10/8/2022 12/8/2022 2/8/2023 4/8/2023 6/8/2023Rate per 100,000 population
Week Ending DateAdults ages 18 –64 years
18–49 years (COVID -19) 18–49 years (Influenza)
50–64 years (COVID -19) 50–64 years (Influenza)
* Influenza Hospitalization Surveillance Network. Seasonal FluSurv -NET surveillance ended on April 30, 2023, for the 2022 –2023 season.05001000150020002500
10/8/2022 12/8/2022 2/8/2023 4/8/2023 6/8/2023Rate per 100,000 population
Week Ending DateAdults ages ≥65 years
65–74 years (COVID -19) 65–74 years (Influenza)
75–84 years (COVID -19) 75–84 years (Influenza)
≥85 years (COVID -19) ≥85 years (Influenza)
14
Percent of COVID -19-and Influenza -Associated Hospitalizations with
ICU admission among Adults by Age Group —COVID -NET and FluSurv -
NET*, 13 States, October 2022 –April 2023
•Influenza Hospitalization Surveillance Network
Limited to COVID -NET hospitalizations with COVID -19-related illness as likely reason for admission1922
18
711141817
12
8
0510152025
18–49 years 50–64 years 65–74 years 75–84 years ≥85 yearsPercent of  COVID -19-and
Influenza -associated Hospitalizations
COVID-19 Influenza
15
Percent of COVID -19-and Influenza -Associated Hospitalizations with in -
hospital death among Adults by Age Group —COVID -NET and FluSurv -
NET*, 13 States, October 2022 –April 2023
2.14.06.4
4.9
4.1
0.72.93.14.34.6
01234567
18–49 years 50–64 years 65–74 years 75–84 years ≥85 yearsPercent of  COVID -19-and
Influenza -associated Hospitalizations
COVID-19 Influenza
•Influenza Hospitalization Surveillance Network
Limited to COVID -NET hospitalizations with COVID -19-related illness as likely reason for admission16
Vaccination Status by Age Group among Non -Pregnant
Adults Ages ≥18 Years Hospitalized for COVID -19 —COVID -
NET, January –June 2023
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission. Unvaccinated : No recorded doses of COVID -19 vaccine. Vaccinated, but no bivalent booster :
Completed a primary series with or without ≥1 booster dose but did not receive an updated bivalent booster dose. Updated bivalent booster : Received updated bivalent booster dose.
Partially vaccinated : Received at least one dose of COVID -19 but was not considered fully vaccinated at the time of a positive SARS -CoV-2 test. Pers ons with unknown vaccination status
are excluded. 3526171153
58
61698 131919
0%10%20%30%40%50%60%70%80%90%100%
18–49 years 50–64 years 65–74 years ≥75 yearsPercent of COVID -19-associated
hospitalizations
Unvaccinated Vaccinated, but no bivalent booster Updated bivalent booster Partially vaccinated
17
▪Hospitalization rates increased in all age groups since mid -July
▪Hospitalization rates highest in older adults and infants <6 months
▪Most children <5 years hospitalized with COVID -19 illness have no underlying medical
conditions
–A higher proportion of hospitalized children and adolescents 5 -17 years have
underlying medical conditions
–Most hospitalized adults have multiple underlying medical conditions
▪COVID -19 continues to cause severe illness; clinical outcomes generally comparable to
influenza -associated hospitalizations
▪Most children and adults hospitalized for COVID -19 since January 2023 had not
received an updated bivalent boosterCOVID -19-associated hospitalizations
18
Coronavirus and Other Respiratory
Viruses Division
Chris Taylor
Kadam Patel
Meredith McMorrow
Influenza Division
Shikha Garg
Catherine Bozio
Alissa O’Halloran
Dawud UjamaaRESP -NET Site investigators and staffAcknowledgements
For more information, contact CDC
1-800 -CDC -INFO (232 -4636)
TTY:  1 -888 -232-6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention.
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.

Summary: Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation  use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences. COVID -19–Associated Hospitalizations among  Infants, Children and Adults —COVID -NET, January – August 2023 ACIP , September 12, 2023 Fiona P . Havers, MD, MHS Team…


04 COVID Saydah 508

National Center for Immunization & Respiratory Diseases
Update: E pidemiologic
Characteristics of Long COVID
Sharon Saydah, PhD, MHS, CDR USPHS
Coronaviruses and Other Respiratory Viruses Division,
Epidemiology Branch
Post COVID Conditions -Longer Term Sequelae Team Lead
September 12, 2023
A general framework for Post -COVID Conditions
Conditions frequently overlap
Patients may experience any combination
*ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
** MIS -C: Multisystem Inflammatory Syndrome in ChildrenWide range of physical and mental health consequences continue or
develop at least 4 weeks after initial COVID -19 or SARS -CoV-2 infection
General consequences of illness and
hospitalization
•Post ICU syndrome
•Other complications of treatment
or illnessPost acute sequelae of SARS -CoV-2
infection
•System specific pathology (e.g.
lung fibrosis, stroke)
•Clinicall y significant symptoms
with unclear pathology (e.g.
ME/CFS* -like, dysautonomia)
•On-going symptoms following
MIS-C**
Long COVID commonly used term for Post -COVID
Conditions
Estimating the Occurrence of Post -COVID Conditions
Prevalence of on -going symptoms lasting at least 3 months
after COVID -19 by age, regardless of COVID status: U.S.
10.81.96.89
7.4
4.2
0.2 0.30.82.74.7
3.8
2.3
0.01.02.03.04.05.06.07.08.09.010.0
0 - 5 years 6 - 11 years 12 - 17 years 18-34 years 35-49 years 50-64 years ≥ 65 yearsPrevalence (%)
Ever Current
UNPUBLISHED CDC DATA –Preliminary  estimates from 2022 National Health Interview SurveyNationally representative of non -institutional population in the U.S., s tatistical software was used to account for NHIS’s complex sampling design.
Trends of Long COVID and significant activity limitations among
adults -United States, June 1 –13, 2022, to June 7 –19, 2023
The prevalence of Long COVID
(currently reporting symptoms lasting ≥
3 months) among non -institutionalized
adults:
•Decreased from June 2022 to January
2023
•Remained unchanged through June
2023Almost 1 in 4 adults with Long COVID
report significant activity limitations
Long COVID and Significant Activity Limitation Among Adults, by Age —United States, June 1 –13, 2022, to June 7 –19, 2023 |
MMWR (cdc.gov)

Using electronic health records and comparing patients with COVID -19 to those
without evidence of COVID -19:
•Among children and adolescents, increased risk of four symptoms and eight
conditions  31–365 days following COVID -19 1,2
–Associated with an increased risk of heart conditions, kidney failure, blood clots,
diabetes, fatigue, smell and taste disorders, neurological conditions
•Among adults, 1 in 5 COVID -19 survivors may have a health condition associated
with previous COVID -19 in the 31 –365 days following COVID -19 3
–Associated with an increased risk of cardiovascular events, kidney disease,
respiratory conditions, diabetes, and neurological conditions 2,4,5,6SARS -CoV-2 infection associated with diagnosis of
incident conditions
1) Post –COVID -19 Symptoms and Conditions Among Children and Adolescents —United States, March 1, 2020 –January 31, 2022 | MMWR ( cdc.gov)
2) Hernandez -Romieu AC et al. JAMA Netw Open. 2022; 5(2 )
3) Bull-Otterson et al. Post -COVID Conditions Among Adult COVID -19 Survivors Aged 18 –64 and ≥65 Years –United States, March 2020 –November 2021 . MMWR May 27, 2022.
