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Adult Polio Vaccination
Sarah Kidd, MD, MPH
ACIP Meeting February 23, 2023
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.
Objectives for Today’s Presentation
Briefly summarize work group deliberations on adult polio vaccination
Present proposed language for adult polio vaccination (anticipate ACIP
vote in June)
Solicit feedback and identify areas where more data are needed prior to an ACIP vote
2000 Recommendations for Inactivated Polio Vaccine (IPV)
Vaccination of Adults
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 should receive a primary vaccination series with IPV
Adults who have had a primary series of OPV or IPV and who are at increased risk can receive another dose of IPV
Poliomyelitis Prevention in the United States (cdc.gov)
2000 Statement on IPV Vaccination for Adults
Questions and problems that came up in 2022
2000 statement focused on adults atincreased risk of poliovirus exposure
Unclear how to define increased risk in setting of circulating vaccine-derived
poliovirus (cVDPV) in US
Unclear recommendation for unvaccinated adults who were not considered at
increased risk of exposure
Unclear recommendation for vaccinated adults and when/if a booster was advised
Poliomyelitis Prevention in the United States (cdc.gov)
Policy Question #1 for Work Group
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 OPV 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 systems
Current Definition of Fully Vaccinated
An adult is considered fully vaccinated if they received:
–
–
– A primary series of ≥3 doses of trivalent OPV (tOPV) or IPV in any combination
administered ≥4 weeks apart
AND
The last dose in the series was given on or after the 4th birthday
AND
The last dose in the series was given ≥6 months after the previous dose
Poliomyelitis Prevention in the United States (cdc.gov )
Public Health Problem
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 asymptomatic
1950
1960
1970
1980
1990
2000
2010
2020Number of poliomyelitis cases 20000
15000
10000
5000
0 Paralytic polio decreased rapidly in the US after
introduction of polio vaccine
25000
1994: Americas
certified polio-free 1955: Salk IPV
1961: Sabin OPV 1979: Last indigenous
Wild-type case in US
2000: IPV only 1997: Sequential enhanced-potency
IPV followed by OPV 1952
1954 1956 1958
1962
1964 1966 1968
1972
1974
1976 1978
1982
1984
1986
1988
1992
1994
1996
1998
2002
2004 2006 2008
2012
2014 2016 2018
Year
Global Paralytic WPV1 and cVDPV Cases1, Previous 12 Months2
WPV1 cases (latest onset)
Pakistan 20 15-Sep-22
Afghanistan 1 29-Aug-22
Mozambique 8 10-Aug-22
cVDPV1 cases (latest onset) DR Congo 92 16-Dec-22 Malawi 4 01-Dec-22 Mozambique 19 20-Nov-22
Madagascar 11 25-Sep-22
cVDPV2 cases (latest onset) Indonesia 2 03-Jan-23 CAR 5 26-Dec-22
Algeria 3 13-Dec-22 DR Congo 260 10-Dec-22 Yemen 121 02-Dec-22 Chad 36 11-Nov-22
Sudan 1 31-Oct-22 Cameroon 2 30-Oct-22 Niger 13 27-Oct-22
Nigeria 29 27-Oct-22 Mali 1 26-Oct-22
Benin 10 09-Oct-22
Togo 1 30-Sep-22
Ghana 3 14-Sep-22 Somalia 4 23-Aug-22
USA 1 20-Jun-22
Ethiopia 1 01-Apr-22
Mozambique 4 26-Mar-22 Eritrea 1 02-Mar-22
cVPDV3 case (latest onset)
Israel 1 12-Feb-22
Polio Now – GPEI (polioeradication.org )
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 yrs of age had received the recommended 3 doses of IPV (zip code level as low as 37%)
• No additional paralytic cases have been identified
Wastewater Testing for Poliovirus
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
Most recent positive sample was collected on December 15, 2022; no detections in samples collected in last 7 weeks
No additional paralytic polio cases identified
–Seroprevalence of Poliovirus Antibodies by Age,
United States NHANES Serosurvey, 2009–2010
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)
Source: Wallace et al, BMC Public Health 2016.
