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DRUGS & SUPPLEMENTS
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Polioral
How old is patient? |
Polioral uses
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Dosage and administration
- How supplied
- References
INDICATIONS AND USAGE
Polioral vaccine is indicated for active immunization of infants, children, and adults for the prevention of poliomyelitis caused by Polioral Types 1, 2, and 3. (28)
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. (29) Following the eradication of poliomyelitis caused by wild Polioral from the Western Hemisphere (including North and South America) (30), an IPV-only schedule was recommended to eliminate VAPP. (7)
All children should receive four doses of IPV at ages 2, 4, 6 to 18 months, and 4 to 6 years. OPV is no longer available in the US and is not recommended for routine immunization. (7)
Previous clinical poliomyelitis (usually due to only a single Polioral type) or incomplete immunization with OPV are not contraindications to completing the primary series of immunization with Polioral vaccine.
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 section).
ADULTS
General Recommendations
Routine primary Polioral vaccination of adults residing in the US is not recommended. Unimmunized adults who are potentially exposed to wild Polioral and have not been adequately immunized should receive polio vaccination in accordance with the schedule given in the DOSAGE AND ADMINISTRATION section. (28)
Persons with previous wild Polioral disease who are incompletely immunized or unimmunized should be given additional doses of Polioral vaccine if they fall into one or more categories listed.
The following categories of adults are at an increased risk of exposure to wild polioviruses: (28) (31)
- Travelers to regions or countries where poliomyelitis is endemic or epidemic.
- Healthcare workers in close contact with patients who may be excreting polioviruses.
- Laboratory workers handling specimens that may contain polioviruses.
- Members of communities or specific population groups with disease caused by wild polioviruses.
IMMUNODEFICIENCY AND ALTERED IMMUNE STATUS
Polioral vaccine 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. Immunogenicity of Polioral vaccine in individuals receiving immunoglobulin could be impaired, and patients with an altered immune state may or may not develop a protective response against paralytic poliomyelitis after administration of IPV. (32)
As with any vaccine, vaccination with Polioral vaccine may not protect 100% of individuals.
Use with other vaccines: refer to DOSAGE AND ADMINISTRATION section for this information.
CONTRAINDICATIONS
Polioral vaccine is contraindicated in persons with a history of hypersensitivity to any component of the vaccine, including 2-phenoxyethanol, formaldehyde, neomycin, streptomycin, and polymyxin B.
No further doses should be given if anaphylaxis or anaphylactic shock occurs within 24 hours of administration of one dose of vaccine.
Vaccination of persons with an acute, febrile illness should be deferred until after recovery; however, minor illness, such as mild upper respiratory infection, with or without low grade fever, are not reasons for postponing vaccine administration.
WARNINGS
Neomycin, streptomycin, polymyxin B, 2-phenoxyethanol, and formaldehyde are used in the production of this vaccine. Although purification procedures eliminate measurable amounts of these substances, traces may be present (see DESCRIPTION section), and allergic reactions may occur in persons sensitive to these substances (see CONTRAINDICATIONS section).
Systemic adverse reactions reported in infants receiving IPV concomitantly at separate sites or combined with DTP have been similar to those associated with administration of DTP alone. (11) Local reactions are usually mild and transient in nature.
Although no causal relationship between Polioral vaccine and Guillain-Barré Syndrome (GBS) has been established, (28) GBS has been temporally related to administration of another inactivated Polioral vaccine. Deaths have been reported in temporal association with the administration of IPV (see ADVERSE REACTIONS section).
PRECAUTIONS
GENERAL
Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient's history with respect to possible sensitivity to the vaccine or similar vaccines.
Healthcare providers should question the patient, parent or guardian about reactions to a previous dose of this product, or similar product.
Epinephrine injection and other appropriate agents should be available to control immediate allergic reactions.
Healthcare providers should obtain the previous immunization history of the vaccinee, and inquire about the current health status of the vaccinee.
Immunodeficient patients or patients under immunosuppressive therapy may not develop a protective immune response against paralytic poliomyelitis after administration of IPV.
Administration of Polioral vaccine is not contraindicated in individuals infected with HIV. (33) (34) (35)
Special care should be taken to ensure that the injection does not enter a blood vessel.
INFORMATION FOR PATIENTS
Patients, parents, or guardians should be instructed to report any serious adverse reactions to their healthcare provider.
