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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.Adult Polio Vaccination
Sarah Kidd, MD, MPH
ACIP Meeting
June 21, 2023
▪Summarize work group deliberations on adult polio vaccination
–Recommendations for unvaccinated and incompletely vaccinated adults
–Recommendations for booster doses of IPV
▪Present work group’s proposed language for an ACIP voteObjectives for Today’s Presentation
▪Problem
–Is the problem of public health importance?
▪Benefits & Harms
–How substantial are the desirable anticipated effects?
–How substantial are the undesirable anticipated effects?
–Do the desirable effects outweigh the undesirable effects?
–What is the overall certainty of this evidence for the critical outcomes?
▪Values
–Does the target population feel that the desirable effects are large relative to the undesirable effects?
–Is there important uncertainty about or variability in how much people value the main outcome?
▪Acceptability
–Is the intervention acceptable to key stakeholders?
▪Resource Use
–Is the intervention a reasonable and efficient allocation of resources?
▪Equity
–What would be the impact on health equity?
▪Feasibility
–Is the intervention feasible to implement?ACIP Evidence to Recommendations ( EtR) Framework
▪Vaccination is recommended for certain adults who are at greater risk for exposure
to polioviruses than the general population
▪Unvaccinated adults who are at increased risk of exposure should receive a primary
vaccination series with IPV
▪Adults who have had a primary series of oral polio vaccine (OPV) or IPV and who
are at increased risk of exposure can receive another dose of IPV2000 Recommendations for Inactivated Polio Vaccine (IPV)
Vaccination of Adults
Poliomyelitis Prevention in the United States (cdc.gov)
▪2000 statement focused on adults at increased risk of poliovirus exposure
▪Uncertainty about how to define increased risk in setting of circulating vaccine -
derived poliovirus ( cVDPV ) in US
▪Unclear guidance for unvaccinated adults who were notknown to be at increased
risk of exposure
▪Uncertainty about vaccinated adults and when/if a booster was advised2000 Statement on IPV Vaccination for Adults
Questions that arose in 2022
Poliomyelitis Prevention in the United States (cdc.gov)
IPV = inactivated polio vaccine
tOPV = trivalent oral polio vaccine▪Should completion of a primary polio vaccination series with IPV be recommended
for unvaccinated and incompletely vaccinated adults in the US?
–Population: Unvaccinated and incompletely vaccinated (with tOPV or IPV) US adults aged ≥18 years
–Intervention: Completion of a primary vaccination series with IPV
–Comparison: No vaccination or partial series completion
–Outcomes:
•Prevention of paralytic poliomyelitis
•Serologic immunity to poliovirus types 1, 2, and 3
•Serious adverse events following vaccination
•Indirect effects, e.g., community transmission, impact on health systemsPolicy Question #1 for Work Group
▪A primary series of ≥3 doses of tOPV or IPV in any combination administered ≥4
weeks apart
AND
▪The last dose in the series was given on or after the 4thbirthday
AND
▪The last dose in the series was given ≥6 months after the previous doseCurrent Definition of Fully Vaccinated
Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP) Regarding Routine Poliovirus Vaccination
(cdc.gov) ; Poliomyelitis Prevention in the United States (cdc.gov)
▪Poliovirus infection can cause
poliomyelitis and lifelong paralysis
–Paralytic disease occurs in <1% of
infections (varies by serotype)
–Non-paralytic clinical illness occurs in
~25%, including 1% –5% with aseptic
meningitis
–Approximately 75% of infections are
asymptomaticPublic Health Problem
Paralytic polio decreased rapidly in the US after
introduction of polio vaccine
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20201994: Americas
certified polio -free
YearNumber of poliomyelitis cases1955: Salk IPV
1961: Sabin OPV1979: Last indigenous
Wild -type case in US
2000: IPV only1997 : Sequential enhanced -potency
