Mosby's GenRx®, 10th ed.

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Polio Vaccine, Inactivated (002060)

CATEGORIES:

Indications: Immunization, poliomyelitis

Pregnancy Category C

WHO Formulary

FDA Approval Pre 1982

FDA DRUG CLASS: Vaccines/Antisera

BRAND NAMES: Imovax Polio (Finland, Hong-Kong, Israel); Ipol (US); Polio Salk "Sero" (Austria); Poliovax (US); (International brand names outside U.S. in italics)

DESCRIPTION:

Poliovirus Vaccine Inactivated, produced by Pasteur Merieux Serums & Vaccins S.A., is a sterile suspension of three types of poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). The viruses are grown in cultures of VERO cells, a continuous line of monkey kidney cells, by the microcarrier technique. The viruses are concentrated, purified, and made noninfectious by inactivation with formaldehyde. Each sterile immunizing dose (0.5 ml) of trivalent vaccine is formulated to contain 40 D antigen units of Type 1, 8 D antigen units of Type 2, and 32 D antigen units of Type 3 poliovirus, determined by comparison to a reference preparation. The poliovirus vaccine is dissolved in phosphate buffered saline. Also present are 0.5% of 2-phenoxyethanol and a maximum of 0.02% of formaldehyde per dose as preservatives. Neomycin, streptomycin and polymyxin B are used in vaccine production, and although purification procedures eliminate measurable amounts, less than 5 ng neomycin, 200 ng streptomycin and 25 ng polymyxin B per dose may still be present. The vaccine is clear and colorless and should be administered subcutaneously.

CLINICAL PHARMACOLOGY:

Poliovirus Vaccine Inactivated is a highly purified, inactivated poliovirus vaccine produced by microcarrier culture.1,2 This culture technique and improvements in purification, concentration and standardization of poliovirus antigen have resulted in a more potent and more consistently immunogenic vaccine than the Poliovirus Vaccine Inactivated which was available in the U.S. prior to 1988. These new methods allow for the production of vaccine that induces antibody responses in most children after administering fewer doses3 than with vaccine available prior to 1988.

Studies in developed3 and developing4,5 countries with a similar inactivated poliovirus vaccine produced by the same technology have shown that a direct relationship exists between the antigenic content of the vaccine, the frequency of seroconversion, and resulting antibody titer.

A study in the U.S. was carried out, which involved 219 two-month-old infants who had received three doses of a Poliovirus Vaccine Inactivated manufactured by the same process as Poliovirus Vaccine Inactivated except the cell substrate was primary monkey kidney cells. Seroconversion to all three Types of poliovirus was demonstrated in 99% of these infants after two doses of vaccine. Following a third dose of vaccine at 18 months of age, high titers of neutralizing antibody were present in 99.1% of children to Type 1 and 100% of children to Types 2 and 3 polioviruses.6

Additional studies were carried out in the U.S. with Poliovirus Vaccine Inactivated. Results were reported for 120 infants who received two doses of Poliovirus Vaccine Inactivated at 2 and 4 months of age. Of these 120 children, detectable serum neutralizing antibody was induced after two doses of vaccine in 98.3% (Type 1), 100% (Type 2) and 97.5% (Type 3) of the children. In 83 children receiving three doses at 2, 4, and 12 months of age detectable serum neutralizing antibodies were detected in 97.6% (Type

1) and 100% (Types 2 and 3) of the children.7,8

Poliovirus Vaccine Inactivated reduces pharyngeal excretion of poliovirus.9-12 Field studies in Europe have demonstrated immunity in populations thoroughly immunized with another IPV.13-17 A survey of Swedish children and young adults given a Swedish IPV demonstrated persistence of circulating antibodies for at least 10 years to all three types of poliovirus.13

Paralytic polio has not been reported in association with administration of Poliovirus Vaccine Inactivated. INDICATIONS AND USAGE:

Poliovirus Vaccine Inactivated is indicated for active immunization of infants, children and adults for the prevention of poliomyelitis. Recommendations on the use of live and inactivated poliovirus vaccines are described in the ACIP Recommendations18,19 and the 1988 American Academy of Pediatrics Red Book.20

INFANTS, CHILDREN, AND ADOLESCENTS

General Recommendations: It is recommended that all infants, unimmunized children and adolescents not previously immunized be vaccinated routinely against paralytic poliomyelitis.18 Poliovirus Vaccine Inactivated should be offered to individuals who have refused Poliovirus Vaccine Live Oral Trivalent (OPV) or in whom OPV is contraindicated. Parents should be adequately informed of the risks and benefits of both inactivated and oral polio vaccines so that they can make an informed choice (Report of An Evaluation of Poliomyelitis Vaccine Policy Options, Institute of Medicine, National Academy of Sciences, Washington, D.C., 1988).

