Poliovirus Vaccine (Systemic)

This monograph includes information on the following:

1) Poliovirus Vaccine Inactivated * 
2) Poliovirus Vaccine Inactivated Enhanced Potency
3) Poliovirus Vaccine Live Oral

VA CLASSIFICATION
Primary: IM100


Note: The Centers for Disease Control and Prevention (CDC), in collaboration with state and local health departments, conducts national surveillance for poliomyelitis {01}. Therefore, suspected cases of poliomyelitis should be reported immediately to local or state health departments {01}.
The National Childhood Vaccine Injury Act of 1986 requires health care providers to report serious adverse events following poliovirus vaccination {01} {15}. The events that must be reported are detailed in the Reportable Events Table within this Act, and include paralytic poliomyelitis and any acute complications or sequelae of paralytic poliomyelitis {01}.
All cases of suspected or confirmed side/adverse effects following the administration of a poliovirus vaccine should be reported to the U.S. Department of Health and Human Services" Vaccine Adverse Events Reporting System (VAERS) {01} {15}.

Commonly used brand name(s): Ipol3; Orimune1.

Other commonly used names are:
eIPV — Poliovirus Vaccine Inactivated Enhanced Potency
; IPV —Poliovirus Vaccine Inactivated
; N-IPV —Poliovirus Vaccine Inactivated Enhanced Potency
; OPV —Poliovirus Vaccine Live Oral
; Sabin vaccine —Poliovirus Vaccine Live Oral
; Salk vaccine — Poliovirus Vaccine Inactivated
; TOPV —Poliovirus Vaccine Live Oral

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

*Not commercially available in the U.S.

Not commercially available in Canada.



Category:


Immunizing agent (active)—

Indications

General considerations
Poliomyelitis, which occurs worldwide, is caused by poliovirus types 1, 2, and 3 {01} {25}. In countries where poliovirus is still endemic, paralytic disease is most often caused by poliovirus type 1, less frequently by poliovirus type 3, and least frequently by poliovirus type 2 {01} {25}. The virus is transmitted from person to person primarily by direct fecal-oral contact; however, it also can be transmitted by indirect contact with infectious saliva or feces or by contaminated sewage or water {01} {25}.

Since the introduction of poliovirus vaccines, poliomyelitis control has been achieved in the Americas {01} {02} {26}. The last reported case in the U.S. of indigenously acquired poliomyelitis caused by poliovirus was in 1979 {02}. No cases have occurred in the western hemisphere since August 1991 {02}. These and other findings from national surveillance in countries of the Americas led to the certification in 1994 by an international commission that the wild-type poliovirus transmission has been interrupted in the Americas, thus achieving a goal established by the Pan American Health Organization in 1985 {02} {31}.

However, these countries can remain free of poliomyelitis only by reducing or eliminating the risk for poliovirus importation {01} {26}. Imported wild-type polioviruses have been associated with outbreaks in Gambia, Oman, Malaysia, Namibia, the Netherlands, Jordan, and Taiwan {14} {26}. To prevent recurrent importation, the best long-term solution is to eradicate wild-type poliovirus reservoirs in polio-endemic countries that are major exporters of wild-type polioviruses {14}.

Experience in Canada illustrates the continuing potential for importation of wild-type poliovirus into the U.S. until global eradication is achieved {01}. In 1993 and 1996, health officials in Canada isolated wild-type poliovirus in stool samples of Canadian residents {01}. The strain isolated in 1993 was linked epidemiologically and by genomic sequencing to the 1992 poliomyelitis outbreak in the Netherlands {01}.

In 1988 the World Health Assembly, the governing body of the World Health Organization (WHO), adopted the goal of global poliomyelitis eradication by the year 2000 {01} {04} {05} {06} {25} {28}. The goal of poliovirus eradication initiative (PEI) is to eliminate the circulation of wild-type poliovirus {24}. PEI has reduced the number of reported poliomyelitis cases worldwide by more than 80%, and worldwide eradication of the disease by the year 2000 appears feasible {01} {02} {05} {24}.

