Poliovirus vaccine, inactivated, IPV is a parenteral non-infectious, sterile suspension of inactivated poliovirus type 1(Mahoney), type 2 (MEF-1), and type 3 (Saukett). The vaccine promotes active immunity to all 3 wild-types of poliovirus. Clinical infection is usually due to a single poliovirus type. Complete vaccination can be achieved with OPV, IPV, or a combination of both. The current IPV vaccine available in the US is sometimes referred to as enhanced-potency IPV (eIPV); it has an increased amount of poliovirus antigen per dose compared to formulations that were available before 1987. Oral poliovirus vaccine (OPV) regimens have been preferred for primary poliovirus prophylaxis, but in 1997 the Centers for Disease Control noted that the relative benefits of OPV versus IPV have diminished due to the elimination of wild-type poliovirus in the Western hemisphere and the reduced threat of natural poliovirus importation into the United States. The risk of OPV-associated paralytic poliomyelitis is now less acceptable as a potential side-effect in the general population. Furthermore, fully immunized people may still develop vaccine-associated paralytic poliomyelitis (VAPP) from patients that receive OPV. Close, susceptible contacts OPV recipients may contract vaccine-derived polioviruses (VDPV); OPV vaccinees can excrete VDPV for a month or longer after receiving OPV. In contrast, paralytic polio and VAPP have not been associated with inactivated poliovirus vaccine (IPOL(R)) administration. In the US, the all-IPV primary immunization regimen is recommended and has been since January of 2000 for infants, children and adults, both immunocompetent and immunodeficient. Children less than 18 years of age and certain adults, including those with a history of clinical poliomyelitis, still need to receive the complete immunization series (3 or 4 injections). The first IPV formulation was FDA-approved in 1955.
General Administration Information
For storage information, see specific product information within the How Supplied section.
NOTE: According to U.S. federal laws, the health care provider must record in the patient's permanent record: the manufacturer, lot number, date of administration, and the name and address of the person administering the vaccine. Screen all potential vaccine recipients for a prior severe reaction to the IPV. Do not give the IPV to anyone with a past severe reaction to the vaccine (see Contraindications). Pregnant patients and those with a moderate or severe illness regardless of the presence of a fever may not be appropriate vaccine recipients.
-Give the required vaccine information materials (VIMs) and inform the patient, guardian, or parent of the benefits and risks of the vaccine.
Route-Specific Administration
Injectable Administration
-The inactivated polio vaccine (IPV) is administered intramuscularly or subcutaneously; do not give intravenously.
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. The solution should be clear and colorless. If particulate matter or discoloration exist, do not administer the vaccine.
-If separate administration sites and syringes are used, IPOL may be given at the same time as diphtheria, tetanus, whole-cell or acellular pertussis, Haemophilus influenzae type b (Hib), and hepatitis B vaccines. No interferences on achievement of immunity have been observed. Injection sites need to be at least 1 inch apart so that any local reaction can be attributed to the appropriate vaccine. If the third dose of IPV is given to a child between 12 and 18 months old, concurrent administration of the Measles/Mumps/Rubella vaccines, MMR and or other vaccines may be desirable. While data regarding any immunological interference are not available regarding the simultaneous use of the IPV with other vaccines including the MMR, pneumococcal vaccine, polyvalent, varicella virus vaccine live, and the influenza virus vaccine, the American College of Immunization Practices (ACIP) has generally encouraged simultaneous administration for the recommended age groups if no contraindications exist. The current information in the guidelines is that inactivated vaccines do not interfere with the immune response to other inactivated vaccines or to live vaccines. Consult recent ACIP guidelines for the most current recommendations on immunization schedules and contraindications. Please note that the ACIP recommendations are not updated annually but rather as new data dictate.
Preparation:
-Do not mix the IPV with any other vaccine in the same syringe.
-A separate, single-use prefilled syringe and needle or a sterile disposable unit must be used for each person receiving IPV. Do not recap needles. Dispose of used materials in an appropriate biohazard container.
Intramuscular Administration
-Before administration, clean the skin over the injection site with a suitable cleansing agent.
-The preferred IM injection sites are the midlateral aspect of the thigh (particularly for infants) and the deltoid muscle of the upper arm (usually suitable for older children or adults). Do NOT inject into the gluteal area or other areas where there may be a major nerve trunk.
