03 Chikungunya Hills 508

National Center for Emerging and Zoonotic Infectious Diseases
EVIDENCE TO RECOMMENDATIONS FOR
CHIKUNGUNYA VACCINE USE AMONG
LABORATORY WORKERS
Susan Hills, MBBS, MTH
CDC Lead , Chikungunya Vaccines Work Group
Arboviral Diseases Branch
Division of Vector -Borne Diseases
Fort Collins, Colorado
ACIP meeting, October 26, 2023
Infections among laboratory workers
At least 44 chikungunya virus infections identified among laboratory
workers worldwide over ~ 50 years1–3
–43 cases overt disease, 1 asymptomatic infection, no deaths
4 disease cases in US laboratorians since chikungunya became notifiable disease in 2015
–One case hospitalized for observation, no deaths
Identified cases underestimate all infections as no formal laboratory surveillance system
1.The Subcommittee on Arbovirus Laboratory Safety of the American Committee on Arthropod -Borne Viruses. Am J Trop Med Hyg 1980;
2.Rusnak JM, et al. J Occup Environ Med 2004; 3. US national arboviral disease surveillance system, 2015 –2022
Routes of transmission
Aerosol
Percutaneous
–Needlestick while working with and
injecting mice
–Forceps prick while dissecting mosquitoes infected with chikungunya virus
Mucosal (possible)

Policy question
Should chikungunya vaccine be recommended for
laboratory staff at risk for chikungunya virus infection?
Laboratory worker Evidence to Recommendations notes
Same GRADE assessment as vaccination for travelers
Considered data on cross -protection from vaccine against
3 genotypes of chikungunya virus
–Only limited data from laboratory studies to confirm cross-
protection
–Chikungunya virus considered single serotype and limited
genotype -specific differences in antigenicity
–No evidence of re -infection in humans with different genotypes
Evidence to Recommendations: Public health problem
Topic Decision Comment
Public health
problemNo, not of public health importance overall•Only occasional US laboratory -acquired
infections reported
•Potential for acute infection with severe polyarthralgia and possible chronic
arthralgia
Values Laboratorians likely think
desirable effects large relative to undesirable effects
No important variability•Scientists will understand risks of disease
and risks and benefits of vaccination
Evidence to Recommendations: Public health problem
Topic Decision Comment
Public health
problemNo, not of public health importance overall•Only occasional US laboratory -acquired
infections reported
•Potential for acute infection with severe polyarthralgia and possible chronic
arthralgia
Values Laboratorians likely think
desirable effects large relative to undesirable effects
No important variability•Scientists will understand risks of disease
and risks and benefits of vaccination
Evidence to Recommendations: Acceptability
Topic Decision Comment
Acceptability Yes, acceptable to key
stakeholders•Acceptable for occupational health directors, laboratory managers, and laboratorians because will improve safety
Resource use Yes, reasonable and efficient allocation of resources•Limited number of staff undertaking research or specific diagnostic work with chikungunya virus
•Small cost to avoid impact and costs of worker becoming infected
Equity Probably increased •If employer offers vaccination, will improve safety for staff and addresses an occupational health issue
Evidence to Recommendations: Resource use
Topic Decision Comment
Acceptability Yes, acceptable to key
stakeholders•Acceptable for occupational health directors, laboratory managers, and laboratorians because will improve safety
Resource use Yes, reasonable and efficient allocation of resources•Limited number of staff undertaking research or specific diagnostic work with chikungunya virus
•Small cost to avoid impact and costs of worker becoming infected
Equity Probably increased •If employer offers vaccination, will improve safety for staff and addresses an occupational health issue
Evidence to Recommendations: Equity
Topic Decision Comment
Acceptability Yes, acceptable to key
stakeholders•Acceptable for occupational health directors, laboratory managers, and laboratorians because will improve safety
Resource use Yes, reasonable and efficient allocation of resources•Limited number of staff undertaking research or specific diagnostic work with chikungunya virus
•Small cost to avoid impact and costs of worker becoming infected
Equity Probably increased •If employer offers vaccination, will improve safety for staff and addresses an occupational health issue
Evidence to Recommendations: Feasibility
Topic Decision Comment
Feasibility Yes, feasible •Likely build on existing occupational
health program
Balance of consequences
o Undesirable
consequences clearly outweighdesirable consequences in most settingso Undesirable consequences probably outweigh desirable consequences in most settingso The balance between desirable and undesirable consequences is
closely balanced or uncertaino Desirable
consequences
probably
outweigh
undesirable
consequences
in most settingso Desirable
consequences clearly outweigh undesirable consequences in most settingso There is insufficient evidence to determine the balance of consequences
Draft recommendation
Chikungunya vaccination is recommended for laboratory
workers with potential for exposure to chikungunya virus
Information accompanying recommendations
Local biosafety committee should undertake risk assessment
of potential for chikungunya virus exposure considering
–Type of work to be performed
–Biosafety level at which work is being conducted
Vaccination not necessary for workers handling routine clinical samples
Draft recommendation
Chikungunya vaccination is recommended for laboratory
workers with potential for exposure to chikungunya virus

Summary: National Center for Emerging and Zoonotic Infectious Diseases EVIDENCE TO RECOMMENDATIONS FOR  CHIKUNGUNYA VACCINE USE AMONG  LABORATORY WORKERS Susan Hills, MBBS, MTH CDC Lead , Chikungunya Vaccines Work Group Arboviral Diseases Branch Division of Vector -Borne Diseases Fort Collins, Colorado ACIP meeting, October 26, 2023 Infections among laboratory workers At least 44 chikungunya virus infections identified among laboratory  workers worldwide over ~ 50 years1–3  –43 cases overt disease, 1…


01 Dengue chen 508

Centers for Disease Control and Prevention
National Center for Emerging and Zoonotic Infectious Diseases
Updates on Dengue Vaccines
Wilbur Chen, MD
October 26, 2023

Dengue is endemic in
6U.S. territories and freely associated states.

Dengvaxia ™ACIP Recommendation June 2021
Three doses of Dengvaxia are
indicated for the prevention of
dengue disease caused by dengue virus serotypes 1, 2, 3, and 4 in people 9–16 years old with:
•laboratory confirmation of
previous dengue virus infection
AND
•living in endemic areas.

Takeda Dengue Vaccine (TAK -003) has been under
review by the FDA since Nov 2022
Dengue Workgroup presented to ACIP 3 times
Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov2022 2023
•Takeda dengue
vaccine safety and efficacy presentation
•Workgroup summary and interpretation•Policy questions
•Cost -effective (CE) analysis
(CDC/Notre Dame)
•Comparison of CE models
•Partial EtR•Dengue epidemiology
•Review of Sanofi dengue vaccine and ACIP recommendation•Plan to present draft recommendations
Overall VE
61.2% (56.0, 65.8%)
VE in Seropositives
64.2% (58.4, 69.2%)VE in Seronegatives
53.5% (41.6– 62.9%)
VE in Seropositives by Serotype
DENV -1 56.1% (44.6, 65.2%)
DENV -2 80.4% (73.1, 85.7%)
DENV -3 52.3% (36.7, 64.0%)
DENV -4 70.6% (39.9, 85.6%)VE in Seronegatives by Serotype
DENV -1 45.4% (26.1, 59.7%)
DENV -2 88.1% (78.6, 93.3%)
DENV -3 -15.5% (-108.2, 35.9%)
DENV -4 -105.6% (-628.7, 42.0%)TAK-003 Efficacy* Outcome: Virologically Confirmed Dengue
Unpublished data presented by Takeda to ACIP and ASTMH*57 months after first dose, s ignificant results bolded. Number for seropositive placebo
participants 4,855 and vaccine 9,666; Seronegative placebo 1,832 and vaccine 3,714.
Overall VE
84.1% (77.8, 88.6%)
VE in Seropositives
85.9% (78.7, 90.7%)VE in Seronegatives
79.3% (63.5, 88.2%)
VE in Seropositives by Serotype
DENV -1 66.8% (37.4, 82.3%)
DENV -2 95.8% (89.6, 98.3%)
DENV -3 74.0% (38.6, 89.0%)
DENV -4 100% (NE, NE)†VE in Seronegatives by Serotype
DENV -1 78.4% (43.9, 91.7%)
DENV -2 100% (NE, NE)§
DENV -3 -87.9% (-573.4, 47.6%)¶
DENV -4 100 % (NE, NE)**TAK-003 Efficacy* Outcome: Hospitalization
†DENV -4 Placebo events: 3 TAK-003 events: 0§DENV -2 Placebo events: 23    TAK -003 events: 0
¶DENV -3 Placebo events: 3 TAK-003 events: 11
**DENV -4 Placebo events: 1 TAK-003 events: 0
*57 months after first dose, s ignificant results bolded. Number for seropositive placebo
participants 4,855 and vaccine 9,666; Seronegative placebo 1,832 and vaccine 3,714. Unpublished data presented by Takeda to ACIP and ASTMH
European Medicines Agency (EMA) Committee for
Medicinal Products for Human Use (CHMP) issued positive opinion for TAK- 003
October 2023
•EU-M4all: parallel review for EU and participating dengue endemic
countries globally
•TAK-003 vaccine approved in multiple countries
‒EU, UK, Brazil, Argentina, Indonesia, & Thailand
On July 11, Takeda voluntarily withdrew
TAK-003 from FDA review.
https://www.takeda.com/newsroom/statements/2023/takeda -announces -voluntary -withdrawal -of-US-biologics -license -application -for-dengue -vaccine -candidate -TAK-003/

WHO SAGE Recommendations for TAK -003
Sept 25, 2023
•Consider for introduction in settings with high dengue disease burden and
high transmission intensity
•SAGE recommended the vaccine be introduced to children aged 6 to 16
years of age.
‒Within that age range, the vaccine should be introduced about 1-2 years prior to
the age -specific peak incidence of dengue- related hospitalizations.
‒The vaccine should be administered in a 2 -dose schedule with a 3 -month interval
between doses.
Future Dengue Vaccine Work
•Dengue workgroup will be paused until TAK -003 is re -submitted to FDA or a
new vaccine submitted for approval
ACIP Dengue Vaccines Workgroup
ACIP Members
Wilbur Chen (Chair)
Kathy Poehling
Beth Bell
Veronica McNally
CDC Co- Lead
Gabriela Paz -Bailey
Laura Adams
Ex Officio Members
Kaitlyn Morabito (NIH)
Ralph LeBlanc (FDA)
Ihid Carneiro Leao (FDA)
Kirk Prutzman (FDA)
Srihari Seshadri (DOD)Liaison RepresentativesElizabeth Barnett (AAP)
Rob Schechter (AIM)
Consultants
Edwin Asturias
Robert Atmar
Alan Barrett
Iris Cardona
Anna Durbin
Tony Marfin
Kristen Pierce
Anita ShetCDC Contributors
Josh Wong
Mimi Eckert
Rachel Eidex
Alfonso Hernandez
Susan HillsTerri Hyde
Mike McNeil
Jorge Munoz
Erin Staples
Cindy Weinbaum
Rita Helfand

Summary: Centers for Disease Control and Prevention National Center for Emerging and Zoonotic Infectious Diseases Updates on Dengue Vaccines Wilbur Chen, MD October 26, 2023  Dengue is endemic in 6U.S. territories and freely associated states.  Dengvaxia ™ACIP Recommendation June 2021 Three doses of Dengvaxia are  indicated for the prevention of  dengue disease caused by dengue virus serotypes 1, 2, 3, and 4 in people 9–16 years old with: •laboratory confirmation of  previous dengue virus infection AND…


