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Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.Updates to Interim Clinical Considerations for
Use of COVID -19 Vaccines
Evelyn Twentyman, MD MPH
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
Overview of implications
▪Simple and singular for most
▪Flexible for people at higher risk
▪Customized recommendations for young childrenImplications of the new recommendations
▪Simple and singular for most
▪Flexible for people at higher risk
▪Customized recommendations for young childrenImplications of the new recommendations
Previous recommendations for people aged ≥6 years
without immunocompromise
New recommendations for people aged ≥6 years without
immunocompromise who have not yet received a bivalent
mRNA dose
One bivalent
mRNA dose
New recommendations for people aged ≥6 years without immunocompromise who
have not yet received a bivalent mRNA dose , regardless of COVID -19 vaccination
history
One bivalent
mRNA dose≥1 monovalent
Moderna dose
≥1 monovalent
Novavax dose
≥1 monovalent
Janssen dose
No COVID -19
vaccine doses≥1 monovalent
Pfizer -BioNTech
dose
New recommendations for aged ≥6 years without
immunocompromise who have already received a bivalent
mRNA dose
One bivalent
mRNA dose
Vaccination is complete.
No doses are indicated at this time.
▪Simple and singular for most
▪Flexible for people at higher risk
▪Customized recommendations for young childrenImplications of the new recommendations
Flexible for people at higher risk of severe COVID -19:
People aged ≥65 years who have not yet received a bivalent
mRNA dose
One bivalent
mRNA doseOptional additional
bivalent mRNA dose
At least
4 months
Flexible for people at higher risk of severe COVID -19:
People aged ≥65 years who have already received a bivalent
mRNA dose
One bivalent
mRNA doseOptional additional
bivalent mRNA dose
At least
4 months
New flexibility for people at higher risk of severe COVID -19:
People aged ≥6 years with immunocompromise* who have
already received a bivalent mRNA dose
*Including those with imminent immunocompromise (e.g., prior to organ transplant; other causes.)One bivalent
mRNA doseOptional additional
bivalent mRNA dose
At least
2monthsAdditional
bivalent mRNA
doses as needed
At least
2monthsStem cell transplant
CAR-T therapy
B-cell depletion
Others
▪Simple and singular for most
▪Flexible for people at higher risk
▪Customized recommendations for young childrenImplications of the new recommendations
Doses previously recommended:
Moderna:
•2monovalent primary series doses +
•1 bivalent booster dose
Pfizer:
•2or3monovalent primary series
doses +
•1 bivalent primary series doseTransitioning from the monovalent to the bivalent era for
children without immunocompromise aged 6 months –4 years
Doses now recommended:
Customized by COVID -19
vaccination history such that all
children receive:
•At least 2 vaccine doses in total
including
•At least 1 bivalent dose
Number of
doses
indicated, by
manufacturer
Vaccination complete.COVID -19 vaccination
status April 2023
Previously received vaccine(s)COVID -19 vaccination algorithm for people without immunocompromise, ages 6 months –4 years, mRNA vaccines April 2023*
Vaccinated Unvaccinated
1dose bivalent Moderna1dose
monovalent
Moderna2doses
monovalent
Moderna
2doses
bivalent
Pfizer -
BioNTech1dose
monovalent
Pfizer -
BioNTech2doses
monovalent
Pfizer -
BioNTech3doses
monovalent
Pfizer -
BioNTech
1dose bivalent Pfizer -
BioNTech2doses
monovalent
Moderna and 1
dose bivalent
Moderna2doses
monovalent
Pfizer -BioNTech
and 1dose
bivalent Pfizer -
BioNTech
*To see product -specific doses and intervals of administration, see Table 1 and 2 forthcoming in Interim Clinical Considerations , forthcoming.2doses
bivalent
ModernaOR3doses
bivalent
Pfizer -
BioNTech
Doses previously recommended:
Moderna:
•2monovalent primary series doses +
•1 bivalent booster dose
Pfizer:
•2or3monovalent primary series
doses +
•1 bivalent primary series doseTransitioning from the monovalent to the bivalent era for
children without immunocompromise aged 5 years
Doses now recommended:
Customized so that Moderna
recipients receive:
•At least 2 vaccine doses in total
including
•At least 1 bivalent dose
And Pfizer recipients receive:
•At least 1 bivalent dose
Vaccination complete.Number of
doses
Indicated, by
manufacturerPreviously received vaccine(s)COVID -19 vaccination
status April 2023 Vaccinated Unvaccinated
1 or more doses
monovalent
Moderna1 or more doses
monovalent
Pfizer -BioNTechAny doses
monovalent
Pfizer -BioNTech
and 1dose
bivalent Pfizer -
BioNTech2doses
monovalent
Moderna and 1
dose bivalent
mRNA
OR2doses
bivalent
Moderna1dose
bivalent
Pfizer -
BioNTech1dose
bivalent
Pfizer -
BioNTechCOVID -19 vaccination algorithm for people without immunocompromise, age 5 years, mRNA vaccines April 2023*
*To see product -specific doses and intervals of administration, see reference Table 1 in Interim Clinical Considerations, forthc oming1dose
bivalent
Moderna
▪Adults and children aged 6 years and older are up to date with COVID -19 vaccines if they got a bivalent
(updated) COVID -19 vaccine.
