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Tracy Beth Høeg, M.D., Ph.D.
FDA Ex Officio to ACIP
Senior Advisor for Clinical Sciences
Office of the Commissioner (OC) &Center for Biologics Evaluation and Research (CBER)US Food and Drug Administration
Core Childhood Vaccination
Schedules: An International
Perspective with focus on
the US & Denmark
3
Danish- US double
citizen
MD (WI, USA- MCW),
Residency UC DavisPhD -Epidemiology &
Public Health (U
Copenhagen)
4
45 peer reviewed
publications -last 5
years focus on infectious disease
epidemiology &
vaccines
Before FDA was at
MIT Sloan & practicing physician
5
Core Childhood
Vaccines – as of
January 2025(assumes DTaP ,
HiB, IPV given
separately)
XX, 202X 6Assumes individual rather than
combined DTaP -Hib -HepB -IPV
vaccines given in US
ACIP April 2025- US international outlier in yearly
COVID -19 vaccines for children
7
Core
Vaccines by Country as of January, 2025
8
Image Credit: Jonatan Pallesen 9
Core
Childhood Vaccines -As
of January 2025
Ipsunember XX, 202X 10
Aluminum exposure
in childhood
Center for Xxxxxx Xxxxx Xxxxxxxxxxxxxxxxxx
•Assumes individual
rather than combined DTaP -
Hib-HepB -IPV
vaccines given in US
•What is the “safe” bolus dose of parenteral aluminum in infancy?
11
What do we owe to our children?
Science -based recommendations
•Understand potential for absolute benefit in low
risk populations
•Understand the limitations in our knowledge about adverse effects
•Perform proper randomized, placebo -controlled
studies
•Continually monitor safety and update our recommendations based on evolving knowledge
•Vaccines treated like all medical products; may not be right for all children
12
What do we owe to our children?
Avoid overmedicalizing childhood
•Time in pediatricians’ offices can be spent
differently
•Less focus on medical products; more focus on healthy living
•Decreases overdiagnosis and overtreatment
13
What do we owe to our children?
Recommendations based on
data and not politics
•Manipulating data for political
reasons can be deadly
•Neo-Lamarkism /acquired genetics
•Silencing of opposing views
•Resulted in the death of potentially millions in the Chinese famine
14
Deaths
due to
polio, measlesDeaths and injuries due
to vaccines
15
USA - Political Polarization
Denmark
•Multi -party system
•Culture of Debate
•Transparent decision making
•Research culture (RCTs)
•Extensive documentation of
decision making about
vaccines
•Acknowledge Unknowns
•Promptly reverse
recommendationsHigher level of trust in Public Health Authorities
Undeniably a healthier
population
16
Does the US
have a good
track record in
terms of child
health?
17
Health Conditions -mental health disorders
Source: IHME -GHDx 18
Because the US has a larger high- risk population,
should the core childhood vaccination schedule be
larger ?
•Should healthy children in the US receive different
vaccines than healthy children in Denmark?
•Root cause of diseases
19
Core Childhood
Vaccines -As of
January 2025
20What can we learn from
other countries?
Why do the US and Denmark have
such different core vaccination schedules?
Misconception:
Because of differences in disease
prevalences
21
How do incidences and prevalences of
diseases compare?
US vs Denmark
Hepatitis B:
incidence in mothers & prevalence
of chronic Hepatitis B
https://journals.lww.com/ajg/fulltext/2020/09000/prevalence_of_chronic_hepatitis_b_virus_infection.20.aspx
https://www.cdc.gov/hepatitis -b/hcp/perinatal -provider- overview/index.html#cdc_generic_section_7 -infection -rates -and -
trend
Clinical Overview of Perinatal Hepatitis B | Hepatitis B | CDC
Efficacy of Selective Antenatal Screening for Hepatitis B Among Pregnant Women in Denmark: Is Selective Screening Still an
Acceptable Strategy in a Low -endemicity Country?: Scandinavian Journal of Infectious Diseases: Vol 35, No 6 -7 XX, 202X 23
Incidence of
Meningococcal Disease in
2023
https://www.cidrap.umn.edu/meningitis/cdc- data -show -sharp -rise -rates -meningococcal -disease .