01 COVID Daley 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.
ACIP COVID -19 Vaccines Work Group
Dr. Matthew F. Daley, Work Group Chair
October 26, 2023
▪September 11, 2023
–FDA authorized the updated mRNA COVID -19 vaccines for use in persons ages 6
months –11 years under emergency use authorizations (EUAs)
–FDA approved the updated mRNA COVID -19 vaccines in persons ages ≥ 12 years
under supplemental biologics license applications (BLAs)
▪September 12, 2023
–ACIP voted to recommend vaccination with updated (2023 –2024 Formula) COVID -19
vaccines as authorized under EUA or approved by BLA in persons aged ≥6 months
▪October 3, 2023
–FDA authorized the updated (2023 –2024 Formula) Novavax COVID -19 vaccine for use
in persons aged ≥12 years under EUACOVID -19 vaccine updates
Note: Updated (2023 –2024 Formula) COVID -19 vaccines are monovalent vaccines containing an XBB.1.5 component
Reviewed and discussed:
▪COVID -19 vaccine safety
▪COVID -19 vaccine implementationACIP COVID -19 Work Group Meeting Review
October 2023
▪COVID -19 vaccine implementation Dr. Shannon Stokley
▪COVID -19 policy updates Dr. Megan Wallace
▪DiscussionAgenda
October 26, 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 Lead
▪Megan Wallace
5Liaisons
▪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 Hahn
▪IDSA: Jeff Duchin (primary)Liaisons, 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
6▪Amadea Britton
▪Karen Broder
▪Carolyn Bridges
▪Allison Ciesla
▪Nicole Dowling
▪Daniel Drapeau
▪Tarayn Fairlie
▪Ashley Fowlkes
▪Julianne Gee
▪Samuel Graitcer
▪Lisa Grohskopf
▪Katherine Grusich
▪Aron 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 October 26, 2023 ▪September 11, 2023 –FDA authorized the updated mRNA COVID -19 vaccines for use…


02 COVID Stokley 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.
Implementation Update on
2023 –2024 COVID -19 Vaccines
Shannon Stokley, DrPH
Immunization Services Division
Centers for Disease Control and Prevention
Commercialization Transition
▪The CDC COVID -19 Vaccination Program discontinued on:
–September 12, 2023, as applied to the bivalent Moderna and Pfizer -BioNTech
COVID -19 vaccines
–October 3, 2023, as applied to the ancestral (Original) Novavax COVID -19 Vaccine
▪Providers are encouraged to:
–Continue administering COVID -19 vaccine through their offices/pharmacies/other
practices
–Participate in vaccines.gov
▪Vaccine data reporting has transitioned to routine reporting processes for
jurisdictions that have signed data use agreement (DUA) with CDC.U.S. Government Vaccination Program Discontinuation
▪Updated COVID -19 vaccines are available to most people living in the U.S.
at no cost through their private health insurance, Medicare, and Medicaid
plans.Vaccine Cost/Insurance
*Adults with health insurance that does not cover all COVID -19 vaccine costs, at any Bridge Access Program site which is in-network for their health insurance.Private health
insurance
Plans that are ACA -
compliant c over COVID -
19 vaccines from an in -
network provider at no
cost -sharing.Medicare and Medicaid
Cover COVID -19
vaccines at no -cost
sharingGovernment programs
Provide vaccine at no cost for:
•VFC: Children through 18 years that
are Medicaid eligible, uninsured,
American Indian/Alaska Native, or
underinsured
•Bridge Access Program: Adults ages
18 years and older who are
underinsured* or uninsured
▪There is increasing supply of vaccine to meet demand.
–Moderna, Pfizer -BioNTech, and Novavax are available.
▪CDC is continuing to have conversations with manufacturer and
distributors to ensure timely distribution of COVID -19 vaccines.
▪Visit vaccines.gov to find a COVID -19 vaccine near you.Vaccine Availability
Bridge Access Program
▪CDC’s Bridge Access Program provides no -cost COVID -19 vaccines to
adults without health insurance and adults whose insurance does not
cover all COVID -19 vaccination costs.
–All CDC -recommended COVID -19 vaccines are included in the Bridge Access
Program.
–The Bridge Access Program will end by December 31, 2024.
–The Vaccines for Adults (VFA) program, proposed in the FY 2023 and 2024
Presidential Budget, would be a long -term solution to ensure all adults have access
to recommend vaccinations, including COVID -19 vaccines, at no cost to them.CDC’s Bridge Access Program
Adults 18 years and older without health insurance
-and -
Adults with health insurance that does not cover all COVID -19
vaccine costs (only at Bridge Access Program sites that are in-
network for their health insurance)Who Can Get a No -Cost COVID -19 Vaccine Through the
Bridge Program
Where to Get a No -Cost COVID -19 Vaccine through the
Bridge Access Program?
Visit Vaccines.gov to find a provider that offers no -cost COVID -19
vaccines through the Bridge Access Program!
Community
events or
pop-up sites
with these
groups
Local Healthcare Providers
Retail Pharmacies:
Walgreens, CVS, eTrueNorth (pharmacy aggregator)HRSA -Supported Centers
Bridge Program Ordering and Administration*
*Data as of 10/20/2023
There are >24,000 contracted pharmacy locations and
>380,000 doses have been administered by contracted
pharmacies to individuals without insurance in the U.S.Rx
>4,400 public health safety net providers have placed >6,100
orders for > 287,000 doses of COVID -19 vaccine using 317 funds.
Nationally, 81% of people without insurance are estimated to be
within a 5-mile drive distance to a Bridge Access Program provider.
Vaccination Coverage
Snapshot of COVID -19 vaccine data reporting plans
Administration data from reporting states National Immunization Surveys
Bridge Access Program for COVID -19 Vaccines
Other surveillance systems
Vaccine Safety Datalink
Other data sources
Omnibus surveys
Internet panel survey of pregnant people
Distribution data
National Healthcare
Safety Network
Among 14,715 adults ages 18 years and older, 7.1% reported having
received a COVID -19 vaccine since September 14, 2023.
COVID -19 Vaccination Status and Intent Among Adults Age ≥18 Years by Demographics,
National Immunization Survey -Adult COVID Module, October 8 –14, 2023
Probably or definitely will NOT get vaccinatedUp to date with 2023 -24 COVID -19 vaccine
Definitely will get vaccinated
Probably will get vaccinated or unsure0.88.110.23.57.68.34.64.97.08.22.32.64.77.515.420.56.57.77.1
31.215.123.219.323.927.224.422.924.525.516.520.323.928.730.836.222.327.024.6
21.535.227.946.139.623.151.926.530.732.035.733.035.426.026.025.930.930.430.6
46.541.638.731.228.941.419.145.737.834.345.544.135.937.827.717.440.334.937.6
0 25 50 75 100AI/ANMulti/OtherNH/OPI**HispanicBlackWhiteAsianRuralSuburbanUrban18-2930-3940-4950-6465-7475+MaleFemaleOverall
Weighted %12.57.04.77.27.14.05.89.01.77.8
31.124.635.224.518.818.424.930.215.226.2
35.230.431.229.434.244.531.323.944.028.9
21.238.028.938.839.933.138.136.839.137.1
0 25 50 75 100Transgender/NonbinaryCisgenderGay/Lesbian/Bisexual/OtherStraightIncome unknownBelow povertyAbove poverty, <$75kAbove poverty, ≥$75kNot insuredInsured
Weighted %
Receipt of a COVID -19 vaccine was more frequently reported among
adults who were older, insured, and with higher incomes.
COVID -19 Vaccination Status and Intent Among Adults Age ≥18 Years by Demographics,
National Immunization Survey -Adult COVID Module, October 8 –14, 2023
Probably or definitely will NOT get vaccinatedUp to date with 2023 -24 COVID -19 vaccine
Definitely will get vaccinated
Probably will get vaccinated or unsure0.88.110.23.57.68.34.64.97.08.22.32.64.77.515.420.56.57.77.1
31.215.123.219.323.927.224.422.924.525.516.520.323.928.730.836.222.327.024.6
21.535.227.946.139.623.151.926.530.732.035.733.035.426.026.025.930.930.430.6
46.541.638.731.228.941.419.145.737.834.345.544.135.937.827.717.440.334.937.6
0 25 50 75 100AI/ANMulti/OtherNH/OPI**HispanicBlackWhiteAsianRuralSuburbanUrban18-2930-3940-4950-6465-7475+MaleFemaleOverall
Weighted %12.57.04.77.27.14.05.89.01.77.8
31.124.635.224.518.818.424.930.215.226.2
35.230.431.229.434.244.531.323.944.028.9
21.238.028.938.839.933.138.136.839.137.1
0 25 50 75 100Transgender/NonbinaryCisgenderGay/Lesbian/Bisexual/OtherStraightIncome unknownBelow povertyAbove poverty, <$75kAbove poverty, ≥$75kNot insuredInsured
Weighted %
2.12.72.70.72.22.41.42.1
0 2 4 6 8 10Other/multiple races, non-HispanicBlack, non-HispanicWhite, non-HispanicHispanic12-17 years5-11 years6 months-4 yearsAll children
Percent2.1% of children were reported to have received the updated 2023 -24
COVID -19 vaccination since it was recommended on September 14th,
2023.2023 -24 COVID -19 Vaccination Coverage,
Children Ages 6 Months -17 Years, National Immunization Survey -Child Covid Module (NIS -CCM)
Interviews week of: 10/8/2023 -10/14/2023 (n=2,767)
3.10.81.52.71.40.92.80.83.1
0 2 4 6 8 10UninsuredOther insuranceAny MedicaidRuralSuburbanUrbanUnknown incomeBelow povertyAbove poverty, <$75,000/yearAbove poverty, >=$75,000/year
Percent
Parents’ intent to get their child vaccinated was mixed.
Percentages vaccinated are all <3% and do not show well on this slide, please see previous slide.
2023 -24 COVID -19 Vaccination Coverage and Parental Intent,
Children Ages 6 Months -17 Years, National Immunization Survey -Child Covid Module (NIS -CCM)
Interviews week of: 10/8/2023 -10/14/2023 (n=2,767)
25.430.525.326.529.225.823.226.4
41.939.927.440.136.630.934.733.8
30.626.944.632.732.040.940.737.7
0 20 40 60 80 100Other/multiple races, non-HispanicBlack, non-HispanicWhite, non-HispanicHispanic12-17 years5-11 years6 months-4 yearsAll children
Percent23.728.025.219.524.831.720.023.522.432.5
33.032.933.020.234.937.641.930.433.431.2
43.336.040.958.837.629.437.343.443.433.2
0 20 40 60 80 100UninsuredOther insuranceAny MedicaidRuralSuburbanUrbanUnknown incomeBelow povertyAbove poverty, <$75,000/yearAbove poverty, >=$75,000/year
Percent
▪NIS data collected October 8 -14, 2023 provides estimates about four weeks since the
September 14, 2023 rollout of the 2023 -24 COVID -19 vaccine
▪Children (6 months –17 years)
–2.1% (95% CI: 1.1 -3.0) of children had received the updated 2023 -24 COVID -19 vaccine
–Slightly more than a quarter of children (33.8%, 95% CI: 30.6 -37.1) have a parent who said they
definitely will get their child vaccinated while 2 in 5 children (37.7%, 95% CI: 34.4 -41.0) have a parent
that said they probably or definitely will not get their child vaccinated
▪Adults (≥18 years)
–7.1% (95% CI: 6.3 -8.0) of adults had received the updated 2023 -24 COVID -19 vaccine
–24.6% (95% CI: 23.0 -26.2) of adults said they definitely will get vaccinated, and 37.6% (95% CI: 35.7 -
39.5) said they probably or definitely will not get vaccinatedCOVID Vaccination Coverage Summary
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. Implementation Update on  2023 –2024 COVID -19 Vaccines Shannon Stokley, DrPH Immunization Services Division Centers for Disease Control and Prevention Commercialization…