The healthcare provider should inform the patient, parent, or guardian of the benefits and risks of the vaccine.
The healthcare provider should inform the patient, parent, or guardian of the importance of completing the immunization series.
The healthcare provider should provide the Vaccine Information Statements (VISs) which are required to be given with each immunization.
DRUG INTERACTIONS
There are no known interactions of Polioral vaccine with drugs or foods. Concomitant administration of other parenteral vaccines, with separate syringes at separate sites, is not contraindicated. The first two doses of Polioral vaccine may be administered at separate sites using separate syringes concomitantly with DTaP, acellular pertussis, Haemophilus influenzae type b, and hepatitis B vaccines. From historical data on the antibody responses to diphtheria, tetanus, acellular pertussis, Hib, or hepatitis B vaccines used concomitantly or in combination with Polioral vaccine, no interferences have been observed on the immunological end points accepted for clinical protection. (11) (16) (36) (See DOSAGE AND ADMINISTRATION section.)
If Polioral vaccine has been administered to persons receiving immunosuppressive therapy, an adequate immunologic response may not be obtained. (See PRECAUTIONS – GENERAL section.)
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
Long-term studies in animals to evaluate carcinogenic potential or impairment of fertility have not been conducted.
PREGNANCY
Animal reproduction studies have not been conducted with Polioral vaccine. It is also not known whether Polioral vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Polioral vaccine should be given to a pregnant woman only if clearly needed.
NURSING MOTHERS
It is not known whether Polioral vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Polioral vaccine is administered to a nursing woman.
PEDIATRIC USE
SAFETY AND EFFECTIVENESS OF Polioral VACCINE IN INFANTS BELOW SIX WEEKS OF AGE HAVE NOT BEEN ESTABLISHED. (12) (20) (See DOSAGE AND ADMINISTRATION section.)
In the US, infants receiving two doses of IPV at 2 and 4 months of age, the seroprevalence to all three types of Polioral was demonstrated in 95% to 100% of these infants after two doses of vaccine. (12) (13)
ADVERSE REACTIONS
Body System As A Whole
In earlier studies with the vaccine grown in primary monkey kidney cells, transient local reactions at the site of injection were observed. Erythema, induration and pain occurred in 3.2%, 1% and 13%, respectively, of vaccinees within 48 hours post-vaccination. Temperatures of ≥39°C (≥102°F) were reported in 38% of vaccinees. Other symptoms included irritability, sleepiness, fussiness, and crying. Because IPV was given in a different site but concurrently with Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP), these 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 alone without IPV. (12) Although no causal relationship has been established, deaths have occurred in temporal association after vaccination of infants with IPV. (37)
Four additional US studies using Polioral vaccine in more than 1,300 infants, (12) between 2 to 18 months of age administered with DTP at the same time at separate sites or combined have demonstrated that local and systemic reactions were similar when DTP was given alone.
| AGE AT IMMUNIZATION | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| REACTION | 2 Months (n=211) | 4 Months (n=206) | 18 Months (n=74) | ||||||
| 6 Hrs. | 24 Hrs. | 48 Hrs. | 6 Hrs. | 24 Hrs. | 48 Hrs. | 6 Hrs. | 24 Hrs. | 48 Hrs. | |
| Local, Polioral vaccine alone | |||||||||
| Erythema >1" | 0.5% | 0.5% | 0.5% | 1.0% | 0.0% | 0.0% | 1.4% | 0.0% | 0.0% |
| Swelling | 11.4% | 5.7% | 0.9% | 11.2% | 4.9% | 1.9% | 2.7% | 0.0% | 0.0% |
| Tenderness | 29.4% | 8.5% | 2.8% | 22.8% | 4.4% | 1.0% | 13.5% | 4.1% | 0.0% |
| Systemic | |||||||||
| Fever >102.2°F | 1.0% | 0.5% | 0.5% | 2.0% | 0.5% | 0.0% | 0.0% | 0.0% | 4.2% |
| Irritability | 64.5% | 24.6% | 17.5% | 49.5% | 25.7% | 11.7% | 14.7% | 6.7% | 8.0% |
| Tiredness | 60.7% | 31.8% | 7.1% | 38.8% | 18.4% | 6.3% | 9.3% | 5.3% | 4.0% |
| Anorexia | 16.6% | 8.1% | 4.3% | 6.3% | 4.4% | 2.4% | 2.7% | 1.3% | 2.7% |
| Vomiting | 1.9% | 2.8% | 2.8% | 1.9% | 1.5% | 1.0% | 1.3% | 1.3% | 0.0% |
| Persistent Crying | Percentage of infants within 72 hours after immunization was 0.0% after dose one, 1.4% after dose two, and 0.0% after dose three. | ||||||||
Digestive System
Anorexia and vomiting occurred with frequencies not significantly different as reported when DTP was given alone without IPV or OPV. (12)
Nervous System
Although no causal relationship between Polioral vaccine and GBS has been established, GBS has been temporally related to administration of another inactivated Polioral vaccine.
