Canadian Immunization Guide
Seventh Edition - 2006

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Part 4
Active Immunizing Agents

Poliomyelitis Vaccine

Epidemiology Preparations approved for use in Canada Efficacy and immunogenicity Recommended usage Schedule and dosage Route of administration Booster doses and re-immunization

Serologic testing Storage requirements Simultaneous administration with other vaccines Adverse reactions Contraindications and precautions Selected references

Poliomyelitis is a disease that may cause irreversible paralysis in less than 1% of infected individuals. It is a highly infectious disease caused by three serotypes of poliovirus. It is spread from person to person principally through the fecal-oral route. The virus is extremely stable and can remain viable in the environment for long periods of time. Following the introduction of inactivated poliovirus vaccines (IPV) in Canada in 1955 and of trivalent oral poliovirus vaccine (OPV) in 1962, indigenously acquired disease has been eliminated (see Figure 13).

Changes since the publication of the 2002 Canadian Immunization Guide include 1) information on the global polio eradication initiative, 2) removal of OPV from the market in Canada but continued use in developing countries, and 3) a change in the guidelines for IPV use in outbreaks and in travellers.

Epidemiology

In Canada

Canada was certified polio-free in 1994. The last major Canadian epidemic of wild poliovirus occurred in 1959, with 1,887 paralytic cases reported. Smaller clusters occurred after that time. In 1978-79, there were 11 paralytic cases among unimmunized individuals in religious groups in Ontario, Alberta and British Columbia, who had contact with imported cases. In 1993, 22 asymptomatic persons with imported wild polio infection were found in the same religious group in Alberta, and in 1996 an asymptomatic person was reported in Ontario. In none of these instances was spread of the virus seen outside the unimmunized groups, presumably because of high levels of immunization in the rest of the population, nor did cases of clinical illness occur in the affected communities in Canada.

More recent cases of paralytic poliomyelitis in Canada have been associated with OPV use. Eleven of 12 paralytic cases in Canada reported between 1980 and 1995 were vaccine associated paralytic poliomyelitis (VAPP). Eight occurred in the contacts of vaccinated persons (three confirmed and five possible), and one was a confirmed vaccine recipient. The remaining two cases were not reviewed but occurred in known contacts of OPV-vaccinated children. Vaccine programs in Canada switched from OPV to IPV in 1995/1996; the last VAPP case occurred in 1995.

In 1985, the Pan American Health Organization (PAHO) adopted a goal of elimination of poliomyelitis from the Americas, and this goal was achieved in 1994. To ensure that Canada remains polio-free, the Public Health Agency of Canada reviews surveillance data for acute flaccid paralysis (AFP) collected by the Immunization Monitoring Program ACTive (IMPACT) system and the Canadian Paediatric Surveillance Program (CPSP), operated by the Canadian Paediatric Society. From 1996 to 2004, between 30 and 63 cases of AFP in children < 15 years of age were reported to the CPSP each year, none attributed to wild or vaccine-derived poliovirus.

The global polio eradication initiative

The World Health Organization (WHO) initially established a goal for the global eradication of polio by 2000. This was amended to 2005 and subsequently to 2008, because polio cases continued to occur in south Asia and west/central Africa. The temporary suspension of OPV vaccination in northern Nigeria in 2003-04 resulted in an outbreak that spread to 14 previously polio-free countries, and wild poliovirus transmission was re-established in six previously polio-free countries. In 2005, three out of six WHO regions have achieved polio eradication: the Americas, the Western Pacific and the European regions.

The WHO's eradication strategy for 2004-08 consists of the following steps: (a) interrupting poliovirus transmission in 2004-05 by increasing OPV coverage in epidemic areas using national immunization days and "mop-up" campaigns, (b) ensuring that there is access to WHO-accredited laboratories for AFP surveillance, (c) achieving certification of global polio eradication in all regions by 2006-08, (d) cessation of OPV use by 2006-08 to prevent circulation of vaccine-derived poliovirus, and (e) ensuring that all regions conduct proper laboratory containment of wild and vaccine-derived polioviruses.