IPV followed by OPV
Global Paralytic WPV1 and cVDPV Cases1, Previous 12 Months2
Polio Now –GPEI (polioeradication.org) WPV1 = wild poliovirus type 1; cVDPV = circulating vaccine -derived poliovirus
Paralytic Polio Case in New York State, July 2022
•A case of paralytic polio caused by vaccine -derived poliovirus type 2 (VDPV2) was
confirmed in an unvaccinated young adult from Rockland County, New York, on
July 21, 2022
•Genetic sequencing has indicated a linkage to polioviruses collected in
wastewater in Israel, United Kingdom, and Canada
•Rockland County has reported overall low vaccine coverage for over 20 years
•In summer 2022, 60% of children under 2 years of age had received 3 doses of
IPV (zip code level as low as 37%)
•No additional paralytic cases have been identified
WWS Report (ny.gov)▪Poliovirus type 2 genetically linked to the case detected
in wastewater samples in New York (Rockland, Orange,
Sullivan, and Nassau counties and New York City)
▪Retrospective testing detected poliovirus as early as
April 2022
▪Only 2 positive samples since November 1st(December
15thin Orange; February 22ndin Rockland)
▪No detections in samples collected in last 15 weeksWastewater Testing for Poliovirus in New York
Poliovirus in New York, 2022
Source: Polio WWS Report (ny.gov)▪One paralytic polio
case in unvaccinated
young adult in
Rockland County, NY
in 2022
▪Likely indicative of
≥1–2 thousand
mostly asymptomatic
infections
National Salk Vaccination Coverage by September 1961 by Age and Race,
Household US Immunization Survey (USIS)
Source: Morris, Public Health Reports 1964.Number of doses (%)
Birth year Age in 1961 0 1–2 ≥3
1957 –1960 1–4 years
White 11% 11% 78%
Non -white 26% 21% 53%
1952 –1956 5–9 years
White 6% 5% 89%
Non -white 13% 16% 72%
1947 –1951 10–14 years
White 6% 5% 89%
Non -white 12% 12% 77%
1942 –1946 15–19 years
White 14% 7% 78%
Non -white 25% 11% 64%
National Salk Vaccination Coverage by September 1961 by Age and Race,
Household US Immunization Survey (USIS)
Source: Morris, Public Health Reports 1964.Number of doses (%)
Birth year Age in 1961 0 1–2 ≥3
1932 –1941 20–29 years
White 34% 11% 55%
Non -white 55% 12% 33%
1922 –1931 30–39 years
White 43% 10% 48%
Non -white 65% 11% 24%
1912 –1921 40–49 years
White 70% 6% 24%
Non -white 83% 6% 11%
1902 –1911 50–59 years
White 90% 3% 8%
Non -white 92% 4% 4%
0102030405060708090100Polio3 Coverage (%)
Year of SurveyNational Surveys of 3 -dose Polio (Polio3) Vaccination
Coverage among Children, United States, 1959 –2017
Sources: Simpson et al, AJPM 2001 Forty years and four surveys: How does our measuring measure up? –ScienceDirect . CDC, MMWR 2001 National, State, and Urban Area Vaccination Coverage Levels Among
Children Aged 19 --35 Months ---United States, 2000 (cdc.gov) . CDC, MMWR 2006 National, State, and Urban Area Vaccination Coverage Among Children Aged 19 --35 Months ---United States, 2005 (cdc.gov) .
CDC, MMWR 2011 National and State Vaccination Coverage Among Children Aged 19 --35 Months ---United States, 2010 (cdc.gov) . Hill et al, MMWR 2016 Vaccination Coverage Among Children Aged 19 –35
Months —United States, 2015 | MMWR (cdc.gov) . Hill et al, MMWR 2018 Vaccination Coverage Among Children Aged 19 –35 Months —United States, 2017 | MMWR (cdc.gov) .USIS -reported Polio3 coverage among
children aged 1 –4 years
NHIS -reported Polio3 coverage among
children aged 24 –35 monthsNIS-reported Polio3 coverage among
children aged 19 –35 months
Percent positive (95% Confidence Interval)
Birth years Age in 2009 –2010 Poliovirus Type 1 Poliovirus Type 2 Poliovirus Type 3
1998 –2004 6–11 years 97.2 (94.7 –98.8) 98.0 (96.4 –99.0) 93.8 (91.8 –95.4)
1990 –1998 12–19 years 94.7 (92.0 –96.6) 98.2 (96.6 –99.2) 84.3 (81.0 –87.2)
1970 –1990 20–39 years 92.7 (90.0 –94.2) 96.9 (95.2 –98.2) 78.6 (74.6 –82.2)
1960 –1970 40–49 years 93.9 (91.6 –95.7) 95.8 (93.8 –97.3) 85.8 (82.3 –88.8)Seroprevalence of Poliovirus Antibodies by Age,
United States NHANES Serosurvey, 2009 –2010
Source: Wallace et al, BMC Public Health 2016.