To achieve the global eradication of poliomyelitis, the WHO has recommended the following four major strategies:    • High routine immunization coverage {06} {07} {16} {18} {28} {33}. Countries should aim to vaccinate at least 90% of infants against polio by 1 year of age through routine immunization services {06} {16}. Infants should receive poliovirus vaccine live oral (OPV) at birth and at 6, 10, and 14 weeks of age for a total of four doses {06} {28}. High levels of routine immunization coverage will reduce incidence of polio to low levels and set the stage for eradication {06}. Until global eradication is achieved, polio-free countries must maintain high levels of immunization coverage to protect themselves against importation of wild poliovirus {06}.
   • National immunization days (NIDs) {06} {07} {16} {18} {23} {27} {28} {31}. Vaccination strategies for poliomyelitis control in regions other than the Americas have consisted primarily of routine immunization {17}. However, routine immunization alone is unlikely to be sufficient to interrupt wild-type poliovirus transmission in most tropical and subtropical regions {17}. Therefore, mass immunization campaigns called NIDs are necessary to stop wild-type poliovirus transmission in these regions {06} {17}. The WHO recommends that all children younger than 5 years of age be immunized, regardless of prior immunization status {06} {16} {23}. Two rounds of immunization are conducted, usually 4 to 6 weeks apart {06} {23}. Each round should be conducted in a short period of time {06}. Some countries may be able to complete a round in 1 or 2 days, but in others a week may be required {06}. To decrease operational difficulties and produce the maximum effect from the dose administered, NIDs should be conducted during the cool, dry season {06}. Population immunity resulting from NIDs appears to be superior to that produced by routine immunization, probably because of passive spread of vaccine virus and seroconversion during the season for low levels of enterovirus transmission {06}. Interrupting transmission is easier when environmental factors inhibit spread of wild-type poliovirus and chains of transmission are few {06}.
   • Acute flaccid paralysis (AFP) surveillance {06} {07} {16} {18} {31} {32}. The purpose of AFP surveillance is to show convincingly that if there were any polio cases occurring, they would be detected {34}. Eradication of wild-type poliovirus requires that sensitive surveillance systems capable of identifying cases of polio be in place in every country {06}. Data from these surveillance systems also will be needed to certify eradication {06}. The asymmetric AFP of poliomyelitis typically caused by wild-type poliovirus can also be caused by enteroviruses other than poliovirus, notably enterovirus 71, as well as polio vaccine virus {06}. Experience has also shown that on occasion, atypical presentations of poliomyelitis may be mistaken clinically for Guillain-Barré syndrome (GBS), transverse myelitis, traumatic neuritis, or other paralytic conditions {06}. Since there are no absolute criteria that will permit polio to be identified on a clinical basis, the WHO recommends laboratory-based AFP surveillance for the purpose of polio eradication {06}. AFP surveillance requires immediate reporting of all cases of AFP in children younger than 15 years of age {06}. Cases are investigated rapidly; clinical and epidemiologic information and two stool samples are collected {06}. The stool samples must be transported under refrigeration to a laboratory of certified competence that is part of the WHO global polio laboratory network {06} {32}. Each specimen is then tested using uniform techniques and standardized reagents {06}. Any poliovirus isolated must be characterized to determine whether it is wild-type or of a vaccine strain {06}. In the advanced stages of eradication, stools from contacts of cases may also be tested {06}. Countries with adequate surveillance systems should find at least one case of AFP each year for every 100,000 children younger than 15 years of age {06}.
   • Mopping up {06} {07} {16} {18} {33}. Successful NIDs will reduce poliovirus transmission to a few final chains of transmission, typically persisting in densely populated areas where inadequate health services yield both low routine immunization coverage and poor performance during NIDs {06}. Surveillance data are used to identify these final reservoirs of wild-type virus infection. Intensive localized immunization campaigns, referred to as “mopping up” campaigns, are conducted to interrupt these final chains {06}. Mopping up campaigns immunize all children younger than 5 years of age, regardless of prior immunization status, in the targeted district {06}. Two doses are delivered approximately 1 month apart {06}. To improve immunization coverage and ensure that the most difficult to reach children are immunized, OPV is taken from house to house {06}.


The key to poliovirus eradication and its certification is a global network of high-quality poliovirus laboratories capable of detecting wild-type virus at the time and place where it occurs {21}. A network of laboratories has been established by the WHO to conduct surveillance for wild-type poliovirus and to provide evidence for the certification of poliomyelitis eradication {21} {22}. These laboratories collaborate with national eradication programs in the detection, reporting, clinical investigation, and virologic testing of stool specimens obtained in connection with cases of AFP and, where indicated, from healthy children and the environment {21}. The disappearance of wild-type poliovirus is documented by determining whether isolates are wild-type or vaccine-derived {21} {22}.

The strategies for eradication of poliomyelitis are based on immunization with OPV designed to interrupt transmission of the wild-type poliovirus and on surveillance for every possible case of poliomyelitis {33}. The successes achieved so far are attributable primarily to the widespread use of OPV, the vaccine recommended by the WHO {02} {06}. Continued progress in poliomyelitis elimination clearly necessitates the use of OPV in those countries in which wild-type poliovirus remains or recently has been endemic {02}. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) reaffirmed its support of the eradication program initiated by the WHO and the use of OPV for this purpose {01}.

Paralytic poliomyelitis caused by naturally occurring poliovirus has been eliminated throughout the Americas and in most developed countries by widespread use of poliovirus vaccines {27} {29}. Many countries used OPV for routine immunization because of ease of administration, low cost, and induction of gastrointestinal mucosal immunity that inhibits the circulation of naturally occurring polioviruses, advantages not traditionally associated with poliovirus vaccine inactivated (IPV) or poliovirus vaccine inactivated enhanced potency (eIPV) {29}. However, OPV, rarely, causes vaccine-associated paralytic poliomyelitis (VAPP) among both vaccinees and their contacts {29}.

The risk of exposure to wild poliovirus in the U.S. is very low and, since 1979, nearly all cases of paralytic poliomyelitis in the U.S. have been OPV-associated {02}. Continued use of OPV for primary immunization in the U.S. would likely result in more cases of VAPP {02}. However, routine immunization against poliomyelitis in the U.S. will need to be continued until worldwide certification of the eradication of wild-type poliovirus {01} {02} {26}.

The risk for VAPP caused by OPV is now judged less acceptable in the U.S. {01} The introduction of eIPV has generated interest in sequential immunization with eIPV given before OPV to reduce the risk of VAPP {29}. An expert panel, convened by the Institute of Medicine (IOM) in 1988, recommended consideration of a routine eIPV-OPV schedule when it became feasible to combine eIPV with other pediatric vaccines to facilitate administration {29}. To decrease the occurrence of VAPP, both the ACIP and the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP) recommended a transition policy that will increase the use of eIPV and decrease the use of OPV in the U.S. {01} {02}

Accepted

Poliomyelitis (prophylaxis)—IPV, eIPV, and OPV are indicated for immunization of infants, children, and adolescents up to 18 years of age, and of adults who are at greater risk of exposure to poliovirus than the general population, against poliomyelitis caused by poliovirus types 1, 2, and 3 according to the following recommendations {01} {02} {08} {09} {10} {11}.
—Unless otherwise contraindicated, all infants 6 weeks of age (preferably at 2 months of age) and older, all children, all adolescents up to 18 years of age, and adults at greater risk of exposure to poliovirus than the general population, should be immunized against poliomyelitis {01} {02}.
—Routine poliovirus immunization of adults residing in the U.S. is not necessary {01}. Most adults have a minimal risk for exposure to polioviruses in the U.S. and most are immune as a result of immunization during childhood {01}. Immunization against poliomyelitis is recommended for certain adults who are at greater risk for exposure to polioviruses than the general population, including:    • Travelers to areas or countries where poliomyelitis is endemic or epidemic {01}.
   • Members of communities or specific population groups with disease caused by wild-type polioviruses {01}.
   • Laboratory workers who handle specimens that may contain polioviruses {01}.
   • Health care workers who have close contact with patients whose bodily fluids or excrement may contain wild-type polioviruses {01}.
   • Unvaccinated adults whose children will be receiving OPV {01}.

