Document text
cdc.gov/coronavirus
Updates to COVID -19 vaccine policy :
Considerations for Future Planning
Sara Oliver, MD, MSPH
ACIP Meeting
April 19, 2023
U.S. COVID -19 vaccine uptake among ages ≥12 years,
August 2021 -January 2023
Source: IZ Data Lake 01,000,0002,000,0003,000,0004,000,0005,000,0006,000,0007,000,000
Primary Series, Ages 12-17 Primary Series, Adults Ages 18-49 Primary Series, Adults Ages 50-64 Primary Series, Adults Ages 65+
Booster, Ages 12-17 Booster, Adults Ages 18-49 Booster, Adults Ages 50-64 Booster Adults Ages 65+Primary series authorization
1stbooster authorization
2ndbooster authorization Bivalent booster authorization Doses Administered
Coverage / Age (years) <2 2–4 5–1112–1718–2424–4950–64>65
At least 1 -dose† 8.6 10.7 39.9 72.1 82.2 85.4 95.0 95.0
Completed primary series 4.5 5.9 32.8 61.7 66.7 72.1 83.8 94.3
Bivalent booster 0.5 0.5 4.6 7.6 7.2 11.8 21.4 42.4
Unvaccinated 91.4 89.3 60.1 28.1 17.8 14.6 —†—†U.S. COVID -19 Vaccination Coverage (%) of Total Population by
Age Group —April 13, 2023
†Note: Coverage is capped at 95%
Source: https://covid.cdc.gov/covid -data -tracker/#vaccination -demographics -trends Updated April 13 , 2023 3
PI=Prediction Interval, VOC=Variants of Concern, VBM=Variants Being Monitored . https://covid.cdc.gov/covid -data-tracker/#variant -proportions Accessed April 18, 2023Trends in weighted variant proportion estimates & Nowcast
United States, November 6, 2022 –April 15, 2023
Collection date, week ending
Estimated Number of Reported COVID -19 Cases by Variant
Variant Proportions Scaled by Positive Nucleic Acid Amplification Test (NAAT) Counts
CDC COVID -19 Lab Coordinating Unit Strain Surveillance and Emerging Variant Group. Data sources: https://covid.cdc.gov/covid -data-tracker/#variant -proportions and
https://covid.cdc.gov/covid -data-tracker/#trends_newtestresultsreported_7daytestingpositive_006M
04M
2MPositive tests / Proportion of viral lineages
Weekly population -based rates of COVID -19-associated hospitalizations
by age group —COVID -NET, March 2020 –April 2023
Gray boxes indicate potential reporting delays. Interpretation of trends should be excluded from these weeks.
https://covid.cdc.gov/covid -data -tracker/#covidnet -hospitalization -network Accessed April 13, 2023
Age Group
Updates to COVID -19 vaccine policy
COVID -19 vaccines:
Where we are now COVID -19 vaccines:
Where we are going Steps toward simple recommendations :
Single formulation for mRNA COVID -19 vaccines
Single (possibly annual) dose for most individuals
Flexibility for vulnerable populations
Goal :
Simple
recommendations
Updates to COVID -19 vaccine policy
Steps toward simple recommendations :
Single formulation for mRNA COVID -19 vaccines
Single (annual?) dose for most individuals
Flexibility for vulnerable populations
Single formulation for mRNA COVID -19 vaccines
▪Many monovalent COVID -19 vaccine products have already expired, others will
expire soon
▪With recent update, FDA removed authorizations for monovalent mRNA COVID -19
vaccine products
▪Harmonization across recommendations with bivalent mRNA COVID -19 vaccines was
discussed at VRBPAC in January and at ACIP meeting in February
Single formulation for mRNA COVID -19 vaccines
Benefits and Harms: Summary from previous ACIP meetings
10▪Bivalent COVID -19 vaccines are able to induce an immune response when given
either as a primary series or a booster dose
–Immunogenicity data showed that a BA.1 bivalent vaccine given as a primary series induced antibody
titers to BA.1 that were 25 times higher than the original monovalent vaccine
–Percentage of patients reporting solicited local or systemic events was similar to or less than percentages
seen after original vaccine, however this may be a result of the larger percent of seropositive participants
in the bivalent vaccine group
▪Limited data to directly compare COVID -19 outcomes after receipt of a monovalent or
bivalent vaccine
–Most studies show improvement in neutralizing antibodies for Omicron variants with a bivalent vaccine
–Bivalent vaccines expanded the immune response and provided increased diversity in antibody response
–While unable to directly compare clinical outcomes for monovalent and bivalent vaccines in the U.S., a
study in the UK found ~ 10% increase in VE for COVID -19 infections
Number of mRNA COVID -19 vaccine products
Moderna: 5 products
Pfizer -BioNTech: 6 products
Previously:
11 TOTAL Products!
Moderna: 2 products
Pfizer -BioNTech: 3 products
Moving forward:
5 Products
Eliminates look -alike vials for
Moderna and Pfizer -BioNTech
Single formulation for mRNA COVID -19 vaccines
Summary from February ACIP meeting
12▪Receiving COVID -19 vaccines continues to be important for prevention of COVID -19
severe disease, hospitalization, and death
▪Many children and adolescents remain unvaccinated for COVID -19
▪COVID -19 vaccine recommendations that are simple to implement may remove some
barriers to uptake
▪Harmonizing the formulation for mRNA COVID -19 vaccines could simplify the
presentations, reduce administration errors, and allow continued access to vaccines
▪ACIP was supportive of a transition of the mRNA COVID -19 vaccine primary series from
monovalent (original) to bivalent (original plus Omicron BA.4/5)
Single formulation for mRNA COVID -19 vaccines
Updates from FDA authorizations
13▪FDA removed the authorizations for monovalent mRNA COVID -19 vaccines
–BLAs are still in place for monovalent products:
•Comirnaty for ages 12 years and older, with limited doses in circulation
•Spikevax for ages 18 years and older, but all doses are currently expired
▪Bivalent mRNA COVID -19 vaccines are now authorized for all indications
▪No changes to current language in other COVID -19 vaccine authorizations
(Novavax or Janssen COVID -19 vaccines)
Single formulation for mRNA COVID -19 vaccines
Implications for CDC recommendations
14▪Transition to bivalent COVID -19 vaccines could simplify the presentations, reduce
administration errors, and allow continued access to vaccines with expiration of
monovalent products
Bivalent mRNA COVID -19 vaccines would now be recommended for all indications
Updates to COVID -19 vaccine policy
Steps toward simple recommendations :
Single formulation for mRNA COVID -19 vaccines
Single (annual?) dose for most individuals
Flexibility for vulnerable populations
Shifts in vaccine -induced, infection -induced, and hybrid immunity against SARS -CoV-
2 among people aged ≥16 years —United States, Quarter 2 2021 –Quarter 3 2022
No infection or vaccination
Vaccine only -induced
antibodies
Infection only -induced
antibodies
Both infection and
vaccination -induced
antibodies (hybrid immunity)
Source: CDC (unpublished)
Shifts in vaccine -induced, infection -induced, and hybrid immunity against SARS -CoV-
2 among people aged ≥16 years by age group —United States, Q2 2021 –Q3 2022
No infection or vaccination
Vaccination without previous
infection
Previous infection without
vaccination
Both previous infection and
vaccination (hybrid
immunity)
16–29 years 30–49 years
50–64 years ≥65 years
Source: CDC (unpublished)
How frequently should people get a COVID -19 vaccine?
▪Increases in COVID -19 cases (left) and hospitalizations (right) have occurred:
–During the winter months and/or
–Due to emergence of new immune escape variants
Cases from October 2021-February 2023 highlighted
Admissions from October 2021 –February 2023 highlighted
https://covid.cdc.gov/covid -data -tracker/#trends_weeklycases_select_00 https://covid.cdc.gov/covid -data -tracker/#new -hospital -admissions
Single (possibly annual) COVID -19 vaccine dose
Summary from February ACIP meeting
▪For most older children, adolescents, and adults, future doses will be additional ‘boost’
after prior infection, prior vaccination, or both
▪Time since last COVID -19 vaccine dose may both increase the incremental benefits of a
COVID -19 vaccine, and decrease the risk of myocarditis
▪Vaccine protection likely declines over time
▪Winter months and immune escape variants have impacted COVID -19 epidemiology
▪A simplified, annual recommendation could help reduce vaccine and message fatigue
▪A plan for a fall booster dose could provide added protection, at a time when many
would be ~1 year from last dose
–Future epidemiology and SARS -CoV-2 virus evolution could help determine the need for
continued annual boosters
Single (possibly annual) COVID -19 vaccine dose
Updates from FDA authorizations
20▪FDA authorized a single age -appropriate mRNA COVID -19 vaccine dose for most individuals
A single age-appropriate dose of a
bivalent Moderna COVID -19 vaccine
is authorized for individuals
ages 6 years and older
who are unvaccinated ,
or at least 2 months after receipt of any
monovalent COVID -19 vaccine. A single age -appropriate dose of a
bivalent Pfizer COVID -19 vaccine
is authorized for individuals
ages 5 years and older
who are unvaccinated ,
or at least 2 months after receipt of any
monovalent COVID -19 vaccine
63828993
0102030405060708090100
Mar-Apr May-Jun Jul-Aug Sep-Oct Nov-DecSeroprevalence (%)
Month7585929799
0102030405060708090100
Mar-Apr May-Jun Jul-Aug Sep-Oct Nov-DecSeroprevalence (%)
MonthInfection-induced Combined (vaccine- and infection-induced)
Pediatric 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) 21