Percent positive (95% Confidence Interval)
Birth years Age & Race/Ethnicity Poliovirus Type 1 Poliovirus Type 2 Poliovirus Type 3
1998 –2004 6–11 years
Mexican -American 98.5 (96.4 –99.5) 98.2 (96.0 –99.4) 97.7 (94.7 –99.3)
Other Hispanic 98.8 (93.5 –100.0) 99.2 (94.7 –100.0) 93.8 (87.0 –97.7)
Non -Hispanic White 96.9 (93.1 –98.9) 97.6 (94.9 –99.1) 92.3 (88.5 –95.2)
Non -Hispanic Black 99.1 (96.0 –99.9) 99.1 (96.3 –99.9) 96.1 (90.6 –98.8)
Non -Hispanic Other 92.8 (83.1 –97.9) 97.6 (87.6 –99.9) 91.1 (81.0 –96.9)
1990 –1998 12–19 years
Mexican -American 93.7 (90.5 –96.1) 98.4 (96.3 –99.4) 80.4 (74.5 –85.4)
Other Hispanic 96.1 (90.2 –98.9) 99.1 (94.7 –100.0) 88.5 (81.0 –93.8)
Non -Hispanic White 94.7 (89.5 –97.8) 97.7 (95.1 –99.2) 84.3 (79.3 –88.5)
Non -Hispanic Black 93.8 (89.4 –96.7) 99.6 (97.7 –100.0) 84.6 (79.3 –89.0)
Non -Hispanic Other 97.1 (90.7 –99.6) 98.6 (93.0 –100.0) 88.5 (79.3 –94.6)Seroprevalence of Poliovirus Antibodies by Age & Race/Ethnicity,
United States NHANES Serosurvey, 2009 –2010
Source: Wallace et al, BMC Public Health 2016.
Birth years Age & Race/EthnicityPercent positive (95% Confidence Interval)
Poliovirus Type 1 Poliovirus Type 2 Poliovirus Type 3
1970 –1990 20–39 years
Mexican -American 91.2 (86.1 –94.9) 93.7 (90.2 –96.2) 76.2 (71.5 –80.4)
Other Hispanic 86.7 (78.5 –92.6) 94.2 (89.8 –97.1) 78.4 (70.5 –84.9)
Non -Hispanic White 93.6 (91.2 –95.5) 97.2 (95.3 –98.5) 79.2 (75.1 –82.9)
Non -Hispanic Black 94.7 (91.5 –96.9) 98.4 (96.4 –99.5) 81.6 (75.8 –86.6)
Non -Hispanic Other 90.5 (82.4 –95.8) 98.9 (92.4 –100.0) 74.3 (54.9 –88.6)
1960 –1970 40–49 years
Mexican -American 89.1 (83.9 –93.1) 88.7 (80.9 –94.1) 75.8 (69.5 –81.3)
Other Hispanic 89.4 (81.6 –94.7) 91.3 (82.4 –96.7) 85.4 (72.5 –93.8)
Non -Hispanic White 94.9 (91.7 –97.1) 97.0 (94.3 –98.6) 87.0 (82.1 –91.0)
Non -Hispanic Black 94.7 (90.0 –97.6) 96.9 (92.1 –99.2) 87.3 (78.7 –93.8)
Non -Hispanic Other 92.9 (75.0 –99.2) 96.1 (87.2 –99.5) 86.2 (68.9 –95.9)Seroprevalence of Poliovirus Antibodies by Age & Race/Ethnicity,
United States NHANES Serosurvey, 2009 –2010
Source: Wallace et al, BMC Public Health 2016.
▪US remains at risk of poliovirus importations as long as there is ongoing transmission
of poliovirus globally
▪Data indicate that most US adults have serologic immunity to poliovirus types 1 –3
▪However, unvaccinated and incompletely vaccinated adults remain susceptible to
paralytic polio if exposed to poliovirusSummary of Problem
Work group interpretation
Is paralytic poliomyelitis a problem of public health importance?EtRDomain: Public Health Problem
NoProbably
noProbably
yesYes VariesDon’t
know
▪Presence of detectable neutralizing antibody is a correlate of protection against
paralytic disease.
–Immunity against paralytic disease may be present even in absence of detectable antibodies.
▪Serologic immunogenicity among infants and children
–70% –100% seropositive after 2 doses
–88% –100% seropositive after 3 doses
▪Estimates of vaccine effectiveness against paralytic polio
–36% –89% for 1 dose
–89% –98% for 2 doses
▪Paucity of data on adults receiving a primary seriesEffectiveness of Enhanced -Potency IPV
Sources: Vidor et al review, PIDJ 1997. Stoeckel et al, Rev Infect Dis 1984. CDC, MMWR 1988. John, Rev Med Virol 1993.
▪Intestinal immunity
–No significant difference between IPV and unvaccinated individuals in the odds of shedding
–IPV vaccination appears to reduce the mean quantity of shed poliovirus by 63% –91%
–Some data to suggest that IPV vaccination reduces duration of shedding ; recent modeling study
indicated no impact of IPV
▪Nasopharyngeal (NP) immunity
–Evidence to suggest similar, low rates of NP shedding (0% –4%) among OPV and IPV vaccineesIPV and Mucosal Immunity
Sources: Hird and Grassly meta -analysis, PLoS Pathogens 2012. Kok et al, Bulletin of WHO 1992. Onorato et al, JID 1991. Brouwer et al, J R Soc Interface 2022.