Post-marketing Experience
The following adverse events have been identified during postapproval use of Polioral vaccine. Because these events are reported voluntarily from a population of uncertain size, it may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting or strength of evidence for a causal relationship.
- Blood and lymphatic system disorders: lymphadenopathy
- General disorders and administration site conditions: agitation, injection site reaction including injection site rash and mass
- Immune system disorders: type I hypersensitivity including allergic reaction, anaphylactic reaction, and anaphylactic shock
- Musculoskeletal and connective tissue disorders: arthralgia, myalgia
- Nervous system disorders: convulsion, febrile convulsion, headache, paresthesia, and somnolence
- Skin and subcutaneous tissue disorders: rash, urticaria
Reporting of Adverse Events
The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other healthcare providers who administer vaccines to maintain permanent vaccination records and to report occurrences of certain adverse events to the US Department of Health and Human Services. Reportable events include those listed in the Act for each vaccine and events specified in the package insert as contraindications to further doses of that vaccine. (38) (39) (40)
Reporting by parents or guardians of all adverse events after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by healthcare providers to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967. (38) (39) (40)
Healthcare providers also should report these events to the Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.
DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The vial and its packaging should be inspected prior to use for evidence of leakage or a faulty seal. If evidence of such defects are observed, the vaccine should not be used. Do not remove the vial stopper or the metal seal holding it in place.
After preparation of the injection site, using a suitable sterile needle and aseptic technique, immediately administer Polioral vaccine intramuscularly or subcutaneously. In infants and small children, the mid-lateral aspect of the thigh is the preferred site. In older children and adults, Polioral vaccine should be administered intramuscularly or subcutaneously in the deltoid area. Polioral should not be combined through reconstitution or mixed with any other vaccine.
To help avoid HIV, HBV (Hepatitis), and other infectious diseases due to accidental needlesticks, contaminated needles should not be recapped or removed, unless there is no alternative or that such action is required by a specific medical procedure.
Care should be taken to avoid administering the injection into or near blood vessels and nerves. 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
The primary series of Polioral vaccine consists of three 0.5 mL doses administered intramuscularly or subcutaneously, preferably eight or more weeks apart and usually at ages 2, 4, and 6 to 18 months. Under no circumstances should the vaccine be given more frequently than four weeks apart. The first immunization may be administered as early as six weeks of age. For this series, a booster dose of Polioral vaccine is administered at 4 to 6 years of age. (41)
Use with Other Vaccines
From historical data on the antibody responses to diphtheria, tetanus, whole-cell or acellular pertussis, Hib, or hepatitis B vaccines used concomitantly with Polioral vaccine, no interferences have been observed on the immunological end points accepted for clinical protection. (16) (36) (See DRUG INTERACTIONS section.)
If the third dose of Polioral vaccine is given between 12 to 18 months of age, it may be desirable to administer this dose with Measles, Mumps, and Rubella (MMR) vaccine and/or other vaccines using separate syringes at separate sites, (28) but no data on the immunological interference between Polioral vaccine and these vaccines exist.
Use in Previously Vaccinated Children
Children and adolescents with a previously incomplete series of polio vaccine should receive sufficient additional doses of Polioral vaccine to complete the series.
Interruption of the recommended schedule with a delay between doses does not interfere with the final immunity. There is no need to start the series over again, regardless of the time elapsed between doses.