04 COVID Wallace 508

cdc.gov/coronavirus
Summary and Work Group
Considerations
Megan Wallace, DrPH, MPH
ACIP Meeting
June 23 , 2023
U.S. COVID -19 vaccine uptake among ages ≥12 years,
August 2021 -June 2023
01,000,0002,000,0003,000,0004,000,0005,000,0006,000,0007,000,000
Primary Series, Adolescents Ages 12-17 Primary Series, Adults Ages 18-49 Primary Series, Adults Ages 50-64 Primary Series, Adults Ages 65+
Booster, Adolescents Ages 12-17 Booster, Adults Ages 18-49 Booster, Adults Ages 50-64 Booster, Adults Ages 65+Primary series authorization
1stbooster authorization
2ndbooster authorization 1stbivalent booster
authorization
2ndbivalent
booster
authorization Doses Administered
Source: IZ Data Lake
Coverage / Age (years) <22–45–1112–1718–2424–4950–64>65
At least one dos e† 8.9 10.9 40.0 72.2 82.3 85.5 95.0 95.0
At least one bivalent dose 0.6 0.6 4.8 7.8 7.4 12.1 21.7 43.3
Unvaccinated 91.1 89.1 60.0 27.8 17.7 14.5 —†—†U.S. COVID -19 Vaccination Coverage (%) of Total Population by
Age Group —May 10, 2023
†Note: Coverage is capped at 95%
Source: https://covid.cdc.gov/covid -data -tracker/#vaccination -demographics -trends Updated June 1, 2023 3
PI=Prediction Interval, VOC=Variants of Concern, VBM=Variants Being Monitored . https://covid.cdc.gov/covid -data-tracker/#variant -proportions Accessed June 1 , 2023Trends in weighted variant proportion estimates & Nowcast
United States, February 19, 2023 –June 10, 2023
Collection date, week ending
4

Weekly population -based rates of COVID- 19-associated hospitalizations
by age group— COVID-NET, March 2020–May 2023
Age Group
.
https://covid.cdc.gov/covid -data -tracker/#covidnet -hospitalization -network Accessed June, 2023
5
▪COVID -19 during pregnancy is associated with severe maternal health outcomes and
adverse pregnancy outcomes
▪Risk of complications lower, but still elevated, during the Omicron predominant
period compared to pre -Omicron period
–Possibly due to the impact of prior infection and vaccination
▪Most hospitalized pregnant persons with a positive SARS -CoV-2 test were not up to
date with vaccinationsCOVID -19 in pregnant people
Summary
6
▪COVID -19-associated hospitalization rates in infants ages 0 –5 months increased in
the Omicron period
–Hospitalization rates similar to those in adults ages 65 –75 years
▪Majority of infants ages 0 –5 months hospitalized with a positive SARS -CoV-2 test
were hospitalized with COVID -19-like symptoms
▪Vaccination at any point in pregnancy appears to be beneficial to infants <6 monthsCOVID -19 in infants
Summary
7
▪Pregnancy remains a risk factor for severe maternal disease and adverse pregnancy
outcomes, even with new variants
▪COVID -19 vaccination improves outcomes for pregnant people, their pregnancies and
their infants
▪Growing body of evidence that COVID -19 mRNA vaccines are safe during pregnancy1
▪Current uptake of updated COVID -19 vaccine is low among pregnant people
–23% of pregnant people received an updated dose2
▪Work group emphasized that pregnant people should receive recommended COVID -19
vaccine dose for protection of themselves and their infants
▪Continue to review data and evaluate COVID -19 recommendations for pregnant
people as neededWork Group interpretation
COVID -19 in pregnant people and infants
1. https://www.cdc.gov/vaccinesafety/research/publications/index.html . COVID -19 Vaccine Safety Articles and Studies by Topic. Pregnancy.
2. https://covid.cdc.gov/covid -data -tracker/#vaccinations -pregnant -women 8
▪Hybrid immunity likely provides better protection than either infection or
vaccination alone
▪Protection likely influenced by cumulative number of vaccine doses, number of
times infected, timing of most recent vaccination or infection, and how closely the
circulating variant matches the vaccine or prior infection
▪Protection can wane over time after both infection and vaccination
▪Receipt of updated vaccine dose can provide additional protection beyond that
received by prior doses or infection and restore protection after waningInfection -induced and hybrid immunity
Summary
9
Current recommendations for mRNA COVID -19 vaccines
≥6 years 6 months –4 years 5 years2 doses
bivalent
Moderna3 doses
bivalent
Pfizer-
BioNTechOR2 doses
bivalent
Moderna1 dose
bivalent
Pfizer-
BioNTechOR1 dose
bivalent
Moderna1 dose
bivalent
Pfizer -
BioNTechOR
Current recommendations for mRNA COVID -19 vaccines
6 –23months 2 –4 yearsQuestion discussed by the Work Group :
Do children ages 2 –4 years continue to
need a multi -dose initial series, or could
they also move to a single (annual?) dose
like older populations

Possible future recommendations for simplification
mRNA COVID -19 vaccines
≥2 years 6–23months2 doses
bivalent
Moderna3 doses
bivalent
Pfizer -
BioNTechOR1 dose
bivalent
Moderna1 dose
bivalent
Pfizer-
BioNTechOR
COVID -19-associated hospitalization rates in infants, children and adolescents aged 6
months through <18 Years —COVID -NET, March 2020 –May 2023
Source: COVID -NET: https://www.cdc.gov/coronavirus/2019 -ncov/covid -data/covid -net/purpose -methods.html . Data March 1, 2020 through March 31, 2023. Pre -Delta: March 1, 2020 –June
19, 2021; Delta: June 20 –December 18, 2021; Omicron BA.1: December 19, 2021 –March 19, 2022; Omicron BA.2: March 20 –June 18, 2022; Omicron BA.5 (J une 19, 2022 –May 27, 2023)Pre-Delta DeltaOmicron
BA.1Omicron
BA.2Omicron BA.5 and later
1302468101214161820
3/7/2020
4/7/2020
5/7/2020
6/7/2020
7/7/2020
8/7/2020
9/7/2020
10/7/2020
11/7/2020
12/7/2020
1/7/2021
2/7/2021
3/7/2021
4/7/2021
5/7/2021
6/7/2021
7/7/2021
8/7/2021
9/7/2021
10/7/2021
11/7/2021
12/7/2021
1/7/2022
2/7/2022
3/7/2022
4/7/2022
5/7/2022
6/7/2022
7/7/2022
8/7/2022
9/7/2022
10/7/2022
11/7/2022
12/7/2022
1/7/2023
2/7/2023
3/7/2023
4/7/2023
5/7/2023Rate per 100,000
6 months <2 years 2-4 years 5-11 years 12-17 years
63828993
0102030405060708090100
Mar-Apr May-Jun Jul-Aug Sep-Oct Nov-DecSeroprevalence (%)
Month7585929799
0102030405060708090100
Mar-Apr May-Jun Jul-Aug Sep-Oct Nov-DecSeroprevalence (%)
MonthPediatric infection -induced and combined (vaccine -and infection -induced)
Seroprevalence from U.S. commercial laboratories —March –December 2022
Source: https://covid.cdc.gov/covid -data -tracker/#pediatric -seroprevalence and unpublished data (CDC) Data from repeat, cross -sectional study on blood specimens collected by commercial laboratories.
Vaccine history is unknown in this study. Infection -induced seroprevalence estimated from blood specimens tested for anti -nucleo capsid antibodies: the number of specimens per 2 -month collection
period were, by age group: 6 –11 months: 157; 12 –23 months: 724; 2 –4 years: 2,165; 5 –11 years: 9,247; and 12 –17 years: 14,570.  C ombined (vaccine -and infection -induced seroprevalence estimated
from specimens tested for both spike and nucleocapsid antibodies: >99% of samples tested for anti -nucleocapsid antibodies were t ested for anti -spike antibodies. 14Infection -induced Combined (vaccine -and infection -induced)

▪Children ages 6 –23 months have higher COVID -19 hospitalization rates; hospitalization
rates among children ages 2 –4 years similar to rates in children 5 –17 years
▪Children ages ≥2 years more likely to be seropositive and may have multiple exposures
through either infection or vaccination
▪However, no randomized, clinical trials compared efficacy or immunogenicity of single
dose versus multiple dose in young pediatric population in the context of high
seroprevalence Children ages 2 –4 years
Multiple initial doses or single (annual?) dose
15
▪COVID -19 vaccines effectively protect children from hospitalization and severe disease
from COVID -19
–Uptake of COVID -19 vaccines in children remains low
▪Work Group would be supportive of a move toward recommendation for a single
(possibly annual) dose in ages 2 –4 years based on hospitalization rates and rates of
seropositivity in this age group
–Work Group did highlight differences in transition to a single dose series from a two-dose
series , compared to a three -dose series
▪Simple recommendations may lead to increased coverage
▪Continue to review data and evaluate COVID -19 vaccine program in context of evolving
epidemiology Work Group interpretation
Multiple doses in children ages 2 -4 years
16
▪June 15, 2023 FDA’s Vaccines and Related Biological Products Advisory Committee
(VRBPAC) met to discuss fall strain composition
▪VRBPAC unanimously voted that the vaccine composition be updated to a
monovalent COVID -19 vaccine with an XBB -lineage of the Omicron variant
▪FDA advised manufacturers to develop vaccines with a monovalent XBB.1.5
composition
▪Anticipate updated vaccine doses will be broadly available in the fall
▪Following updated vaccine authorizations, ACIP will review evidence to inform
updated recommendationsSteps toward recommendation of updated vaccine
https://www.fda.gov/advisory -committees/advisory -committee -calendar/vaccines -and-related -biological -products -advisory -committee -june -15-2023 -meeting -announcement
https://www.fda.gov/vaccines -blood -biologics/updated -covid -19-vaccines -use-united -states -beginning -fall-2023 17
▪COVID -19 vaccines and treatments will likely transition to the commercial
marketplace in fall 2023
–CDC continues to partner closely with state, local, and interagency partners toward
continued successful distribution of COVID -19 vaccines and treatments during this time,
including clarification of processes for ordering, shipping and distribution
–Guidance for partners will be published in summer 2023, prior to the transition to the
commercial marketplace
▪Most Americans will continue to pay nothing out -of-pocket for the COVID -19vaccine
due to their insurance coverage
▪However, approximately 25 million uninsured adults will lose access to affordable
COVID -19 vaccines and treatments if no action were taken
▪The Bridge Access Program for COVID -19 Vaccines and Treatment is a public -private
partnership which serves as a temporary measure to prevent the loss of under -and
uninsured adults' access to COVID -19 vaccines and treatments at no -cost after
commercializationPlanning for Fall 2023
18
▪COVID -19 continues to cause substantial morbidity and mortality across the population,
particularly in groups like older adults and persons with immunocompromising conditions
▪COVID -19 vaccines continue to be the most effective tool we have to prevent serious illness,
hospitalization and death from COVID -19
▪COVID -19 vaccination is important for pregnant people for the protection of themselves and
their infants
▪Most of the population hasn’t received a bivalent vaccine dose
▪Ongoing review of data to continue efforts toward simplification
–Work Group would be supportive of additional simplification for children ages 2 –4 years in the future
▪FDA advised manufacturers to develop vaccines with a monovalent XBB.1.5 composition
▪Anticipate benefits from updated vaccine prior to possible increases in cases over the winter;
ACIP can discuss future vaccine recommendations at upcoming meetings following updated
vaccine authorizationsSummary
19
▪Sara Oliver
▪Danielle Moulia
▪Monica Godfrey
▪Evelyn Twentyman
▪Hannah Rosenblum
▪Lauren Roper
▪Katherine Fleming -Dutra
▪Ruth Link -Gelles
▪Amadea Britton
▪Sarah Meyer
▪Susan Goldstein
▪Mary Chamberland
▪Elisha Hall
▪Valerie Morelli▪JoEllen Wolicki
▪Fiona Havers
▪Romeo Galang
▪Sierra Scarbrough
▪Jefferson Jones
▪Aron Hall
▪Barbara Mahon
▪Coronavirus and other Respiratory Viruses Division
▪National Center for Immunization and Respiratory
DiseasesAcknowledgments
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.
Thank you

