Polio Vaccine

Number: 0402

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses polio vaccine.

1. Medical Necessity

   Aetna considers U.S. Food and Drug Administration (FDA)-approved inactivated polio vaccine (IPV) injection a medically necessary preventive service, according to the recommendations of the Centers for Disease Control and Prevention's (CDC) Advisory Committee for Immunization Practices (ACIP), for the prevention of severe polio disease, including paralysis. Note: Oral polio vaccine (OPV) is no longer recommended by the CDC's ACIP and has been discontinued in the United States.
   
   The CDC's ACIP provides the following recommendations IPV:

   1. Children - a total of 4 doses of IPV at ages 2 months, 4 months, 6 to 18 months, and 4 to 6 years; or
   2. Adults 18 years or older:
      
      
      1. To complete primary vaccination series with IPV for adults who are known or suspected to be unvaccinated or incompletely vaccinated against polio should complete a primary vaccination series with IPV; or
      2. For adults who have received a primary series of trivalent OPV or IPV in any combination and who are at increased risk for exposureFootnote1* to poliovirus may receive another dose of IPV. There is insufficient evidence to support more than one IPV booster dose in adults.
         

   Note: Per CDC's ACIP, for adults who need a primary polio vaccination series, the recommendation is to receive 2 doses of IPV spaced 4 to 8 weeks apart, followed by a 3rd dose administered 6 to 12 months after the 2nd dose. If the interval between doses exceeds the recommended timeframe, there is no need to restart the series. In cases where three doses cannot be given within the recommended intervals before protection is needed (e.g., before travel to a country with endemic polio)Footnote1*, an accelerated schedule is advised based on the available time. Any adult who is not fully vaccinated can complete the series; for instance, if someone has received only 2 doses, they can get the remaining 2 doses. Additionally, fully vaccinated individuals who are at increased risk of exposure to poliovirus may receive one lifetime booster dose of IPV. However, available data do not indicate the need for more than a single lifetime booster dose with IPV for adults (Kidd et al., 2023; CDC, 2024).

2. Policy Limitations and Exclusions 

   Footnote1* Some Aetna plans exclude coverage of immunizations required for travel or because of work related risk. Please check benefit plan descriptions for details.

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
CPT codes covered if selection criteria are met:
90698	Diphtheria, tetanus toxoids, acellular pertussis vaccine, Haemophilus influenzae type b, and inactivated poliovirus vaccine (DTaP-IPV/Hib), for intramuscular use
90713	Poliovirus vaccine, inactivated, (IPV), for subcutaneous or intramuscular use
90723	Diphtheria, tetanus toxoids, acellular pertussis vaccine, hepatitis B, and inactivated poliovirus vaccine (DTaP-HepB-IPV), for intramuscular use
Other CPT codes related to the CPB:
90460	Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; first or only component of each vaccine or toxoid administered
90461	each additional vaccine or toxoid component administered (List separately in addition to code for primary procedure)
90471	Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); 1 vaccine (single or combination vaccine/toxoid)
90472	each additional vaccine (single or combination vaccine/toxoid) (List separately in addition to code for primary procedure)
ICD-10 codes covered if selection criteria are met:
Z20.89	Contact with and (suspected) exposure to other communicable diseases [poliomyelitis]
Z23	Encounter for immunization [DTP + polio]

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Background

Poliomyelitis is a viral disease that causes inflammation of the gray matter of the spinal cord. Infection causes fever, pains, and gastroenteric disturbances in the acute stage, followed by a flaccid paralysis of one or more muscular groups, which is later followed by atrophy. Since 1979, the only indigenous cases of poliomyelitis reported in the United States have been associated with the use of oral polio vaccine (OPV). Oral polio vaccine (OPV) can cause polio (1 case per 2.4 million doses distributed) because it contains live, but weakened, virus. Until recently, the benefits of OPV use (i.e., intestinal immunity, secondary spread) outweighed the risk for vaccine-associated paralytic polio (VAPP). Widespread childhood vaccination has led to the complete eradication of wild-type poliovirus infection in the United States.