4)Post –acute sequalae of COVID -19 and cardiac outcomes in U. S. military members -ScienceDirect
5) Risk of persistent and new clinical sequelae among adults aged 65 years and older during the post -acute phase of SARS -CoV-2 infe ction: retrospective cohort study | The BMJ
6) Long -term neurologic outcomes of COVID -19 | Nature Medicine
In a prospective study of adults testing positive and negative for COVID -19:
•Following acute -COVID -like illness among adults, on -going symptoms decrease after
3 months, but 16% continue to experience on -going symptoms at 12 months
•Many adults reported new emerging or re -emerging symptoms at 6, 9, and 12
months following acute COVID -like illness
•Symptoms were not unique to SARS -CoV-2 infection
In the Veterans Affairs patient population:
•Post -COVID Conditions decreased 90 days after acute COVID -19, with increased risk
of new conditions continuing for up to 2 years.Post -COVID Conditions symptoms and duration
Prevalence of Symptoms ≤12 Months After Acute Illness, by COVID -19 Testing Status Among Adults —United States,
December 2020 –March 2023 | MMWR (cdc.gov)
Postacute sequelae of COVID -19 at 2 years | Nature Medicine
•Female sex
•Older age (sometimes)
–Adolescents compared to younger children
–Middle -aged adults compared to younger and older adults for symptoms
–Older adults compared to younger adults for incident conditions
•Severity of COVID -19 illness
•Underlying health conditions prior to COVID -19
•Lower socio -economic status
•Did not get COVID -19 vaccineGroups associated with a higher likelihood of
developing Long COVID
Maglietta G et al. Prognostic Factors for Post -COVID -19 Syndrome: A Systematic Review and Meta -Analysis. JCM
2022
Socioeconomic inequalities of Long COVID -UK.  Shabnam et al. 2023 (sagepub.com)
Hastie. et al. Outcomes among confirmed cases and matched comparison group in the Long COVID in Scotland
Study. Nature 2022
Epidemiology of Long Coronavirus Disease in US Adults | Clinical Infectious Diseases | Oxford Academic (oup.com)
Frontiers | Hospital admission and vaccination as predictive factors of long COVID -19 symptoms (frontiersin.org)
COVID -19 Vaccines and Post -COVID Conditions
COVID -19 vaccination
(1 or 2 doses) reduces
Post -COVID Conditions
compared to no
vaccination among
those with SARS -CoV-2
infection
Protective effect of COVID -19 vaccination against
long COVID syndrome: A systematic review and
meta -analysis -ScienceDirect
•COVID -19 cases diagnosed from
March 2021 –February 2022,
followed through August 2022
•161,531 with COVID vaccination
prior to infection matched 1:1
with patients without
vaccinationAssociations of prior
COVID -19 vaccination and
risk of PCC categories 6
months following SARS -
CoV-2 infection, by age
group: Mar 2021 -Feb 2022
UNPUBLISHED DATA
Vaccine Safety Datalink Adjusted RR (95% CI)
COVID -19 mRNA vaccination associated with reduced occurrence of Post COVID
Conditions following SARS -CoV-2 infection in a US cohort of adult essential workers,
June 2021 --September 2022
Unpublished data from the HEROES/RECOVER cohort. HEROES Protocol ; RECOVER ProtocolTotal (N =936)Unvaccinated
(n= 157)Vaccinated 2 doses (≥ 14 days)
(n= 301)Vaccinated 3 doses (≥ 7 days)
(n=478)
N (Col %) N (Row %) N (Row%) aOR (95% CI)a N (Row%) aOR (95% CI)a
1 or more symptoms 221 (23.6) 42 (19.0) 74 (33.5) 1.00 (0.80 -1.27) 105 (47.5) 0.84 (0.67 -1.06)
2 or more symptoms 158 (16.9) 27 (17.1) 62 (39.2) 1.22 (0.94 -1.59) 69 (43.7) 0.76 (0.58 -0.99)
Cardiovascular symptoms 107 (11.4) 19 (17.8) 44 (41.1) 1.32 (0.98 -1.78) 44 (41.1) 0.73 (0.54 -0.99)
Gastrointestinal
symptoms 46 (4.9) 12 (26.1) 17 (37.0) 1.04 (0.67 -1.61) 17 (37.0) 0.60 (0.39 -0.94)
General symptoms 142 (15.2) 26 (18.3) 58 (40.8) 1.22 (0.94 -1.60) 58 (40.8) 0.81 (0.62 -1.05)
Neurological symptoms 128 (13.7) 26 (20.3) 44 (34.4) 1.08 (0.81 -1.43) 58 (45.3) 0.75 (0.57 -0.99)
Other symptoms 80 (8.5) 19 (23.8) 29 (36.3) 1.08 (0.77 -1.51) 32 (40.0) 0.68 (0.48 -0.95)
COVID -19 mRNA vaccination associated with reduced occurrence of
Post COVID Conditions following Omicron SARS -CoV-2 infection in a US
cohort of children aged 5 -17 years, July 2021 --September 2022
Unvaccinated,
148 (row %)Vaccinated1,
474 (row %)OR (95% CI) Adjusted OR2
(95% CI)
1 or more PCC symptoms 12 (43) 16 (57) 0.63 (0.43 -0.93) 0.66 (0.43 -0.99)
2 or more PCC symptoms 11 (52) 10 (48) 0.52 (0.34 -0.81) 0.52 (0.32 -0.83)
Respiratory PCC symptoms 10 (53) 9 (47) 0.52 (0.33 -0.82) 0.53 (0.32 -0.86)
Non -Respiratory PCC symptoms 10 (42) 14 (58) 0.64 (0.42 -0.98) 0.70 (0.45 -1.10)
PCC Impact on function 9 (56) 7 (44) 0.51 (0.22 -1.15) 0.62 (0.21 -1.83)
Unpublished data from the PROTECT cohort. PROTECT Protocol
Summary
•Post -COVID Conditions are common following SARS -CoV-2 infection, decrease
with time since infection, and has decreased since the start of the pandemic
•Symptoms and conditions associated with Post -COVID Conditions are not
unique to having had SARS -CoV-2 infection
•Post -COVID Conditions are associated with increased health care utilization and
significant activity limitations
•Accumulating evidence that COVID -19 vaccination reduces Post -COVID
Conditions among both children and adultsImportant take home messages
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the
official position of the Centers for Disease Control and Prevention.