—For unvaccinated adults, primary immunization with eIPV is recommended {01}, because the risk for VAPP after administration of OPV is higher among adults than among children {01}.
—The WHO recommends the use of OPV, both for use in routine immunization programs and for polio eradication, in countries where the wild-type polioviruses have not been eradicated {06}.

Note: OPV is essential for polio eradication because of its superior ability to induce secretory immunity in the intestines, the primary site of poliovirus replication {06}. OPV is also preferred because it is administered orally, simplifying logistics for and improving the safety of mass campaigns {06}. The low cost of OPV makes it readily available for use in both developing and industrialized countries {06}.
Both the ACIP of the CDC and the Committee on Infectious Diseases of the AAP support the WHO's recommendations on the use of OPV in countries where the wild-type poliovirus has not been eradicated {01} {02}.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Source—
    Produced from a mixture of three types of attenuated polioviruses that have been grown on human diploid (MRC-5) cell cultures or that have been propagated in monkey kidney cell culture {01} {08} {09} {10} {11}.
    Poliovirus vaccine inactivated (IPV) and Poliovirus vaccine inactivated enhanced potency (eIPV): The polioviruses are inactivated with formaldehyde {01} {09} {11}.
    Poliovirus vaccine live oral (OPV): Contains the live, attenuated polioviruses {01} {08} {10}.

Mechanism of action/Effect:

OPV induces intestinal immunity against poliovirus reinfection, which explains its effectiveness in controlling the wild-type poliovirus circulation {02}. In addition, OPV persists in the pharynx for 1 to 2 weeks and is excreted in the feces for several weeks or longer after administration {02}. Consequently, the vaccine virus can be transmitted to contacts and results in their immunization {02}. However, in rare cases, vaccine-associated paralytic poliomyelitis (VAPP) can occur in these contacts as well as in those vaccinated {02}.

Mucosal immunity is induced by IPV and eIPV but to a lesser extent than with OPV {02}. IPV and eIPV inhibit pharyngeal acquisition of poliovirus and, to a lesser extent, intestinal acquisition {02}.


Protective effect

The effectiveness of OPV has been amply demonstrated by its success in the U.S. and in many other areas of the world in preventing poliomyelitis and in interrupting the circulation of wild-type polioviruses {12} {15}. OPV in a three-dose series results in sustained, probably lifelong, protection against paralytic disease caused by each of the three poliovirus serotypes in more than 95% of recipients {02} {12}.

Clinical trials conducted in Canada demonstrated that eIPV could establish long-lasting immunity in vaccinees {12}. More than 98% of vaccinees had seroconverted following the first two doses of the vaccine, at 2 and 4 months of age {12}. The third dose, at 18 months, increased the rate of seroconversion to 99.7%, which declined only slightly, to 99.3%, by the time of the fourth dose at 4 to 6 years of age {12}. The latter dose raised seroconversion rates to 100%, and only the type 3 seroconversion rate declined, to 98%, by 8 to 9 years of age {12}.


Duration of protective effect

The limited data on antibody persistence suggest that immunity is prolonged and perhaps lifelong {02}.


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Adequate and well-controlled studies have not been done in humans {08} {09}. Although no conclusive evidence documents the adverse effects of poliovirus vaccine inactivated (IPV), poliovirus vaccine inactivated enhanced potency (eIPV), and poliovirus vaccine live oral (OPV) in pregnant women and their developing fetuses, vaccination of pregnant women should be avoided {01} {03} {15}. However, OPV may be given to pregnant women who are at substantial risk of imminent exposure to poliovirus infection, such as during international travel {15}. Alternatively, eIPV should be given if immunization can be completed before anticipated exposure {15}.

Studies have not been done in animals {08} {09}.

FDA Pregnancy Category C {08} {09}.

Breast-feeding

Breast-feeding does not interfere with successful immunization against poliomyelitis with IPV, eIPV, or OPV {01}. Although high concentrations of antipoliovirus antibody in the breast milk of some mothers theoretically could interfere with the immunogenicity of OPV in breast-fed infants, no such association has been demonstrated {15}. Infants should be immunized according to the recommended schedule regardless of the infant's mode of feeding {15}.

Women who have not received the recommended immunizations before or during pregnancy may be immunized postpartum regardless of breast-feeding status {15}. If previously unvaccinated or if traveling to a highly endemic area, a breast-feeding mother may be given eIPV {15}.

Pediatrics

Infants up to 6 weeks of age—Use is not recommended in the U.S. and Canada {08} {09} {10} {11}; however, the World Health Organization (WHO) recommends vaccination of infants at birth (see General Considerations) {06} {28}.

Infants and children 6 weeks of age and older—Pediatrics-specific problems that would limit the usefulness of this vaccine in children in this age group are not expected {08} {09} {10} {11}.


Geriatrics


Appropriate studies on the relationship of age to the effects of poliovirus vaccine have not been performed in the geriatric population. However, geriatrics-specific problems that would limit the usefulness of this vaccine in the elderly are not expected.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this vaccine.