https://en.ssi.dk/surveillance -and -preparedness/surveillance -in-denmark/annual- reports -on-disease -
incidence/m/meningococcal -disease -202324•<5/million in both the US and
Denmark
USA and Denmark Meningococcal Incidence over time
https://www.cdc.gov/acip/downloads/slides -2024 -10-23-24/01 -mening -Loehr- 508.pdf
https://ugeskriftet.dk/videnskab/vaccination- til-forebyggelse -af-meningokoksygdom
25
There has been an increase in Measles Cases in
the US and Europe
https://statistik.ssi.dk/sygdomsdata#!/?sygdomskode=M
EAS&xaxis=Aar&show=Graph&datatype=Individual 26
Measles Cases by Vaccination Status in Europe
https://www.ecdc.europa.eu/sites/default/files/documents/
MEAS -AER -2024-Report.pdf27
Measles Cases in Denmark Over Time
Ipsunember XX, 202Xhttps://statistik.ssi.dk/sygdomsdata#!/?sygdomskode=MEA
S&xaxis=Aar&show=Graph&datatype=Individual28
Vaccination
Rates by Age 5 in 2024
CDC. Vaccination Coverage and Exemptions among Kindergartners. 2025.
https://www.ssi.dk/vaccinationer/tilslutning -til-bornevaccinationsprogrammet -2024 29
2024 MMR vaccination
rates by state
The estimated critical
minimum vaccination threshold to prevent measles outbreaks is around 90%
https://publichealth.jhu.edu/sites/default/files/2024 -
09/Measles -Risk -Assessment-
Methodology_9.19.24.pdf
Ipsunember XX, 202X Center for Xxxxxx Xxxxx Xxxxxxxxxxxxxxxxxx 30
November 2025
31
Which countries
have or are at risk
of loss of measles elimination
status?
32Current numbers - December 2025
When and why do
citizens not trust
core childhood
vaccination
recommendations?
33Current numbers
Rubella
•Rubella can cause congenital rubella syndrome
•Has a community immunity threshold of 83 -85%
•Some pockets of America and entire states, such as
Idaho and Wisconsin, with average vaccination rates
below this, at risk of rubella outbreaks.
Otani N, Shima M, Ueda T, Nakajima K, Takesue Y , Yamamoto T, Okuno T. Changes in the Epidemiology of Rubella: The Influence of Vaccine -Introducing Methods and COVID -
19. Vaccines (Basel). 2023 Aug 12;11(8):1358. doi: 10.3390/vaccines11081358. PMID: 37631927; PMCID: PMC10458369.
https://www.kff.org/medicaid/kindergarten -routine -vaccination- rates -continue -to-
decline/#:~:text=While%20measles%20has%20been%20officially,of%20an%20outbreak%20is%20higher34
Trust in US
healthcare decreased from 72% to 40%
35
Trust
decreased from 72% to 40%
Ipsunember XX, 202X 36
School based
vaccine mandates?
37
Focus on Denmark
The Current Core Childhood Vaccination Schedule
38
Denmark Core Childhood Vaccines
39
Core Vaccines
by Country as of January, 2025
40
Evolution of the
Core Vaccine Schedule in USA
41
Image Credit: Jonatan Pallesen 42
Danish Decision
Making about
Childhood
Vaccines
Examples of Child vaccines that were never or are no longer on the schedule43
COVID -19 Vaccine
Denmark was the first high income
nation to remove the COVID -19 vaccine
from childhood schedule
Ahead of the international curve
44
Head of Danish Ministry of health stating in June of
2022 that vaccinating children for COVID- 19 was a
mistake
Director of the Danish Health Authority: https://nyheder.tv2.dk/samfund/2022 -06-22-set -i-bakspejlet -fik-vi-ikke -meget -ud-af-at -vaccinere -
boernene -erkender -brostroem 45
Influenza Vaccine:
introduction for all
children ages 2- 6
in 2021 was
reversed in 2023
46
Pandemrix Vaccine History
•2009 H1N1 Pandemic Influenza
vaccine
•Side effects and narcolepsy Coverup/delayed reporting
•Never recommended for children in Denmark
•Now essentially of all Europe does not recommend seasonal influenza vaccine as core childhood vaccine
•1300 people with narcolepsy, mostly children
47
Hepatitis B Vaccine
•Hvis man indfører en vaccine,
som nogle vil opfatte som
mindre væsentlig , vil dette
kunne påvirke den generelle
holdning til vaccination i
negative retning .
•Resultatet heraf kunne være , at
det allerede eksisterende
program opnår lavere
tilslutning i fremtiden .
https://www.sst.dk/ -
/media/Udgivelser/2004/hepatitis_b_180204, -d-,pdf.ashx48
Hepatitis B Vaccine
•If one includes a vaccine which
some consider less important,
it could negatively affect the view of vaccines in general.