For more information:
Sharon Saydah, PhD, MHS zle0@cdc.govQuestions?

Summary: National Center for Immunization & Respiratory Diseases Update: E pidemiologic  Characteristics of Long COVID Sharon Saydah, PhD, MHS, CDR USPHS Coronaviruses and Other Respiratory Viruses Division,  Epidemiology Branch Post COVID Conditions -Longer Term Sequelae Team Lead September 12, 2023  A general framework for Post -COVID Conditions Conditions frequently overlap Patients may experience any combination *ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ** MIS -C: Multisystem…


05 COVID Link Gelles 508

1
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.
Updates to COVID -19 vaccine effectiveness (VE) in
the U.S
September 12, 2023
Ruth Link -Gelles, PhD, MPH
CDR, US Public Health Service
COVID -19 Vaccine Effectiveness Program Lead
Centers for Disease Control and Prevention
2▪Included today:
–VE against emergency department/urgent care encounters in young children
–VE against emergency department/urgent care encounters in older children, adolescents, and adults
–VE against hospitalization and critical illness in adults
▪Note: updates in this presentation are meant to complement results of the GRADE
presentationOrganization of presentation
3▪High rates of infection -induced immunity
by July –August 2022.*
▪VE findings should be interpreted as the
incremental benefit provided by COVID -19
vaccination in a population with a high
prevalence of infection -induced immunity.Context for interpreting VE across age groups
* https://www.cdc.gov/vaccines/acip/meetings/downloads/slides -2023 -06-21-23/03 -COVID -Jones -508.pdf ; data on children aged 6 months –17 years is from cross -sectional blood specimens collected by
commercial laboratories. Data on persons aged ≥16 years is from a longitudinal, national cohort of >70,000 blood donors.Age group% with infection -induced
immunity
6-11 month 66%
12-23 months 74%
2-4 years 83%
5-11 years 88%
12-17 years 86%
16-29 years 83%
30-49 years 78%
50-64 years 68%
≥65 years 48%
4
Vaccine effectiveness in young children
VISION Network (emergency department/urgent care encounters)
Updates based on analyses in recent MMWR:
•Link -Gelles R, Ciesla AA, Rowley EA, et al. Effectiveness of Monovalent and Bivalent mRNA Vaccines in Preventing
COVID -19–Associated Emergency Department and Urgent Care Encounters Among Children Aged 6 Months –5
Years —VISION Network, United States, July 2022 –June 2023. MMWR Morb Mortal Wkly Rep 2023;72:886 –892.
DOI: http://dx.doi.org/10.15585/mmwr.mm7233a2
55VISION Multi -Site Network of Electronic Health Records
▪Design: Test-negative case -control
▪Population: Immunocompetent children
aged 6 months –4 or 5 years visiting a
participating emergency department or
urgent care (ED/UC) with COVID -19-like
illness (CLI) with a SARS -CoV -2 NAAT test
result within 14 days before or 72 hours
after encounter
−Cases : CLI with positive NAAT for SARS -CoV -2
−Controls : CLI with negative NAAT for SARS -CoV -2
▪Vaccination data: Documented by electronic health records and state
and city registries
▪Dates of analysis: July 2022 –August 2023
66VISION: Estimates of VE for original monovalent Moderna primary series vaccine
(children aged 6 months –5 years) against ED/UC encounters , July 4, 2022 –August 9,
2023*
Vaccination status (months since last dose) Total testsSARS -CoV -2
positive, N (%)Median interval since
last dose, days (IQR)Adjusted
VE (95% CI)
Moderna , 1 dose ( partial series; ages 6mo –5years)
July 4, 2022 –June 17, 2023
Unvaccinated 90,737 4,966 (5.5) NA Ref
1 (original) monovalent dose (≥14 days) 1,053 47 (4.5) 66 (30 –127) 23 (−3 to 43)
Moderna , 2 doses ( complete series; ages 6mo –5years)
August 1, 2022 –June 17, 2023
Unvaccinated 85,746 4,061 (4.7) NA Ref
2 (original) monovalent doses (≥14 days) 3,736 98 (2.6) 105 (64 –169) 31 (15 to 44)
2 (original) monovalent doses (14 -59 days) 811 23 (2.8) 38 (26 –49) 46 (17 to 64)
2 (original) monovalent doses (≥60 days) 2,925 75 (2.6) 124 (91 –193) 24 (4 to 40)
-40 -20 0 20 40 60 80 100
Vaccine Effectiveness (%)
* Different analysis periods were used for each product and dose number because vaccinated children became eligible to be inc luded 14 days after the dose at different times: 1
dose of Moderna and Pfizer -BioNTech on July 4, 2022; 2 doses of Pfizer -BioNTech on July 25, 2022; 2 doses of Moderna on August 1 , 2022; 3 doses of Pfizer -BioNTech on
September 19, 2022; bivalent doses on December 24, 2022.
77VISION: Estimates of VE for original monovalent Pfizer -BioNTech primary series vaccine (children
aged 6 months –4 years) against ED/UC encounters , July 4, 2022 –June 17, 2023
Vaccination status (months since last dose) Total testsSARS -CoV -2
positive, N (%)Median interval since
last dose, days (IQR)Adjusted
VE (95% CI)
Pfizer , 1 dose ( partial series; ages 6mo –4 years)
July 4, 2022 –June 17, 2023
Unvaccinated 79,480 4,632 (5.8) NA Ref
1 (original) monovalent dose (≥14 days) 1,640 78 (4.8) 60 (29 –112) 8 (−16 to 27)
Pfizer , 2 doses ( partial series; ages 6mo –4 years)
July 25, 2022 –June 17, 2023
Unvaccinated 75,965 3,990 (5.2) NA Ref
2 (original) monovalent doses (≥14 days) 2,682 78 (2.9) 70 (41 –121) 34 (16 to 47)
2 (original) monovalent doses (14 -59 days) 1,138 34 (3.0) 37 (25 –47) 44 (21 to 61)
2 (original) monovalent doses (≥60 days) 1,544 44 (2.9) 111 (82 –164) 23 (−5 to 43)
Pfizer , 3 doses ( complete series; ages 6mo –4 years)
September 19, 2022 –June 17, 2023
Unvaccinated 66,847 2,992 (4.5) NA Ref
3 (original) monovalent doses (≥14 days) 1,542 33 (2.1) 82 (43 –153) 38 (12 to 56)
3 (original) monovalent doses (14 -59 days) 573 6 (1.1) 35 (26 –46) 71 (36 to 87)**
3 (original) monovalent doses (≥60 days) 969 27 (2.8) 132 (89 –187) 16 (−24 to 43)**
-40 -20 0 20 40 60 80 100
Vaccine Effectiveness (%)* Different analysis periods were used for each product and dose number because vaccinated children became eligible to be inc luded 14 days after the dose at different times: 1 dose of Moderna and
Pfizer -BioNTech on July 4, 2022; 2 doses of Pfizer -BioNTech on July 25, 2022; 2 doses of Moderna on August 1, 2022; 3 doses of P fizer -BioNTech on September 19, 2022; bivalent doses on December 24,
2022.