Blood products, antibody-containing or
Immune globulin (IG)    (do not appear to interfere with the immune response to OPV; OPV may be administered concurrently with immune globulins if necessary. Since IPV and eIPV are inactivated products, there is no reason to expect interference, and IPV or eIPV can be administered without regard to immune globulins)


» Immunosuppressants such as corticosteroids, alkylating agents, antimetabolites, or
» Radiation therapy    (because normal defense mechanisms are suppressed, the patient's antibody response to any of the poliovirus vaccines may be decreased; in addition, the use of a live virus vaccine, such as OPV, may potentiate the replication of the vaccine virus, possibly causing poliomyelitis infection secondary to the vaccine; therefore, OPV should not be administered to these patients; although a protective immune response in these persons cannot be assured, eIPV may confer some protection {01}. The precaution does not apply to corticosteroids used as replacement therapy, for short-term [less than 2 weeks] systemic therapy, or by other routes of administration that do not cause immunosuppression)

    (where there is a family history of congenital or hereditary immune deficiency conditions, OPV vaccination should not be given until the patient's immune competence is demonstrated; administration of eIPV is recommended)


Live virus vaccines, other    (data are lacking on impairment of antibody responses to rubella, measles, mumps, or OPV when these vaccines are administered on different days within 1 month of each other; however, OPV and measles, mumps, and rubella virus vaccine live [or its individual component vaccines] can be administered at any time before, with, or after each other, if indicated)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Note: There is no long-term carrier state of poliovirus in immunocompetent persons {25}. Once fecal virus excretion has ceased, that person is no longer a source of infection {25}. However, harboring of poliovirus may occur among immunocompromised persons {25}. Vaccine virus was recovered from the cerebrospinal fluid of a patient 1 year after immunization and continually from the stools of two patients 17 and 25 months, respectively, after immunization {25}. In a patient with agammaglobulinemia, replication of vaccine virus persisted for at least 684 days {25}.
If OPV is inadvertently administered to a household contact of an immunodeficient patient, the patient and the recipient of OPV should avoid close contact for approximately 4 to 6 weeks after vaccination {01}. If this is not feasible, rigorous hygiene and hand washing after contact with feces (e.g., after diaper changing) and avoidance of contact with saliva (e.g., sharing food or utensils) may be an acceptable but less effective alternative {01}. Maximum excretion of vaccine virus occurs within 4 weeks after oral vaccination {01}.


Except under special circumstances, this vaccine should not be used when the following medical problems exist:
» Debilitated condition, advanced or
» Illness, moderate or severe, with or without fever    (administration of IPV, eIPV, or OPV should be postponed or avoided; minor illnesses, such as mild upper respiratory infections, do not preclude administration of vaccine {10})


» Diarrhea, persistent or
» Viral infection or
» Vomiting, persistent    (the presence of other viruses, including poliovirus and other enteroviruses, in the intestinal tract may interfere with the replication of OPV and, therefore, with final immunity. Alternatives in the presence of the above illnesses include administration of eIPV or, in the case of persistent diarrhea, the administration of OPV without counting that administration as part of the primary series)


» Immune deficiency conditions, congenital or hereditary, family history of or
» Immune deficiency conditions, primary or acquired    (OPV should not be administered to persons who have immunodeficiency disorders such as severe combined immunodeficiency syndrome, agammaglobulinemia, or hypoagammaglobulinemia, since these persons are at substantially increased risk for vaccine-associated paralytic poliomyelitis [VAPP] {01} {10})

    (OPV should not be administered to persons with altered immune states resulting from malignant diseases such as leukemia, lymphoma, or generalized malignancy {01} {10})

    (OPV should not be administered to persons whose immune systems have been compromised by therapy with corticosteroids, alkylating agents, antimetabolites, or radiation, or by human immunodeficiency virus [HIV] infection {01} {10})

    (OPV should not be used to vaccinate household contacts of immunodeficient patients; eIPV is recommended {01} {10})

    (administration of eIPV to immunodeficient persons is safe; although a protective immune response in these persons cannot be assured, eIPV may confer some protection {01} {10})


» Allergy to neomycin, polymyxin B, or streptomycin    (patients allergic to neomycin, polymyxin B, or streptomycin may be allergic to poliovirus vaccines (eIPV or OPV) because trace amounts of neomycin, polymyxin B, and streptomycin are used in the production of the vaccine to prevent bacterial overgrowth in the viral culture; OPV is contraindicated in persons who previously have had an anaphylactic reaction to OPV or to these antibiotics; since eIPV contains trace amounts of neomycin, polymyxin B, and streptomycin, there is a possibility of hypersensitivity reactions in individuals sensitive to these antibiotics {01})


Risk-benefit should be considered when the following medical problem exists
» Sensitivity to poliovirus vaccine


Side/Adverse Effects

Note: The available evidence indicates that administration of poliovirus vaccine live oral (OPV), poliovirus vaccine inactivated (IPV), or poliovirus vaccine inactivated enhanced potency (eIPV) does not measurably increase the risk for Guillain-Barré syndrome (GBS) {01} {03}. Preliminary findings from two studies in Finland led to a contrary conclusion in a review conducted by the Institute of Medicine (IOM) in 1993 {01} {03}. The investigators in Finland reported an apparent increase in the incidence of GBS that was temporally associated with a mass vaccination campaign during which OPV was administered to children and adults who previously had been vaccinated with IPV {01}. However, after the IOM review was completed, these data were reanalyzed and an observational study was completed in the U.S. {01} {03} Neither the reanalysis nor the newly completed study provided evidence of a causal relationship between OPV administration and GBS {01} {02} {03}.
In rare instances, administration of OPV has been associated with vaccine-associated paralytic poliomyelitis (VAPP) in healthy recipients and their contacts {01}. No procedures are currently available for identifying persons, other than those with immunodeficiency, who are at risk for such adverse reactions {01}. Although this is a rare occurrence, vaccinees or their parents, and their susceptible, close, personal contacts should be informed of the risk {01}.
Between 1980 and 1994, a total of 125 cases of VAPP were reported in the U.S. {02} The rate of VAPP after the first dose of OPV is approximately one case per 760,000 doses of OPV distributed, including recipient and contact cases {02}. The risk of a recipient case after the first dose of OPV is estimated to be one per 1.5 million doses; for a contact case resulting from exposure to a first-dose recipient it is one per 2.2 million doses {02}. For subsequent doses, the risk is substantially lower for both recipients and contacts {02}. The risk for VAPP in immunodeficient persons is 3200- to 6800-fold higher than that for immunologically healthy OPV recipients {02}. The sequential use of eIPV and OPV for primary immunization is recommended to reduce the risk of VAPP by 50% {01} {02}. The rationale for the sequential schedule is that two doses of eIPV induce sufficient humoral immunity in most recipients to prevent VAPP from occurring due to subsequent administration of OPV, thereby inducing optimal intestinal immunity and sustaining humoral immunity {02}.

