Poliovirus Vaccine (Inactivated)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, suspension:

IPOL: Type 1 poliovirus 40 D-antigen units, type 2 poliovirus 8 D-antigen units, and type 3 poliovirus 32 D-antigen units per 0.5 mL (0.5 mL, 5 mL) [contains 2-phenoxyethanol, formaldehyde, calf serum protein, neomycin (may have trace amounts), streptomycin (may have trace amounts), and polymyxin B (may have trace amounts)]

Pharmacology

Mechanism of Action

As an inactivated virus vaccine, poliovirus vaccine induces active immunity against poliovirus types 1, 2, and 3 infection

Use: Labeled Indications

Poliovirus prevention:

Active immunization of infants (≥6 weeks [US labeling]; ≥2 months [Canadian labeling]), children, adolescents, and adults for prevention of poliomyelitis caused by poliovirus types 1, 2, and 3.

US labeling: Infants (as young as 6 weeks), children, adolescents, and adults

Canadian labeling: Infants (as young as 2 months), children, adolescents, and adults

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for the following:

• All infants and children (first dose given at 2 months of age) (CDC/ACIP, 58[30] 2009)

Routine immunization of adults in the United States is generally not recommended. Adults with previous wild poliovirus disease, who have never been immunized, or those who are incompletely immunized may receive inactivated poliovirus vaccine if they fall into one of the following categories (CDC/ACIP [Prevots 2000]):

• Travelers to regions or countries where poliomyelitis is endemic or epidemic
• Healthcare workers in close contact with patients who may be excreting poliovirus
• Laboratory workers handling specimens that may contain poliovirus
• Members of communities or specific population groups with diseases caused by wild poliovirus
• Incompletely vaccinated or unvaccinated adults in a household or with other close contact with children receiving oral poliovirus (may be at increased risk of vaccine associated paralytic poliomyelitis)

Contraindications

Hypersensitivity to any component of the vaccine, including 2-phenoxyethanol, formaldehyde, neomycin, streptomycin and polymyxin B; anaphylaxis or anaphylactic shock occurring within 24 hours of administration of 1 dose of vaccine; acute, febrile illness (excluding minor illness with or without low-grade fever).

Dosage and Administration

Dosing: Adult

Immunization: IM, SubQ:

Previously unvaccinated: Administer 0.5 mL per dose for a total of 3 doses given as follows: Two 0.5 mL doses administered at 1- to 2-month intervals, followed by a third dose 6 to 12 months later. If <3 months, but at least 2 months are available before protection is needed, 3 doses may be administered at least 1 month apart. If administration must be completed within 1 to 2 months, give 2 doses at least 1 month apart. If <1 month is available, give 1 dose.

Incompletely vaccinated: Adults with at least 1 previous dose of OPV, <3 doses of IPV, or a combination of OPV and IPV equaling <3 doses, administer at least one 0.5 mL dose of IPV. Additional doses to complete the series may be given if time permits.

Completely vaccinated and at increased risk of exposure: One 0.5 mL dose

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Consult CDC/ACIP annual immunization schedules for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (ACIP [Kroger 2017]).

Primary immunization:Note: Use of the minimum age and minimum intervals (4 weeks) during the first 6 months of life should only be done when the vaccine recipient is at risk for imminent exposure to circulating poliovirus (shorter intervals and earlier start dates may lead to lower seroconversion) (CDC/ACIP 2009). Refer to CDC/ACIP for guidance on schedules and interval for individuals who received polio vaccination(s) (including oral formulation) outside of the US (CDC/ACIP [Marin 2017]).

Infants and Children 6 weeks to 47 months: IM, SubQ: 0.5 mL per dose for a total of 3 doses administered as follows: 2 months, 4 months, and 6 to 18 months of age

Booster immunization: Children 4 to 6 years: IM, SubQ: 0.5 mL as a single dose; administered at least 6 months from the previous dose

Catch-up immunization: Infants, Children, and Adolescents 4 months to 18 years: Note: Do not restart the series if doses have been given (OPV and/or IPV) refer to current immunization guidelines for specific schedule and timing of dose based on patient age and previous number of doses. IM, SubQ: 0.5 mL per dose for a total of 1 to 4 doses

Administration

IM, SubQ: For IM or SubQ administration; do not administer IV. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, patients should be vaccinated while seated or lying down (ACIP [Kroger 2017]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record. Imovax Polio (Canadian product) should be shaken well before use.