-Use different syringes and different injection sites when concomitant administration of other vaccines or immunoglobulin is required.
Subcutaneous Administration
-Prior to administration, clean the skin over the injection site with a suitable cleansing agent.
-The preferred SC injection sites are the anterolateral aspect of the thigh (particularly for infants) and the deltoid area of the upper arm (usually suitable for older children).
-Use different syringes and different injection sites when concomitant administration of other vaccines or immunoglobulin is required.
The most common adverse reaction to the poliovirus vaccine, inactivated, IPV is an injection site reaction (usually erythema, swelling and tenderness). Of patients who received an earlier formulation of the vaccine, 3.2% had erythema, 1% had induration, and 13% had pain within 48 hours of vaccine receipt. Among children 2-18 months of age who received inactivated poliovirus vaccine (IPOL) intramuscularly, 0-1.4% had erythema within 48 hours after the injection. More children had swelling (0-11.4%) or tenderness (0-29.4%).
Systemic adverse events such as fever, restlessness, drowsiness, anorexia, nausea, vomiting, and inconsolable crying observed in children who received the poliovirus vaccine, inactivated, IPV (IPOL) are difficult to ascertain because the vaccine was given concomitantly with the DTP (acellular pertussis) vaccine or with Tripedia. The percentages of patients who had each adverse event are comparable in frequency and severity to the numbers reported for the whole-cell DTP given alone. Temperatures of 39 degrees C (102 degrees F) or greater within 48 hours of vaccine receipt occurred in 0-4.2% of vaccine recipients. The percentages of patients who had irritability were 6.7-64.5%; inconsolable crying (0-1.4%); anorexia (1.3-16.6%); vomiting (0-2.8%); and sleepiness (described as lethargy, malaise, or drowsiness, 4-60.7%).
Allergic reactions and anaphylactoid reactions such as anaphylactic shock and angioedema are acknowledged possible adverse effects associated with the poliovirus vaccine, inactivated, IPV. Serious allergic reactions usually occur within a few hours after vaccine receipt. The vaccine recipient may have difficulty breathing, wheezing, tachycardia, urticaria, dizziness, or swelling of the face and throat areas. Have epinephrine injection (1:1000) and other appropriate agents available to control immediate allergic reactions. Development of a severe allergic reaction precludes subsequent IPV administration.
A causal relationship has not been established between the poliovirus vaccine, inactivated, IPV (IPOL) and either Guillain-Barre syndrome or death. However, temporal relationships between deaths of infants who received the inactivated poliovirus vaccine and Guillain-Barre syndrome and another inactivated poliovirus vaccine have been observed.
Seizures (including febrile seizures), headache, syncope, and paresthesias have been noted during postmarketing experience with poliovirus vaccine, inactivated, IPV.
Prior to administration, health care personnel should inform the patient, parent, guardian, or responsible adult of the poliovirus vaccine, inactivated, IPV benefits and risks. This should include the provision of the vaccine information statement from the manufacturer. The responsible adult should report any adverse reaction following vaccine administration to the health care provider. The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. This includes, but is not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is (800) 822-7967. All adverse events experienced by a vaccine recipient need to be reported by the health care professional. The vaccine manufacturer also requests that any adverse events be reported to them by calling (800) 822-2463.
Poliovirus vaccine, inactivated, IPV is contraindicated for use in patients who have experienced anaphylaxis or anaphylactic shock within 24 hours of a previous dose of the vaccine or any of its components, as well as patients with streptomycin hypersensitivity, neomycin hypersensitivity, polymyxin hypersensitivity, formaldehyde hypersensitivity, or 2-phenoxyethanol hypersensitivity. These components are used in the manufacturing process and trace amounts may be present in the vaccine. With any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.
Do not give inactivated poliovirus vaccine, IPV via intravenous administration or intraarterial administration. IPV should be administered intramuscularly or subcutaneously only. Patients with thrombocytopenia, vitamin K deficiency, a coagulopathy (e.g., hemophilia), or those receiving anticoagulant therapy should be monitored closely when given IPV because bleeding can occur at the intramuscular or subcutaneous injection site.