Summary: cdc.gov/coronavirus Summary and Work Group  Considerations Megan Wallace, DrPH, MPH ACIP Meeting June 23 , 2023 U.S. COVID -19 vaccine uptake among ages ≥12 years,  August 2021 -June 2023 01,000,0002,000,0003,000,0004,000,0005,000,0006,000,0007,000,000 Primary Series, Adolescents Ages 12-17 Primary Series, Adults Ages 18-49 Primary Series, Adults Ages 50-64 Primary Series, Adults Ages 65+ Booster, Adolescents Ages 12-17 Booster, Adults Ages 18-49 Booster, Adults Ages 50-64 Booster, Adults Ages…


01 COVID Daley 508

cdc.gov/coronavirus
ACIP COVID -19 Vaccines Work Group
Dr. Matthew F. Daley, Work Group Chair
April 19, 2023
▪April 18, 2023: FDA1updated COVID -19 vaccine emergency use authorizations
(EUAs):
–Use of bivalent mRNA vaccines for all doses/indications administered to individuals
ages 6 months and older
–Additional dose(s) for certain populationsCOVID -19 vaccine update:
FDA authorizations
21. https://www.fda.gov/news -events/press -announcements/coronavirus -covid -19-update -fda-authorizes -changes -simplify -use-bivalent -mrna-covid -19-vaccines
▪Review of pediatric COVID -19 vaccine data
▪Epidemiology of COVID -19, including among adults ≥65 years of age
▪Vaccine effectiveness (VE) updates
▪Preliminary results for pediatric cost effectiveness analyses
▪Discussions for additional doses in vulnerable populationsACIP COVID -19 Work Group Meeting Review
March –April 2023
3
▪Vaccine safety updates
▪Vaccine effectiveness data updates
▪Epidemiology and hospitalization data
▪Benefit -risk analysis
▪Considerations for transition to bivalent primary series
▪Future directions of COVID -19 vaccines, including updates to vaccine policyFebruary ACIP COVID -19 Meeting Review
February 24, 2023
4
▪COVID -19 vaccine program updates Dr. Peacock (CDC)
▪COVID -19 vaccine safety updates Dr. Shimabukuro (CDC)
▪Update: v -safe after vaccination health checker Dr. Shimabukuro (CDC)
▪Updates to COVID -19 vaccine effectiveness in the US Dr. Link -Gelles (CDC)
▪Updates to COVID -19 vaccine policy:
Data and Work Group considerations Dr. Oliver (CDC)
▪Updates to Interim Clinical Considerations Dr. Twentyman (CDC)
Break
▪Public Comment
▪DiscussionAgenda:
Wednesday April 19, 2023
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
▪IHS: Uzo Chukwuma
▪CMS: Jeff Kelman
▪BARDA: Christine Oshansky
▪HHS: David Kim
▪CDC: Alan Lam
CDC Leads
▪Sara Oliver
▪Evelyn TwentymanWork Group members
6Liaisons
▪AAFP: Jonathan Temte
▪AAP: Sean O’Leary
▪ACOG: Denise Jamieson (primary),
Laura Riley (alternate)
▪ACP: Jason Goldman
▪ADS: Emily Kahn
▪AGS: Ken Schmader
▪AIM: Rob Shechter (primary),
Jane Zucker (alternate)
▪AMA: Sandra Fryhofer
▪ANA: Ruth Francis (alternate)
▪APhA: Michael Hogue
▪ASTHO: Marcus Plescia
▪CSTE: Paul Cieslak, Christine Hahn
IDSA: Jeff Duchin (primary)Liaisons, cont’d
▪NACCHO: Matt Zahn (primary),
Jeff Duchin (alternate)
▪NACI: Matthew Tunis (primary),
Nicole Forbes (alternate)
▪NFID: Bill Schaffner (primary),
Marla Dalton (alternate)
▪NMA: Patricia Whitley -Williams
▪SHEA: Preeti Mehrotra
Marci Drees (alternate)
Consultants
▪Ed Belongia
▪Kathy Kinlaw
▪Dayna Matthew
▪Kathleen Neuzil
▪Stanley Perlman
▪Peter Szilagyi
▪Hank Bernstein
▪Sarah Meyer
▪Elisha Hall
▪Megan Wallace
▪Danielle Moulia
▪Lauren Roper
▪Hannah Rosenblum
▪Katherine Fleming -Dutra
▪Monica Godfrey
▪Susan Goldstein
▪Mary Chamberland
▪Stephen Hadler
▪JoEllen Wolicki
▪Melinda Wharton
▪Jessica MacNeil
▪Amanda CohnCDC participants
7▪Ruth Link -Gelles
▪Amadea Britton
▪Carolyn Bridges
▪Allison Ciesla
▪Nicole Dowling
▪Ashley Fowlkes
▪Heather Scobie
▪Natalie Thornburg
▪Tom Shimabukuro
▪John Su
▪Julianne Gee
▪Karen Broder
▪Rita Helfand
▪Jefferson Jones
▪Yvonne Bolen▪Pragna Patel
▪Amanda Payne
▪Georgina Peacock
▪Jose Romero
▪Laura Steinhardt
▪Ryan Wiegand
▪Patricia Yu
▪Yon Yu▪Samuel Graitcer
▪Lisa Grohskopf
▪Katherina Grusich
▪Aaron Hall
▪Terri Hyde
▪Cynthia Jorgensen
▪Kristen Nordlund
▪Sierra Scarbrough
▪Edwin Shanley
▪Andrew Kroger
▪Lauri Markowitz
▪Noelle -Angelique Molinari
▪Michael McNeil
▪Morgan Najdowski
▪Ismael Ortega -Sanchez
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.
Thank you!

Summary: cdc.gov/coronavirus ACIP COVID -19 Vaccines Work Group Dr. Matthew F. Daley, Work Group Chair April 19, 2023 ▪April 18, 2023: FDA1updated COVID -19 vaccine emergency use authorizations  (EUAs): –Use of bivalent mRNA vaccines for all doses/indications administered to individuals  ages 6 months and older –Additional dose(s) for certain populationsCOVID -19 vaccine update: FDA authorizations 21. https://www.fda.gov/news -events/press -announcements/coronavirus -covid -19-update -fda-authorizes…


02 COVID Peacock 508

For more information: www.cdc.gov/COVID19
COVID -19 Vaccine Program Updates
Georgina Peacock, MD, MPH, FAAP
Director, Immunization Services Division
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention (CDC)
Overarching Objectives for the U.S. COVID -19
Vaccination Program
Ensure safety and
effectiveness of
COVID -19
vaccinesReduce mortality,
morbidity, and
incidence of
COVID -19 diseaseHelp minimize
disruption to
society and
economy, including
maintaining
healthcare capacityEnsure equity in
vaccine allocation
and distribution
End of the Public Health Emergency on May 11, 2023
and the COVID -19 Vaccination Program
▪What will change
▪Possible reduced submission of vaccine administration data from some
jurisdictions which may limit completeness of administration data on a national
level
▪Most jurisdictions have signed a COVID -19 vaccine Data Use Agreement extension
through the end of 2023
End of the Public Health Emergency on May 11, 2023
and the COVID -19 Vaccination Program
•What will notchange
▪CDC working with public and private partners to learn more about the short -and
long -term health effects associated with COVID -19, who is affected, and why –
and implementing vaccine recommendations to optimize protection
▪FDA’s EUAs for COVID -19 products (including vaccines)
▪All vaccines purchased by the U.S. government will continue to be distributed and
available for free
Public Health Emergency ending ≠ Commercialization
Commercialization of COVID -19 Vaccines
•Commercialization of COVID -19 vaccines is the transition of vaccines previously purchased by the U.S. Government
(USG), to established pathways of procurement, distribution, and payment by both public and private payers
•Timeline: Likely in early Fall
–Considerations include what will be authorized by FDA and recommended by CDC, and what will align with a
strain change for potential variants
•After commercialization, vaccines will remain free for most people through the Vaccines for Children Program,
Children’s Health Insurance Program, most commercial insurance, Medicare, and Medicaid programs
https://aspr.hhs.gov/COVID -19/Pages/FAQ -Commercialization.aspx
▪Vaccination equity : when everyone has fair and just access to
vaccination.
▪CDC works with national, state, tribal, territorial, healthcare, and
community partners to ensure all people have fair and just
access to vaccination.
▪CDC uses a Social Vulnerability Index to support areas at
increased risk.
▪Making sure the uninsured have continued access to COVID -19
vaccines with as few financial barriers as possible is a top
priorityFocus on Vaccination Equity

Pharmacies Help
Increase Access
to Vaccines

▪HHS recently announced intent to amend the declaration under the PREP Act for
medical countermeasures against COVID -19.
▪By issuing this amendment, the HHS Secretary intends to extend immunity liability to
pharmacists, pharmacy interns, and pharmacy technicians to administer COVID -19
and seasonal influenza vaccines through December 2024.
▪Additional information on the planned amendment to the declaration under the
PREP Act can be found at https://www.hhs.gov/about/news/2023/04/14/factsheet -
hhs-announces -amend -declaration -prep -act-medical -countermeasures -against -
covid19.htmlPublic Readiness and Emergency Preparedness (PREP)
Act for Medical Countermeasures against COVID -19
Inflation Reduction Act
https://www.cms.gov/newsroom/fact -sheets/inflation -reduction -act-lowers -health -care -costs -millions -americans
The proposed Vaccines for Adults program would reduce the spread of vaccine -
preventable diseases and pave the way to greater health equity
VACCINES FOR
ADULTS
PROGRAM
VACCINE PURCHASE
Purchase of recommended
vaccines for all uninsured
adults
PROGRAM OPERATIONS
CDC staff and systems for scientific
and policy support, program
monitoring, and vaccine safety and
distributionPROVIDER FEES
Covering the cost of supplies,
patient education, storage, and
staffing
PROVIDER FEE
MANAGEMENT
Contracts to administer the provider
reimbursement process
VACCINE CONFIDENCE
Support vaccine equity through partnerships, communications, and
technical assistanceAND EQUITY ACTIVITIES**These activities are funded
in the FY24 CDC Budget with
base immunization funding,
not the newly proposed
mandatory funding proposal
that would support the rest
of these activities.
FY24 President's Budget Request: Vaccines for Adults (VFA)

Looking Forward
Continued
surveillance of
virusesContinuing focus
on vaccine equity
Continued vaccine
effectiveness
studies
Communicating about
the Public Health
Emergency ending
Collaborating with
partners on vaccine
commercialization
Increasing
vaccine
confidence

Summary: For more information: www.cdc.gov/COVID19 COVID -19 Vaccine Program Updates Georgina Peacock, MD, MPH, FAAP Director, Immunization Services Division National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention (CDC) Overarching Objectives for the U.S. COVID -19  Vaccination Program Ensure safety and  effectiveness of  COVID -19  vaccinesReduce mortality,  morbidity, and  incidence of  COVID -19 diseaseHelp minimize  disruption to  society and  economy,…


