ACIP Evidence to Recommendations for Primary Polio Vaccination Among Adults Aged ≥18 Years

About

The Evidence to Recommendations (EtR) frameworks describe information considered in moving from evidence to ACIP vaccine recommendations.

Summary

Question: Should completion of a primary polio vaccination series with inactivated poliovirus vaccine (IPV) be recommended for unvaccinated and incompletely vaccinated adults in the United States?

Population: Unvaccinated and incompletely vaccinated adults aged ≥18 years in the United States

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

Background

In July 2022, a case of paralytic polio caused by vaccine-derived poliovirus type 2 (VDPV2) was confirmed in an unvaccinated young adult in Rockland County, New York.1 Retrospective and prospective wastewater testing in Rockland and several surrounding counties demonstrated the presence of poliovirus type 2 genetically linked to the case in New York as early as April 2022 and as recently as February 2023.123 Genetic sequencing indicated a linkage between the VDPV2 in New York to polioviruses detected in wastewater in Israel, the United Kingdom, and Canada. These findings represent the second documentation of poliovirus circulation in the United States since wild poliovirus was declared eliminated from the United States in 1979. The previous instance, in 2005, was a type 1 VDPV.4

The most recent ACIP recommendations addressing adult polio vaccination were published in 2000.5 In the 2000 publication, a primary polio vaccination series was recommended for unvaccinated or incompletely vaccinated adults at increased risk of poliovirus exposure. However, there was no clear recommendation for unvaccinated or incompletely vaccinated adults who were not considered to be at increased risk of exposure. The 2022 identification of the paralytic polio case in an unvaccinated young adult and the ongoing circulation of WPV1 and VDPVs globally highlighted the need to re-examine the recommendations for polio vaccination among US adults.

Problem

References in this table:167

Criteria Work Group Judgements Evidence Additional Information
Is the problem of public health importance? Yes Poliovirus infection can cause permanent paralysis. Prior to the introduction of polio vaccines, polio outbreaks in the United States (US) were associated with thousands of paralytic cases each year (6). Although vaccination and improved sanitation eliminated indigenous circulation of poliovirus in many countries, including the US, wild poliovirus type 1 and vaccine-derived polioviruses (VDPVs) continue to circulate globally (7). In 2022, a case of paralytic polio caused by type 2 VDPV was identified in an unvaccinated young adult in New York state (1). This virus was genetically linked to viruses detected in wastewater in the United Kingdom, Israel, and Canada.

Benefits and Harms

References in this table:89101112131415161718192021

Criteria Work Group Judgements Evidence Additional Information
How substantial are the desirable anticipated effects? Large Humoral immunity: The presence of neutralizing antibody is an accepted correlate of protection against paralytic disease (8). Seroconversion rates and antibody titers following vaccination vary depending on age at first dose and vaccination schedule, but three IPV doses administered ≥2 months apart in infants ≥2 months of age results in ≥95% seroconversion one month after the last dose (9,10).

Vaccine effectiveness: The effectiveness of the original Salk IPV for paralytic polio prevention has been established (11,12). A case-control study using the current enhanced potency formulation of IPV in Senegal found an estimated vaccine effectiveness of 36% for one dose and 89% for two doses (13).

Mucosal immunity: While IPV prevents severe disease, it does not prevent gastrointestinal infection or shedding in the stool (14). However, IPV appears to have an impact on nasopharyngeal shedding. Studies show similar, low (0%–4%) rates of nasopharyngeal shedding following exposure among both OPV and IPV recipients (15,16).

 Because IPV is routinely given during childhood, there is a paucity of data on previously unvaccinated adults who receive a primary series.
How substantial are the undesirable anticipated effects? Minimal Data from more than 20 years of use as part of the routine childhood vaccination schedule have demonstrated that IPV has an excellent safety profile. Local reactions at the injection site were reported during clinical trials, with 14%–29% of recipients reporting tenderness, 3%–11% reporting induration, and 0.5%–1% reporting erythema (17). Concurrent administration of IPV with other vaccines was not associated with increased frequency or severity of reported adverse reactions compared with the other vaccines alone (9,18,19). No serious adverse events have been causally associated with use of the current formulation of IPV (19–21).
Do the desirable effects outweigh the undesirable effects? Favors intervention Large desirable effects outweigh minimal undesirable effects of vaccination with IPV.