Poliovirus vaccine, inactivated, IPV is contraindicated for use in patients with any acute, febrile illness. Administration of the vaccine to patients with minor illness, such as diarrhea or mild upper respiratory infection with or without fever, is acceptable. Try not to miss available vaccination opportunities, especially among possible noncompliant patients or caregivers.
Patients with significant immunosuppression may not have an adequate antibody response to poliovirus vaccine, inactivated, IPV. Immunosuppressed persons may include patients with human immunodeficiency virus (HIV) infection; acquired immunodeficiency syndrome (AIDS); severe combined immunodeficiency (SCID); hypogammaglobulinemia; agammaglobulinemia; altered immune states due to generalized neoplastic disease; or an immune system compromised by radiation therapy or drug therapy (e.g., chemotherapy or corticosteroid therapy with greater than physiologic doses). Short-term (< 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive. Patients vaccinated with IPV within 2 weeks before starting immunosuppressive therapy or while receiving immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored. Hematopoietic stem cell transplant recipients should be revaccinated routinely 6 months after the transplant, regardless of the source of the transplanted stem cells.
No adequate and well-controlled studies have been conducted in pregnant women receiving poliovirus vaccine, inactivated, IPV and the risk of vaccination to a human fetus or to a woman's reproductive capacity is unknown. Animal reproductive studies have also not been performed. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated vaccines to pregnant women have not resulted in adverse effects in the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm. The manufacturer recommends administration of the vaccine only if clearly needed. Anti-idiotypic antibodies to poliovirus present in the mother's serum may cross the placenta and actively induce an immune response by the fetus. Anti-idiotypic antibodies are antibodies that recognize idiotypic determinants on antibodies. Thus, babies born to mothers that have been vaccinated for poliovirus may have anti-poliovirus antibody production without direct antigen (poliovirus) exposure. The secretory antibodies, such as IgG and IgM, against poliovirus found in newborns are not transported from the mother to the fetus. Vaccination of all infants is still imperative, as the efficacy and duration of any maternally-induced immunity are unknown.
There is no information on the excretion of the inactivated poliovirus vaccine (IPV) in human milk. The manufacturer recommends caution when administering to nursing mothers; however according to the Advisory Committee on Immunization Practices (ACIP), breast-feeding does not adversely affect immunization of the vaccine recipient. Breast feeding actively stimulates the infant's immune response. Human milk of women vaccinated for poliovirus contains anti-idiotypic antibodies to poliovirus. Anti-idiotypic antibodies are antibodies that recognize idiotypic determinants on antibodies to poliovirus. Thus, breast-fed babies of mothers that have been vaccinated for poliovirus may have anti-poliovirus antibody production without direct antigen (poliovirus) exposure. Vaccination of these infants is still imperative, as the efficacy and duration of any maternally-induced immunity are unknown. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.
Syncope has been associated with the administration of poliovirus vaccine, inactivated, IPV. Prior to administration of the vaccine, ensure procedures are in place to prevent injury secondary to falls.
General Dosing Information
-Interruption of the recommended schedule should not interfere with the final immunity achieved with poliovirus vaccine, inactivated, IPV. Regardless of the time elapsed between doses, there is no need to start the series over again.
-The use of reduced volume or fractional doses is not recommended as protection against disease.
-Premature infants should be immunized according to their chronological age, regardless of birth weight.
-Sequential IPV/oral poliovirus vaccine (OPV) childhood immunization schedule is no longer recommended in the US for primary immunization, and OPV is no longer distributed within the country. Fully immunized people may still develop vaccine-associated paralytic poliomyelitis from patients who receive OPV.
For poliovirus prophylaxis:
-for routine poliovirus prophylaxis:
Subcutaneous or Intramuscular dosage:
Infants and Children 2 months to 6 years: 0.5 mL IM or subcutaneously given at 2, 4, and 6 to 18 months, ideally at intervals of at least 8 weeks apart; the minimum interval between doses is 4 weeks. Administer a final booster dose of 0.5 mL IM or subcutaneously after the fourth birthday and at least 6 months after the previous dose; ideally, administration should occur between 4 to 6 years. Children younger than 4 years of age who have already received 4 doses of IPV should receive an additional booster dose at 4 to 6 years of age.