03 COVID Shimabukuro 508

National Center for Emerging and Zoonotic Infectious Diseases
mRNA COVID -19 bivalent booster vaccine
safety update
Advisory Committee on Immunization Practices (ACIP) meeting
April 19, 2023
Tom T. Shimabukuro, MD, MPH, MBA
Director, Immunization Safety Office
Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention (CDC)

Topics
▪Describe current data on ischemic stroke following
mRNA COVID -19 bivalent booster vaccination
•CDC’s Vaccine  Safety Datalink (VSD) Rapid Cycle Analysis (RCA)
signal assessment for ischemic stroke after Pfizer -BioNTech
COVID -19 mRNA bivalent booster dose vaccination in the age
group ≥65 years old
•Vaccine Adverse Event Reporting System (VAERS) data on
ischemic stroke following mRNA COVID -19 bivalent booster
dose vaccination
2
VSD COVID -19 Rapid Cycle Analysis:
Analyses of Ischemic Stroke after Pfizer -
BioNTech Bivalent Booster Dose
Prepared by:
Kaiser Permanente Northern California Vaccine Study Center
Presented by Tom Shimabukuro, MD, MPH, MBA
Centers for Disease Control and Prevention
3
Vaccine Safety Datalink (VSD)
▪Established in 1990
▪Collaborative project between CDC and 9 integrated healthcare organizations
▪Includes electronic health record data on ~12.5 million individuals across all sites 4
VSD RCA for bivalent boosters
▪Pre-specified outcomes were assessed during weekly sequential
monitoring after COVID -19 bivalent booster vaccination*
•Risk of pre -specified outcomes 1 –21 days following a bivalent vaccination
compared with bivalent vaccinated individuals who were 22 –42 days
following the bivalent dose (vaccinated concurrent comparator method)
•All analyses adjusted for age, sex, race/ethnicity, VSD site, calendar time
(days) and seasonality (time)
•Signal if p -value <0.01 (1 -sided)
* Rapid Cycle Analysis (RCA) to monitor the safety of COVID -19 vaccines in near real -time within the Vaccine Safety Datalink. Av ailable at:
Rapid Cycle Analysis (RCA) to monitor the safety of COVID -19 vaccines in near real -time within the Vaccine Safety Datalink (cdc. gov) 5
6VSD COVID -19 vaccine RCA prespecified surveillance outcomes
Prespecified outcomes Settings
Acute disseminated encephalomyelitis Emergency dept, Inpatient
Acute myocardial infarction Emergency dept, Inpatient
Acute respiratory distress syndrome Emergency dept, Inpatient
Anaphylaxis * Emergency dept, Inpatient
Appendicitis Emergency dept, Inpatient
Bell’s palsy Emergency dept, Inpatient, Outpatient
Cerebral venous sinus thrombosis Emergency dept, Inpatient
Disseminated intravascular coagulation Emergency dept, Inpatient
Encephalitis / myelitis / encephalomyelitis Emergency dept, Inpatient
Guillain -Barré syndrome Emergency dept, Inpatient
Immune thrombocytopenia Emergency dept, Inpatient, Outpatient
Kawasaki disease Emergency dept, Inpatient
Multisystem inflammatory syndrome in children/adults (MIS -C/MIS -A) Emergency dept, Inpatient
Myocarditis / pericarditis * Emergency dept, Inpatient
Narcolepsy / cataplexy Emergency dept, Inpatient, Outpatient
Pulmonary embolism Emergency dept, Inpatient
Seizures/Convulsions (including 0 -7 days for youngest ages) Emergency dept, Inpatient
Stroke, hemorrhagic Emergency dept, Inpatient
Stroke, ischemic Emergency dept, Inpatient
Thrombosis with thrombocytopenia syndrome Emergency dept, Inpatient
Thrombotic thrombocytopenic purpura Emergency dept, Inpatient
Transverse myelitis Emergency dept, Inpatient
Venous thromboembolism Emergency dept, Inpatient, Outpatient
*All outcomes are first ever in the ICD -10 era, except anaphylaxis which is first in 7 days, and myocarditis/pericarditis which is first in 60 days▪In COVID -19 bivalent booster vaccine monitoring, VSD RCA detected a statistical signal for ischemic stroke after
Pfizer -BioNTech bivalent booster vaccination in the age group 65 years and older
▪No other VSD RCA pre -specified surveillance outcomes have signaled in any age groups for either of the mRNA
COVID -19 bivalent booster vaccines or when data for the two mRNA vaccine types are combined/pooled
VSD investigations of an RCA signal to assess whether it
reflects a real effect of vaccination on an outcome
▪Data quality assessment for errors, anomalies, or missing/late -arriving data
▪Analyses using different comparators than primary concurrent (e.g., un -boosted,
unvaccinated or “historical” comparators) to supplement our primary analyses
▪Additional investigations to provide context (e.g., background rates, etc.)
▪Graphic displays of outcome incidence day by day after vaccination, using temporal scan
statistics to assess apparent clustering
•Examine the temporal clustering of outcome events in subgroups defined by demographics, site or
simultaneous exposure (e.g., flu vaccine)
▪If the signal is driven by a strong association in one subgroup or VSD site, further
analyses by site or subgroup as appropriate
▪Chart review to confirm cases and collect additional data (e.g., date of symptom onset).
▪Consider epidemiologic studies to further investigate surveillance findings
7Rapid Cycle Analysis (RCA) to monitor the safety of COVID -19 vaccines in near real -time within the Vaccine Safety Datalink. Avai lable at: Rapid
Cycle Analysis (RCA) to monitor the safety of COVID -19 vaccines in near real -time within the Vaccine Safety Datalink (cdc.gov)
VSD COVID -19 RCA analyses:
Ischemic stroke after Pfizer -BioNTech
bivalent booster among people ≥65
years of age
COVID -19 bivalent booster doses and influenza vaccine doses
administered over time among persons aged ≥65 years, by vaccine type
9
VSD RCA ischemic stroke definition
ICD-10 CODES TO FIND INCIDENT
CASES  ICD-10 CODES FOR LOOKBACK TO ADJUST
ONSET DATE  (in all settings)ICD-10 CODES -TO DETECT PREVALENCE
(history of, in all settings)                         ICD-10 CODES -OTHER CAUSE EXCLUSIONS (in all settings)
Stroke, ischemic
(settings = Emergency, Inpatient)Codes to adjust Stroke, ischemic onset
(if seen within 1 day before case)Stroke, ischemic -Review for Prevalence -1ST EVER Other possible causes of Stroke, ischemic
G45.8 Other transient cerebral
ischemic attacks and
related syndromes Adjust onset date if occurs in the 1 day prior to
incident case:Exclude if occurs EVER prior to incident case:Exclude if COVID -19 in the last 30 days prior to incident case (not
including same day):
G45.9 Transient cerebral
ischemic attack,
unspecifiedCOVID -19 DIAGNOSIS
I63.* Cerebral infarction Z92.82 Status post administration of tPA
(rtPA ) in a different facility within
the last 24 hours prior to admission
to current facilityZ86.73 Personal history of transient ischemic
attack (TIA), and cerebral infarction
without residual deficitsOR
COVID -19 POSITIVE LAB TEST
R51.* Headache I69.* Sequelae of cerebrovascular disease Exclude if occurs in the time period noted prior to incident case
(not including same day):
R47.* Speech disturbances, not
elsewhere classified I48.*Atrial fibrillation and flutter (if seen EVER prior to
incident case)
R29.810 Facial weakness I21.* Acute myocardial infarction  (if seen within 28 days prior
to incident case)
R53.1 Weakness
S15.*Injury of blood vessels at neck level (if seen within 1 day
prior to incident case)
R42.* Dizziness and giddiness
I74.*Arterial embolism and thrombosis (if seen within 1 day
prior to incident case)
R41.82 Altered mental status, unspecified D57.* Sickle -cell disorders (if seen EVER prior to incident case)
R40.4 Transient alternation of awareness
D68.5*Primary thrombophilia (if seen EVER prior to incident
case)
G81.9* Hemiplegia, unspecified
H53.9 Unspecified visual disturbance
H53.13* Sudden visual loss
10
Bivalent RCA concurrent comparator analyses of
ischemic strokes during a 1 –21-day Risk Interval versus
a 22–42-day Comparison Interval (data through April 8, 2023)
Nominal analysis Sequential analysis
Age group
(years)VaccineRisk
events (N)Comp
events (N)Adjusted
Rate Ratio95%
Confidence
Interval1-sided
p-valueSignal thi
week?
1-sided
p <0.01s
18–64Pfizer
Moderna49
1852
321.09
0.560.73–1.63
0.30–1.010.372
0.981No
No
65+ Pfizer 158 145 1.26 0.99–1.60 0.032 No
Moderna 80 77 1.21 0.87–1.68 0.142 No
11
Ischemic stroke after Pfizer -BioNTech bivalent booster, age ≥65
years, counts and adjusted rate ratios ( Oct 16, 2022 –April 8, 2023 )
12 Red dot represents sequential signal: p -value <0.01 (1 -sided)RR= 1.26 (95% CI 0.99 –1.60)
95% Age group
(years)Interval
(days)Comparators VaccineRisk
events (N)Comp
events (N)Adjusted
Rate RatioConfidence
IntervalP-value
(2-sided)
Not bivalent65+ 1–21 Pfizer 168 2536 1.01 0.86–1.19 0.907boosted
* Analyses only included outcomes through April 8, 2023.
13Supplemental RCA analyses:
Ischemic strokes during the 1–21-day interval comparing bivalent boosted
vs. un -boosted concurrent comparators (but eligible for bivalent booster )*
Cases in 1 –21-day Cases in 22 –42-day Adjusted
Analytic population Risk Interval Comparison Interval Rate Ratio** P-value
(N=139) (N=108) (95% CI)
Bivalent Pfizer + same -day
high-dose or adjuvanted flu 43 27 1.59 (0.99 –2.61) 0.06
vaccine
Bivalent Pfizer + same day8 11 0.73 (0.28 –1.83) 0.50standard dose flu vaccine
Bivalent Pfizer without any107 99 1.08 (0.82 –1.42) 0.58same day flu vaccine
14* Analyses only include vaccination data through January 14, 2023 , and stroke outcome data through Feb 25, 2023
** Adjusted by 5 -year age groupsPost-signal analyses*:
Ischemic stroke incidence during days 1 –21 compared with days 22 –42,
among ≥65 years with and without simultaneous influenza vaccination
Ischemic stroke following bivalent Pfizer -BioNTech mRNA
COVID -19 booster vaccination in people ages 65+ years
▪Statistical signal
•The statistical signal persisted during the November 2022 –January 2023 timeframe
•The rate ratio has slowly attenuated from 1.92 to 1.26 and has not met signaling
criteria during the past 10 weekly analyses
▪Additional signal investigation analyses
•Supplemental analyses using un -boosted concurrent comparators showed a rate ratio
RR=1.01 (95% CI 0.86 –1.19; p -value 0.907)
•Analyses evaluating simultaneous high -dose or adjuvanted flu vaccine showed a rate
ratio RR=1.59 (95% CI 0.99 –2.61; p -value 0.06)
‒Separate analyses did not detect an elevated RR for stroke after flu vaccine alone (data not shown)
•Supplemental analyses suggest comparison interval (22 –42 days) rates were lower
than expected (data previously presented to ACIP February 24, 2023*)
15*ACIP Meeting COVID -19 mRNA bivalent booster vaccine safety --February 24, 2023 (cdc.gov)
Vaccine Adverse Event Reporting System
(VAERS)
VAERS is the nation’s early warning system for vaccine safety
+
Vaccine Adverse Event
Reporting System
http://vaers.hhs.gov
17
U.S. reports to VAERS following bivalent booster COVID -19 mRNA
vaccination among ages ≥5 years*(as of April 2, 2023) (N=28,363)
▪Distribution by age, sex, and serious status similar regardless of manufacturer
•Most reports (93%) were non -seriousManufacturerMedian
Age (IQR),
yearsMale†
N (%)Female†
N (%)Non -serious
N (%)£Serious
N (%)Doses
admin‡
Pfizer -BioNTech 56 (35–69) 6,599 (38) 10,580 (61) 16,124 (93) 1,307 (8) 35,256,444
Moderna 62 (45–71) 4,159 (38) 6,620 (61) 10,209 (93) 725 (7) 19,900,255
Total 59 (39–70) 10,758 (38) 17,198 (61) 26,331 (93) 2,032 (7) 55,156,699
* Includes reports after Moderna bivalent booster among ages ≥6 years
† Excludes 407 (1%) reports where sex was not reported
£2 reports documented receipt of Moderna and Pfizer Bivalent, they are counted in each group but only counted once total
‡Doses administered among children ages 5 –11 years vaccinated during October 18, 2022 –March 29, 2023 18
Reports to VAERS of ischemic stroke/transient ischemic attack (TIA) after
bivalent COVID -19 mRNA vaccination in people ages ≥18 years
(as of April 2, 2023)
▪149 verified reports of ischemic stroke/TIA
•Ischemic stroke ( 110), TIA ( 35), ischemic stroke + TIA (4)
•Pfizer -BioNTech bivalent ( 112), Moderna bivalent (37)
•Median age: 72 years (IQR: 66–79years)
•Median time to onset: 13 days (IQR: 4 –29 days)
•68males, 81 females
•All verified reports (149, 100%) had at least one risk
factor for ischemic stroke
‒The most common was hypertension (89, 60%)
•Simultaneous influenza vaccination
‒18–64 years: standard dose (6)
‒≥65 years: high -dose (10), adjuvanted (3), standard dose (2),
unknown type (1)Preliminary reports of ischemic
stroke/TIA (N= 252)
Under review*
(n=34)
Excluded based
upon chart
review (n= 9)
Verified ischemic stroke/TIA by
chart review (n= 149) *Awaiting medical records and/or healthcare provider interview; some still processing
19Non -ischemic stroke
verified by chart review
(n=60)