Values

References in this table:222

Criteria Work Group Judgements Evidence Additional Information
Does the target population feel that the desirable effects are large relative to undesirable effects? Varies An Annenberg Science Knowledge Survey conducted in October 2022 found that 59% of US adults believed having polio would be “extremely bad”, and an additional 26% said it would be “very bad” (22). Additionally, 85% said they were likely to recommend that an eligible person in their household get vaccinated with the polio vaccine. Unvaccinated adults in the US are likely a heterogeneous group, and their values might differ from the general population.
Is there important uncertainty about or variability in how much people value the main outcomes? Probably important uncertainty or variability Unvaccinated adults in the US consist of at least two groups: (1) persons whose families had the opportunity for vaccination but chose not to; and (2) and persons whose families were amenable to vaccination but encountered barriers or missed opportunities for vaccination.

Acceptability

Criteria Work Group Judgements Evidence Additional Information
Is the intervention acceptable to key stakehold-ers? Probably yes IPV is currently recommended for unvaccinated adults at increased risk of poliovirus exposure, and booster doses of IPV are available to adults at increased risk of poliovirus exposure. Prevention of paralytic polio has been a public health priority for decades, and IPV vaccination has been well-accepted among stakeholders to date.

Resource Use

Criteria Work Group Judgements Evidence Additional Information
Is the intervention a reasonable and efficient allocation of resources? Probably yes/Yes There currently is just one US-licensed manufacturer of stand-alone IPV, and there are an unknown number of adults who believe they are unvaccinated or undervaccinated. New York State and New York City did not experience any significant IPV supply issues in 2022, despite identification of a polio case, national media attention, and a concerted effort by the health departments to vaccinate unvaccinated persons, including adults. Demand for IPV could potentially exceed supply, particularly if many adults assume they were not previously vaccinated. However, the work group believed this issue could be mitigated by providing guidance about who should be considered unvaccinated in the clinical considerations.

Equity

Criteria Work Group Judgements Evidence Additional Information
What would be the impact of the intervention on health equity? Probably increased A recommendation that unvaccinated and incompletely vaccinated adults should complete a primary series with IPV would likely increase equity by providing an opportunity to receive catch-up polio vaccination for adults who were not vaccinated as children. Assuring equitable access to vaccination sites providing IPV will be an important consideration for implementation.

Feasibility

Criteria Work Group Judgements Evidence Additional Information
Is the intervention feasible to implement? Probably yes Currently, IPV is recommended for unvaccinated adults at increased risk of poliovirus exposure, and previously vaccinated adults at increased risk of poliovirus exposure may receive a booster dose of IPV. These recommendations have been in practice for over 20 years and have been feasible to implement. Changing from a risk-based recommendation to a uniform recommendation for unvaccinated or incompletely vaccinated adults could potentially overwhelm health systems if there were a large increase in demand. However, New York State and New York City did not experience any significant supply or distribution issues in 2022, despite identification of a polio case, national media attention, and a concerted effort by the health departments to vaccinate unvaccinated persons, including adults. General adult medicine offices do not typically stock IPV, so access to vaccination sites that do stock IPV (e.g., health departments and travel clinics) could be a barrier to implementation. There were also concerns about potential effects on health systems and their vaccine screening and patient recall algorithms. However, the work group believed these concerns could be mitigated with clear guidance for who is eligible for vaccination in the clinical considerations.

Balance of consequences

For unvaccinated and incompletely vaccinated adults known to be at increased risk of exposure to poliovirus: Desirable consequences clearly outweigh undesirable consequences in most settings.

For unvaccinated and incompletely vaccinated adults not known to be at increased risk of exposure to poliovirus: Desirable consequences probably outweigh undesirable consequences in most settings.

Is there sufficient information to move forward with a recommendation? Yes

Policy options for ACIP consideration

ACIP recommends the intervention.

Draft recommendation (text)

Adults (aged ≥18 years) who are known or suspected to be unvaccinated or incompletely vaccinated against polio should complete a primary vaccination series with IPV.

Additional considerations (optional)

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.

Final deliberation and decision by the ACIP

ACIP recommends the intervention.

Adults (aged ≥18 years) who are known or suspected to be unvaccinated or incompletely vaccinated against polio should complete a primary vaccination series with IPV.

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Content Source:
National Center for Immunization and Respiratory Diseases (NCIRD)
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  2. Ryerson AB, Lang D, Alazawi MA, et al. Wastewater Testing and Detection of Poliovirus Type 2 Genetically Linked to Virus Isolated from a Paralytic Polio Case — New York, March 9–October 11, 2022. MMWR Morb Mortal Wkly Rep 2022;71(44):1418–1424. doi: 10.15585/mmwr.mm7144e2.
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  12. Melnick JL, Benyesh-Melnick M, Pena R, et al. Effectiveness of Salk Vaccine. Analysis of Virologically Confirmed Cases of Paralytic and Nonparalytic Poliomyelitis. JAMA 1961; 175:1159–1162. doi: 10.1001/jama.1961.03040130043010.
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