** This estimate is imprecise, which might be due to there being a relatively small number of persons in each level of vaccin ation or case status. This imprecision indicates that the actual VE could be
substantially different from the point estimate shown, and estimates should therefore be interpreted with caution. Additional data accrual could increase precision and allow more precise interpretation.
88VISION: Estimates of VE for ≥1bivalent vaccine (children aged 6 months –4 or 5 years) against ED/UC
encounters , December 24, 2022 –June 17, 2023
Vaccination status (months since last dose) Total testsSARS -CoV -2
positive, N (%)Median interval since
last dose, days (IQR)Adjusted
VE (95% CI)
Regardless of manufacturer, ≥1 bivalent dose (ages 6mo –5years)
Unvaccinated 34,582 1,505 (4.3) NA Ref
≥1 bivalent dose (≥14 days) 458 8 (1.8) 66 (39 –103) 61 (22 to 83)**
-60 -40 -20 0 20 40 60 80 100
Vaccine Effectiveness (%)
*This estimate was calculated using unadjusted exact methods due to the small number of vaccinated case -patients. Five vaccinate d case -patients received bivalent Pfizer -BioNTech doses and three received Moderna
doses; vaccinated control -patients included those who received both bivalent Moderna (126) and Pfizer -BioNTech (324) doses.
This estimate is imprecise, which might be due to there being a relatively small number of persons in each level of vaccinati on or case status. This imprecision indicates that the actual VE could be substantially different
from the point estimate shown, and estimates should therefore be interpreted with caution. Additional data accrual could incr ease precision and allow more precise interpretation.
Children included in the bivalent analysis were either unvaccinated (received 0 COVID -19 vaccine doses) or had received ≥1 bival ent vaccine dose from either manufacturer. Among those who received a bivalent
vaccine dose, any combination of original monovalent and bivalent doses was included, but at minimum children had to have rec eived 2 Moderna doses or 3 Pfizer -BioNTech doses (i.e., a complete primary series).
9▪1 dose of original monovalent Moderna or Pfizer -BioNTech vaccines did not provide
significant protection
▪2 doses of either product (and 3 doses of Pfizer -BioNTech) provided protection against
ED/UC and hospitalization, though waning was evident (similar to older children and
adults)
▪A bivalent dose provided protection, though sample size was limited.
▪Median interval since receipt of the most recent dose among children who had not
completed their primary series was longer than expected based on the recommended
dosing intervals →some children not completing primary seriesConclusions: Vaccine effectiveness in young children
10
Updates to bivalent vaccine effectiveness
VISION Network
Updates based on analyses in recent MMWRs:
Link -Gelles, et al. Estimates of Bivalent mRNA Vaccine Durability in Preventing COVID -19–Associated Hospitalization
and Critical Illness Among Adults with and Without Immunocompromising Conditions —VISION Network, September
2022 –April 2023. https://www.cdc.gov/mmwr/volumes/72/wr/mm7221a3.htm
IVY Network
Updates based on analyses in recent MMWR:
•DeCuir, Surie, et al. MMWR. Effectiveness of Monovalent mRNA COVID -19 Vaccination in Preventing COVID -19–
Associated Invasive Mechanical Ventilation and Death Among Immunocompetent Adults During the Omicron
Variant Period —IVY Network, 19 U.S. States, February 1, 2022 –January 31, 2023.
https://www.cdc.gov/mmwr/volumes/72/wr/mm7217a3.htm
1111VISION Multi -State Network of Electronic Health Records
▪Design: Test-negative case -control
▪Population: Persons admitted to a
participating emergency department,
urgent care, or hospital with COVID -19-like
illness (CLI) with a SARS -CoV -2 NAAT test
result within 14 days before or 72 hours
after encounter or admission
−Cases : CLI with positive NAAT for SARS -CoV -2
−Controls : CLI with negative NAAT for SARS -CoV -2
▪Vaccination data: Documented by electronic health records and state
and city registries
▪Dates of analysis: September 2022 –August 2023
1212VISION: Absolute VE of original monovalent and bivalent booster doses
against ED/UC encounters among immuno competent persons, by age
group –September 2022 –August 2023
VE estimates adjusted for age, sex, race and ethnicity, geographic region, and calendar time. CDC unpublished datamRNA Dosage PatternTotal
testsSARS -CoV -2-
test -positive,
N (%)Median interval
since last dose,
days (IQR)Adjusted VE (95% CI)
Unvaccinated
5-17 years 41,910 1,446 (4) -- Ref
18-64 years 90,349 8,201 (9) -- Ref
≥65 years 17,108 2,453 (14) -- Ref
Original monovalent doses only
5-17 years 28,369 1,092 (4) 334 (253 -439) 7 (-1 to 15)
18-64 years 14,9267 14,270 (10) 441 (334 -564) 2 (-1 to 5)
≥65 years 69,989 8,538 (12) 383 (266 -531) 17 (12 to 21)
Bivalent booster, 7 -59 days earlier
5-17 years 1,858 30 (2) 30 (18 -44) 63 (46 to 74)
18-64 years 9,763 549 (6) 33 (21 -46) 56 (52 to 60)
≥65 years 1,1826 970 (8) 35 (21 -48) 59 (55 to 62)
Bivalent booster, 60 -119 days earlier
5-17 years 1,268 37 (3) 89 (74 -105) 36 (10 to 54)
18-64 years 9,558 682 (7) 86 (72 -102) 39 (34 to 44)
≥65 years 12,753 1,255 (9) 87 (73 -102) 47(42 to 51)
-20 0 20 40 60 80 100
Vaccine Effectiveness (%)
1313VISION: Absolute VE of original monovalent and bivalent booster doses
against hospitalization among immuno competent adults, by age group –
September 2022 –August 2023
VE estimates adjusted for age, sex, race and ethnicity, geographic region, and calendar time. Updated from: Link -Gelles et al., MMWR, https://www.cdc.gov/mmwr/volumes/72/wr/mm7221a3.htm
* These estimates are imprecise, which might be due to there being a relatively small number of persons in each level of vacc ination or case status. This imprecision indicates that the actual VE