  VAERS reports and reporting rates of ischemic stroke/TIA in the 3 weeks after
mRNA COVID -19 bivalent vaccination in people ages 18 –39, 40 –64, and ≥65 years
(as of April 2, 2023)
Chart -verified reports Chart -verified reports Background + reports under review
Reporting rate Reporting rate Age group Obs Doses Obs Doses ExpVaccine (per million (per million † (years) reports admin* reports admin* cases doses admin) doses admin)
18–39 Pfizer -BioNTech 3 6,334,671 0.5 3 6,334,671 0.5 88
18–39 Moderna 0 3,048,913 0 1 3,048,913 0.3 42
40–64 Pfizer -BioNTech 13 12,419,399 1.0 17 12,419,399 1.4 1,168
40–64 Moderna 4 7,028,873 0.6 5 7,028,873 0.7 661
≥65 Pfizer -BioNTech 51 13,693,161 3.7 60 13,693,161 4.4 4,993
≥65 Moderna 19 9,622,716 2.0 23 9,622,716 2.4 3,509
* Doses administered as of April 5, 2023
† Ramirez et al. Trends in Transient Ischemic Attack Hospitalizations in the United States. J Am Heart Assoc . 2016;5(9):e004026. (Estimated expected cases based upon observed annual incidence in 2010 for
ages 25 –44, 45 –54, and 65 –84 years, adjusted for period corresponding to 3 weeks after vaccination). 20
VAERS monitoring: COVID -19 mRNA bivalent booster
vaccination and ischemic stroke
▪No unusual or unexpected reporting patterns observed, and no
evidence of a safety concern detected for ischemic stroke with either
mRNA COVID -19 bivalent boosters in VAERS monitoring
21
Summary
COVID -19 mRNA bivalent booster vaccination safety –data
from other monitoring systems and programs*
▪FDA monitoring in the CMS data and Department of Veterans Affairs monitoring in the VA
system have not detected any safety signals for ischemic stroke following COVID -19
mRNA bivalent boosters using historical comparator designs
▪Surveillance conducted by international regulatory and public health partners has not
detected a safety concern for ischemic stroke following bivalent COVID -19 mRNA booster
vaccination
▪No evidence of a safety signal for ischemic stroke in Pfizer’s global monitoring of bivalent
COVID -19 mRNA booster vaccination
▪No safety signals were detected for ischemic stroke for primary series or monovalent
boosters for Pfizer -BioNTech or Moderna COVID -19 vaccines in U.S. and global monitoring
23*These surveillance activities did not include analyses to evaluate the effect of simultaneous flu vaccination; different
formulations of COVID -19 mRNA bivalent booster vaccinations were used globally
Further evaluation and key next steps
Further evaluation
▪Consult with other surveillance systems to better understand:
•Possible role of simultaneous high -dose or adjuvanted flu vaccination with COVID -19
vaccination
•Possible decreased rate of stroke observed in VSD in the 3 –6 weeks following vaccination
▪In the process of chart reviewing a random sample of 100 cases across VSD sites
▪Continue monitoring in VAERS
Key next steps
▪CDC continues to recommend that everyone eligible for a COVID -19 mRNA
bivalent booster or a flu vaccine get vaccinated
▪CDC and FDA are engaged in epidemiologic analyses regarding simultaneous
vaccination with COVID -19 mRNA bivalent booster and flu vaccines
24
Acknowledgements
25▪CDC Immunization Safety Office
•VAERS Team
•V-safe Team
•Clinical Immunization Safety Assessment
(CISA) Project
•Vaccine Safety Datalink (VSD) Team
▪COVID -19 Vaccine Task Force Data Monitoring
and Reporting Group▪Kaiser Permanente Northern California (VSD)
▪Marshfield Clinic Research Institute (VSD)
▪VSD sites
•HealthPartners Institute, Minneapolis, MN
•Kaiser Permanente Colorado, Denver, CO
•Kaiser Permanente Northwest, Portland, OR
•Kaiser Permanente Southern California, Los Angeles, CA
•Kaiser Permanente Washington, Seattle, WA
•Denver Health, Denver, CO
Disclaimer/disclosures
▪The findings and conclusions in this presentation are those of the presenters and
do not necessarily represent the official position of the CDC
▪Mention of a product or company name is for identification purposes only and
does not constitute endorsement by CDC
▪Dr. Nicola Klein reports research support from Pfizer for COVID -19 vaccine clinical
trials and from Pfizer, GlaxoSmithKline, Merck and Sanofi Pasteur for unrelated
studies
26
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.
Photo credit: James Gathany
(https://wwwn.cdc.gov/phil/
Details.aspx?pid=8876 )
Extra Slides
Ischemic stroke by day after Pfizer -BioNTech bivalent
boosters, people ages ≥65 Years*
*Data cutoff 2/28/2023Cluster days 13 –22,
p-value = .0637
29

Summary: National Center for Emerging and Zoonotic Infectious Diseases mRNA COVID -19 bivalent booster vaccine  safety update Advisory Committee on Immunization Practices (ACIP) meeting April 19, 2023 Tom T. Shimabukuro, MD, MPH, MBA Director, Immunization Safety Office Division of Healthcare Quality Promotion  Centers for Disease Control and Prevention (CDC)  Topics ▪Describe current data on ischemic stroke following  mRNA COVID -19 bivalent booster vaccination  •CDC’s Vaccine  Safety Datalink (VSD)…


04 COVID Shimabukuro 508

National Center for Emerging and Zoonotic Infectious Diseases
Update: v -safe after vaccination health checker
Advisory Committee on Immunization Practices (ACIP) meeting
April 19, 2023
Tom T. Shimabukuro, MD, MPH, MBA
Director, Immunization Safety Office
Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention (CDC)

Topics
▪Overview of v -safe
▪Contributions of v -safe to the COVID -19 response
▪Historical and current participation in v -safe
▪Planning for the wind -down of the current system and
development of next version of v -safe
▪Continued safety monitoring of COVID -19 vaccines
2
Overview of v -safe for COVID -19 vaccines
3▪Implemented December 2020
▪Designed to collect near -real time data by direct outreach to
COVID -19 vaccine recipients
•Initially conceived to rapidly collect basic safety data (local and
systemic reactogenicity, health impacts) at the onset of the COVID -19
vaccination program to provide early data while other systems, such
as VAERS and the Vaccine Safety Datalink, were accruing data
•Identified vaccinated pregnant persons for possible enrollment in the
COVID -19 Vaccine Pregnancy Registry
•Was useful in rapidly collecting early safety data when authorizations
and recommendations expanded to other age and risk groups (e.g.,
additional doses for immunocompromised persons)
•Was quickly adapted to capture simultaneous administration of other
non-COVID vaccines (e.g., flu vaccine)
▪Designed, built, and supported in collaboration with Oracle
Health Services under a donation agreement with HHS
Overview of v -safe for COVID -19 vaccines (continued)
4▪Enrollment by self -registration on smartphone with any
dependents added to guardian’s account
▪Survey completion prompted by text message reminders for
“health check -ins”
▪Call follow -up to all participants who report a medically
attended event
▪Robust participation in its first year
•9.3 million participants / 131 million health surveys completed
▪Total participation to date
•10.1 million participants / 151 million health surveys completed
Key contributions of v -safe to COVID -19 vaccine safety
5*V-safe identifies pregnant people for enrollment in Vaccine Pregnancy Registry | CDC
▪V-safe has been particularly effective in characterizing the basic safety of COVID -19 vaccines during
early vaccine introduction and following new authorizations and recommendations
▪V-safe successfully accomplished its mission and worked as intended
Participation in v -safe for COVID -19 vaccines
6010,000,00020,000,00030,000,00040,000,00050,000,00060,000,00070,000,00080,000,00090,000,000100,000,000
0500,0001,000,0001,500,0002,000,0002,500,000
Dec-20
Jan-21
Feb-21
Mar-21
Apr-21
May-21
Jun-21
Jul-21
Aug-21
Sep-21
Oct-21
Nov-21
Dec-21
Jan-22
Feb-22
Mar-22
Apr-22
May-22
Jun-22
Jul-22
Aug-22
Sep-22
Oct-22
Nov-22
Dec-22
Jan-23
Feb-23
Mar-23New v -safe registrants by month
New Active Registrants Doses COVID-19 Vaccine Administered in United States
Active registrants defined as those completing at least one survey by April 9, 2023
Doses COVID -19 vaccine administered sourced from COVID Data TrackerDoses Registrants
Next steps for v -safe
7▪Timing for final registration and completing surveys will be announced soon
▪Follow up will continue on reports of medically attended health events
▪Next generation v -safe is under development
•Plans to collect data on new vaccines
•Will allow greater flexibility for surveys and use CDC IT infrastructure
•Designed to permit longer -term support for collecting data rapidly from a large
number of vaccine recipients
CDC vaccine safety monitoring for COVID -19 vaccines
8▪Safety monitoring and assessment of COVID -19 vaccines will continue in:
•Vaccine Adverse Events Reporting System (VAERS)
VAERS | Vaccine Safety | CDC , Vaccine Adverse Event Reporting System (VAERS) (hhs.gov)
•Vaccine Safety Datalink (VSD)
Vaccine Safety Datalink (VSD) | VSD | Monitoring | Ensuring Safety | Vaccine Safety | CDC
•Clinical Immunization Safety Assessment (CISA) Project
Clinical Immunization Safety Assessment (CISA) Project | CISA | Monitoring | Ensuring Safety | Vaccine Safety | CDC
CDC vaccine safety monitoring
9▪Strong, complementary systems are in place―both new and established
VAERS v-safe VSD CISA Project
Full list of U.S. COVID -19 vaccine safety monitoring systems
https://www.cdc.gov/coronavirus/2019 -ncov/vaccines/safety.html
Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), Clinical Immunization Safety Assessment (CISA)
Acknowledgements
10▪CDC Immunization Safety Office
•V-safe Team
▪COVID -19 Vaccine Task Force Data Monitoring and Reporting Group
▪CDC NCEZID and DHQP Communications Teams
▪Oracle Health Services
▪Participants in v -safe
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.
Photo credit: James Gathany
(https://wwwn.cdc.gov/phil/
Details.aspx?pid=8876 )