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
    
Fever over 39 °C (102 °F) —incidence 38% with injection{09}{11}

Incidence rare
    
Anaphylactic reaction {08}{09}{10}{11}(difficulty in breathing or swallowing; hives; itching, especially of soles or palms; reddening of skin, especially around ears; swelling of eyes, face, or inside of nose; unusual tiredness or weakness, sudden and severe)



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Anorexia (loss of appetite)
    
irritability
    
fatigue (tiredness){08}{09}{10}{11}

Incidence less frequent
    
Delayed-type allergic reaction, cell-mediated (itching or skin rash)—with injection{09}{11}
    
redness, soreness, hard lump, tenderness, or pain at injection site —with injection{09}{11}





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Poliovirus Vaccine (Systemic) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this vaccine
»   Conditions affecting use, especially:
Sensitivity to poliovirus vaccine or allergy to neomycin, polymyxin B, or streptomycin

Pregnancy—Not recommended for pregnant women unless high-risk exposure is unavoidable





Use in children—Not recommended in infants up to 6 weeks of age in the U.S. and Canada; however, the World Health Organization (WHO) recommends vaccination of infants at birth (see General Considerations)

Other medications, especially immunosuppressants or radiation therapy
Other medical problems, especially advanced debilitated condition; family history of congenital or hereditary immune deficiency conditions; moderate or severe illness, with or without fever; persistent diarrhea or vomiting; primary or acquired immune deficiency conditions; or viral infection



Diet
Patients on low-sugar diets should be cautioned that the oral solution form of poliovirus vaccine may be administered on a sugar cube

Proper use of this vaccine

» Proper dosing

Precautions after receiving this vaccine
Checking with physician before receiving any other live virus vaccines within 1 month of this vaccine


Side/adverse effects
In rare instances (approximately 1 case in 760,000 doses of distributed vaccine), healthy persons who have taken the live oral polio vaccine (OPV) and healthy persons who are close contacts of adults or children who have taken OPV have been infected by the poliovirus and become paralyzed

No paralysis caused by polio infection has occurred with the injected inactivated polio vaccine (IPV) since 1955 when the vaccine contained live viruses that accidentally had not been inactivated

Signs of potential side effects, especially fever over 39 °C (102 °F) and anaphylactic reaction


General Dosing Information
Poliovirus vaccine live oral (OPV) is administered orally {08} {10}. The vaccine should not be administered parenterally {08}.

Poliovirus vaccine inactivated enhanced potency (eIPV) and poliovirus vaccine inactivated (IPV) are administered intramuscularly or subcutaneously {09}. The vaccines should not be administered intravenously {09}.

In September 1994, an international commission declared that there had been no single case of wild-virus poliomyelitis in the Americas for 3 years and, based on the evidence of the surveillance from every country in the Americas, the commission was convinced that poliovirus transmission had been interrupted {34}. Despite the eradication of polio from the region, immunization activities must continue unabated until all countries worldwide have eliminated poliomyelitis {34}.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) and the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP) offer a transitional recommendation for routine immunization of individuals against poliomyelitis {01} {02}. This recommendation includes the use of regimens of sequential eIPV and OPV, eIPV only, and OPV only {01} {02}. Immunization schedules using regimens of sequential eIPV and OPV, eIPV only, or OPV only are effective; and all these regimens are acceptable options for the prevention of poliomyelitis {01}.

Each regimen has advantages and disadvantages {02}. Parents or other caregivers should be informed of the advantages and disadvantages of the three acceptable regimens {02}.

Expanded use of eIPV in the U.S. is indicated during the transition period of global eradication of poliomyelitis to reduce the risk of vaccine-associated paralytic poliomyelitis (VAPP) and to maintain immunity against wild-type poliovirus infection {01} {02}. The AAP recommends the following for poliomyelitis immunization of infants and children in the U.S.:    • Poliovirus vaccine should be given at 2 months, 4 months, 12 to 18 months, and 4 to 6 years of age, for a total of four doses at or before school entry. For children who receive OPV only, the third dose may be given as early as 6 months of age {02}. An additional dose at school entry is not indicated for children who receive the third dose of the vaccine on or after their fourth birthdays {02}.
   • Immunization with eIPV only is recommended:    —For immunocompromised persons and their household contacts, because OPV is contraindicated for persons with this condition {02}. Poliovirus is found in respiratory secretions for several days and in the stool for several weeks after vaccination and transmission to household contacts occurs frequently {02}.
   —For infants and children for whom adult household members are identified as being inadequately vaccinated against poliomyelitis, because unimmunized adults are at increased risk of VAPP {02}.
   —When the number of injections is not likely to decrease compliance and when eIPV is preferred by health care providers and parents or other caregivers {02}.

   • Immunization with OPV only is recommended:    —When parents or providers prefer not to have the child receive the additional injections needed if eIPV were to be used {02}.
   —For infants and children starting a vaccination regimen after 6 months of age in whom an accelerated schedule is necessary to complete immunizations, an OPV-only regimen will minimize the number of injections required at each visit {02}. For similar reasons, in populations with low vaccination rates, OPV may be preferred to expedite implementation of the routine childhood immunization schedule {02}.