could be substantially different from the point estimate shown, and estimates should therefore be interpreted with caution. A dditional data accrual could increase precision and allow more precise
interpretation.mRNA Dosage PatternTotal
testsSARS -CoV -2-
test -positive,
N (%)Median interval
since last dose,
days (IQR)Adjusted VE
(95% CI)
18-64 years
Unvaccinated (ref) 13,089 803 (6) -- Ref
Original monovalent doses only 19,799 1,129 (6) 455 (333 -575) 15 (6 to 23)
Bivalent booster, 7 -59 days earlier 1,208 45 (4) 33 (21 -45) 61 (46 to 71)
Bivalent booster, 60 -119 days earlier 1,248 87 (7) 87 (73 -102) 15 (-8 to 33)
Bivalent booster, 120 -179 days earlier 1,075 59 (6) 147 (134 -163) -1 (-35 to 24)*
≥65 years
Unvaccinated (ref) 12,015 1,688 (14) -- Ref
Original monovalent doses only 37,001 4,216 (11) 402 (288 -555) 25 (20 -30)
Bivalent booster, 7 -59 days earlier 4,607 328 (7) 35 (21 -48) 67 (62 -71)
Bivalent booster, 60 -119 days earlier 5,252 490 (9) 88 (73 -104) 53 (48 -58)
Bivalent booster, 120 -179 days earlier 4,482 415 (9) 149 (134 -164) 28 (18 -36)
-40 -20 0 20 40 60 80 100
Vaccine Effectiveness (%)
1414VISION: Absolute VE of original monovalent and bivalent booster doses
against hospitalization and critical illness among immuno competent
adults aged ≥18 years –September 2022 –August 2023
Critical illness defined as admission to intensive care unit or death; case -patients were persons admitted to ICU or who experie nced death associated with COVID -19, and
control patients were persons hospitalized without COVID -19. VE estimates adjusted for age, sex, race and ethnicity, geographic region, and calendar time. Updated from: Link -
Gelles et al., MMWR, https://www.cdc.gov/mmwr/volumes/72/wr/mm7221a3.htmmRNA Dosage PatternTotal
testsSARS -CoV -2-
test -positive,
N (%)Median interval
since last dose,
days (IQR)Adjusted VE
(95% CI)
Hospitalization
Unvaccinated (ref) 25,104 2,491 (10) -- Ref
Original monovalent doses only 56,800 5,345 (9) 420 (306 -563) 22 (17 -26)
Bivalent booster, 7 -59 days earlier 5,815 373 (6) 34 (21 -47) 65 (61 -69)
Bivalent booster, 60 -119 days earlier 6,500 577 (9) 87 (73 -103) 48 (42 -53)
Bivalent booster, 120 -179 days earlier 5,557 474 (9) 149 (134 -164) 22 (13 -30)
Critical illness
Unvaccinated (ref) 23,140 527 (2) -- Ref
Original monovalent doses only 52,352 897 (2) 422 (306 -564) 32 (23 -40)
Bivalent booster, 7 -59 days earlier 5,504 62 (1) 34 (21 -47) 69 (59 -77)
Bivalent booster, 60 -119 days earlier 6,023 100 (2) 87 (73 -103) 50 (36 -60)
Bivalent booster, 120 -179 days earlier 5,144 61 (1) 149 (134 -164) 46 (28 -60)
-20 0 20 40 60 80 100
Vaccine Effectiveness (%)
1515VISION: Absolute VE of original monovalent and bivalent booster doses
against hospitalization among adults ≥18 years, by immunocompromise
status –September 2022 –August 2023
VE estimates adjusted for age, sex, race and ethnicity, geographic region, and calendar time. Updated from: Link -Gelles et al., MMWR,
https://www.cdc.gov/mmwr/volumes/72/wr/mm7221a3.htmmRNA Dosage PatternTotal
testsSARS -CoV -2-
test -positive,
N (%)Median interval
since last dose,
days (IQR)Adjusted VE
(95% CI)
Without immunocompromising conditions
Unvaccinated (ref) 25,104 2,491 (10) -- Ref
Original monovalent doses only 56,800 5,345 (9) 420 (306 -563) 22 (17 -26)
Bivalent booster, 7 -59 days earlier 5,815 373 (6) 34 (21 -47) 65 (61 -69)
Bivalent booster, 60 -119 days earlier 6,500 577 (9) 87 (73 -103) 48 (42 -53)
Bivalent booster, 120 -179 days earlier 5,557 474 (9) 149 (134 -164) 22 (13 -30)
With immunocompromising conditions
Unvaccinated (ref) 5,044 440 (9) -- Ref
Original monovalent doses only 16,937 1,575 (9) 397 (276 -539) 1 (-11-12)
Bivalent booster, 7 -59 days earlier 1,970 168 (9) 34 (20 -47) 31 (16 -43)
Bivalent booster, 60 -119 days earlier 2,336 172 (7) 88 (74 -104) 40 (27 -50)
Bivalent booster, 120 -179 days earlier 2,188 166 (8) 149 (134 -164) 12 (-7-28)
-20 0 20 40 60 80 100
Vaccine Effectiveness (%)
1616IVY Network —25 hospitals, 20 U.S. States
▪Design : Prospective, case -control
▪Population : Adults aged ≥18 years hospitalized with
Acute respiratory illness (ARI)*
–Cases: ARI and test positive for SARS -CoV-2 by NAAT or
antigen test within 10 days of illness
–Controls : ARI and test negative for SARS -CoV-2 and influenza
by NAAT within 10 days of illness
▪Vaccination data: Electronic medical records (EMR),
state and city registries, and self -report
▪Specimens: Upper respiratory specimens obtained
for central RT -qPCR testing and sequencing
▪Dates of analysis: September 2022 –May 2023
*ARI is defined as presence of any one of the following: fever, cough, shortness of breath, chest imaging consistent with pne umo nia, hypoxemia
1717IVY: Absolute VE against COVID -19 hospitalization among
immuno competent adults aged ≥18 years —September 8, 2022 –May
31, 2023
Case vaccination
status, no. (%)Control
vaccination
status, no. (%)Median time
since last dose,
days (IQR)Adjusted VE*,
% (95% CI)
18–64 years N=927 N=1,680
Unvaccinated 307 (33) 483 (29) -- Ref
Original monovalent doses only 514 (55) 979 (58) 412 (297 –533) 20 (4 –34)
Bivalent booster dose, 7 –89 days earlier 48 (5) 123 (7) 54 (33 –71) 43 (16 –62)
Bivalent booster dose, 90 –179 days earlier 58 (6) 95 (6) 130 (110 –151) 17 (-28 to 46)**
≥65 years N=1,556 N=1,971
Unvaccinated 238 (15) 274 (14) -- Ref
Original monovalent doses only 992 (64) 1108 (56) 385 (278 –510) 1 (-20 to 19)
Bivalent booster dose, 7 –89 days earlier 131 (8) 329 (17) 52 (29 –68) 53 (37 –66)
Bivalent booster dose, 90 –179 days earlier 195 (13) 260 (13) 130 (109 –151) 10 (-24 to 35)**
*VE adjustments: Age, sex, race/ ethnicity, admission date (biweekly), and HHS region