Summary: National Center for Emerging and Zoonotic Infectious Diseases Update: v -safe after vaccination health checker Advisory Committee on Immunization Practices (ACIP) meeting April 19, 2023 Tom T. Shimabukuro, MD, MPH, MBA Director, Immunization Safety Office Division of Healthcare Quality Promotion  Centers for Disease Control and Prevention (CDC)  Topics ▪Overview of v -safe ▪Contributions of v -safe to the COVID -19 response ▪Historical and current participation in v -safe ▪Planning for the…


05 COVID Link Gelles 508

Centers for Disease Control and Prevention
National Center for Immunization and Respiratory DiseasesCenters for Disease Control and Prevention
National Center for Immunization and Respiratory DiseasesCenters 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
COVID-19 vaccine effectiveness updates
19 April 2023
Ruth Link-Gelles, PhD, MPH
LCDR, US Public Health Service COVID-19 Vaccine Effectiveness Program Lead 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.

       Organization of presentation
 Updates on vaccine effectiveness (VE) of monovalent vaccines against
symptomatic infection in children aged 6 months–4 years (Pfizer-BioNTech)
and 6 months–5 years (Moderna)
 Update on VE of monovalent and bivalent vaccines against severe disease in
adults with and without immunocompromising conditions
2

     -
- - – — –
–Estimates of Effectiveness of Monovalent mRNA Vaccines in Preventing
Symptomatic SARS-CoV-2 Infection Among Children Aged 3–5 Years,
Increasing Community Access to Testing Program
Updated analyses based on: Fleming Dutra KE, Ciesla AA, Roper, LE et al. Preliminary Estimates of Effectiveness of Monovalent mRNA Vaccines in Preventing
Symptomatic SARS CoV 2 Infection Among Children Aged 3 5 Years Increasing Community Access to Testing Program, United States, July 2022 February 2023. MMWR Morb Mortal Wkly Rep 2023;72:177 182. DOI: http://dx.doi.org/10.15585/mmwr.mm7207a3
3
Percent of people receiving COVID-19 vaccine by age and date administered
– United States, December 14, 2020 – April 12, 2023
https://covid.cdc.gov/covid-data-tracker/#vaccination-demog r aphics-trends 4

    Increasing Community Access to Testing (ICATT) Program: VE of monovalent
COVID-19 vaccines against symptomatic infection in children aged 3-5 years
 Nationwide community-based drive-through SARS-CoV-2 testing via pharmacies
 Self-reported vaccine history at time of registration for SARS-CoV-2 testing
 Design : Test-negative, case-control analysis*
 Population : Immunocompetent children aged 3 – 4/5** years with ≥1 COVID-like
sy
mptom and nucleic acid amplification testing (NAAT)
 Period for analysis:
• Tested: July 4, 2022*** – April 8, 2023, BA.4/BA.5 and XBB predominant period
*Models adjusted for: age, gender, race, ethnicity, social vulnerability index and HHS region of the testing location, underlying conditions (presence versus absence), pharmacy
chain conducting the test, local incidence (cases per 100,000 by individual county and state in the 7 days before test date), and date of testing. ** ICATT testing is generally limited to children ages 3 and up. ***Analysis start date depended on vaccine/dose number being analyzed: Pfizer and Moderna 1
st doses started 7/4/2022; Pfizer 2nd dose started 7/25/2022; Moderna 2nd dose
started 8/1/2022; Pfizer 3rd dose started 9/19/2022. 5

ICATT: Estimates of VE for primary series monovalent Moderna vaccine (children aged
3–5 yea
rs) against symptomatic infection , July 4, 2022 – April 8, 2023
6Updated from: Fleming-Dutra, Ciesla, Roper, et al. MMWR February 16, 2023.
*Test registrants who report receiving COVID-19 vaccines are asked to report the total number of doses and manufacturer(s) of vaccines received
and for the most recent dose, month and year of receipt; therefore, the number of months between a vaccine dose and testing is a whole number calculated as the difference between the month and year of testing and the month and year of the vaccine dose. For doses received in the same month or the month before SARS-CoV-2 testing, an additional question was asked to specify whether the dose was received ≥2 weeks before testing, and only doses received ≥2 weeks before testing were included. 17% and 21% of children who received 1 and 2 doses of Moderna, respectively, reported a prior infection >90 days before the current test.Vaccination status (months since last dose) Total testsSARS-CoV-2
positive, N (%)Adjusted
VE (95% CI)
Moderna, 1 dose (partial series; ages 3-5 years)
July 4, 2022 – April 8, 2023
Unvaccinated 36,779 9,801 (27) Ref
1monovalent dose (2 weeks–1 month)* 515 107 (21) 40 (25 to 52)
Moderna, 2 doses (complete series; ages 3-5 years)
August 1, 2022 – April 8, 2023
Unvaccinated 26,856 5,972 (22) Ref
2 monovalent doses (2 weeks–6 months)* 1,613 183 (11) 47 (37 to 54)
2 monovalent doses (2 weeks–1 month)* 461 48 (10) 61 (47 to 71)
2 monovalent doses (2–3 months)* 647 63 (10) 54 (41 to 65)
2monovalent doses (4–6 months)* 505 72 (14) 18 (-6 to 37)
20 0 20 40 60 80 100
VaccineEffectiveness (%)-
ICATT: Estimates of VE for primary series monovalent Pfizer-BioNTech vaccine (children
aged 3–4 years) against symptomatic infection , July 4, 2022 – April 8, 2023
7Upd
ated from: Fleming-Dutra, Ciesla, Roper, et al. MMWR February 16, 2023.
*Test registrants who report receiving COVID-19 vaccines are asked to report the total number of doses and manufacturer(s) of vaccines received
and for the most recent dose, month and year of receipt; therefore, the number of months between a vaccine dose and testing is a whole number calculated as the difference between the month and year of testing and the month and year of the vaccine dose. For doses received in the same month or the month before SARS-CoV-2 testing, an additional question was asked to specify whether the dose was received ≥2 weeks before testing, and only doses received ≥2 weeks before testing were included. 18%, 19% and 21% of children who received 1, 2, and 3 doses of Pfizer, respectively, reported a prior infection >90 days before the current test.
**There was insufficient power to stratify Pfizer-BioNTech 3-dose VE estimates by time since vaccination.Vaccination status (months since last dose)Total
testsSARS-CoV-2
positive, N (%)Adjusted
VE (95% CI)
Pfizer, 1 dose (partial series; ages 3–4 years)
July 4, 2022–April 8, 2023
Unvaccinated 23,376 6,381 (27) Ref
1 monovalent dose (2 weeks–1 month)* 448 114 (25) 20 (0 to 36)
Pfizer, 2 doses (partial series; ages 3–4 years)
July 25, 2022–April 8, 2023
Unvaccinated 18,492 4,469 (24) Ref
2 monovalent doses (2 weeks–3 months)* 951 140 (15) 40 (28 to 50)
Pfizer, 3 doses (complete series; ages 3–4 years)**
September 19, 2022–April 8, 2023
Unvaccinated 8,610 1,445 (17) Ref
3 monovalent doses (2 weeks–6 months)* 478 64 (13) 27 (4 to 45)
0 0 20 40 60 80 100
VaccineEffectiveness (%)-2

            Limitations
 Vaccine coverage is low in children aged ≤5 years. VE estimates may be less stable when
vaccine coverage is low.
 Prevalence of prior infection in children is high*; consequently, VE in this analysis reflects the current situation among young children in the United States.
 Low vaccination coverage in this age group may impact future ability to estimate VE,
including against more severe outcomes.
 The goal of the U.S. COVID-19 vaccination program is to prevent severe disease; however, VE against symptomatic infection provides important insight into vaccine protection,
especially before VE estimates for key questions are available.
*https://covid.cdc.gov/covid-data-tracker/#pediatric-seroprevalence ; 92% seroprevalence in children 6 months -17 years nationally by December 2022. 8

   Conclusions
 Complete monovalent primary series vaccination helped provide protection for
children aged 3–5 years against symptomatic SARS-CoV-2 infection for at least the
first 3 months after vaccination.
 Waning of monovalent Moderna primary series appears to occur by 4–6 months
after the second dose.
 Initial protection and waning patterns are similar to those observed in older children
and adults in the first months after vaccination.
 Waning of monovalent Pfizer-BioNTech VE against symptomatic infection could not
be assessed but is also likely based on analyses in older children and adults.
 Children should stay up to date with COVID-19 vaccines.
 CDC will continue to monitor VE in this age group, including against severe disease and for bivalent doses.
9

       - –
— –
–Updated estimates of bivalent VE against
emergency department/urgent care encounters
and hospitalizations among adults aged ≥18 years, VISION Network
Updated analyses based on: Tenforde MW, Weber ZA, Natarajan K, et al. Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID 19
Associated Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompetent Adults VISION Network, Nine States, September November 2022. MMWR Morb Mortal Wkly Rep 2023;71:1637 1646. DOI: http://dx.doi.org/10.15585/mmwr.mm7153a1

 Cases :COVID-like illness (CLI) with
positive PCR for SARS-CoV-2 within 14
days before or 72 hours after the admission or encounter

 Controls : CLI with negative PCR for SARS-
CoV-2 VISION Multi-State Network of Electronic Health Records
 Variant periods designated for
analysis based on time when novel sublineage became predominant at study site

 VE adjusted for age, sex, race, ethnicity, geographic region, calendar time, and local rates of SARS-CoV-2 circulation

 Vaccination documented by electronic health records and state and city registries
11