COVID -19 vaccine recommendations in children 5 years and younger
▪Young children likely still need a ‘ prime ’ and ‘ boost ’ to optimize immunity
▪Young children will continue to age into the vaccine recommendations at 6 months and
could be SARS -CoV-2 naïve
▪Additional data forthcoming to evaluate benefits of a multi -dose primary series in all
children ages 5 years and younger, or if the recommendations could be simplified
–Cost effectiveness analysis
–Additional antibody data in young children
Coverage / Age (years) <2 years 2–4 years
At least 1 -dose 8.6 10.7
Completed primary series 4.5 5.9
Unvaccinated 91.4 89.3
Single (possibly annual) COVID -19 vaccine dose
Updates from FDA authorizations
23▪FDA authorized one, two, or three doses of a bivalent mRNA COVID -19 vaccine for
children 6 months –4 or 5 years
▪Number of doses depend on age, as well as number and type of prior COVID -19
vaccine doses received
Single (possibly annual) COVID -19 vaccine dose
Implications for CDC recommendations
24▪A COVID -19 vaccine framework for a single dose could be easy for COVID -19 vaccine
providers to implement, and for the public to understand
▪The current recommendations for a single dose may evolve over time, and could move
to an annual recommendation
A single bivalent dose would be recommended for everyone ages 6 years and older
–For most people, this is not a change: if someone has not received a bivalent vaccine dose
yet, they are recommended to receive one, regardless of their previous vaccine history
Children 6 months through 5 years would receive at least two COVID -19 vaccine doses,
including at least one bivalent COVID -19 vaccine
–Table and detailed guidance to be published in Interim Clinical Considerations
Updates to COVID -19 vaccine policy
Steps toward simple recommendations :
Single formulation for mRNA COVID -19 vaccines
Single (annual?) dose for most individuals
Flexibility for vulnerable populations
Weekly population -based rates of COVID -19-associated hospitalizations
by age group —COVID -NET, March 2020 –April 2023
Gray boxes indicate potential reporting delays. Interpretation of trends should be excluded from these weeks.
https://covid.cdc.gov/covid -data -tracker/#covidnet -hospitalization -network Accessed April 13, 2023
Age Group
Rates of COVID -19 deaths by vaccination status and age, adults ≥65 years —
24 U.S. Jurisdictions, April 2022 –January 2023
https://covid.cdc.gov/covid -data -tracker/#rates -by-vaccine -status Accessed April 14, 2023
Unvaccinated
Vaccinated without updated booster
Vaccinated with updated boosterUnvaccinated
Vaccinated without updated booster
Vaccinated with updated boosterAges 65 –79 yearsAges ≥80 years
▪In a January 2023 survey of adults who had previously received a bivalent booster:
–54% said they were awaiting new guidelines for additional doses
–86% said getting another booster shot was important or a top priorityAdditional updated COVID -19 vaccine doses
Survey data
The survey was conducted January 17 –January 24, 2023, online and by telephone among a nationally representative sample of 1,23 4 U.S. adults
KFF COVID -19 Vaccine Monitor: January 2023. https://www.kff.org/coronavirus -covid -19/poll -finding/kff -covid -19-vaccine -monitor -january -2023/
Accessed February 7, 2023
28
COVID -19 vaccines and older adults (adults ages ≥65 years)
Summary from February ACIP meeting
▪Older adults have higher rates of hospitalization than younger adults
▪Among older adults, vaccination rates with a bivalent COVID -19 vaccine dose remain low
–It is important for older adults to be up to date on current recommendations, including
receiving a bivalent booster
▪ACIP discussed that data were insufficient to support a routine recommendation for
older adults to receive a COVID -19 vaccine doses every 6 months, but acknowledged this
population may continue to be more vulnerable to severe COVID -19 and likely needs
flexibility with COVID -19 vaccine recommendations
Flexibility for vulnerable populations
Updates from FDA authorizations
30▪For adults ages ≥65 years, a single dose of a bivalent mRNA COVID -19 vaccine (either
Moderna COVID -19 Vaccine or Pfizer -BioNTech COVID -19 vaccine) may be administered
at least 4 months following the first dose of a bivalent COVID -19 vaccine
Flexibility for vulnerable populations
Implications for CDC recommendations
31▪The bivalent COVID -19 vaccine continues to provide protection against severe COVID -19
disease, and rates of hospitalization or death among older adults who have received a
bivalent booster continue to be low
▪However, some older adults may benefit from an additional updated COVID -19 vaccine
dose prior to possible future recommendations for updated vaccines this fall
Adults ages 65 years and older may now choose to receive another
updated COVID -19 vaccine dose