   • The sequential use of eIPV and OPV is recommended to reduce the total number of injections required to decrease the risk of VAPP while maintaining optimal intestinal immunity, especially for travelers to areas where poliovirus is still endemic {01} {02}. Sequential administration of eIPV and OPV also may reduce VAPP among household and community contacts of OPV recipients because eIPV provides some degree of intestinal and pharyngeal immunity {01}. For persons younger than 18 years of age, the primary sequential series of eIPV and OPV consists of four doses {01}. The primary series is administered as follows:    —eIPV at 2 months of age {01}.
   —eIPV at 4 months of age {01}.
   —OPV at 12 to 18 months of age {01}.
   —OPV at 4 to 6 years of age {01}.
For persons of any age, the first three doses should be separated by at least 4 weeks, preferably by 6 to 8 weeks {01}.


The ACIP recommends the use of eIPV followed by OPV for primary poliovirus immunization of children in the U.S. {01}

The considerations that support expanded use of eIPV apply primarily to countries where wild-type poliovirus transmission has been interrupted for several years {02}. OPV remains the vaccine of choice for global eradication in the following areas:    • Areas where wild-type poliovirus recently has been or currently is circulating {02}.
   • Most developing countries where the higher cost of eIPV or IPV prohibits its use {02}.
   • Areas where inadequate sanitation necessitates an optimal mucosal barrier to wild-type virus circulation {02}.


For unvaccinated adults, primary vaccination with eIPV is recommended because the risk for VAPP after administration of OPV is higher among adults than among children {01}. Two doses of eIPV should be administered at intervals of 4 to 8 weeks; a third dose should be administered 6 to 12 months after the second dose {01}.

If three doses of eIPV cannot be administered within the recommended intervals before protection is needed, the following alternatives are recommended {01}:    • If 8 or more weeks are available before protection is needed, three doses of eIPV should be administered at least 4 weeks apart {01}.
   • If 4 to 8 weeks are available before protection is needed, two doses of eIPV should be administered at least 4 weeks apart {01}.
   • If less than 4 weeks are available before protection is needed, a single dose of OPV or eIPV is recommended {01}.
   • The remaining doses of vaccine should be administered later, at the recommended intervals, if the person remains at increased risk {01}.


Adults who have had a primary series of OPV or eIPV and who are at increased risk for exposure to poliovirus may receive another dose of either OPV or eIPV {01}. Persons who may be at increased risk include:    • Travelers to areas where poliomyelitis is endemic {01}.
   • Certain laboratory personnel {01}.
   • Medical staff directly involved with the provision of care to patients whose bodily fluids and excrement may contain poliovirus {01}.
These adults are not at increased risk for VAPP {01}. The need for administration to adults of more than one supplementary dose of either eIPV or OPV has not been established {01}.

Because of the overriding importance of ensuring prompt and complete immunization, sequential use of eIPV and OPV vaccinations in children should begin regardless of the poliovirus vaccine status of adult household contacts {01}. If unvaccinated or inadequately vaccinated persons are known to reside in the child's household, eIPV alone should be used to complete the child's vaccination, thereby reducing the already minimal risk for VAPP among adult household contacts {01}.

In general, simultaneous administration of the most widely used live and inactivated vaccines does not impair antibody responses or increase rates of adverse effects. Vaccines recommended for administration at 12 to 15 months of age can be administered at either one or two visits. There are equivalent antibody responses and no clinically significant increases in the frequency of adverse events when diphtheria toxoid, tetanus toxoid, and pertussis vaccine (DTP); measles, mumps, rubella virus vaccine live; OPV; IPV; or eIPV; and Haemophilus influenzae type b conjugate vaccine (HbCV) are administered either simultaneously at different sites or at separate times. If a child might not be brought back for future vaccinations, all vaccines (including DTP [or DTaP]; measles, mumps, rubella virus vaccine live; OPV [or eIPV, or IPV]; varicella; HbCV; and hepatitis B vaccines) may be administered simultaneously, as appropriate to the child's age and previous vaccination status {01} {15}.

Diet/Nutrition
To avoid hyperglycemia, OPV should not be administered on a sugar cube to a patient on a low-sugar diet.

For treatment of adverse effects
Recommended treatment includes:

   • For mild hypersensitivity reaction—Administering antihistamines and, if necessary, corticosteroids {13}. In mild anaphylaxis, antihistamines or subcutaneous epinephrine may be all that is necessary if the condition is progressing slowly and is not life-threatening, regardless of the organ or system affected {13}. Under these circumstances, the risks associated with intravenous epinephrine administration outweigh the benefits {13}.
   • For severe hypersensitivity or anaphylactic reaction—Administering epinephrine. Antihistamines or corticosteroids may also be administered as required {13}. Epinephrine is the treatment of choice for severe hypersensitivity or anaphylactic reaction {13}. If the patient's condition is not stable, epinephrine should be infused. Norepinephrine may preferable if there is no bronchospasm {13}. For bronchospasm, epinephrine should be given with corticosteroids {13}. Other bronchodilators, such as intravenous aminophylline or albuterol by nebulization, also should be considered {13}.

POLIOVIRUS VACCINE LIVE ORAL


Oral Dosage Forms

POLIOVIRUS VACCINE LIVE ORAL (ORAL SOLUTION) USP

Usual adult dose
Immunizing agent (active)
Oral, 0.5 mL (U.S.) or 0.5 mL or 3 drops (Canada—specific dose depends on manufacturer) {08} {10}.


U.S.:
Two doses administered not less than six and preferably eight weeks apart, with the third dose administered six to twelve months following the second dose {08}.



Canada:
Two or three doses administered six to twelve weeks apart {10}.