In 2000, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommended exclusive use of the inactivated poliovirus vaccine (IPV) for routine polio immunization in the United States, effectively discontinuing use of the oral poliovirus vaccine (OPV). This recommendation followed the elimination of indigenous wild poliovirus transmission in the U.S. in 1979 and recognition that OPV was responsible for all remaining paralytic polio cases, occurring at an estimated rate of 6–8 cases annually through vaccine‑associated paralytic poliomyelitis (VAPP). OPV, developed by Albert Sabin, contains a live attenuated virus that can rarely revert to neurovirulence and cause paralysis, with a risk estimated at approximately 1 case per 2.4 million doses distributed. In contrast, IPV, developed by Jonas Salk, contains inactivated poliovirus and provides effective protection against poliomyelitis without the risk of vaccine‑derived disease. With continued absence of wild poliovirus in the United States, ACIP determined that the risk of OPV‑associated paralysis outweighed its benefits, leading to adoption of an all‑IPV schedule to eliminate preventable vaccine‑associated cases (Prevots et al., 2000). OPV is no longer licensed or available in the U.S., although it is still used in may parts of the world (CDC, 2024).

Inactivated poliovirus vaccine may be given concurrently with other vaccines. If injectable polio vaccine (IPV) and DTaP or DTP are given at the same time, they should be administered in separate syringes because of possible interference. An investigational, dual-chambered syringe that allows mixing of selective DTP or DTaP and IPV preparations just before injection has been developed.

Guidelines for preventing infections in hematopoietic cell transplant (HCT) recipients by the Center for International Blood & Marrow Transplant Research, National Marrow Donor Program, European Group for Blood and Marrow Transplantation, American Society for Blood and Marrow Transplantation, Canadian Blood and Marrow Transplant Group, Infectious Diseases Society of America, Society for Healthcare Epidemiology of America, Association of Medical Microbiology and Infectious Disease, and the CDC (Ljungman et al., 2009) indicated that oral poliovirus vaccine (live) should not be given to hematopoietic stem cell recipients since an effective, inactivated alternative exists.

The American Academy of Pediatrics (2011) stated that despite marked progress in global polio eradication, the threat of polio importation into the United States remains; therefore, all children should be protected against the disease. The standard schedule for poliovirus immunization consists of four doses of inactivated poliovirus vaccine at 2, 4, and 6 through 18 months, and at 4 through 6 years of age. The minimum interval between doses 1 and 2, as well as between doses 2 and 3, is 4 weeks, while the minimum interval between doses 3 and 4 is 6 months. The minimum age for dose 1 is 6 weeks. Minimum age and intervals should be used when there is an imminent threat of exposure, such as travel to an area where polio is endemic or epidemic. The final dose in the inactivated poliovirus vaccine series should be administered at 4 through 6 years of age, regardless of the number of doses administered before the 4th birthday, and at least 6 months since the last dose was received.

Nelson et al. (2012) stated that oral poliovirus vaccine (OPV) will likely be insufficient to completely eradicate polio due to its propensity to mutate into neurovirulent forms and its inability to produce adequate immunity in certain areas of the world. Inactivated polio vaccine, a killed vaccine that cannot mutate, may be more effective than OPV in certain populations and will likely be required for global polio eradication. However, the high cost of inactivated polio vaccine is prohibitive in many areas of the world. Intradermal administration has the potential to lower the dose and, thus, the cost of inactivated polio vaccine. These investigators reviewed the clinical studies to date on intradermal fractional dose polio vaccination. They concluded that intradermal IPV vaccination shows potential as a means to reduce the cost and increase the ease of administration of inactivated polio vaccine, but additional research is needed to determine the optimal fractional dose, timing, and role of adjuvants in intradermal inactivated polio vaccine vaccination, as well as the clinical significance of different antibody titers above the threshold for seroconversion.