-for polio prophylaxis in unvaccinated or incompletely vaccinated adults:
Subcutaneous or Intramuscular dosage:
Adults: 0.5 mL IM for 3 doses. Administer the second dose 1 to 2 months after the first and the third dose 6 to 12 months (minimum 5 months) after the second.
-for poliovirus prophylaxis in vaccinated adults who are at risk for exposure to poliovirus:
Subcutaneous or Intramuscular dosage:
Adults: 0.5 mL IM or subcutaneously as a single booster dose. Available data do not indicate the need for more than a single lifetime booster dose with IPV.
Maximum Dosage Limits:
-Adults
0.5 mL/dose subcutaneously or IM.
-Geriatric
0.5 mL/dose subcutaneously or IM.
-Adolescents
0.5 mL/dose subcutaneously or IM.
-Children
0.5 mL/dose subcutaneously or IM.
-Infants
6 weeks and older: 0.5 mL/dose subcutaneously or IM.
less than 6 weeks: Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. However, consult current immunization schedules for recommended vaccines for use in young pediatric dialysis patients; the ACIP states that all routine vaccinations are likely effective in patients with chronic renal disease.
*non-FDA-approved indication
There are no drug interactions associated with Poliovirus Vaccine, Inactivated, IPV products.
Poliovirus vaccine, inactivated, IPV stimulates the immune system to produce antibodies against poliovirus wild-types 1, 2, and 3. Following intramuscular or subcutaneous administration, the antigens (inactivated viruses) get presented to the antigen-presenting cells (e.g., B cells, macrophages). The antigen-presenting cells process and present the antigens and allow B-cells to proliferate, differentiate, and produce anti-poliovirus serum antibodies. The serum anti-poliovirus antibodies are capable of opsonization, neutralization, and complement activation. In natural infection, the polio viruses invade and replicate in mucosal tissues. The virus may invade the blood stream and produce disease at distant systemic sites. Parenteral immunization with non-replicating agents, such as the IPV may fail to induce specific mucosal responses. Vaccination with either IPV or the live attenuated oral poliovirus vaccine (OPV) usually induces secretory antibody (IgA) production in the pharynx and gut, but mucosal immunity induced by IPV is less than mucosal immunity induced by OPV. The development of serum anti-poliovirus antibodies caused by either OPV or IPV are effective in the prevention of systemic disease despite their different routes of administration. The IPV helps reduce pharyngeal acquisition of poliovirus and to a lesser extent, intestinal acquisition. Herd immunity is possible with IPV, including populations vaccinated only with IPV.
Poliovirus Vaccine, Inactivated, IPV is administered intramuscularly or subcutaneously. The pharmacokinetics of the vaccine are not well defined. Poliovirus antibodies have been found in the serum, the pharynx, and the gut. Poliovirus antibodies are distributed into breast milk. A direct relationship exists between the antigenic content of IPV, the frequency of seroconversion, and resulting antibody titers. Detectable serum neutralizing antibodies to all three types of poliovirus have been reported for at least 10 years in children that received an IPV only immunization schedule.
Affected cytochrome P450 (CYP450) enzymes and drug transporters: None
-Special Populations
Pediatrics
After 3 doses of IPV administered to 65 infants at 2, 4, and 12 months of age, development of serum neutralizing, nasopharyngeal neutralizing, and nasopharyngeal IgA antibodies was evaluated. Serum and nasopharyngeal secretions were collected 1 month after vaccination. After 2 doses, 96.4% of patients had detectable concentrations of serum neutralizing antibodies to poliovirus types 1 and 3, while 100% had antibodies to type 2. After 3 doses, 100% of patients had detectable serum antibodies to poliovirus types 2 and 3, while 96.2% had antibodies to type 1, with a final geometric mean titers of 1954.28, 5835.37 and 5187.4 for types 1, 2, and 3, respectively. Detectable nasopharyngeal neutralizing antibodies against poliovirus types 1, 2, and 3 were present in 43.4%, 60.4%, and 66% of patients, respectively after the third dose of IPV. Nasopharyngeal IgA antibodies to poliovirus were detected in 88.7% (type 1), 90.6% (type 2), and 88.7% (type 3) of patients after the third dose.