Note: Except in certain circumstances as specified in the General Dosing Information and Indications sections, in the U.S. and Canada OPV is not indicated for adults; eIPV is the poliovirus vaccine of choice in the U.S. and Canada when immunization is indicated for adults. Where OPV is indicated for adults, the frequency and number of doses may be different from the Usual adult dose above, according to the specific circumstances (see General Dosing Information ) {01} {02} {08} {10}.



Usual pediatric dose
Immunizing agent (active)
Oral, 0.5 mL (U.S.) or 0.5 mL or 3 drops (Canada—specific dose depends on manufacturer) {08} {10}.


Infants:


First dose—
U.S.: At 6 to 12 weeks of age, commonly with the first DTP inoculation at 2 months of age {08}.

Canada: Not earlier than 2 months of age {10}.



Second dose—
U.S.: Not less than six and preferably eight weeks after the first dose, commonly with the second DTP inoculation at 4 months of age {08}.

Canada: Six to twelve weeks after the first dose {10}.



Third dose—
U.S.: Eight to twelve months after the second dose, commonly with the measles, mumps, and rubella virus vaccine live and fourth DTP inoculations at 15 months of age, but may be administered at any time between 12 and 24 months of age {08}.

Canada: Six to twelve weeks after the second dose {10}.



Booster doses—
U.S.: Upon entering school, usually between 4 and 6 years of age {08}. However, this booster dose is not required in children who receive the third dose of the primary series on or after their fourth birthday {08}.

Canada: Eight to fifteen months after the third dose; during the first school year; and around 15 years of age {10}.

Note: U.S.—An optional additional dose may be administered at 6 months of age (along with the third DTP inoculation) in areas with a high risk of poliovirus exposure {08}.





Children up to 18 years of age who did not follow the above schedule:
U.S.—The first two doses should be administered not less than six and preferably eight weeks apart, and the third dose should be administered six to twelve months following the second dose {08}.

Canada—Two doses six to twelve weeks apart, followed by the booster doses above {10}.



Note: When there are time constraints with regard to immunization, the vaccination schedule may be accelerated for infants and children up to 18 years of age so that the first dose may be given at or after 6 weeks of age, the second dose given six to eight weeks later, and the third dose given six weeks to twelve months later. Moreover, the second and third doses may be given as close as four weeks apart if necessary {08} {10}.


Strength(s) usually available
U.S.—


The equivalent of 10 5.4 to 10 6.4 for Type 1, 10 4.5 to 10 5.5 for Type 2, and 10 5.2 to 10 6.2 for Type 3 of the TCID 50 (quantity of virus estimated to infect 50% of inoculated cultures) of the U.S. Reference Poliovirus, Live, Attenuated, per 0.5 mL (Rx) [Orimune]{08}

Canada—


Approximately 1,000,000 infectious particles of Type 1, approximately 100,000 infectious particles of Type 2, and approximately 300,000 infectious particles of Type 3, per 0.5 mL (Rx)[Generic] (I.A.F.)


Approximately 1,000,000 infectious particles of Type 1, approximately 100,000 infectious particles of Type 2, and approximately 300,000 infectious particles of Type 3, per three-drop dose (Rx)[Generic] (Connaught){09}

Packaging and storage:
Preserve at a temperature that will maintain ice continuously in a solid state {08} {30}. Because of its sorbitol content, this vaccine may remain fluid at temperatures above -14 °C (+7 °F) {08}. If frozen, the vaccine must be completely thawed prior to use. Preserve thawed vaccine at a temperature between 2 and 8 °C (36 and 46 °F) {30}. Vaccine that has been thawed may be carried through a maximum of 10 freeze-thaw cycles, provided the temperature does not exceed 8 °C (46 °F) during the periods of thaw and that the total cumulative duration of thaw does not exceed 24 hours {08} {30}. If the 24-hour period is exceeded, the vaccine must be used within 30 days, during which time it must be stored at a temperature between 2 and 8 °C (36 and 46 °F) {08}.

Note: Childhood vaccines that currently are included in the Expanded Programme on Immunization (EPI) of the World Health Organization (WHO) vary widely in terms of their thermostability {33}. The least stable is the trivalent OPV, composed of live, attenuated viruses that must retain infectivity in order to replicate within the vaccine recipient {33}.
In 1996, suppliers of OPV through the United Nations Children's Fund (UNICEF) introduced individual time and temperature vaccine vial monitors (VVMs) on each vial of OPV {33}. This technology also will be made available to other producers as soon as possible {33}. These VVMs, which can be tailored to the thermostability of the vaccine produced by each individual manufacturer, along with a relaxation in vaccine vial opening rules announced by EPI in 1995, will allow health centers to use a vial of OPV until it is empty, as long as visual inspection shows no sign of contamination and the VVM indicates that the vaccine has not been thermally inactivated {33}. Proper use of VVMs is expected to reduce wastage of OPV significantly {33}.


Preparation of dosage form:
The vaccine must be completely thawed prior to use {08} {30}.

The vaccine may be administered directly or mixed with distilled water, chlorine-free tap water, Syrup NF, or milk. Alternatively, it may be adsorbed on foods, such as bread, cake, or cube sugar.

Stability:
The vaccine contains phenol red as a pH indicator {08}. The usual color of the vaccine is pink, although some containers of vaccine may exhibit a yellow coloration {08}. The color of the vaccine prior to use (red-pink-yellow) has no effect on the virus or on the efficacy of the vaccine {08}.

Auxiliary labeling:
   • For oral use only {08}.


POLIOVIRUS VACCINE INACTIVATED


Parenteral Dosage Forms

POLIOVIRUS VACCINE INACTIVATED (INJECTION) USP

Usual adult dose
Immunizing agent (active)
Intramuscular or subcutaneous, 1 mL {35} {36}:


First dose:
At initial visit {35} {36}.



Second dose:
Four to eight weeks after the first dose {35} {36}.



Third dose:
Four to eight weeks after the second dose {35} {36}.