VISION: Absolute VE of monovalent and bivalent booster against ED/U C
encounters among immunocompetent adults aged ≥18 years, by age group –
September 2022 – March 2023*
*Unpublished CDC data.  1
2SARS-CoV-2- Median interval
mRNA Dosage PatternTotal
teststest-positive,
N (%)since last dose,
days (IQR)Adjusted VE
(95% CI)
Aged 18-64 years
Unvaccinated (ref) 55,418 5,699 (10) -- Ref
Monovalent doses only, last dose ≥2 months earlier 81,766 8,518 (10) 391 (311-518) 4 (0-7)
Bivalent booster, 7-59 days earlier 6,744 399 (6) 33 (20-46) 53 (48-58)
Bivalent booster, 60-119 days earlier 5,834 428 (7) 84 (71-100) 42 (35-47)
Bivalent booster, 120-179 days earlier 2,352 243 (10) 139 (129-153) 15 (2-26)
Aged ≥65 years
Unvaccinated (ref) 10,559 1,833 (17) -- Ref
Monovalent doses only, last dose ≥2 months earlier 42,019 5,721 (14) 343 (215-441) 20 (15-25)
Bivalent booster, 7-59 days earlier 9,103 724 (8) 35 (21-47) 61 (57-64)
Bivalent booster, 60-119 days earlier 9,086 935 (10) 86 (73-101) 47 (42-52)
Bivalent booster, 120-179 days earlier 3,857 483 (13) 139 (129-153) 25 (16-34)
0 20 40 60 80 100Vaccine Effectiveness (%)
VISION: Absolute VE of monovalent and bivalent booster against
hospit
alization among immunocompetent adults aged ≥18 years, by age
group – September 2022 – March 2023*
*Unpublished CDC data.  **Not included due to imprecise estimates (confidence intervals >50 percentage points). 13SARS-CoV-2- Median interval
mRNA Dosage PatternTotal
teststest-positive,
N (%)since last dose,
days (IQR)Adjusted VE
(95% CI)
Aged 18-64 years
Unvaccinated (ref) 7,126 565 (8) -- Ref
Monovalent doses only, last dose ≥2 months earlier 9,621 659(7) 388 (300-522) 21 (10-30)
Bivalent booster, 7-59 days earlier 839 28 (3) 33 (21-46) 68 (53 to 79)
Bivalent booster, 60-119 days earlier 746 56 (8) 84 (70-101) 27 (2 to 46)
Bivalent booster, 120-179 days earlier 268 21 (8) 137 (128-150) **
Aged ≥65 years
Unvaccinated (ref) 6,687 1,132 (17) -- Ref
Monovalent doses only, last dose ≥2 months earlier 20,474 2,735 (13) 354 (232-460) 25 (18 to 31)
Bivalent booster, 7-59 days earlier 35 (21-47) 64 (59 to 69) 3,494 264 (8)
Bivalent booster, 60-119 days earlier 3,561 358 (10) 86 (73-102) 53 (46 to 59)
Bivalent booster, 120-179 days earlier 1,472 158 (11) 139 (128-152) 39 (26 to 50)
0 20 40 60 80 100
Vaccine Effectiveness (%)
VISION: Absolute VE of bivalent booster against hosp italization among
immunocompromised adults aged ≥18 years –
September 2022 – March 2023*
*Unpublished CDC data. 1
4Median SARS-CoV-2-
mRNA Dosage PatternTotal
teststest-positive,
N (%)interval
since last dose,
days (IQR)Adjusted VE
(95% CI)
Unvaccinated (ref) 2,763 295 (11) -- Ref
Monovalent doses only, last dose ≥2 months earlier 9,232 977 (11) 343 (225-452) 5 (-10 to 18)
Bivalent booster, 7-59 days earlier 1,518 134 (9) 33 (19-46) 30 (12 to 44)
Bivalent booster, 60-119 days earlier 1,610 125 (8) 87 (73-102) 43 (28 to 55)
Bivalent booster, 120-179 days earlier 723 59 (8) 139 (129-152) 31 (4 to 50)
-20 0 20 40 60 80 100
Vaccine Effectiveness (%)

          Characteristics of patients with COVID-19-associated hospitalizations, — VISION
Network, 10 States, October 29, 2022–March 29, 2023
All hospitalizations Critical hospitalizations*
Characteristic N=9499 N=1839
Age, median (IQR), years 75 (65–84) 74 (63–83)
Female sex, No. (%) 4818 (50.7) 881 (47.9)
No. of categories of underlying medical conditions, median (IQR)** 3 (2–4) 4 (3–5)
Immunocompromising condition, No. (%) 1677 (17.7) 438 (23.8)
COVID-19 vaccination status, No. (%)
Unvaccinated 2842 (29.9) 625 (34.0)
Complete primary series 2273 (23.9) 451 (24.5)
Primary series + 1 booster dose 2388 (25.1) 445 (24.2)
Primary series + 2 booster doses 1320 (13.9) 218 (11.9)
Primary series + 3 booster doses 668 (7.0) 97 (5.3)
Primary series + 4 booster doses 8 (0.1) 3 (0.2)
Received mRNA bivalent dose*** 1567 (16.5) 269 (14.6)
*Admitted to an intensive care unit and/or in-hospital death.
**Categories of underlying medical conditions include pulmonary, cardiovascular, cerebrovascular, neurological or musculoskeletal, endocrine or metabolic, hematologic, renal, hepatic, and immune.
***Any mRNA vaccine doses received on or after September 2, 2022 were considered to be bivalent.
Note: this analysis includes recipients of mRNA or Janssen primary series

  - –
— –
–Updated estimates of bivalent VE against
hospitalizations among adults aged ≥65 years,
IVY Network
Updated analyses based on: Surie D, DeCuir J, Zhu Y, et al. Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID 19 Associated
Hospitalization Among Immunocompetent Adults Aged ≥65 Years IVY Network, 18 States, September 8 November 30, 2022. MMWR Morb Mortal Wkly Rep 2022;71:1625 1630. DOI: http://dx.doi.org/10.15585/mmwr.mm715152e2

                          IVY Network — 25 hospitals, 20 U.S. States
 Design : Prospective, case-control
 Period : September 8, 2022–April 1, 2023
 Population : Adults aged ≥18 years hospitalized
w
ith COVID-like illness (CLI)*

 Cases: CLI and test positive for SARS-CoV-2 by RT
-
P
CR or antigen test within 10 days of illness

 Controls: CLI and test negative for SARS-CoV-2 and
influenza by RT-PCR within 10 days of illness

 VE adjustments: Age, sex, race and ethnicity,
admission date (biweekly), and HHS region
*COVID-like illness (CLI) is defined as presence of any one of the following: fever, cough, shortness of breath, chest imaging consistent with pneumonia, new or worsening hypoxemia 17

Absolute and relative VE against COVID-19 hospitalizations
among immunocompetent adults aged ≥65 years — IVY
Network, September 8, 2022 – April 1, 2023
18Vaccinated Median time
Vaccinated cases, controls, since last dose, Adjusted VE,
no./total no. (%) no./total no. (%) days (IQR) % (95% CI)
Absolute VE
Unvaccinated (Ref) --
Monovalent doses only, last dose ≥2 months earlier 783/997 (79) 884/1101 (80) 373 (259–476) 13 (-9 to 30)
Bivalent booster dose, 7–59 days earlier 61/275 (22) 175/392 (45) 34 (19–49) 65 (49–77)
Bivalent booster dose, 60–119 days earlier 105/319 (33) 183/400 (46) 89 (73–103) 43 (17–60)
Bivalent booster dose, 120–179 days earlier 73/287 (25) 92/309 (30) 141 (129–154) 22 (-26 to 52)
Relative VE
Monovalent doses only, last dose ≥2 months earlier (Ref)
Bivalent booster dose, 7–59 days earlier 61/844 (7) 175/1059 (17) 34 (19–49) 60 (45–71)
Bivalent booster dose, 60–119 days earlier 105/888 (12) 183/1067 (17) 89 (73–103) 35 (14–51)
Bivalent booster dose, 120–179 days earlier 73/856 (9) 92/976 (9) 141 (129–154) 17 (-21 to 42)
-40 -20 0 20 40 60 80 100
Vaccine Effectiveness (%)

Estimates of monovalent VE against invasive
mechanical ventilation and death among adults
aged ≥18 years, IVY Network
IVY: Effectiveness of 2-4 monovalent mRNA COVID-19 vaccine doses against
COVI
D-19 invasive mechanical ventilation or death among
immunocompetent adults aged ≥18 years — IVY Network, February 1, 2022 –
January 31, 2023
20Median time
Vaccinated since last Absolute
Vaccinated cases,
no./total no. (%)controls,
no./total no. (%)dose,
days (IQR)adjusted VE,
% (95% CI)
Overall 216/362 (60) 3080/4059 (76) 248 (138–378) 62 (52–70)
Age group, yrs --
18–64 85/163 (52) 1421/2095 (68) 263 (144–380) 57 (39–70)
≥65 131/199 (66) 1659/1964 (84) 238 (133–375) 69 (57–78)
Time since last dose to illness, days
7–179 63/209 (30) 1112/2091 (53) 109 (68–145) 76 (66–83)
180–364 95/241 (39) 1110/2089 (53) 269 (220–317) 54 (37–66)
≥365 58/204 (28) 858/1837 (47) 455 (402–549) 56 (36–69)
-20 0 20 40 60 80 100
Vaccine Effectiveness (%)
Effectiveness of monovalent mRNA COVID-19 vaccines against COVID-19
invasive mechanical ventilation or death among immunocompetent adults
aged ≥18 years — IVY Network, February 1, 2022 – January 31, 2023
2
1Median time
Vaccinated since last Absolute
Vaccinated cases,
no./total no. (%)controls,
no./total no. (%)dose,
days (IQR)adjusted VE,
% (95% CI)
Time since last dose to illness, by no. of doses
received
7–179 days before illness
2 doses 6/152 (4) 108/1087 (10) 114 (72–153) –*
3 doses 42/188 (22) 633/1612 (39) 116 (75–147) 70 (55–81)
§4 doses 15/91 (17) 353/860 (41) 94 (55–135) 84 (69–92)
≥180 days before illness
2 doses 81/227 (36) 953/1932 (49) 418 (326–531) 50 (32–64)
3 doses 66/212 (31) 901/1880 (48) 292 (235–366) 59 (42–72)
§4 doses 4/80 (5) 108/615 (18) 223 (197–258) –*
*VE estimate not reported because of insufficient sample size
§Logistic regression models for VE of 4 monovalent doses were restricted to patients aged ≥50 years admitted during April 5, 2022–January 31, 20230 20 40 60 80 100
Vaccine Effectiveness (%)

         Limitations of VE against severe disease
 For estimates of absolute vaccine effectiveness, if unvaccinated are meaningfully
different from vaccinated individuals (e.g., by COVID-19 risk factors), estimates may
be biased.
 For estimates of relative vaccine effectiveness, residual protection from prior doses is
an important consideration.
 Information on prior infection is limited, although we know rates of prior infection in the U.S. population are high.
 VE against COVID-19-associated hospitalization may underestimate protection against more severe COVID-19 disease.
22

            Conclusions: updates to VE of bivalent COVID-19 boosters
 Bivalent boosters are helping provide additional protection against emergency
department/urgent care encounters and hospitalization, though evidence of
waning
 For most people who received monovalent doses and are eligible for a bivalent
booster, more than a year has elapsed since their last monovalent dose. Because of waning, they may have limited remaining protection.
 Vaccines provide durable protection against the most critical illness (mechanical ventilation and death)
 CDC will continue ongoing monitoring of VE, including for all outcomes of interest and for all authorized vaccines in the U.S. (Pfizer-BioNTech, Moderna, Janssen, Novavax) with a focus on assessing new policy recommendations and VE in
populations at higher risk of severe COVID-19
23

 Acknowledgements
CDC COVID-19 Vaccine Effectiveness and
Policy Team
 Amadea Britton
 Allison Ciesla
 Monica Godfrey
 Eric Griggs
 Katherine Fleming-Dutra
 Morgan Najdowski
 Sara Oliver
 Amanda Payne
 Lauren Roper
 Laura Steinhardt
 Evelyn Twentyman
 Megan Wallace
 Ryan Wiegand VE platforms teams, including:
 Sarah Ball
 Jennifer DeCuir
 Monica Dickerson
 Margaret Dunne
 Matthew Levy
 Patrick Mitchell
 Palak Patel
 Caitlin Ray
An
d many more!!!  Sarah Reese
 Zach Smith
 Diya Surie
 Zack Weber
 Mark Tenforde
24

         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 DiseasesCenters for Disease Control and Prevention National Center for Immunization and Respiratory DiseasesCenters 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  COVID-19 vaccine effectiveness updates  19 April 2023  Ruth Link-Gelles, PhD, MPH  LCDR, US…