COVID -19 vaccines and people who are immunocompromised
Summary from February ACIP meeting
▪Immunocompromised adults can have less robust immune response to COVID -19
vaccines
▪There are no currently authorized prophylactic monoclonal antibody products for
populations at highest risk of COVID -19
▪ACIP discussed that data were insufficient to support a routine recommendation for
people who are immunocompromised to receive a COVID -19 vaccine doses every 6
months, but acknowledged this population may continue to be more vulnerable to
severe COVID -19 and likely needs flexibility with COVID -19 vaccine recommendations
Flexibility for vulnerable populations
Updates from FDA authorizations
33▪For persons with moderate to severely immunocompromising conditions, a single dose
of a bivalent mRNA COVID -19 vaccine may be administered at least 2 months following
the first dose of a bivalent COVID -19 vaccine
▪Additional age -appropriate bivalent mRNA COVID -19 vaccine doses may be
administered to immunocompromised persons at the discretion of the healthcare
provider, taking into consideration the individual’s clinical circumstances
Flexibility for vulnerable populations
Implications for CDC recommendations
34▪For people who are immunocompromised, additional doses have been recommended
previously and current updates continue to allow additional protection to a vulnerable
population
▪Updates also allow flexibility to adjust to individual’s specific circumstances, including
timing of immunosuppression as well as the possible need for re -vaccination after
particular events (e.g. stem cell transplant)
–Additional guidance to be published in Interim Clinical Considerations
People who are immunocompromised may now choose to receive another updated
COVID -19 vaccine dose -and-
Have the flexibility to receive additional doses based on their clinical circumstances
Updates to COVID -19 vaccine policy
Steps toward simple recommendations :
Single formulation for mRNA COVID -19 vaccines
Single (possibly annual) dose for most individuals
Flexibility for vulnerable populations
Goal :
Simple
recommendations
Updates to COVID -19 vaccine policy
Steps toward simple recommendations :
Single formulation for mRNA COVID -19 vaccines
Single (possibly annual) dose for most individuals
Flexibility for vulnerable populations
Goal :
Simple
recommendations
Future a dditional steps may be possible :
Simplifications for all COVID -19 vaccines
Possible updated vaccines this fall
Continue to evaluate data -driven ways to
simplify pediatric program
Flexibility and simple guidance
▪COVID -19 vaccines continue to be the most effective tool we have to prevent serious
illness, hospitalization and death from COVID -19
▪Simple recommendations are easier to communicate, which may improve uptake
▪Anticipate that an updated fall vaccine could be available
▪Based on available data, anticipate benefits of COVID -19 vaccines given this fall
–Updates to COVID -19 vaccine policy can also acknowledge possible future recommendations
▪For most people, the current doses needed remain unchanged : a single bivalent vaccine
is recommended and there could be an updated vaccine/recommendation this fall
–Flexibility for vulnerable populations
–Young children continue to be recommended for multiple doses to prime/boost immune response,
and will continue to review additional dataUpdates to COVID -19 vaccine policy
Steps toward simple recommendations
▪Continue to review data and evaluate COVID -19 vaccine program in context of
evolving epidemiology
▪Early COVID -19 vaccine recommendations made in light of a highly susceptible,
immune naive population, with limited treatment options
▪Increases in population -level immunity through both vaccine and infection,
SARS -CoV-2 virus evolution, availability of anti -viral treatments, and review of COVID -
19 epidemiology and hospitalization rates can lead to evidence -based updates in
vaccine policy
▪Work is ongoing to review additional data, continue efforts for simplification
▪Work Group supportive of simplified recommendations as well as flexibility for
vulnerable populations Work Group interpretation
Steps toward simple recommendations
▪Monica Godfrey
▪Evelyn Twentyman
▪Danielle Moulia
▪Megan Wallace
▪Hannah Rosenblum
▪Lauren Roper
▪Katherine Fleming -Dutra
▪Ruth Link -Gelles
▪Amadea Britton
▪Sarah Meyer
▪Julianne Gee
▪Susan Goldstein
▪Mary Chamberland
▪Elisha Hall▪Valerie Morelli
▪JoEllen Wolicki
▪Heather Scobie
▪Sierra Scarbrough
▪Jefferson Jones
▪Aron Hall
▪Barbara Mahon
▪Coronavirus and other Respiratory Viruses Division
▪National Center for Immunization and Respiratory
DiseasesAcknowledgments
Question for ACIP
40▪What are ACIP's thoughts on simplified recommendations as well as
flexibility for vulnerable populations?
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