Zaman et al. (2023) noted that type 2 circulating vaccine-derived polioviruses (cVDPV2) from Sabin oral poliovirus vaccines (OPVs) are the leading cause of poliomyelitis. A novel type 2 OPV (nOPV2) has been developed to be more genetically stable, with similar tolerability and immunogenicity to that of Sabin type 2 vaccines, to mitigate the risk of cVDPV2. In a randomized, controlled, double-blind, phase-II clinical trial, these researchers examined these aspects of nOPV2 in poliovirus vaccine-naive newborn infants. They enrolled newborn infants at the Matlab Health Research Centre in Chandpur, Bangladesh. This trial included healthy infants who were a single birth after at least 37 weeks' gestation. Infants were randomly assigned (2:1) to receive either 2 doses of nOPV2 or a placebo, administered at age 0 to 3 days and at 4 weeks. Exclusion criteria included receipt of rotavirus or any other poliovirus vaccine, any infection or illness at the time of enrollment (vomiting, diarrhea, or intolerance to liquids), diagnosis or suspicion of any immunodeficiency disorder in the infant or a close family member, or any contraindication for venipuncture. The primary safety outcome was safety and tolerability after 1 and 2 doses of nOPV2, given 4 weeks apart in poliovirus vaccine-naive newborn infants, while the primary immunogenicity outcome was the seroconversion rate for neutralizing antibodies against type 2 poliovirus, measured 28 days after the 1st and 2nd vaccinations with nOPV2. Study staff recorded solicited and unsolicited adverse events (AEs) after each dose during daily home visits for 7 days. Poliovirus neutralizing antibody responses were measured in sera drawn at birth and at ages 4 weeks and 8 weeks. Between September 21, 2020, and August 16, 2021, these researchers screened 334 newborn infants, of whom 3 (less than 1%) were found to be ineligible and 1 (less than 1%) was withdrawn by the parents; the remaining 330 (99%) infants were assigned to receive nOPV2 (n = 220 [67%]) or placebo (n = 110 [33%]). nOPV2 was well-tolerated; 154 (70%) of 220 newborn infants in the nOPV2 group and 78 (71%) of 110 in the placebo group had solicited AEs, which were all mild or moderate in severity. Severe unsolicited AEs occurred in 11 (5%) vaccine recipients and 5 (5%) placebo recipients, and were considered unrelated to vaccination. A total of 306 (93%) of 330 infants had seroprotective maternal antibodies against type 2 poliovirus at birth, decreasing to 58 (56%) of 104 in the placebo group at 8 weeks. In the nOPV2 group, 196 (90%) of 217 infants seroconverted by week 8 after 2 doses, with 214 (99%) having seroprotective antibodies. The authors concluded that nOPV2 was well-tolerated and immunogenic in newborn infants, with 2 doses, at birth and 4 weeks, resulting in almost 99% of infants having protective neutralizing antibodies.

Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) Recommendations

The CDC's Advisory Committee on Immunization Practices (ACIP) recommends that children in the United States receive inactivated poliovirus vaccine (IPV) as part of their routine immunizations to protect against polio. IPV can sometimes be administered in combination with other vaccines, and parents are encouraged to discuss this option with their child's doctor. Children should receive a total of four doses at the following ages — the first dose at 2 months, the second dose at 4 months, the third dose between 6 and 18 months, and the fourth dose at 4 to 6 years old. For children who are behind on their vaccinations, it is important to complete the series according to the recommended catch-up schedule (CDC, 2024).

Most adults were likely vaccinated against poliovirus during childhood. For adults who need a primary polio vaccination series, the recommendation is to receive two doses of inactivated poliovirus vaccine (IPV) spaced 4 to 8 weeks apart, followed by a third dose administered 6 to 12 months after the second dose. If the interval between doses exceeds the recommended timeframe, there is no need to restart the series. In cases where three doses cannot be given within the recommended intervals before protection is needed, such as prior to traveling to a country with endemic polio, an accelerated schedule is advised based on the available time. Any adult who is not fully vaccinated can complete the series; for instance, if someone has received only two doses, they can get the remaining two. Additionally, fully vaccinated individuals who are at increased risk of exposure to poliovirus may receive one lifetime booster dose of IPV. Available data do not indicate the need for more than a single lifetime booster dose with IPV for adults (Kidd et al., 2023; CDC, 2024).

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References