** These estimates are imprecise, which might be due to there being a relatively small number of persons in each level of vac cination or case status. This imprecision indicates that the
actual VE could be substantially different from the point estimate shown, and estimates should therefore be interpreted with caution. Additional data accrual could increase precision and
allow more precise interpretation.-40 -20 0 20 40 60 80 100
Vaccine Effectiveness (%)
1818IVY: Absolute VE against COVID -19 hospitalization among adults
aged ≥18 years , by immunocompromise status —September 8, 2022
–May 31, 2023
Case vaccination
status, no. (%)Control
vaccination
status, no. (%)Median time
since last dose,
days (IQR)Adjusted VE*,
% (95% CI)
Immunocompetent n=2,483 n=3,651
Unvaccinated 545 (22) 757 (21) -- Ref
Original monovalent doses only 1506 (61) 2087 (57) 395 (286 –521) 10 (-4 to 21)
Bivalent booster dose, 7 –89 days earlier 179 (7) 452 (12) 53 (30 –69) 51 (37 –61)
Bivalent booster dose, 90 –179 days earlier 253 (10) 355 (10) 130 (109 –151) 12 (-12 to 31)
Immunocompromised n=809 n=1,257
Unvaccinated 132 (16) 182 (14) -- Ref
Original monovalent doses only 543 (67) 767 (61) 374 (256 –504) 13 (-14 to 33)
Bivalent booster dose, 7 –89 days earlier 59 (7) 160 (13) 46 (26 –72) 55 (29 –71)
Bivalent booster dose, 90 –179 days earlier 75 (9) 148 (12) 126 (107 –152) 43 (7 –65)**
-20 0 20 40 60 80 100
Vaccine Effectiveness (%) * VE adjustments: Age, sex, race /ethnicity, admission date (biweekly), and HHS region
** These estimates are imprecise, which might be due to there being a relatively small number of persons in each level of vac cination or case status. This
imprecision indicates that the actual VE could be substantially different from the point estimate shown, and estimates should therefore be interpreted with
caution. Additional data accrual could increase precision and allow more precise interpretation.
19▪VE waning against hospitalization and ED/UC; more sustained protection against critical
illness
–Difficult to separate impact of time since vaccination from emergence of new variants
▪Patterns are similar across age groups, though low uptake of bivalent doses in younger age
groups prevented assessment of waning beyond 4 months from the bivalent dose.
▪Persons with immunocompromise may have reduced protection after COVID -19 vaccination,
compared with persons without immunocompromise. Historically, COVID -19 VE has been
lower and waned more quickly for adults with immunocompromise compared to adults
without immunocompromise. Trends in bivalent VE are less clear and additional data are
needed.
▪VE findings should be interpreted as the incremental benefit provided by COVID -19
vaccination in a population with a high prevalence of infection -induced immunity.Conclusions: Updates to waning of bivalent vaccine
effectiveness
20CDC COVID -19 Vaccine Effectiveness
and Policy Team
▪Amadea Britton
▪Allison Ciesla
▪Monica Godfrey
▪Eric Griggs
▪Katherine Fleming -Dutra
▪Dani Moulia
▪Morgan Najdowski
▪Erica OkwuaziVE platforms teams, including:
▪Sarah Ball
▪Angela Campbell
▪Jennifer DeCuir
▪Monica Dickerson
▪Margaret Dunne
▪Kiara Everett
▪Shikha Garg
▪Victoria Lazariu
▪Patrick Mitchell
▪Palak Patel
And many more!!!Acknowledgements
▪Heidi Moline
▪Caitlin Ray
▪Sarah Reese
▪Elizabeth Rowley
▪Regina Simeone
▪Zach Smith
▪Diya Surie
▪Mark Tenforde
▪Zack Weber
▪Laura Zambrano▪Josephine Mak
▪Amanda Payne
▪Lauren Roper
▪Laura Steinhardt
▪Megan Wallace
▪Ryan Wiegand
21
For more information, contact CDC
1-800 -CDC -INFO (232 -4636)
TTY:  1 -888 -232-6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention.
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.
Questions?
22
Back -up
23New Vaccine Surveillance Network (NVSN)
Design: active, prospective, population -based ARI surveillance network for pediatric viral
infections at 7 medical centers.
Study population: Children <18 years with ARI are enrolled year -round in the outpatient,
ED, and hospital settings. Healthy controls are enrolled in the outpatient setting (well
child visits).
▪5794 children 6mos -4yrs with acute respiratory illness during July 1, 2022 —June 30, 2023
Data collection: Demographic and clinical data are collected through parent/guardian
interviews and medical chart reviews, and laboratory testing.  Vaccine status verified through
state immunization registries and primary care record review.
NVSN COVID -19 Vaccine Effectiveness Methodology
–Test-negative design. All enrolled children are tested for 8 respiratory viruses.
–Cases = SARS -CoV-2 positive, controls = SARS -CoV-2 negative.
–Regression models adjusted for study site, sex, race, and calendar time (week of enrollment).
–Vaccine status was defined as 1) unvaccinated = received zero COVID -19 vaccine doses of any product, 2) one dose only = received
one COVID -19 vaccine dose of any product, or 3) two or more doses = received two or more COVID -19 vaccine doses of any
product. Children within two weeks of vaccine receipt were excluded.
2424New Vaccine Surveillance Network (NVSN): VE of any product
against emergency department visits and hospitalization,
children 6 months –4 years, July 2022 -June, 2023
Case vaccination
status (n=291)Control vaccination
status (n=5,503)Median time
since last dose,
days (IQR)Adjusted VE*,
% (95% CI)
Unvaccinated 260 (89) 4,691 (85) NA
Vaccinated with ≥1 dose* 31 (11) 812 (15) Not calculated Not calculated
One dose 10 (3) 228 (4) 61 (31 -105) 30 (-36-64)**
Two doses 21 (7) 584 (11) 74 (42 -131) 40 (3 -63)**
-40 -20 0 20 40 60 80 100
Vaccine Effectiveness (%)
* Vaccine status was defined as 1) unvaccinated = received zero COVID -19 vaccine doses of any product, 2) one dose only = receiv ed one COVID -19 vaccine dose of any product, or 3) two
or more doses = received two or more COVID -19 vaccine doses of any product. Children within two weeks of vaccine receipt were ex cluded.