▪Local reactions at injection site reported in trials
–Tenderness in 14% –29%
–Induration in 3% –11%
–Erythema in 0.5% –1.4%
▪Combining IPV with other vaccines is not associated with increased frequency or
severity of reported adverse reactions compared with the other vaccines alone
▪No severe adverse events have been causally associated with use of the current
formulation of IPVSafety
Sources: Sanofi Pasteur Package Insert -IPOL (fda.gov) . Vidor et al, PIDJ 1997. Murdin et al, Vaccine 1996. Wattigney et al, Pediatrics 2001. IOM 1994.
▪>250 million IPV -containing vaccine doses distributed 2000 –2012
▪41,792 adverse event reports submitted for IPV -containing vaccines
–34,880 (88%) were for non -serious events
–95% were among persons <7 years of age
▪Most events were associated with IPV co -administered with other vaccines
▪Standalone IPV accounted for just 0.5% of reports
▪VAERS is passive reporting system, cannot assess causal associationsVaccine Adverse Event Reporting System (VAERS) Data,
2000 –2012
Source: Iqbal et al, Lancet ID 2015.
Work group interpretation
How substantial are the desirable anticipated effects of completing a
primary polio vaccination series in unvaccinated adults?EtRDomain: Benefits & Harms
Minimal Small Moderate Large VariesDon’t
know
Work group interpretation
How substantial are the undesirable anticipated effects of completing a
primary polio vaccination series in unvaccinated adults?EtRDomain: Benefits & Harms
Minimal Small Moderate Large VariesDon’t
know
Work group interpretation
Do the desirable effects of completing a primary polio vaccination series
outweigh the undesirable effects in unvaccinated adults?EtRDomain: Benefits & Harms
Anticipated
benefits
outweigh
anticipated
harmsAnticipated
harms outweigh
anticipated
benefitsVaries Don’t know
Public Knowledge and Beliefs about Poliovirus
Annenberg Science Knowledge (ASK) Survey*, October 2022
*Nationally representative panel of 1,572 US adults surveyed by SSRS for the Annenberg Public Policy Center of the University ofPennsylvania from October 11 -18, 2022; this
was 9thwave of the ASK survey whose respondents were first empaneled in April 2021.
What U.S. Adults Know and Believe About Polio and the Bivalent Covid Booster | The Annenberg Public Policy Center of the Univ ersity of Pennsylvania
▪85% said they were likely
to recommend that an
eligible person in their
household get
vaccinated with the polio
vaccine
▪Values of unvaccinated adults might differ from those of general population
▪Unvaccinated adults are likely a heterogeneous group
–Persons whose families chose for them to not be vaccinated as children
–Persons who missed opportunities to be vaccinated as children
▪Lack of data on how these populations perceive their risk of polio and perceive the
potential positive vs. negative effects of polio vaccination Considerations for Values of Population in Question
(Unvaccinated or Incompletely Vaccinated Adults)
Pros
▪Context of global polio eradication efforts
▪Prevention of paralytic polio has been a public health priority for decades
Cons
▪Competing priorities for clinicians and local public health departments
▪Uncertainty about eligibility for vaccination and true level of risk to adults in the US
outside of outbreak settingAdditional Considerations for Acceptability to Key
Stakeholders
Work group interpretation
Does the target population (unvaccinated or incompletely vaccinated
adults) feel that the desirable effects of vaccination are large relative to
undesirable effects?EtRDomain: Values of Target Population
NoProbably
noProbably
yesYes VariesDon’t
know
Work group interpretation
Is there important uncertainty or variability in how much people value
the main outcome (prevention of paralytic poliomyelitis)?EtRDomain: Values of Target Population
Important
uncertainty
or variabilityProbably
important
uncertainty
or variabilityProbably not
important
uncertainty
or variabilityNo
important
uncertainty
or variabilityNo known
undesirable
outcomes
Work group interpretation
Is the intervention (vaccination of adults known or suspected to be
unvaccinated or incompletely vaccinated) acceptable to key
stakeholders?EtRDomain: Acceptability to Key Stakeholders
NoProbably
noProbably
yesYes VariesDon’t
know
Potential supply:
▪Currently just one US -licensed manufacturer of stand -alone IPV (Sanofi)
▪Three US -licensed manufacturers of combination vaccines that include IPV (Sanofi,
Merck, GSK)
Potential demand:
▪Difficult to quantify: Uncertain number of adults who know they are unvaccinated or
undervaccinatedResource Use and Feasibility: Potential Supply and Demand
▪Paralytic polio case identified in July 2022
▪Persistent wastewater detections in area during summer to early fall 2022
▪National and local media attention
▪Calls for unvaccinated to get vaccinated
▪Concerted health department efforts to reach unvaccinated persons
▪No significant supply issuesResource Use and Feasibility: New York Experience
▪Access to vaccination sites that stock IPV