OPV should not be used in households with immunodeficient individuals because OPV is excreted in the stool by healthy vaccinees and can infect an immunocompromised household member, which may result in paralytic disease. In a household with an immunocompromised member, only Poliovirus Vaccine Inactivated should be used for all those requiring poliovirus immunization.20

Children Incompletely Immunized: Children of all ages should have their immunization status reviewed and be considered for supplemental immunization as follows for adults. Time intervals between doses longer than those recommended for routine primary immunization do not necessitate additional doses as long as a final total of four doses is reached (See DOSAGE AND ADMINISTRATION.)

Previous clinical poliomyelitis (usually due to only a single poliovirus

type) or incomplete immunization with OPV are not contraindications to completing the primary series of immunization with Poliovirus Vaccine Inactivated.

Adults

General Recommendations: Routine primary poliovirus vaccination of adults (generally those 18 years of age or older) residing in the U.S. is not recommended. Adults who have increased risk of exposure to either vaccine or wild poliovirus and have not been adequately immunized should receive polio vaccination in accordance with the schedule given in the DOSAGE AND ADMINISTRATION section.16

The following categories of adults run an increased risk of exposure to wild polioviruses:19

[Image] Travelers to regions or countries where poliomyelitis is endemic or epidemic.

[Image] Health care workers in close contact with patients who may be excreting polioviruses.

[Image] Laboratory workers handling specimens that may contain polioviruses.

[Image] Members of communities or specific population groups with disease caused by wild polioviruses.

[Image] Incompletely vaccinated or unvaccinated adults in a household (or other close contacts) with children given OPV provided that the immunization of the child can be assured and not unduly delayed. The adult should be informed of the small OPV related risk to the contact.

Immunodeficiency And Altered Immune Status

Patients with recognized immunodeficiency are at greater risk of developing paralysis when exposed to live poliovirus than persons with a normal immune system. Under no circumstances should oral live poliovirus vaccine be used in such patients or introduced into a household where such a patient resides.18

Poliovirus Vaccine Inactivated should be used in all patients with immunodeficiency diseases and members of such patients' households when vaccination of such persons is indicated. This includes patients with asymptomatic HIV infection, AIDS or AIDS Related Complex, severe combined immunodeficiency, hypogammaglobulinemia, or agammaglobulinemia; altered immune states due to diseases such as leukemia, lymphoma, or generalized malignancy; or an immune system compromised by treatment with corticosteroids, alkylating drugs, antimetabolites or radiation. Patients with an altered immune state may or may not develop a protective response against paralytic poliomyelitis after administration of Poliovirus Vaccine Inactivated.21

CONTRAINDICATIONS:

Poliovirus Vaccine Inactivated is contraindicated in persons with a history of hypersensitivity to any component of the vaccine, including neomycin, streptomycin and polymyxin B.

If anaphylaxis or anaphylactic shock occurs within 24 hours of administration of a dose of vaccine, no further doses should be given.

Vaccination of persons with any acute, febrile illness should be deferred until after recovery; however, minor illnesses such as mild upper respiratory infections are not in themselves reasons for postponing vaccine administration.

WARNINGS:

Neomycin, streptomycin, and polymyxin B are used in the production of this vaccine. Although purification procedures eliminate measurable amounts of these substances, traces may be present (see DESCRIPTION) and allergic reactions may occur in persons sensitive to these substances.

PRECAUTIONS:

General: Before injection of the vaccine, the physician should carefully review the recommendations for product use and the patient's medical history including possible hypersensitivities and side effects that may have occurred following previous doses of the vaccine.

Epinephrine hydrochloride (1:1000) and other appropriate agents should be available to control immediate allergic reactions.

Concerns have been raised that stimulation of the immune system of a patient with HIV infection by immunization with inactivated vaccines might cause deterioration in immunologic function. However, such effects have not been noted thus far among children with AIDS or among immunosuppressed individuals after immunizations with inactivated vaccines. The potential benefits of immunization of these children outweigh the undocumented risk of such adverse events.18

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long term studies in animals to evaluate carcinogenic potential or impairment of fertility have not been conducted.