** These estimates are imprecise, which might be due to there being a relatively small number of persons in each level of vaccin ation or case status. This imprecision indicates that the actual
VE could be substantially different from the point estimate shown, and estimates should therefore be interpreted with caution . Additional data accrual could increase precision and allow
more precise interpretation.
2525IVY: Absolute VE against COVID -19 hospitalization among
immuno competent adults aged ≥18 years by SARS -CoV -2
subvariant predominance —September 8, 2022 –May 31, 2023
Case vaccination
status, no. (%)Control
vaccination status,
no. (%)Median time
since last dose,
days (IQR)Adjusted VE*,
% (95% CI)
BA.4/5 (September 8 –November 26, 2022) n=688 n=989
Unvaccinated 169 (25) 199 (20)
Original monovalent doses only 479 (70) 692 (70) 311 (195 –403) 32 (12 –47)
Bivalent booster dose, 7 –89 days earlier 40 (6) 98 (10) 29 (16 -45) 68 (46 –81)
BQ.1 (November 27, 2022 –January 17, 2023) n=622 n=1,080
Unvaccinated 145 (23) 223 (21)
Original monovalent doses only 399 (64) 617 (57) 388 (306 –517) 12 (-14 to 32)
Bivalent booster dose, 7 –89 days earlier 78 (13) 240 (22) 55 (37 -69) 54 (33 –68)
XBB.1.5 (January 18 –May 31, 2023) n=1,148 n=1,529
Unvaccinated 231 (20) 335 (22)
Original monovalent doses only 628 (55) 778 (51) 464 (374 –593) -10 (-35 to 10)
Bivalent booster dose, 7 –89 days earlier 61 (5) 114 (7) 65 (46 –80) 33 (0 –54)**
Bivalent booster dose, 90 –179 days earlier 228 (20) 302 (20) 136 (116 –154) -7 (-41 to 19)**
*VE adjustments: Age, sex, race /ethnicity, admission date (biweekly), and HHS region
** These estimates are imprecise, which might be due to there being a relatively small number of persons in each level of vaccin ation or case status. This
imprecision indicates that the actual VE could be substantially different from the point estimate shown, and estimates should therefore be interpreted with caution.
Additional data accrual could increase precision and allow more precise interpretation.-60 -40 -20 0 20 40 60 80 100
Vaccine Effectiveness (%)
2626VISION: Absolute VE of original monovalent and bivalent booster doses
against hospitalization and critical illness among immuno competent
adults aged ≥18 years, during XBB predominance –January –July 2023
CDC unpublished data. VE estimates adjusted for age, sex, race and ethnicity, geographic region, and calendar time.
Variant predominance based on regional circulation: https://covid.cdc.gov/covid -data -tracker/#variant -proportions
* These estimates are imprecise, which might be due to there being a relatively small number of persons in each level of vaccin ation or case status. This imprecision indicates that the actual VE could be substantially different
from the point estimate shown, and estimates should therefore be interpreted with caution. Additional data accrual could incr ease precision and allow more precise interpretation.mRNA Dosage PatternTotal
testsSARS -CoV -2-
test -positive,
N (%)Median interval
since last dose,
days (IQR)Adjusted VE
(95% CI)
Hospitalization
Unvaccinated (ref) 10,443 700 (7) -- Ref
Original monovalent doses only 23,140 1,662 (7) 511 (411 -639) 13 (5 -22)
Bivalent booster, 7 -59 days earlier 701 33 (5) 38 (23 -49) 57 (38 -70)
Bivalent booster, 60 -119 days earlier 2,350 165 (7) 98 (83 -110) 42 (31 -52)
Bivalent booster, 120 -179 days earlier 5,067 434 (9) 150 (136 -165) 21 (9 -31)
Critical illness
Unvaccinated (ref) 9,890 147 (2) -- Ref
Original monovalent doses only 21,751 273 (1) 512 (412 -640) 25 (7 -40)
Bivalent booster, 7 -59 days earlier 674 6 (1) 38 (23 -49) 58 (4 -82)*
Bivalent booster, 60 -119 days earlier 2,211 26 (1) 98 (83 -110) 49 (20 -67)
Bivalent booster, 120 -179 days earlier 4,690 57 (1) 150 (136 -165) 44 (22 -60)
-20 0 20 40 60 80 100
Vaccine Effectiveness (%)
2727VISION: Absolute VE of original monovalent and bivalent booster doses against
hospitalization among immuno competent adults aged ≥18 years, by SARS -CoV -2
subvariant predominance –September 2022 –August 2023
CDC unpublished data. VE estimates adjusted for age, sex, race and ethnicity, geographic region, and calendar time.
Variant predominance based on regional circulation: https://covid.cdc.gov/covid -data -tracker/#variant -proportionsmRNA Dosage PatternTotal
testsSARS -CoV -2-
test -positive,
N (%)Median interval
since last dose,
days (IQR)Adjusted VE
(95% CI)
BA.4/BA.5 predominance (September 2022 –November 2022)
Unvaccinated (ref) 5427 606 (11) -- Ref
Original monovalent doses only 14521 1377 (10) 312 (183 -397) 28 (19 -35)
Bivalent booster, 7 -59 days earlier 1856 129 (7) 25 (15 -37) 58 (49 -66)
BQ.1 predominance (December 2022 –January 2023)
Unvaccinated (ref) 4,193 619 (15) -- Ref
Original monovalent doses only 9,787 1,300 (13) 390 (296 -495) 28 (19 -35)
Bivalent booster, 7 -59 days earlier 1,870 133 (7) 41 (28 -51) 69 (62 -75)
Bivalent booster, 60 -119 days earlier 2,780 288 (10) 82 (71 -94) 52 (44 -59)
XBB predominance (February 2023 –August 2023)
Unvaccinated (ref) 10,443 700 (7) -- Ref
Original monovalent doses only 23,140 1,662 (7) 511 (411 -639) 13 (5 -22)
Bivalent booster, 7 -59 days earlier 701 33 (5) 38 (23 -49) 57 (38 -70)
Bivalent booster, 60 -119 days earlier 2,350 165 (7) 98 (83 -110) 42 (31 -52)
Bivalent booster, 120 -179 days earlier 5,067 434 (9) 150 (136 -165) 21 (9 -31)
-20 0 20 40 60 80 100
Vaccine Effectiveness (%)
2828VISION: Absolute VE of original monovalent and bivalent booster doses
against ED/UC encounters among immuno competent children and
adolescents, by age group –September 2022 –August 2023
VE estimates adjusted for age, sex, race and ethnicity, geographic region, and calendar time. Updated from: Link -Gelles et al., MMWR, https://www.cdc.gov/mmwr/volumes/72/wr/mm7221a3.htm
* These estimates are imprecise, which might be due to there being a relatively small number of persons in each level of vacc ination or case status. This imprecision indicates that the actual VE