▪Potential effects on health system screening and recall algorithms
–Will need clear guidance for who is eligible for vaccination
▪Feasibility of implementing risk -based recommendations, particularly if risk of
exposure in the population changes over timeAdditional Resource and Feasibility Considerations
Work group interpretation
Is the intervention (vaccination of adults known or suspected to be
unvaccinated or incompletely vaccinated) a reasonable and efficient
allocation of resources?EtRDomain: Resource Use
NoProbably
noProbably
yesYes VariesDon’t
know
Work group interpretation
Is the intervention (vaccination of adults known or suspected to be
unvaccinated or incompletely vaccinated) feasible to implement?EtRDomain: Feasibility
NoProbably
noProbably
yesYes VariesDon’t
know
▪Different rates of childhood vaccination and poliovirus immunity
▪Opportunity to receive catch -up polio vaccination as an adult likely increases equity
▪No known differences in vaccine effectiveness among immunocompetent persons in
the US setting
▪Assuring equitable access to vaccination sites with IPV will be an important
consideration for implementation Equity Considerations
Work group interpretation
What would be the impact (of vaccinating adults known or suspected to
be unvaccinated or incompletely vaccinated) on health equity?EtRDomain: Equity
Reduced
equityProbably
reduced
equityProbably
no impactProbably
increased
equityIncreased
equityVariesDon’t
know
For unvaccinated/incompletely vaccinated adults known to be at increased risk of
poliovirus exposure:Work Group Judgement: Balance of Consequences
Completing a Primary Polio Vaccination Series
Undesirable
consequences
clearly
outweigh
desirable
consequences
in most settingsUndesirable
consequences
probably
outweigh
desirable
consequences
in most settingsThe balance
between
desirable and
undesirable
consequences
is closely
balanced or
uncertainDesirable
consequences
probably
outweigh
undesirable
consequences
in most settingsDesirable
consequences
clearly
outweigh
undesirable
consequences
in most
settingsThere is
insufficient
evidence to
determine the
balance of
consequences
For unvaccinated/incompletely vaccinated adults NOT specifically known to be at
increased risk of poliovirus exposure :Work Group Judgement: Balance of Consequences
Completing a Primary Polio Vaccination Series
Undesirable
consequences
clearly
outweigh
desirable
consequences
in most settingsUndesirable
consequences
probably
outweigh
desirable
consequences
in most settingsThe balance
between
desirable and
undesirable
consequences
is closely
balanced or
uncertainDesirable
consequences
probably
outweigh
undesirable
consequences
in most
settingsDesirable
consequences
clearly
outweigh
undesirable
consequences
in most settingsThere is
insufficient
evidence to
determine the
balance of
consequences
Situations that put adults at increased risk of exposure
to poliovirus include:
▪Travelers who are going to countries where polio is epidemic or
endemic (For additional information, see Polio: For Travelers).
▪Laboratory and healthcare workers who handle specimens that
might contain polioviruses.
▪Healthcare workers or other caregivers who have close contact
with a person who could be infected with poliovirus.
▪Unvaccinated or incompletely vaccinated adults whose children
will be receiving oral poliovirus vaccine (for example, international
adoptees or refugees).
▪Unvaccinated or incompletely vaccinated adults living or working
in a community where poliovirus is circulating.Considerations for a Risk -Based vs. Uniform
Recommendation for All Unvaccinated Adults
Situations that put adults at increased risk of exposure
to poliovirus include:
▪Travelers who are going to countries where polio is epidemic or
endemic (For additional information, see Polio: For Travelers).
▪Laboratory and healthcare workers who handle specimens that
might contain polioviruses.
▪Healthcare workers or other caregivers who have close contact
with a person who could be infected with poliovirus.
▪Unvaccinated or incompletely vaccinated adults whose children
will be receiving oral poliovirus vaccine (for example, international
adoptees or refugees).
▪Unvaccinated or incompletely vaccinated adults living or working
in a community where poliovirus is circulating.Considerations for a Risk -Based vs. Uniform
Recommendation for All Unvaccinated Adults
•Individual -level;
•Opportunity to
anticipate risk and
vaccinate prior to
potential exposure
Situations that put adults at increased risk of exposure
to poliovirus include:
▪Travelers who are going to countries where polio is epidemic or
endemic (For additional information, see Polio: For Travelers).
▪Laboratory and healthcare workers who handle specimens that
might contain polioviruses.
▪Healthcare workers or other caregivers who have close contact
with a person who could be infected with poliovirus.
▪Unvaccinated or incompletely vaccinated adults whose children
will be receiving oral poliovirus vaccine (for example, international
adoptees or refugees).