▪Children 6 months through 5 years of age who received the Pfizer -BioNTech COVID -19 vaccine are up to
date if:
–They are 6 months to 4 years of age and got at least 3 COVID -19 vaccine doses, including at least one
bivalent (updated) COVID -19 vaccine dose.
–They are 5 years of age and got at least 1 bivalent (updated) COVID -19 vaccine dose.
▪Children 6 months through 5 years of age who got the Moderna COVID -19 vaccine are up to date if they got
at least two Moderna COVID -19 vaccine doses, including at least one bivalent (updated) COVID -19 vaccine
dose.
▪You may be eligible for additional COVID -19 vaccine doses if:
–You are 65 years of age and older and got your first bivalent (updated) COVID -19 vaccine booster 4 or
more months ago.
–You are moderately or severely immunocompromised and received a bivalent (updated) COVID -19
vaccine booster 2 or more months ago.
▪If you are unable or choose not to get a recommended bivalent mRNA vaccine, you will be up to date if you
got the Novavax COVID -19 vaccine doses approved for your age group. Stay Up to Date with COVID -19 Vaccines
Implications for vaccine providers
Moderna
Pfizer -BioNTech
Novavax
JanssenFewer COVID -19 Vaccine Products in Use
Bivalent Bivalent
BivalentBivalent BivalentBivalent Bivalent
Bivalent Bivalent Bivalent
All remaining Janssen vaccine doses
expire by May 6th2023Manufacturer Products Previously in Use Products Now in Use
▪CDC’s Interim Clinical Considerations for Use of Authorized
COVID -19 Vaccines will be updated with comprehensive tables
of vaccine doses and dosages indicated
•For each age group
•By history of COVID -19 vaccines received, for children ages 6 months
through 5 years
▪Revision of clinical guidance materials is underway
▪COCA Call to be held May 11th, 2023*Additional help for providers is on the way
*Please visit https://emergency.cdc.gov/coca/ for complete details
Implications for public health
Bivalent COVID -19 vaccine coverage is low.
COVID -19 Data Tracker, last updated April 13, 2023, CDC COVID Data Tracker: Vaccinations in the US16.7% of the total U.S.
population has received a
bivalent COVID -19 vaccine.20.2% of adults aged
≥18 years in the U.S. have
received a bivalent COVID -
19 vaccine.
COVID -19 Data Tracker, last updated April 13, 2023, https://covid.cdc.gov/covid -data -tracker/#vaccination -demographics -trends43%22%12%7%8%5%
> 65 years50–64 years25–49 years18–24 years12–17 years5–11 years2–4 years<2 yearsBivalent COVID -19 Vaccination Coverage by AgeBivalent COVID -19 vaccine coverage generally decreases with
decreasing age.
COVID -19 Data Tracker, last updated April 14, 2023, https://covid.cdc.gov/covid -data -tracker/#vaccination -demographics -trendsBivalent COVID -19 vaccine c overage is lower among Black, non -
Hispanic, Hispanic/Latino , and Native Hawaiian or Other Pacific
Islander .
17%12%24%9%9%22%15%
White, NHNHOPI, NHMultiracial, NHHispanic/LatinoBlack, NHAsian, NHAI/AN, NHBivalent COVID -19 Vaccination Coverage by Race/Ethnicity
COVID -19 Data Tracker, last updated April 14, 2023, https://covid.cdc.gov/covid -data -tracker/#vaccination -demographics -trendsBivalent COVID -19 vaccine coverage is lower among those with lower
income.
39%29%27%
Above poverty,
income >$75KAbove poverty,
income <$75KBelow povertyBivalent COVID -19 vaccine coverage by income among adults aged ≥18 years
COVID -19 Data Tracker, last updated April 14, 2023, https://covid.cdc.gov/covid -data -tracker/#vaccination -demographics -trendsBivalent COVID -19 vaccine coverage is lower among those without
health insurance .
35%15%
With Health
InsuranceWithout
Health
InsuranceBivalent COVID -19 vaccine coverage among adults aged ≥18 years by insurance status
▪COVID -19 vaccines continue to be the most effective tool we have to prevent serious
illness, hospitalization and death from COVID -19
–Uptake of the updated (bivalent) COVID -19 vaccines is not yet equitable, and
remains generally low
▪Simple recommendations are easier to communicate, which may improve vaccine
uptake
▪CDC is continuing to work toward additional materials for vaccine providers,
clinicians and the general public to make it easy for everyone to get up to date and
stay up to date with COVID -19 vaccinesReflections and Next Steps
▪Sara Oliver
▪Hannah Rosenblum
▪Mary Chamberland
▪Susan Goldstein
▪Elisha Hall
▪JoEllen Wolicki
▪Katherine Fleming -Dutra
▪Ruth Link -Gelles
▪Monica Godfrey
▪Danielle Moulia
▪Megan Wallace
▪Lauren Roper
▪Amadea Britton
▪Sarah Meyer
▪Julianne Gee▪Heather Scobie
▪Sierra Scarbrough
▪Yvonne Bolen
▪Jefferson Jones
▪Noelle Molinari
▪Aron Hall
▪Barbara Mahon
▪Data Analytics and Visualization Task Force
▪Coronavirus and other Respiratory Viruses
Division
▪Immunization Services 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 o f the Centers for Disease Control and Prevention.