Effectiveness of Enhanced-Potency IPV
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 children1
– 70%–100% seropositive after 2 doses
– 88%–100% seropositive after 3 doses
Estimates of vaccine effectiveness against paralytic polio2
– 36%–89% for 1 dose
– 89%– 98% for 2 doses
Paucity of data on adults receiving a primary series
1. Vidor et al review, PIDJ 1997.
2. Stoeckel et al, Rev Infect Dis 1984. CDC, MMWR 1988. John, Rev Med Virol 1993.
IPV and Mucosal Immunity
Intestinal immunity1
– 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) immunity2
– Evidence to suggest similar, low rates of NP shedding (0%–4%) among OPV and IPV vaccinees
Sources:
1. Hird and Grassly meta-analysis, PLoS Pathogens 2012.
2. Kok et al, Bulletin of WHO 1992. Onorato et al, JID 1991. Brouwer et al, J R Soc Interface 2022.
Safety: IPV is well-tolerated.
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 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.
Vaccine Adverse Event Reporting System (VAERS) Data,
2000–2012
>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 associations
Reported adverse events were similar and proportional to other vaccines
Source: Iqbal et al, Lancet ID 2015.
Considerations for a Risk-Based vs. Uniform
Recommendation for 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 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). • Individual-level;
Laboratory and healthcare workers who handle specimens that • Opportunity to
anticipate risk an d
vaccinate prior to
potential exposure might contain polioviruses.
Healthcare workers or other caregivers who have close contact
with a person who could be infected with poliovirus.
U nvaccinated 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 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 • Population-level;
• Group already at
increased risk at time risk is recognized;
• Potential missed opportunities for
adoptees or refugees). vaccination prior to
Unvaccinated or incompletely vaccinated adults living or working exposure in a community where poliovirus is circulating.
Pros and Cons of a Uniform Recommendation for
Unvaccinated and Incompletely Vaccinated Adults
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
considerations
Proposed Language for Unvaccinated and Incompletely
Vaccinated Adults
Majority of work group believe pros of uniform recommendation outweigh cons;
approximately 1/3 favor maintaining the current risk-based recommendation
Majority Recommendation :
Adults who are known or suspected to be unvaccinated or incompletely vaccinated against polio should complete a primary vaccination series with IPV.
Clinical Considerations :
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.
Policy Question #2 for Work Group
Should a booster IPV dose be recommended for adults in the US who have
previously completed a primary polio vaccination series?
– Population: US adults aged >18 years who have completed a primary polio vaccination series (with
trivalent OPV, 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 systems
Boosters: 2000 Statement and Rationale
2000 Statement: “ Adults who have had a primary series of OPV or IPV and who are
at increased risk 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 tOPV
CDC MMWR 1977; CDC MMWR 1986.
–Unclear Need for IPV Booster in Vaccinated Adults:
Seroprevalence of Poliovirus Antibodies by Age, United States
NHANES Serosurvey, 2009–2010
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)
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.
Source: Wallace et al, BMC Public Health 2016.
Benefits of IPV Booster
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 seropositive Data from Grimprel et al, Vaccine 2005:
Seropositivity before and 1 month after IPV -
containing booster by study group and poliovirus serotype
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.
Strong Majority of Work Group Agree with Current
Recommendation for Adult IPV Booster
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.
Thank you to
ACIP voting members
– Oliver Brooks (Chair)
– Lynn Bahta
Liaisons the ACIP Polio Work Group Members
– 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
Ex Officio
– Robin Levis, FDA
– Robin Wisch, FDA Consultants
– Edwin Asturias
– Doug E Campos-Outcalt
– Emily Lutterloh
– Walt Orenstein
– Jennifer Rosen
– Eli Rosenberg
CDC
– Achal Bhatt
– Stephanie Bialek
– Thomas Clark
– Kathleen Dooling
– Brian Edlin
– Concepcion Estivariz
– Halle Getachew
– Sarah Kidd
– Janelle King
– Elisabeth Krow-Lucal
– 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 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.