▪Unvaccinated or incompletely vaccinated adults living or working
in a community where poliovirus is circulating.Considerations for a Risk -Based vs. Uniform
Recommendation for All Unvaccinated Adults
•Population -level;
•Group already at
increased risk at
time risk is
recognized;
•Potential missed
opportunities for
vaccination prior to
exposure
Challenges in 2022:
•In which of these
counties are
unvaccinated adults
considered at increased
risk of exposure?
•When are unvaccinated
adults in these counties
no longer at increased
risk of exposure?
•Are unvaccinated adults
traveling to these
counties at increased
risk of exposure?
WWS Report_6_19_23 (ny.gov)
Pros:
▪Allows unvaccinated adults and their health care providers to take advantage of
opportunities to get vaccinated before they are at increased risk of exposure
▪Brings adult polio vaccination policy closer in line with other routine childhood
vaccines, e.g., MMR and varicella vaccines
▪Is less complicated policy to communicate and understand (i.e., recommendation
doesn’t change based on latest wastewater data)Pros and Cons of a Uniform Recommendation for
Unvaccinated and Incompletely Vaccinated Adults
Cons:
▪Most adults in the United States have a low risk of poliovirus exposure and paralytic
polio, and most adults received primary polio vaccination series as children
▪Demand for IPV could potentially exceed supply, particularly if a large number of
adults without documentation of polio vaccination status assume they were not
vaccinated
–However, this issue can be mitigated by providing guidance for this group in the clinical
considerationsPros and Cons of a Uniform Recommendation for
Unvaccinated and Incompletely Vaccinated Adults
▪Majority of work group believe pros of uniform recommendation outweigh cons;
approximately 1/3 favor current risk -based recommendation (and adding language
for those not known to be at increased risk of exposure)
Proposed Language :
Adults who are known or suspected to be unvaccinated or incompletely vaccinated
against polio should complete a primary vaccination series with IPV.Proposed Language for Unvaccinated and Incompletely
Vaccinated Adults
▪In general, unless there are specific reasons to believe they were not vaccinated,
most adults who were born and raised in the United States can assume they were
vaccinated against polio as children. Polio vaccination has been part of the routine
childhood immunization schedule for decades and is still part of the routine
childhood immunization schedule. Adults who received any childhood vaccines
almost certainly were vaccinated for polio.Important Context to Be Included in Clinical Considerations
2ndPolicy Question: Adult IPV Boosters
▪Should a booster IPV dose be recommended for adults at increased risk of
poliovirus exposure who have previously completed a primary polio vaccination
series?
–Population: US adults aged ≥18 years at increased risk of poliovirus exposure who have completed
a primary polio vaccination series (with tOPV , IPV, or a combination of both)
–Intervention: Booster dose of IPV
–Comparison: Adults who completed a primary series but did not receive a booster dose
–Outcomes:
•Prevention of paralytic poliomyelitis
•Serologic immunity to poliovirus types 1, 2, and 3
•Serious adverse events following vaccination
•Indirect effects, e.g., community transmission, impact on health systemsPolicy Question #2 for Work Group
▪2000 Statement: “ Adults who have had a primary series of OPV or IPV and who are
at increased risk [of exposure to poliovirus] can receive another dose of IPV.
Available data do not indicate the need for more than a single lifetime booster
dose with IPV for adults .”
▪Rationale
–Longstanding recommendation since tOPV was used in routine immunization
–Actual need for supplementary dose not established, but “there is value in assuring protection
against infection with wild polioviruses when exposure can reasonably be expected.” (1977 ACIP
Statement)
–At least 2 reported cases of paralytic polio in adult travelers who had completed a primary
vaccination series with Salk IPV and/or tOPVBoosters: 2000 Statement and Rationale
CDC MMWR 1977; CDC MMWR 1986.
▪IHR Emergency Committee recommendation for travelers DEPARTING countries with
poliovirus circulation, to prevent exportation
–Applies to residents and travelers staying >4 weeks
–If implemented by a country, proof of polio vaccination (IPV or tOPV ) within the last 12 months could be
required prior to leaving the country
–Still included in most recent Polio IHR Statement
▪2014 MMWR:
“Adults who have completed a routine series of polio vaccine are considered to have lifelong
immunity to poliovirus but data are lacking. As a precaution, persons aged ≥18 years who are
traveling to areas where there has been WPV circulation in the last 12 months and who have
received a routine series with either IPV or OPV in childhood should receive another dose of IPV
before departure. For adults, available data do not indicate the need for more than a single lifetime
booster dose with IPV.”2014 Interim Guidance
In Response to WHO Polio International Health Regulations (IHR) Emergency Committee Temporary
Recommendations
Wallace MMWR 2014; Statement of the thirty -fifth Polio IHR Emergency Committee (who.int)
Percent positive (95% Confidence Interval)
Birth years Age in 2009 –2010 Poliovirus Type 1 Poliovirus Type 2 Poliovirus Type 3
1998 –2004 6–11 years 97.2 (94.7 –98.8) 98.0 (96.4 –99.0) 93.8 (91.8 –95.4)
1990 –1998 12–19 years 94.7 (92.0 –96.6) 98.2 (96.6 –99.2) 84.3 (81.0 –87.2)
1970 –1990 20–39 years 92.7 (90.0 –94.2) 96.9 (95.2 –98.2) 78.6 (74.6 –82.2)
1960 –1970 40–49 years 93.9 (91.6 –95.7) 95.8 (93.8 –97.3) 85.8 (82.3 –88.8)Unclear Need for IPV Booster in Vaccinated Adults:
Seroprevalence of Poliovirus Antibodies by Age, United States
NHANES Serosurvey, 2009 –2010
Source: Wallace et al, BMC Public Health 2016.NOTE: Presence of detectable neutralizing antibody is a correlate of protection against paralytic disease.