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or
any use by other CDC CIOs or any external audiences.
Additional Flowcharts
Vaccination complete. Optional additional doses as needed**Previously received vaccine(s)
Number of
doses
Indicated, by
manufacturer COVID -19 vaccination
status April 2023
1 or more
doses
monovalent
Moderna2dose
monovalent
Pfizer -BioNTech
and 1dose
bivalent mRNA2doses
monovalent
Moderna and 1
dose bivalent
mRNA
1dose bivalent Moderna
1dose bivalent Pfizer -BioNTechOR1 or more
doses
monovalent
Pfizer -
BioNTechVaccinated UnvaccinatedCOVID -19 vaccination algorithm for people who are NOT moderately or severely immunocompromised, age 6 years and older, mRNA vacc ines April 2023*
*To see product -specific doses and intervals of administration, see reference Table 1 in Interim Clinical Considerations, forthcoming.
**People ages 65+ have the option to receive 1 additional bivalent mRNA dose at least 4 months after the first dose of a biva lent mRNA vaccine.
Tables
COVID -19 vaccination history Bivalent vaccine Number of bivalent
doses indicatedDosage (mL/ug) Vaccine vial cap and label colors Interval between doses
UnvaccinatedModerna
___or___20.25 mL/25 ug Dark blue cap; gray label borderDose 1 and Dose 2:
4–8 weeks
Pfizer BioNTech30.2 mL/3 ug MaroonDose 1 and Dose 2:
3–8 weeks
Dose 2 and dose 3:
At least 8 weeks
1 dose monovalent Moderna Moderna 1 0.25 mL/25 ug Dark blue cap; gray label border 4-8 weeks after monovalent dose
2 doses monovalent Moderna Moderna 1 0.2 mL/10 ug Dark pink cap; yellow label border At least 8 weeks after last monovalent dose
2 doses monovalent Moderna
and 1 dose bivalent Moderna NA; previously received 1
bivalent vaccine dose NA NA NA NA
1 dose monovalent Pfizer -
BioNTechPfizer BioNTech 2 0.2 mL/3 ug MaroonDose 1: 3 –8 weeks after monovalent dose
Dose 1 and Dose 2: At least 8 weeks
2 doses monovalent Pfizer -
BioNTechPfizer BioNTech 1 0.2 mL/3 ug Maroon At least 8 weeks after last monovalent dose
3 doses monovalent Pfizer -
BioNTechPfizer BioNTech 1 0.2 mL/3 ug Maroon At least 8 weeks after last monovalent dose
2 doses monovalent Pfizer -
BioNTech and 1 dose bivalent
Pfizer -BioNTechNA; previously received 1
bivalent vaccine doseNA NA NA NATable 1. COVID -19 vaccination schedule for people who are NOT moderately or severely immunocompromised
by COVID -19 vaccination history, April 2023 :Ages 6 months –4 years
COVID -19 vaccination history Bivalent vaccine Number of bivalent
doses indicatedDosage (mL/ug) Vaccine vial cap and label colors Interval between doses
UnvaccinatedModerna
___or___20.25 mL/25 ug Dark blue cap; gray label borderDose 1 and Dose 2:
4–8 weeks
Pfizer BioNTech 1 0.2 mL/10 ug Orange
1 dose monovalent Moderna Moderna
___or___1 0.25 mL/25 ug Dark blue cap; gray label border 4–8 weeks after monovalent dose
Pfizer BioNTech 1 0.2 mL/10 ug Orange At least 8 weeks after monovalent dose
2 doses monovalent Moderna Moderna
___or___1 0.2 mL/10 ug Dark pink cap; yellow label border At least 8 weeks after last monovalent dose
Pfizer BioNTech 1 0.2 mL/10 ug Orange At least 8 weeks after last monovalent dose
2 doses monovalent Moderna
and 1 dose bivalent mRNA NA; previously received
1 bivalent vaccine doseNA NA NA NA
1 or more doses monovalent
Pfizer -BioNTech Pfizer -BioNTech10.2 mL/10 ug Orange At least 8 weeks after last monovalent dose
2 doses monovalent Pfizer -
BioNTech and 1 dose bivalent
Pfizer -BioNTechNA; previously received
1 bivalent vaccine dose NA NA NA NATable 1. COVID -19 vaccination schedule for people who are NOT moderately or severely immunocompromised
by COVID -19 vaccination history, April 2023 :Age 5 years