•The result of this could be that
the current [vaccination]
program would have lower uptake.
https://www.sst.dk/ -
/media/Udgivelser/2004/hepatitis_b_180204, -d-,pdf.ashx49
Hepatitis B Vaccine: Targeted Program
https://www.eurosurveillance.org/cont
ent/10.2807/esw.10.44.02827-enhttps://www.ssi.dk/vaccinationer/risikogrupper/personer -med -sarlig- risiko -
for-hepatitis -b-
smitte#:~:text=Nogle%20grupper%20har%20dog%20en,Dag%200%20(evt.50•Substantial costs of hep B
vaccine coverage & low opportunity for benefit
•Population -wide
vaccination could not be justified from a health economics perspective
•List of high risk groups which have vaccination coverage
Meningococcal Vaccine
https://ugeskriftet.dk/videnskab/vaccination-til -
forebyggelse -af-meningokoksygdom51“Weekly writings for physicians”
Meningococcal Vaccine
https://ugeskriftet.dk/videnskab/vaccination-til -
forebyggelse -af-meningokoksygdom52•Opportunity for benefit among
non high risk children is very low
•Uncertainty about effectiveness
•Adding additional vaccines to
the core vaccine list may cause
some parents to opt out of other vaccines
•If the vaccine causes fevers in infant when given with other vaccines, this could have
negative consequences for
physicians and parents
Meningococcal Vaccine
https://ugeskriftet.dk/videnskab/vaccination-til -
forebyggelse -af-meningokoksygdom53
•List of high risk situations
•Asplenia
•Compliment deficiency
•Receiving Eculizumab (causes
compliment deficiency)
•Travel to high prevalence regions
•Meningococcal outbreak
•Required for study in the US
•Can be considered for student dormitory conditions
Rotavirus: rationale for not including
in Child Vaccination Schedule
•232 page document in Danish
describing the decision
•Will be reviewed again in the near future
•It has until now been the message of the Danish Ministry of Health that Denmark not introduce vaccines into the child vaccination schedule just because it is an option
•The Danish child vaccination program has… a goal of protecting children from infections that can be either deadly or have long term health consequences•Infection with rotavirus essentially never results in death or chronic consequences in a country like Denmark
•Literature review has not shown that this vaccine has an effect on children’s mortality
https://www.sst.dk/ -/media/Udgivelser/2012/Vaccination -mod -
rotavirus ---en -medicinsk -teknologivurdering/Vaccination-mod -
rotavirus -%E2%80%93-en -medicinsk -teknologivurdering.ashx54
Varicella Vaccine
Cons
•Worry that natural immunity is
stronger (they cite data supporting)
•Only 4% of genera/family physicians would recommend the vaccine to healthy children
•Insufficient data about long term effects
•Pros
•Denmark has a very low rate of stay -
at-home parents and they would
miss less work
https://www.speam.dk/files/21/skoldkoppevaccine_i_danm
ark.pdf .55
Varicella Vaccine
Cons
•Worry that natural immunity is
stronger (cite data supporting)
•Only 4% of family physicians would recommend the vaccine to healthy children
•Insufficient data about long term effects
Pros
•Denmark has a very low rate of stay -at-home parents and they
would miss less work
https://www.speam.dk/files/21/skoldkoppevaccine_i_danm
ark.pdf .56•bekymring om, at immuniteten er
•svagere efter vaccine.
•4% af de praktiserende læger synes at raske børn skal vaccineres mod skoldkopper,
•Fortsat utilstrækkelige data på langtidseffekten
•Gevinsten i Danmark kan være større end for mange andre lande, da andelen af hjemmegående mødre/fædre er lavere.
RSV Long Acting Monoclonal Antibodies
•Unfavorable imbalance in all cause mortality in all
four phase 3 randomized trials of standard dose
57
Ipsunember XX, 202X 58
Danish Child Vaccination Benefits
•Increase Trust in and Focus on Core Childhood Vaccines
•Based on thorough, transparent decision making and continually
updated and debated
•Prevent outbreaks of most deadly vaccine preventable diseases
•Equipoise=Opportunity for research
•Re-evaluate the evidence base for vaccines not currently on core
childhood vaccine schedule in Denmark with randomized trials
•Monitor Diseases such as Rotavirus; may be larger opportunity for
absolute benefit in the US population
59
Danish Vaccination Schedule Benefits
•Make more time for addressing overall health at doctors'
appointments/spend less time in the healthcare system/decrease
the medicalization of childhood
•Opportunity to better define high risk groups to target
•Improve informed consent
•Minimize coercion
60
Questions about Adopting the
Danish Schedule in the US
•Would it be appropriate to stop Varicella vaccine given high
vaccination uptake and chance of increasing average age of
chickenpox
•Perform thorough, updated Risk -Benefit analysis of evidence for 2
doses of HPV in girls and boys?
61
Questions about Adopting the
Danish Schedule in the US
•Would it be appropriate to stop Varicella vaccine given high
vaccination uptake and chance of increasing average age of
chickenpox
•Perform thorough, updated Risk -Benefit analysis of evidence for 2
doses of HPV in girls and boys?
62
FIN