Immunity against paralytic disease may be present even in absence of detectable antibodies.
▪No data on vaccine effectiveness of primary
series + booster vs. primary series only
▪Serologic studies in adults with heterogeneous
pre-booster vaccination
histories/seropositivity: 98% –100% were
seropositive 1 month after an IPV -containing
booster
▪One study followed up trial participants 10
years post -booster: 98% –100% still seropositiveBenefits of IPV Booster
Sources: Broderick et al, Vaccine 2015; Domenicus et al, Vaccine 2014; Fukushima et al, Vaccines 2022; Grimprel et al, Vaccine 2005; Kovac et al, Vaccine 2015; Larnaudie et al,
Human Vaccines 2010; Zimmermann et al, Vaccine 2013.Data from Grimprel et al, Vaccine 2005:
Seropositivity before and 1 month after IPV-
containing booster by study group and
poliovirus serotype
▪Local reactions at injection site reported in trials
–Tenderness in 14% –29%
–Induration in 3% –11%
–Erythema in 0.5% –1.4%
▪Combining IPV with other vaccines is not associated with increased frequency or
severity of reported adverse reactions compared with the other vaccines alone
▪No severe adverse events have been causally associated with use of the current
formulation of IPVSafety of IPV
Sources: Sanofi Pasteur Package Insert -IPOL (fda.gov) . Vidor et al, PIDJ 1997. Murdin et al, Vaccine 1996. Wattigney et al, Pediatrics 2001. IOM 1994.
Work group interpretation
For adults at increased risk of poliovirus exposure who were previously
vaccinated, how substantial are the desirable anticipated effects of
receiving a booster dose of IPV?EtRDomain: Benefits & Harms
Minimal Small Moderate Large VariesDon’t
know
Work group interpretation
For adults at increased risk of poliovirus exposure who were previously
vaccinated, how substantial are the undesirable anticipated effects of
receiving a booster dose of IPV?EtRDomain: Benefits & Harms
Minimal Small Moderate Large VariesDon’t
know
Work group interpretation
For adults at increased risk of poliovirus exposure who were previously
vaccinated, do the desirable effects of receiving a booster dose of IPV
outweigh the undesirable effects?EtRDomain: Benefits & Harms
Anticipated
benefits
outweigh
anticipated
harmsAnticipated
harms outweigh
anticipated
benefitsVaries Don’t know
Public Knowledge and Beliefs about Poliovirus
Annenberg Science Knowledge (ASK) Survey*, October 2022
*Nationally representative panel of 1,572 US adults surveyed by SSRS for the Annenberg Public Policy Center of the University ofPennsylvania from October 11 -18, 2022; this
was 9thwave of the ASK survey whose respondents were first empaneled in April 2021.