To manage unforeseen outbreaks, WHO may develop a stockpile of the current trivalent OPV or monovalent OPV (mOPV) for each of the three serotypes of poliovirus. The advantage of mOPV is that it would induce mucosal immunity to the specific outbreak strain and would not result in the ongoing circulation of the remaining two vaccine strains in the community. However, mOPV is not available in North America. The alternative is to establish an adequate supply of IPV to vaccinate susceptible individuals.

Preparations approved for use in Canada

This chapter will deal only with vaccines that are currently marketed in Canada.

• DT Polio Adsorbed (diphtheria and tetanus toxoids adsorbed and poliomyelitis vaccine), Sanofi Pasteur Ltd.
• Inactived Poliomyelitis Vaccine [IPV], Sanofi Pasteur Ltd.
• Pentacel^® (Act-HIB^® [Haemophilus influenzae b conjugate vaccine (tetanus protein conjugate)] reconstituted with Quadracel^®), Sanofi Pasteur Ltd.
• Quadracel^® (component pertussis vaccine and diphtheria and tetanus toxoids adsorbed combined with inactivated poliomyelitis vaccine, [DTaP-IPV]), Sanofi Pasteur Ltd.
• Td Polio Adsorbed (tetanus and diphtheria toxoids and inactived poliomyelitis vaccine adsorbed), Sanofi Pasteur Ltd.

Only IPV is currently marketed in Canada and recommended for routine use. All provinces and territories use IPV in routine immunization programs. OPV is no longer recommended because most cases of paralytic polio from 1980 to 1995 were associated with OPV. Furthermore, OPV is no longer marketed in Canada.

IPV preparations are produced either in Vero cells or in human diploid (MRC-5) cells. All are formalin-inactivated products with enhanced potency and are significantly more immunogenic than the first-generation IPV. They each contain the three types of wild poliovirus: type 1 (Mahoney), type 2 (MEF-1) and type 3 (Saukett). Streptomycin, polymyxin B and neomycin may be present as preservatives.

For a list of all approved products in Canada, please refer to Table 1 in the General Considerations chapter.

Efficacy and immunogenicity

IPV produces immunity to all three types of poliovirus in over 90% of people following two doses of vaccine given at least 4-8 weeks apart, and in close to 100% following a booster given 6 to 12 months later.

Recommended usage

Infants and children

To avoid the risk of VAPP, the exclusive use of IPV for routine immunization is recommended in Canada.

Adults

Routine polio immunization is not considered necessary for previously unimmunized adults in Canada who do not intend to travel to areas in which polio outbreaks occur, as there is a negligible risk of exposure to wild polioviruses in the Americas.

Exposure to wild polioviruses

Immunization with IPV is recommended for previously unimmunized adults and children who may be or are exposed to wild polioviruses. These include

• Travellers to areas of countries where these viruses are circulating
• Residents of communities in which a visitor or new refugee/immigrant may be excreting the viruses
• Health care workers in close contact with individuals who may be excreting the viruses
• Laboratory workers handling specimens that may contain the viruses

Schedule and dosage

Children (< 18 years of age)

For routine immunization beginning in infancy, four doses of IPV are recommended, in combination with other routinely administered vaccines (diphtheria, tetanus, acellular pertussis (DTaP) and Haemophilus influenzae type b (Hib)) at 2 months, 4 months, 18 months and 4 to 6 years of age (pre-school booster). The fourth dose is not needed if the third dose is given on or after the fourth birthday. It is acceptable to give an additional dose of IPV at 6 months of age for convenience of administration in combination with DTaP and Hib.

For unimmunized children > 4 years of age, two doses of IPV plus a third dose constitute a complete series. The first two doses of IPV are recommended 4 to 8 weeks apart, followed by a third dose 6 to 12 months later. For children who began their polio immunization series in a country where OPV was used, immunization may be completed in Canada using IPV, and there is no need to re-start the series.