could be substantially different from the point estimate shown, and estimates should therefore be interpreted with caution. A dditional data accrual could increase precision and allow more precise
interpretation.mRNA Dosage PatternTotal
testsSARS -CoV -2-
test -positive,
N (%)Median interval
since last dose,
days (IQR)Adjusted VE
(95% CI)
5-17 years
Unvaccinated (ref) 41,910 1,446 (4) -- Ref
Original monovalent doses only 28,369 1,092 (4) 334 (253 -439) 7 (-1 to 15)
Bivalent booster, 7 -59 days earlier 1,858 30 (2) 30 (18 -44) 63 (46 to 74)
Bivalent booster, 60 -119 days earlier 1,268 37 (3) 89 (74 -105) 36 (10 to 54)
5-11 years
Unvaccinated (ref) 31,608 905 (3) -- Ref
Original monovalent doses only 14,956 396 (3) 309 (193 -368) 13 (2 to 24)
Bivalent booster, 7 -59 days earlier 1,004 13 (1) 29 (17 -42) 62 (34 to 78)
12-17 years
Unvaccinated (ref) 10302 541 (5) -- Ref
Original monovalent doses only 13413 696 (5) 394 (291 -496) 2 (-11 to 13)
Bivalent booster, 7 -59 days earlier 854 17 (2) 32 (19 -47) 64 (40 to 78)
-40 -20 0 20 40 60 80 100
Vaccine Effectiveness (%)
29
Updated estimates of VE against
symptomatic infection among children and
adolescents aged 5 –17 and adults aged ≥18
years29
30▪Absolute VE: comparing the frequency of health outcomes in vaccinated and
unvaccinated people
–E.g., comparing outcomes in people vaccinated with an updated bivalent booster versus no
vaccine at all
▪Relative VE: comparing the frequency of health outcomes in people who received
one type of vaccine to people who received a different vaccine or by comparing
people who received more vaccine doses to those who received fewer doses
–E.g., comparing outcomes in people vaccinated with an updated bivalent booster versus
monovalent vaccine only
▪In the analyses presented today, relative vaccine effectiveness can be interpreted as
the additional protection provided by an updated bivalent booster among people
who already received monovalent COVID -19 vaccinesInterpreting absolute and relative vaccine effectiveness
31▪Nationwide community -based drive -through SARS -CoV-2 testing via pharmacies
▪Self-reported vaccine history at time of registration for COVID -19 testing
▪Design : Test -negative, case -control analysis*
▪Population : Children and adolescents aged 5 –17 years and adults aged ≥18 years with ≥1 COVID -like
symptom and nucleic acid amplification testing (NAAT)
▪Exclusion criteria: Excluded individuals <4 months from last monovalent dose and individuals with
immunocompromising conditions
▪Periods for analysis:
•Tested: December 1, 2022 –February 13, 2023**
•Includes periods of both BA.5 -related sublineage and XBB/XBB.1.5 sublineage predominanceICATT: Relative VE of bivalent booster against symptomatic infection in
children and adolescents aged 5 –17 years and adults aged ≥18 years
*Models adjusted for: age, gender, race, ethnicity, social vulnerability index and HHS region of the testing location, underlyin g conditions (presence versus absence), local incidence (cases per 100,000 by individual county and
state in the 7 days before test date), and date of testing
**Analysis is an update of data published in Link -Gelles R, Ciesla AA, Roper LE, et al. Early estimates of bivalent mRNA booster dose vaccine effectiveness in preventing symptomatic SARS -CoV-2 infection attributable to SARS -CoV-
2 Omicron BA.5 -related and XBB/XBB.1.5 -related sublineages among immunocompetent adults —Increasing Community Access to Testing Program, United States, December 2022 –January 2023. MMWR Morb Mortal Wkly Rep
2023;72.  https://www.cdc.gov/mmwr/volumes/72/wr/mm7205e2.htm31
3232ICATT: Relative VE of bivalent booster against symptomatic infection in children and
adolescents aged 5 –17 years, December 1, 2022 –February 13, 2023*
*Unpublished CDC data. Age group, years/mRNA Dosage PatternTotaltestsSARS -CoV -2 positive tests, Adjusted VE
N (row %) (95% CI)
5-11 years (authorized for bivalent booster
on October 12, 2022 )
Received 2 -3monovalent doses only (Ref) 4,855 1,433 (30) Ref
2 weeks -1 month since bivalent booster 600 73 (12) 65 (55 to 73)
2-3 months since bivalent booster 881 139 (16) 54 (43 to 62)
4-5 months since bivalent booster 58 10 (17) ----
12-17 years (authorized for bivalent booster
on September 1, 2022)
Received 2 -3 monovalent doses only (Ref) 8,243 3,194 (39) Ref
2 weeks -1 month since bivalent booster 443 73 (16) 68 (58 to 75)
2-3 months since bivalent booster 1,122 230 (20) 56 (49 to 62)
4-5 months since bivalent booster 283 68 (24) 53 (37 to 64)
0 20 40 60 80 100
Vaccine Effectiveness %
33ICATT: Relative VE of bivalent booster against symptomatic infection in adults aged
≥18 years, December 1, 2022 –February 13, 2023*
*Unpublished CDC data. 33Age group, years/mRNA Dosage PatternTotaltestsSARS -CoV -2 positive tests, Adjusted VE
N (row %) (95% CI)
18-49 years
Received 2 -3 monovalent doses only (Ref) 182,741 82,043 (45) Ref
2 weeks -1 month since bivalent booster 10,758 3,127 (29) 51 (49 to 53)
2-3 months since bivalent booster 32,577 10,206 (31) 45 (43 to 46)
4-5 months since bivalent booster 9,197 2,882 (31) 41 (38 to 44)
50-64 years
Received 2 -4 monovalent doses only (Ref) 60,822 31,878 (52) Ref
2 weeks -1 month since bivalent booster 6,223 2,331 (37) 46 (43 to 49)
2-3 months since bivalent booster 18,399 7,898 (43) 32 (29 to 34)
4-5 months since bivalent booster 4,837 2,030 (42) 28 (23 to 32)
≥65 years
Received 2 -4 monovalent doses only (Ref) 28,307 14,246 (50) Ref
2 weeks -1 month since bivalent booster 4,579 1,788 (39) 38 (34 to 42)
2-3 months since bivalent booster 19,071 8,080 (42) 27 (25 to 30)
4-5 months since bivalent booster 5,796 2,431 (42) 21 (16 to 26)
0 20 40 60 80 100
Vaccine Effectiveness %

Summary: 1 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. Updates to COVID -19 vaccine effectiveness (VE) in  the U.S September 12, 2023 Ruth Link -Gelles, PhD, MPH CDR, US Public Health Service COVID -19 Vaccine Effectiveness…