Pregnancy: REPRODUCTIVE STUDIES--PREGNANCY CATEGORY C: Animal reproduction studies have not been conducted with Poliovirus Vaccine Inactivated. It is also not known whether Poliovirus Vaccine Inactivated can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Poliovirus Vaccine Inactivated should be given to a pregnant woman only if clearly needed.

Pediatric Use: Safety and efficacy of Poliovirus Vaccine Inactivated have been shown in children 6 weeks of age and older.6,8 (See DOSAGE AND

ADMINISTRATION.)

DRUG INTERACTIONS:

There are no known interactions of Poliovirus Vaccine Inactivated with drugs or foods. Simultaneous administration of other parenteral vaccines is not contraindicated.

ADVERSE REACTIONS:

In earlier studies with the vaccine grown in primary monkey kidney cells, transient local reactions at the site of injection were observed during a clinical trial.6 Erythema, induration and pain occurred in 3.2%, 1% and 13%, respectively, of vaccinees within 48 hours post-vaccination. Temperatures [Image] 39°C ([Image] 102°F) were reported in up to 38% of vaccinees. Other symptoms noted included sleepiness, fussiness, crying, decreased appetite, and spitting up of feedings. Because Poliovirus Vaccine Inactivated was given in a different site but concurrently with Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP), systemic reactions could not be attributed to a specific vaccine. However, these systemic reactions were comparable in frequency and severity to that reported for DTP given without IPV.

In another study using Poliovirus Vaccine Inactivated in the United States, there were no significant local or systemic reactions following injection of the vaccine. There were 7% (6/86), 12% (8/65) and 4% (2/45) of children with temperatures over 100.6°F, following the first, second and third doses respectively. Most of the children received DTP at the same time as IPV and therefore it was not possible to attribute reactions to a particular vaccine; however, such reactions were not significantly different than when DTP is given alone.

Although no causal relationship between Poliovirus Vaccine Inactivated and Guillain-Barre Syndrome (GBS) has been established,22 GBS has been temporally related to administration of another Poliovirus Vaccine Inactivated.

NOTE: The National Childhood Vaccine Injury Act of 1986 requires the keeping of certain records and the reporting of certain events occurring after the administration of vaccine, including the occurrence of any contraindicating reaction. Poliovirus Vaccines are listed vaccines covered by this Act and health care providers should ensure that they comply with the terms thereof.23

DOSAGE AND ADMINISTRATION:

Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration. If these conditions exist, vaccine should not be administered.

After preparation of the injection site, immediately administer the vaccine subcutaneously. In infants and small children, the mid-lateral aspect of the thigh is the preferred site. In adults the vaccine should be administered in the deltoid area.

Care should be taken to avoid administering the injection into or near blood vessels and nerves. After aspiration, if blood or any suspicious discoloration appears in the syringe, do not inject but discard contents and repeat procedures using a new dose of vaccine administered at a different site. DO NOT ADMINISTER VACCINE INTRAVENOUSLY.

Children

Primary Immunization: A primary series of Poliovirus Vaccine Inactivated consists of three 0.5 ml doses administered subcutaneously. The interval between the first two doses should be at least four weeks, but preferably eight weeks. The first two doses are usually administered with DTP immunization and are given at two and four months of age. The third dose should follow at least six months but preferably 12 months after the second dose. It may be desirable to administer this dose with MMR and other vaccines, but at a different site, in children 15-18 months of age. All children who received a primary series of Poliovirus Vaccine Inactivated, or a combination of IPV and OPV, should be given a booster dose of OPV or IPV before entering school, unless the final (third dose) of the primary series was administered on or after the fourth birthday.18

The need to routinely administer additional doses is unknown at this time.18

A final total of four doses is necessary to complete a series of primary and booster doses. Children and adolescents with a previously incomplete series of IPV should receive sufficient additional doses to reach this number.

Adults

Unvaccinated Adults: For unvaccinated adults at increased risk of exposure to poliovirus, a primary series of Poliovirus Vaccine Inactivated is recommended. While the responses of adults to primary series have not been studied, the recommended schedule for adults is two doses given at a 1 to 2 month interval and a third dose given 6 to 12 months later. If less than 3 months but more than 2 months are available before protection is needed, 3 doses of Poliovirus Vaccine Inactivated should be given at least 1 month apart. Likewise, if only 1 or 2 months are available, two doses of Poliovirus Vaccine Inactivated should be given at least 1 month apart. If less than 1 month is available, a single dose of either OPV or IPV is recommended.