Fourth dose:
Six to twelve months after the third dose {35} {36}.


Note: If a booster is required following the primary series, either IPV or OPV may be administered {35} {36}.
If immediate protection is needed against poliomyelitis, OPV or eIPV should be administered {01}.



Usual pediatric dose
Immunizing agent (active)
Intramuscular or subcutaneous, 1 mL {35} {36}:


First dose:
At initial visit, preferably at 6 to 12 weeks of age, commonly with the first DTP inoculation at 2 months of age {35} {36}.



Second dose:
Four to eight weeks after the first dose, commonly with the second DTP inoculation at 4 months of age {35} {36}.



Third dose:
Four to eight weeks after the second dose, commonly with the third DTP inoculation at 6 months of age {35} {36}.



Fourth dose:
Six to twelve months after the third dose, commonly with the measles, mumps, and rubella virus vaccine live and fourth DTP inoculations at 15 months of age {35} {36}.



First booster dose:
Children who have completed the primary series of four doses of IPV should receive a booster dose of IPV or eIPV or one dose of OPV upon entering school, usually between 4 and 6 years of age. However, this booster dose of IPV or eIPV or the OPV dose is not required in children who receive the fourth dose of the primary series of IPV on or after their fourth birthday.



Note: In areas where wild-type poliovirus recently has been or currently is circulating, OPV is the poliovirus vaccine of choice {01} {02}.


Strength(s) usually available
U.S.—
Not commercially available.

Canada—
Not commercially available.

Packaging and storage:
Store between 2 and 8 °C (36 and 46 °F) {35} {36}. Do not freeze {35} {36}.

Auxiliary labeling:
   • Shake well {35} {36}.
   • Do not freeze {35} {36}.


POLIOVIRUS VACCINE INACTIVATED ENHANCED POTENCY


Parenteral Dosage Forms

POLIOVIRUS VACCINE INACTIVATED ENHANCED POTENCY (INJECTION)

Usual adult dose
Immunizing agent (active)
Intramuscular or subcutaneous, 0.5 mL {09} {11}:


First dose:
At initial visit {09} {11}.



Second dose:
Four to eight weeks (preferably eight weeks) after the first dose {09} {11}.



Third dose:
Six to twelve months (preferably closer to twelve months) after the second dose {09} {11}.


Note: If a booster is required following the primary series, either eIPV or OPV may be administered {09} {11}.
If immediate protection is needed against poliomyelitis, OPV or eIPV should be administered {09} {11}.



Usual pediatric dose
Immunizing agent (active)
Intramuscular or subcutaneous, 0.5 mL {09} {11}:


First dose:
At 6 to 8 weeks of age (preferably at 8 weeks of age), commonly with the first DTP inoculation at 2 months of age {09} {11}.



Second dose:
Four to eight weeks (preferably eight weeks) after the first dose, commonly with the second DTP inoculation at 4 months of age {09} {11}.



Third dose:
Six to twelve months (preferably closer to twelve months) after the second dose, commonly with the measles, mumps, and rubella virus vaccine live and fourth DTP inoculations at 15 months of age {09} {11}.



First booster dose:
Children who have completed the primary series of three doses of eIPV should receive a booster dose of eIPV or one dose of OPV upon entering school, usually between 4 and 6 years of age. However, this booster dose of eIPV or the OPV dose is not required in children who receive the third dose of the primary series of eIPV on or after their fourth birthday.



Additional booster doses:
The need for routinely administered booster doses of enhanced-potency IPV is not known at this time.


Note: In areas where wild-type poliovirus recently has been or currently is circulating, OPV is the poliovirus vaccine of choice {02}.



Strength(s) usually available
U.S.—


40, 8, and 32 D-Antigen units of types 1, 2, and 3, respectively, determined by comparison to a reference preparation, per 0.5 mL (Rx) [Ipol][Generic]{09}

Canada—


40, 8, and 32 D-Antigen units of types 1, 2, and 3, respectively, determined by comparison to a reference preparation, per 0.5 mL (Rx)[Generic]{11}

Packaging and storage:
Store between 2 and 8 °C (36 and 46 °F) {09} {11}. Do not freeze {09} {11}.

Auxiliary labeling:
   • Shake well {09} {11}.
   • Do not freeze {09} {11}.



Revised: 10/19/1998



References
  1. Centers for Disease Control and Prevention (CDC). Recommendations of the Advisory Committee on Immunization Practices: poliomyelitis prevention in the United States—introduction of a sequential vaccination schedule of inactivated poliovirus vaccine followed by oral poliovirus vaccine. MMWR Morb Mortal Wkly Rep 1997; 46(RR-3): 1-25.
  1. The Committee on Infectious Diseases of the American Academy of Pediatrics (AAP). Poliomyelitis prevention: recommendations for use of inactivated poliovirus vaccine and live oral poliovirus vaccine. Pediatrics 1997; 99(2): 300-5.
  1. Centers for Disease Control and Prevention (CDC). Recommendations of the Advisory Committee on Immunization Practices: update—vaccine side effects, adverse reactions, contraindications, and precautions. MMWR Morb Mortal Wkly Rep 1996; 45(RR-12): 8-10.
  1. Centers for Disease Control and Prevention (CDC). Update: mass vaccination with oral poliovirus vaccine-Asia and Europe, 1996. MMWR Morb Mortal Wkly Rep 1997; 45(42): 911-4.
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  1. Reichler MR, Kharabsheh S, Rhodes P, et al. Increased immunogenicity of oral poliovirus vaccine administered in mass vaccination campaigns compared with the routine vaccination program in Jordan. J Infect Dis 1997; 175 Suppl 1: S198-S204.
  1. Jian Z, Jing-jin Y, Linkins RW, et al. Effect of target age of supplemental immunization campaigns on poliomyelitis ocurrence in China. J Infect Dis 1997; 175 Suppl 1: S210-S214.
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