The need to routinely administer additional doses is unknown at this time. (28)
Adults
Unvaccinated Adults
A primary series of Polioral vaccine is recommended for unvaccinated adults at increased risk of exposure to Polioral. While the responses of adults to primary series have not been studied, the recommended schedule for adults is two 0.5 mL doses given at a 1 to 2 month interval and a third 0.5 mL dose given 6 to 12 months later. If less than 3 months but more than 2 months are available before protection is needed, three doses of Polioral vaccine should be given at least 1 month apart. Likewise, if only 1 or 2 months are available, two 0.5 mL doses of Polioral vaccine should be given at least 1 month apart. If less than 1 month is available, a single 0.5 mL dose of Polioral vaccine is recommended.
Incompletely Vaccinated Adults
Adults who are at an increased risk of exposure to Polioral and who have had at least one dose of OPV, fewer than three doses of conventional IPV or a combination of conventional IPV or OPV totaling fewer than three doses should receive at least one 0.5 mL dose of Polioral vaccine. Additional doses needed to complete a primary series should be given if time permits. (28)
Completely Vaccinated Adults
Adults who are at an increased risk of exposure to Polioral and who have previously completed a primary series with one or a combination of polio vaccines can be given a 0.5 mL dose of Polioral vaccine.
The preferred injection site of Polioral vaccine for adults is in the deltoid area.
HOW SUPPLIED
Vial containing ten 0.5 mL doses: NDC 49281-860-78. Supplied as package: NDC 49281-860-10.
STORAGE
The vaccine is stable if stored in the refrigerator at 2°C to 8°C (35°F to 46°F). The vaccine must not be frozen.
Protect from light.
REFERENCES
- van Wezel AL, et al. Inactivated Polioral vaccine: Current production methods and new developments. Rev Infect Dis 6 (Suppl 2): S335-S340, 1984.
- Montagnon BJ, et al. Industrial scale production of inactivated Polioral vaccine prepared by culture of Vero cells on microcarrier. Rev Infect Dis 6 (Suppl 2): S341-S344, 1984.
- McBean AM, et al. Serologic response to oral polio vaccine and enhanced-potency inactivated polio vaccines. Am J Epidemiol 128: 615-628, 1988.
- Murdin AD, et al. Inactivated Polioral vaccine: past and present experience. Vaccine 8: 735-746, 1996.
- Sabin AB. Poliomyelitis. In Brande AI, Davis CE, Fierer J (eds) International Textbook of Medicine, Vol II. Infectious Diseases and Medical Microbiology. 2nd ed. Philadelphia, WB Saunders, 1986.
- Prevots DR, et al. Vaccine-associated paralytic poliomyelitis in the United States, l980-1994: current risk and potential impact of a proposed sequential schedule of IPV followed by OPV (Abstract #H90). In: Abstracts of the 36th Interscience Conference on Antimicrobial Agents and Chemotherapy. Washington, DC. American Society for Microbiology, 179, 1996.
- ACIP. Updated Recommendations of the Advisory Committee on Immunization Practices. Poliomyelitis Prevention in the United States. MMWR 49: No. RR-5, 2000.
- Salk J, et al. Antigen content of inactivated Polioral vaccine for use in a one- or two-dose regimen. Ann Clin Res 14: 204-212, 1982.
- Salk J, et al. Killed Polioral antigen titration in humans. Develop Biol Standard 41: 119-132, 1978.
- Salk J, et al. Theoretical and practical considerations in the application of killed Polioral vaccine for the control of paralytic poliomyelitis. Develop Biol Standard 47: 181-198, 1981.
- Unpublished data available from Sanofi Pasteur SA.
- Unpublished data available from Sanofi Pasteur Inc.
- Faden H, et al. Comparative evaluation of immunization with live attenuated and enhanced potency inactivated trivalent Polioral vaccines in childhood: Systemic and local immune responses. J Infect Dis 162: 1291-1297, 1990.
- Vidor E, et al. The place of DTP/eIPV vaccine in routine pædiatric vaccination. Rev Med Virol 4: 261-277, 1994.
- Bottiger M. Long-term immunity following vaccination with killed Polioral vaccine in Sweden, a country with no circulating Polioral. Rev Infect Dis 6 (Suppl 2): S548-S551, 1984.
- Plotkin SA, et al. Inactivated polio vaccine for the United States: a missed vaccination opportunity. Pediatr Infect Dis J 14: 835-839, 1995.
- Marine WM, et al. Limitation of fecal and pharyngeal Polioral excretion in Salk-vaccinated children. A family study during a Type 1 poliomyelitis epidemic. Amer J Hyg 76: 173-195, 1962.