What U.S. Adults Know and Believe About Polio and the Bivalent Covid Booster | The Annenberg Public Policy Center of the Univ ersity of Pennsylvania
▪85% said they were likely
to recommend that an
eligible person in their
household get
vaccinated with the polio
vaccine
Work group interpretation
Does the target population (adults at increased risk of poliovirus
exposure who were previously vaccinated) feel that the desirable effects
of a booster dose are large relative to undesirable effects?EtRDomain: Values of Target Population
NoProbably
noProbably
yesYes VariesDon’t
know
Work group interpretation
Is there important uncertainty or variability in how much people value
the main outcome (prevention of paralytic poliomyelitis)?EtRDomain: Values of Target Population
Important
uncertainty
or variabilityProbably
important
uncertainty
or variabilityProbably not
important
uncertainty
or variabilityNo
important
uncertainty
or variabilityNo known
undesirable
outcomes
▪Current recommendation (“Adults who have had a primary series of OPV or IPV and
who are at increased risk [of exposure to poliovirus] can receive another dose of
IPV.”) is long -standing and is generally accepted and feasible
▪If “at increased risk of exposure” group is expanded (e.g., to include previously
vaccinated adults in certain US areas with poliovirus circulation), feasibility might be
affected
▪New York State and New York City experience in 2022
–No significant IPV supply issuesConsiderations for Acceptability, Feasibility, and Resources
Work group interpretation
Is the intervention (providing a booster IPV dose to adults at increased
risk of poliovirus exposure who previously completed a primary polio
vaccination series) acceptable to key stakeholders?EtR Domain: Acceptability to Key Stakeholders
NoProbably
noProbably
yesYes VariesDon’t
know
Work group interpretation
Is the intervention (providing a booster IPV dose to adults at increased
risk of poliovirus exposure who previously completed a primary polio
vaccination series) a reasonable and efficient allocation of resources?EtR Domain: Resource Use
NoProbably
noProbably
yesYes VariesDon’t
know
Work group interpretation
Is the intervention (providing a booster IPV dose to adults at increased
risk of poliovirus exposure who previously completed a primary polio
vaccination series) feasible to implement?EtRDomain: Feasibility
NoProbably
noProbably
yesYes VariesDon’t
know
▪No known differences in response to primary series by socioeconomic group in US
setting
▪No groups or settings known to be disadvantaged by current recommendation
▪Potential increased equity by boosting immunity in those at increased risk of
exposure, especially persons with potential occupational exposures to poliovirusEquity Considerations from Work Group
Work group interpretation
What would be the impact (of providing a booster IPV dose to adults at
increased risk of poliovirus exposure who previously completed a
primary polio vaccination series) on health equity?EtRDomain: Equity
Reduced
equityProbably
reduced
equityProbably
no impactProbably
increased
equityIncreased
equityVariesDon’t
know
IPV booster for adults at increased risk of poliovirus exposure who have
previously completed a primary polio vaccination seriesWork Group Judgement: Balance of Consequences
Undesirable
consequences
clearly
outweigh
desirable
consequences
in most settingsUndesirable
consequences
probably
outweigh
desirable
consequences
in most settingsThe balance
between
desirable and
undesirable
consequences
is closely
balanced or
uncertainDesirable
consequences
probably
outweigh
undesirable
consequences
in most settingsDesirable
consequences
clearly
outweigh
undesirable
consequences
in most settingsThere is
insufficient
evidence to
determine the
balance of
consequences
▪Risk-based
▪Shared clinical decision -making
Proposed Language:
▪Adults who have received a primary series of tOPV or IPV in any combination and
who are at increased risk of poliovirus exposure may receive another dose of IPV.
Available data do not indicate the need for more than a single lifetime booster
dose with IPV for adults.Majority of Work Group Agree with Current
Recommendation for Adult IPV Booster
Situations that put adults at increased risk of exposure to poliovirus include:
▪Travelers who are going to countries where polio is epidemic or endemic (For additional information,
see Polio: For Travelers).
▪Laboratory and healthcare workers who handle specimens that might contain polioviruses.
▪Healthcare workers or other caregivers who have close contact with a person who could be infected
with poliovirus.Clinical Considerations
▪ACIP voting members
–Oliver Brooks (Chair)
–Lynn Bahta
–Sybil Cineas
▪Liaisons
–Lynn Fisher, American Academy of Family Physicians
–Chandy C John, American Academy of Pediatrics
–Sandra Fryhofer , American Medical Association
–Kathy Kudish, Association of Immunization Managers
–Marcus Plescia , Association of State and Territorial Health Officials
–Paul R Cieslak , Council of State and Territorial Epidemiologists
–Christine Hahn, Council of State and Territorial Epidemiologists
–Tina Q. Tan, Infectious Diseases Society of America
–Adenike Shoyinka , Infectious Diseases Society of America
–Mary Wilson, International Society of Travel Medicine
–Jaqueline Lawler, National Association of County and City Health Officials
–Kathy Edwards, Pediatric Infectious Diseases Society
–Joseline Zafack , Public Health Agency of Canada*
–Oliver Baclic , Public Health Agency of Canada*Polio Work Group Members
*In the event of a Work Group poll, CDC, FDA, and Public Health Agency of Canada members are not included.▪Consultants
–Edwin Asturias
–Doug E Campos -Outcalt *
–Emily Lutterloh
–Walt Orenstein
–Jennifer Rosen
–Eli Rosenberg
▪Ex Officio
–Robin Levis , FDA*
–Robin Wisch , FDA*
▪CDC*
–Achal Bhatt
–Stephanie Bialek
–Thomas Clark
–Brian Edlin
–Concepcion Estivariz
–Halle Getachew
–Sarah Kidd
–Janelle King
–M. Steve Oberste
–Janell Routh
–Eileen Yee
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.
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any use by other CDC CIOs or any external audiences.Questions and Discussion