For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) should be used for the vaccination and firm pressure on the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (ACIP [Kroger 2017]).

Storage

Store under refrigeration 2°C to 8°C (35°F to 46°F); do not freeze. Protect from light

Drug Interactions

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Test Interactions

May temporarily suppress tuberculin skin test sensitivity (4-6 weeks)

Adverse Reactions

Percentages noted with concomitant administration of DTP or DTaP vaccine and observed within 48 hours of injection.

>10%:

Central nervous system: Irritability (7% to 65%; most common in infants 2 months of age), fatigue (4% to 61%)

Gastrointestinal: Anorexia (1% to 17%)

Local: Tenderness at injection site (≤29%), swelling at injection site (≤11%)

1% to 10%:

Central nervous system: Excessive crying (≤1%; reported within 72 hours)

Gastrointestinal: Vomiting (1% to 3%)

Local: Erythema at injection site (≤3%)

Miscellaneous: Fever (>39°C: ≤4%)

<1%, postmarketing, and/or case reports: Agitation, anaphylactic shock, anaphylaxis, arthralgia, drowsiness, febrile seizures, headache, hypersensitivity reaction, lymphadenopathy, myalgia, paresthesia, seizure, skin rash, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2017]).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2017]).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2017]).
• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2017]).
• Polio infection: Patients with prior clinical poliomyelitis or incomplete immunization with oral poliovirus vaccine (OPV) may receive inactivated poliovirus vaccine (IPV).

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2017]).
• Immune globulin: Immune response may be decreased in patients receiving immune globulin.
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The use of combination vaccines is generally preferred over separate injections, taking into consideration provider assessment, patient preference, and adverse events. When using combination vaccines, the minimum age for administration is the oldest minimum age for any individual component; the minimum interval between dosing is the greatest minimum interval between any individual components. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible; however, vaccination should not be deferred because a specific brand name is unavailable (ACIP [Kroger 2017]).

Special populations:

• Altered immunocompetence: Consider deferring immunization during periods of severe immunosuppression; may have a reduced response to vaccination. According to the manufacturer, patients with HIV infection, severe combined immunodeficiency, hypogammaglobulinemia, agammaglobulinemia, or altered immunity (due to corticosteroids, alkylating agents, antimetabolites, or radiation) may receive inactivated poliovirus vaccine (IPV). In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2017]; IDSA [Rubin 2014]).
• Pediatric: Use of the minimum age and minimum intervals during the first 6 months of life should only be done when the vaccine recipient is at risk for imminent exposure to circulating poliovirus (shorter intervals and earlier start dates may lead to lower seroconversion). Apnea has occurred following intramuscular vaccine administration in premature infants; consider clinical status implications. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (ACIP [Kroger 2017]).

Dosage form specific issues:

• 2-phenoxyethanol: Products may contain 2-phenoxyethanol.
• Calf serum protein: Products may contain calf serum protein.
• Formaldehyde: Products may contain formaldehyde.
• Neomycin: Products may contain neomycin.
• Polymyxin B: Products may contain polymyxin B.
• Streptomycin: Products may contain streptomycin.

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2017]). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the annual ACIP Recommended Immunization Schedules (refer to CDC schedule for detailed information). Specific recommendations for vaccination in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions as well as contacts of immunocompromised patients are available from the IDSA (Rubin 2014).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2017]).

Monitoring Parameters

Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2017]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy

Pregnancy Considerations

Animal reproduction studies have not been conducted. Although adverse effects of IPV have not been documented in pregnant women or their fetuses, vaccination of pregnant women should be avoided on theoretical grounds. Pregnant women at increased risk for infection and requiring immediate protection against polio may be administered the vaccine (CDC/ACIP [Prevots 2000]).

Patient Education

What is this drug used for?

• It is used to prevent polio.

Frequently reported side effects of this drug

• Injection site pain, redness, or swelling
• Irritability (children)
• Loss of strength and energy (children)
• Lack of appetite (children)

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Twitching
• Trouble swallowing
• Trouble speaking
• Change in balance
• Burning or numbness feeling
• Muscle weakness
• Abnormal movements
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.