- Bottiger M, et al. Vaccination with attenuated Type 1 Polioral, the Chat strain. II. Transmission of virus in relation to age. Acta Paed Scand 55: 416-421, 1966.
- Dick GWA, et al. Vaccination against poliomyelitis with live virus vaccines. Effect of previous Salk vaccination on virus excretion. Brit Med J 2: 266-269, 1961.
- Wehrle PF, et al. Transmission of Polioral; III. Prevalence of polioviruses in pharyngeal secretions of infected household contacts of patients with clinical disease. Pediatrics 27: 762-764, 1961.
- Adenyi-Jones SC, et al. Systemic and local immune responses to enhanced-potency inactivated Polioral vaccine in premature and term infants. J Pediatr 120: No 5, 686-689, 1992.
- Chin TDY. Immunity induced by inactivated Polioral vaccine and excretion of virus. Rev Infect Dis 6 (Suppl 2): S369-S370, 1984.
- Salk D. Herd effect and virus eradication with use of killed Polioral vaccine. Develop Biol Standard 47: 247-255, 1981.
- Bijerk H. Surveillance and control of poliomyelitis in the Netherlands. Rev Infect Dis 6 (Suppl 2): S451-S456, 1984.
- Lapinleimu K. Elimination of poliomyelitis in Finland. Rev Infect Dis 6 (Suppl 2): S457-S460, 1984.
- Conyn van Spaendonck M, et al. Circulation of Polioral during the poliomyelitis outbreak in the Netherlands in 1992-1993. Amer J Epidemiology 143: 929-935, 1996.
- Strebel PM, et al. Epidemiology of poliomyelitis in the United States one decade after the last reported case of indigenous wild virus associated disease. Clin Infect Dis 14: 568-579, 1992.
- ACIP. Poliomyelitis prevention in the United States: introduction of a sequential vaccination schedule of Inactivated Polioral Vaccine followed by Oral Polioral Vaccine. MMWR 46: No. RR-3, 1997.
- WHO. Weekly Epidemiology Record 54: 82-83, 1979.
- Certification of poliomyelitis eradication - the Americas, 1994. MMWR 43: 720-722, 1994.
- Institute of Medicine. An evaluation of poliomyelitis vaccine poliomyelitis vaccine policy options. Washington, DC. National Academy of Sciences, 1988.
- ACIP. Immunization of children infected with human T-lymphotropic virus type III/lymphadenopathy-associated virus. MMWR 35: 595-606, 1986.
- ACIP. General recommendations on immunization. MMWR 43: No. RR-1, 1994.
- Barbi M, et al. Antibody response to inactivated polio vaccine (eIPV) in children born to HIV positive mothers. Eur J Epidemiol 8: 211-216, 1992.
- Varon D, et al. Response to hemophilic patients to Polioral vaccination: Correlation with HIV serology and with immunological parameters. J Med Virol 40: 91-95, 1993.
- Vidor E, et al. Fifteen-years experience with vero-produced enhanced potency inactivated Polioral vaccine (eIPV). Ped Infect Dis J, 312-322, 1997.
- Stratton, R. et al. Adverse Events Associated with Childhood Vaccines. Polio Vaccines. National Academy Press, 295-299, 1994.
- CDC. Vaccine Adverse Event Reporting System - United States. MMWR 39: 730-733, 1990.
- CDC. National Childhood Vaccine Injury Act. Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37: 197-200, 1988.
- Food & Drug Administration. New Reporting Requirements for Vaccine Adverse Events. FDA Drug Bull 18 (2), 16-18, 1988.
- Recommended childhood immunization schedule - United States, 1999. MMWR 48: 12-16, 1999.
Product Information as of August 2015
Manufactured by:
Sanofi Pasteur SA
Marcy L'Etoile France
US Govt License #1724
Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
1-800-VACCINE (1-800-822-2463)
969640
10 DOSES
IPV
Polioral Vaccine
Inactivated - Polioral ®
Dosage: 0.5 mL IM or SC.
See enclosed package insert.
Store at 2° to 8°C (35° to 46°F).
DO NOT FREEZE.
Rx only
US Govt Lic #1724
Mf by: Sanofi Pasteur SA,
Marcy L'Etoile France
Dist by: Sanofi Pasteur Inc.
NDC 49281-860-78
Polioral pharmaceutical active ingredients containing related brand and generic drugs:
Polioral available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.