ACIP Evidence to Recommendations for Booster Doses of Inactivated Poliovirus Vaccine (IPV) 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 a booster inactivated poliovirus vaccine (IPV) dose be recommended for adults at increased risk of poliovirus exposure who have previously completed a primary polio vaccination series?

Population: Adults aged ≥18 years at increased risk of poliovirus exposure who have completed a primary polio vaccination series with trivalent oral poliovirus vaccine (tOPV), IPV, or a combination of both

Intervention: Booster dose of IPV

Comparison: Completion of a primary series without 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

Background

The most recent ACIP recommendations addressing booster doses of IPV for adults were published in 2000.1 The 2000 publication stated, “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.” A recommendation allowing a polio vaccine booster for adults at increased risk of poliovirus exposure has been in place since at least 1977.2 The need for a booster dose of IPV had not been established, but neutralizing antibodies wane over time, and it was thought that there was potential value in providing a booster dose when exposure to poliovirus could reasonably be expected.2

In 2014, the World Health Organization (WHO) Polio International Health Regulations (IHR) Emergency Committee issued temporary recommendations for travelers departing from countries with poliovirus circulation.3 These recommendations were aimed at preventing exportation of poliovirus outside of the country. If implemented by a country, proof of polio vaccination within the last 12 months could be required for residents or long-term visitors (>4 weeks) prior to leaving the country. A version of these recommendations has been included in subsequent WHO Polio IHR statements.4 In response to these new WHO recommendations, which differed from the 2000 ACIP recommendations, CDC published interim guidance on IPV boosters for international travelers stating, “As a precaution, persons aged ≥18 years who are traveling to areas where there has been WPV [wild poliovirus] 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.”5

The 2022 identification of the paralytic polio case in an unvaccinated young adult and the ongoing circulation of wild poliovirus type 1 (WPV1) and vaccine-derived polioviruses (VDPVs) globally67 highlighted the need to re-examine the recommendations for polio vaccination among US adults and either revise or re-affirm ACIP recommendations for IPV boosters for previously vaccinated adults.

Problem

References in this table:678

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 (8). Although vaccination and improved sanitation eliminated indigenous circulation of poliovirus in many countries, including the US, WPV type 1 and VDPVs continue to circulate globally (6). In 2022, a case of paralytic polio caused by type 2 VDPV was identified in an unvaccinated young adult in New York state (7). This virus was genetically linked to viruses detected in wastewater in the United Kingdom, Israel, and Canada.

Benefits and Harms

References in this table:91011121314151617181920212223

Criteria Work Group Judgements Evidence Additional Information
How substantial are the desirable anticipated effects? Small/Moderate Serologic data show that a large majority of US adults (≥79%) continue to have neutralizing antibodies to all three types of poliovirus, indicating that immunity from tOPV or IPV vaccination is long-lasting (9). There are no data on the comparative vaccine effectiveness of a primary series alone compared to a primary series plus IPV booster. However, serologic studies in adults with varying vaccination histories and a range of pre-booster seropositivity have shown an increase in the proportion that are seropositive after an IPV booster, reaching 98%–100% seropositivity one month after administration of the booster (10–15). One follow-up study demonstrated that 98%–100% continued to be seropositive 10 years following the booster dose (16). There have been at least 2 reported cases of paralytic polio in adult travelers who had completed a primary series with either Salk IPV, trivalent OPV (tOPV), or a combination of these (17). However, further details on these cases are not available and it is unknown whether a booster dose would have prevented these cases.
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 (18). 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 (19–21). No serious adverse events have been causally associated with use of the current formulation of IPV (21–23).
Do the desirable effects outweigh the undesirable effects? Favors intervention Small or moderate desirable effects outweigh minimal undesirable effects of receiving a booster dose of IPV.

Values

References in this table:24

Criteria Work Group Judgements Evidence Additional Information
Does the target population feel that the desirable effects are large relative to undesirable effects? Probably yes/Don’t know 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” (24). Additionally, 85% said they were likely to recommend that an eligible person in their household get vaccinated with the polio vaccine.
Is there important uncertainty about or variability in how much people value the main outcomes? Probably not important uncertainty or variability/No important uncertainty or variability

Acceptability

References in this table:1

Criteria Work Group Judgements Evidence Additional Information
Is the intervention acceptable to key stakehold-ers? Probably yes/Yes The current recommendation is that previously vaccinated persons at increased risk of poliovirus exposure can receive an additional dose of IPV (1). This recommendation has been in practice for more than 20 years and is widely accepted.

Resource Use

Criteria Work Group Judgements Evidence Additional Information
Is the intervention a reasonable and efficient allocation of resources? Probably yes
There currently is just one US-licensed manufacturer of stand-alone IPV. The current recommendation allowing for an IPV booster for previously vaccinated persons at increased risk of exposure has been in practice for more than 20 years without any significant resource concerns.
 The work group noted that if the “at increased risk of exposure” group increases in size (e.g., to include previously vaccinated adults in certain US areas with poliovirus circulation), increased demand might strain available resources. However, New York State and New York City did not experience any significant supply or distribution issues in 2022 when they called for New Yorkers at increased risk of exposure, including health care providers, to receive a booster dose of IPV.

Equity

Criteria Work Group Judgements Evidence Additional Information
What would be the impact of the intervention on health equity? Probably increased The work group believed that the current recommendation allowing for an additional IPV dose had the potential to increase equity by boosting immunity in those who were at increased risk of exposure, particularly in persons with potential occupational exposure to poliovirus. There are no known differences in response to a primary polio vaccination series by demographic or socioeconomic group in the US setting, and there are no data to suggest that any groups are disadvantaged by the current recommendation.

Feasibility

References in this table:1

Criteria Work Group Judgements Evidence Additional Information
Is the intervention feasible to implement? Probably yes/Yes The current recommendation is that previously vaccinated persons at increased risk of poliovirus exposure can receive an additional dose of IPV (1). This recommendation has been in place for more than 20 years without significant feasibility issues. The work group noted that if the “at increased risk of exposure” group increases in size (e.g., to include previously vaccinated adults in certain US areas with poliovirus circulation), feasibility might be affected. However, New York State and New York City did not experience any significant supply or distribution issues in 2022 when they called for New Yorkers at increased risk of exposure, including health care providers, to receive a booster dose of IPV.

Balance of consequences

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 who have received a primary series of trivalent OPV (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.

Final deliberation and decision by the ACIP

ACIP recommends the intervention.

Adults who have received a primary series of trivalent OPV (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.

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Content Source:
National Center for Immunization and Respiratory Diseases (NCIRD)
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