No additional doses of IPV are recommended for traveling children whose primary series of IPV is complete. Previously unimmunized children exposed to imported wild polio or traveling to areas with polio outbreaks should start the primary series of IPV, with due consideration given to a more accelerated schedule (i.e. three doses with only 4 to 6 weeks between each dose). If IPV cannot be secured, children traveling in a region where OPV is available may receive the necessary doses of OPV to complete their series. These parents should be informed that there is a small risk of VAPP with OPV (see Adverse Reactions, below).

Adults ( ≥ 18 years of age)

Adults who completed the primary series of IPV or OPV during childhood and are traveling to developed countries (e.g., North America, Europe, Mediterranean, Japan, Australia, New Zealand) do not require a booster of IPV. However, those traveling to areas that have wild polio or vaccine-derived poliovirus outbreaks should receive a single booster of IPV.

Unimmunized adults or those with unknown polio immunization history who may be exposed to imported wild polio cases in Canada or who are traveling to areas where there are polio outbreaks should receive two doses of IPV, given 4 to 8 weeks apart, with a third dose 6-12 months later. Travelers departing in less than 4 weeks should receive the first dose of IPV and the remaining doses later, at the recommended intervals. Incompletely immunized adults who have previously received less than a full primary course of IPV or OPV should receive the remaining dose(s) of poliovirus vaccine as IPV, regardless of the interval since the last dose.

Route of administration

IPV is injected subcutaneously according to the dose specified in the manufacturer's package insert. Combination vaccines must be administered intramuscularly because of the presence of adsorbed tetanus and diphtheria toxoids.

Booster doses and re-immunization

The need for booster doses of poliovirus vaccine in fully immunized adults has not been demonstrated. Hence, booster doses of vaccine are not routinely recommended for adults who have completed the primary series during childhood. For those at high risk of exposure to polio (e.g., military personnel, workers in refugee camps in endemic areas, travelers to areas where there are epidemics), a single booster dose of IPV is recommended.

Children and adults who undergo hematopoietic stem cell or bone marrow transplantation will lose any previously acquired immunity to poliovirus after the transplantation. These patients require three doses of IPV to reconstitute their immunity to poliovirus, starting 12 months after the transplantation. Please refer to the Immunization of Immunocompromised Persons chapter for the recommended intervals.

Serologic testing

There is no indication for pre- or post-immunization serology.

Storage requirements

IPV-containing vaccines should be stored in the refrigerator at a temperature of +2º C to +8º C. The vaccine should not be frozen.

Simultaneous administration with other vaccines

IPV vaccine, usually given in combination as DTaP-IPV or DTaP-IPV-Hib, may be given at the same time as measles, mumps and rubella (MMR), varicella, pneumococcal conjugate, meningococcal C conjugate, hepatitis B vaccines and influenza vaccines at separate sites and with a separate needle and syringes. IPV may be simultaneously given with the adolescent Tdap vaccine, but at separate sites and with separate syringes.

Adverse reactions

Serious adverse events are rare following immunization and, in most cases, the data are insufficient to determine a causal association.

The side effects of currently available IPV are normally limited to minor local reactions. As with all vaccines, anaphylaxis has been reported rarely. OPV may cause paralytic disease in recipients and incompletely immunized contacts at a rate of approximately 1 per 2.4 million doses distributed. Individuals travelling or living abroad whose children may be exposed to OPV should be made aware of this risk.

Contraindications and precautions

IPV should not be administered to people who have experienced an anaphylactic reaction to a previous dose of IPV, streptomycin, polymyxin B or neomycin. IPV can be given without risk to those who are immunodeficient or immunosuppressed and to people who will have household or close contact with such people. Less than optimal protection may be induced in those who are immunocompromised.