Incompletely Vaccinated Adults: Adults who are at an increased risk of exposure to poliovirus and who have had at least one dose of OPV, fewer than 3 doses of conventional IPV or a combination of conventional IPV or OPV totalling fewer than 3 doses should receive at least 1 dose of OPV or Poliovirus Vaccine Inactivated. Additional doses needed to complete a primary series should be given if time permits.

Completely Vaccinated Adults: Adults who are at an increased risk of exposure to poliovirus and who have previously completed a primary series with one or a combination of polio vaccines can be given a dose of either OPV or IPV.19

Storage: The vaccine is stable if stored in the refrigerator between 2°C and 8°C (35°F to 46°F). The vaccine must not be frozen.

REFERENCES:

1. van Wezel, A.L., et al: Inactivated poliovirus vaccine: Current production methods and new developments. Rev Infect Dis 6 (Suppl 2): S335-S340, 1984 2. Montagnon, B.J., et al: Industrial scale production of inactivated poliovirus vaccine prepared by culture of Vero cells on microcarrier. Rev Infect Dis 6 (Suppl 2): S341-S344, 1984 3. Salk, J., et al: Antigen content of inactivated poliovirus vaccine for use in a one- or two-dose regimen. Ann Clin Res 14: 204-212, 1982 4. Salk, J., et al: Killed poliovirus antigen titration in humans. Develop Biol Standard 41: 110-132, 1978 5. Salk, J., et al: Theoretical and practical considerations in the application of killed poliovirus vaccine for the control of paralytic poliomyelitis. Develop Biol Standard 47: 181-198, 1981 6. McBean, A.M., et al: Serologic response to oral polio vaccine and enhanced-potency inactivated polio vaccines. Am J Epidemiol 128: 615-628, 1988 7. Unpublished data available from Pasteur Merieux Serums & Vaccins S.A. 8. Faden, H., et al: Comparative evaluation of immunization with live attenuated and enhanced potency inactivated trivalent poliovirus vaccines in childhood: Systemic and local immune responses. J Infect Dis 162: 1291-1297, 1990 9. Marine, W.M., et al: Limitation of fecal and pharyngeal poliovirus excretion in Salk-vaccinated children. A family study during a Type 1 poliomyelitis epidemic. Amer J Hyg 76: 173-175, 1962 10. Bottiger, M., et al: Vaccination with attenuated Type 1 poliovirus, the Chat strain. II. Transmission of virus in relation to age. Acta Paed Scand

55: 416-421, 1966

11. Dick, G.W.A., et al: Vaccination against poliomyelitis with live virus vaccines. Effect of previous Salk vaccination on virus excretion. Brit Med J 2: 266-269, 1961 12. Wehrle, P.F., et al: Transmission of poliovirus; III. Prevalence of polioviruses in pharyngeal secretions of infected household contacts of patients with clinical disease. Pediatrics 27: 762-764, 1961 13. Bottiger, M: Long-term immunity following vaccination with killed poliovirus vaccine in Sweden, a country with no circulating poliovirus. Rev Infect Dis 6 (Suppl 2): S545-551, 1984 14. Chin, T.D.Y.: Immunity induced by inactivated poliovirus vaccine and excretion of virus. Rev Infect Dis 6 (Suppl 2): S369-S370, 1984 15. Salk, D.: Herd effect and virus eradication with use of killed poliovirus vaccine. Develop Biol Standard 47: 247-255, 1981 16. Bijerk, H.: Surveillance and control or poliomyelitis in the Netherlands. Rev Infect Dis 6 (Suppl 2): S451-S456, 1984 17. Lapinleimu, K.: Elimination or poliomyelitis in Finland. Rev Infect Dis 6 (Suppl 2): S457-S460, 1984 18. Immunization Practices Advisory Committee (ACIP), Poliomyelitis

Prevention: Enhanced-Potency Inactivated Poliomyelitis Vaccine Supplementary Statement. MMWR 36: 795-798, 1987 19. ACIP: Poliomyelitis Prevention, MMWR 31: 22-26 and 31-34, 1982 20. Report of the Committee on Infectious Diseases, American Academy of Pediatrics, 21st ed: 334-342, 1988 21. ACIP: Immunization of children infected with human T-lymphotropic virus type III/lymphadenopathy-associated virus. MMWR 35: 595-606, 1986 22. WHO: Weekly Epidemiology Record 54: 82-83, 1979 23. National Childhood Vaccine Injury Act: Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37: 197-200, 1988

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