There are no contraindications to the use of IPV in susceptible women who are either pregnant or lactating. However, there is no reason to use IPV during pregnancy (a primary series or a booster dose), unless there is significant risk of exposure to poliovirus (e.g., travel to a country experiencing wild polio cases, or exposure to an imported polio case within Canada).

Selected references

American Academy of Pediatrics, Committee on Infectious Diseases. Prevention of poliomyelitis: recommendations for use of only inactivated poliovirus vaccine for routine immunization. Pediatrics 1999;104(6):1404-6.

Caceres VM, Sutter RW. Sabin monovalent oral polio vaccines: review of past experiences and their potential use after polio eradication. Clinical Infectious Diseases 2001;33(4):531-41.

Carlson J, Bell A, Cashman N et al. Health Canada Working Group on Polio Eradication. <Protocol for the investigation of acute flaccid paralysis and suspected paralytic poliomyelitis. Canada Communicable Disease Report 1998;24(4):25-30.

Centers for Disease Control and Prevention. Isolation of wild poliovirus type 3 among members of a religious community objecting to vaccination - Alberta, Canada, 1993. Morbidity and Mortality Weekly Report 1993;42(17):337-39.

Centers for Disease Control and Prevention. Epidemiologic notes and reports follow-up on poliomyelitis - United States, Canada, Netherlands. Morbidity and Mortality Weekly Report 1997;46(50):1195-99.

Centers for Disease Control and Prevention. Poliomyelitis prevention in the United States: updated recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report 2000;49(RR-5):1-22.

Committee to Advise on Tropical Medicine and Travel (CATMAT). Poliomyelitis vaccination for international travellers. Canada Communicable Disease Report 2003;29(ACS-10):1-7.

Modlin JF, Halsey NA, Thomas ML et al. Humoral and mucosal immunity in infants induced by three sequential inactivated poliovirus vaccine-live attenuated oral poliovirus vaccine immunization schedules. Journal of Infectious Diseases 1997;175(Suppl 1):S228-34.

NVAC-ACIP Joint Working Group and Centers for Disease Control and Prevention. Ensuring preparedness for potential poliomyelitis outbreaks: recommendations for the US poliovirus vaccine stockpile from the National Vaccine Advisory Committee and the Advisory Committee on Immunization Practices. Archives of Pediatrics and Adolescent Medicine 2004;158(12):1106-12.

Patriarca PA, Sutter RW, Oostvogel PM. Outbreaks of paralytic poliomyelitis, 1976-1995. Journal of Infectious Diseases 1997;175(Suppl 1):S165-72.

Plotkin SA, Orenstein WA. Vaccines. 3rd edition. Philadelphia: W.B. Saunders Company, 1999.

Rutty CJ, Barreto L, Van Exan R et al. Conquering the crippler: Canada and the eradication of polio. Canadian Journal of Public Health 2005;96(2):I2-24.

Varughese PV and Canadian Paediatric Society. Acute flaccid paralysis. In: Canadian Paediatric Surveillance Program (CPSP): 2003 results. Ottawa: CPS, 2003.

Varughese PV, Carter AO, Acres SE et al. Eradication of indigenous poliomyelitis in Canada: impact of immunization strategies. Canadian Journal of Public Health 1989;80(5):363-68.

Vidor E, Meschievitz C, Plotkin S. Fifteen years of experience with Vero-produced enhanced potency inactivated poliovirus vaccine. Pediatric Infectious Disease Journal 1997;16(3):312-22.

World Health Organization. Acute flaccid paralysis surveillance: a global platform for detecting and responding to priority infectious diseases. Weekly Epidemiological Record 2004;79(48):425-32.

World Health Organization. Global polio eradication initiative, strategic plan 2004-2008. Weekly Epidemiological Record 2004;79(6):55-7.

World Health Organization. Progress towards global eradication of poliomyelitis, 2003 and January-April 2004. Weekly Epidemiological Record 2004;79(25):229-34.

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