Polimyelitis Vaccine

Uses and Administration

Poliomyelitis vaccines are used for active immunisation against poliomyelitis. For discussion of immunisation schedules, see under Vaccines, Refer to . There are 3 serotypes of poliovirus, and both live trivalent (oral) and inactivated trivalent poliomyelitis vaccines are used in routine immunisation programmes. Monovalent oral poliomyelitis vaccines against either wild poliovirus types 1 or 3 are used during supplementary immunisation activities in the highest-risk areas; an oral bivalent poliomyelitis vaccine is also being tried. The oral vaccine stimulates the formation of antibodies both in the blood and in the mucosal tissues of the gastrointestinal tract.

In the UK, a trivalent inactivated poliomyelitis vaccine is recommended for the primary immunisation of all age groups, given as a course of 3 doses at intervals of 4 weeks. It is given intramuscularly as a combined diphtheria, tetanus, pertussis (acellular component), poliomyelitis (inactivated), and Haemophilus influenzae vaccine. For children who received primary immunisation during infancy, reinforcing doses are recommended at school entry (diphtheria, tetanus, pertussis, and poliomyelitis) and before leaving school (diphtheria, tetanus, and poliomyelitis). Further reinforcing doses are necessary only in adults exposed to infection including travellers to countries where poliomyelitis is epidemic or endemic and healthcare workers in contact with poliomyelitis cases. A single dose is given, repeated every 10 years if necessary.

In the USA, the recommended schedule consists of four doses of inactivated vaccine given at 2 months, 4 months, 6 to 18 months, and 4 to 6 years of age.

On the occurrence of a single case of paralytic poliomyelitis from wild virus, a single dose of the oral vaccine is recommended for all persons in the neighbourhood, regardless of whether they have previously been immunised. A primary course should be completed in previously unimmunised individuals.

(last reviewed 2010-09-03; last modified 2010-08-31)

References.

(last reviewed 2010-09-03; last modified 2010-09-01)

References

1. CDC. Updated recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding routine poliovirus vaccination.MMWR. 2009; 58: 829–30. PubMed online

2. WHO. Polio vaccines and polio immunization in the pre-eradication era: WHO position paper.Wkly Epidem Rec. 2010; 85: 213–28. PubMed online

Choice of vaccine

Two types of poliomyelitis vaccine are available: live attenuated oral poliomyelitis vaccine (OPV) and inactivated (killed) poliomyelitis vaccine (IPV) given by injection. Both vaccines are highly effective against all 3 types of poliovirus but there are advantages and disadvantages associated with their use.

The advantages of OPV are:

it produces an immune response in both the blood and in the lining of the gut, thus preventing both spread of infection to the CNS and multiplication of the virus in the gastrointestinal tract and hence transmission via the stools and saliva

it is given orally and is therefore easy to give without specialist training

it is relatively inexpensive, an important consideration in developing countries in particular.

The disadvantage of OPV is:

it causes very rare cases of vaccine-associated paralytic poliomyelitis (VAPP).

The advantage of IPV is:

it is not a live vaccine and as such carries no risk of VAPP.

The disadvantages of IPV are:

it confers very little immunity in the gastrointestinal tract, hence when an individual immunised with IPV is infected with wild poliovirus the virus can still multiply in the intestines and be shed in the stools, thus risking continued transmission

trained health workers are required to give it by injection

it costs far more than OPV.

Poliomyelitis has now been eradicated from most countries in the world (see Refer to ) and hence many, including the UK and the USA, consider it appropriate to use IPV exclusively for routine immunisation. However, the Global Polio Eradication Initiative will continue to use OPV where necessary until global eradication is achieved, at which time it has stated that the use of OPV should cease as soon as possible while population immunity against poliomyelitis and surveillance sensitivity for paralysis remain high, and be replaced by routine use of IPV.1

(last reviewed 2010-09-03; last modified 2008-07-24)

References

1. WHO. Framework for national policy makers in OPV-using countries: cessation of routine oral polio vaccine (OPV) use after global polio eradication. Geneva: WHO, 2005. Also available at: Link (accessed 12/10/05)

Eradication of infection

By the mid-1980s poliomyelitis was declining in many regions of the world due to mass oral poliomyelitis vaccine immunisation activities and in 1988, WHO announced the goal of eradicating poliomyelitis by the year 2000. Other bodies joined the project which became known as the Global Polio Eradication Initiative.1 Although the goal was not achieved in 2000, very considerable progress has been made. In 1988, wild poliovirus (WPV) was endemic in 125 countries and more than 1000 children became paralysed every day. The last cases of WPV type 2 were reported in October 19992 and by 2006 indigenous transmission of WPV2 infection had been interrupted globally;3 by 2008 transmission of indigenous WPV types 1 and 3 (WPV1 and WPV3) still occurred in 4 countries (Afghanistan, India, Nigeria, and Pakistan).2-4 These countries remain a source of WPV that may be reintroduced into countries where transmission had previously stopped; in 2009, 207 cases were reported from 15 countries after WPV importation.2

Once global WPV transmission has been interrupted, the greatest risk of poliomyelitis being reintroduced will be from the attenuated viruses contained in oral poliomyelitis vaccine, which in rare cases can result in vaccine-associated paralytic polio (VAPP) and outbreaks due to vaccine-derived polioviruses (VDPV).1 The first report of circulating VDPV occurred in 2000 and in 2009 VDPVs were detected in 6 countries;2 VDPVs can circulate even in well-immunised communities and produce polio outbreaks in areas with low rates of oral polio vaccine coverage. Furthermore, they can replicate for years in immunocompromised persons.4 This led to the realisation that complete eradication of poliomyelitis must eventually also include the eradication of the live oral vaccine and that a high level of universal immunity against poliomyelitis will need to be maintained, with the current inactivated poliomyelitis vaccine or a new generation inactivated poliomyelitis vaccine, even after wild poliovirus is eradicated.5

(last reviewed 2010-09-03; last modified 2010-09-01)

References

1. Global Polio Eradication Initiative. Information available at: Link (accessed 14/12/09)

2. CDC. Progress towards interruption of wild poliovirus transmission—worldwide, 2009.MMWR. 2010; 59: 545–50. PubMed online

3. CDC. Wild poliovirus type 1 and type 3 importations—15 countries, Africa, 2008–2009.MMWR. 2009; 58: 357–62. PubMed online

4. CDC. Update on vaccine-derived polioviruses—worldwide, January 2008–June 2009.MMWR. 2009; 58: 1002–6. PubMed online

5. Chumakov K, Ehrenfeld E. New generation of inactivated poliovirus vaccines for universal immunization after eradication of poliomyelitis.Clin Infect Dis. 2008; 47: 1587–92. PubMed

Adverse Reactions

As for vaccines in general, Refer to .

Vaccine-associated paralytic poliomyelitis has been reported rarely in recipients of oral poliomyelitis vaccines and in contacts of recipients (see Refer to ).

(last reviewed 2010-09-03; last modified 2008-08-04)

Carcinogenicity

Some poliomyelitis vaccines given in the 1950s and 1960s were found to be contaminated with Simian virus ( SV40 ) from the monkey cell cultures used in the manufacturing process.1Once the contamination was realised, steps were taken to eliminate it from future vaccines. However, SV40 is believed to possess biological properties consistent with cancer-causing viruses and epidemiological studies have consequently been conducted to assess whether vaccine recipients have subsequently developed cancer. Although these studies did not find any increased cancer risk, a report by the USA Institute of Medicine in 2002 concluded that these studies were sufficiently flawed to preclude any conclusion being reached. Studies have also assessed the risk to offspring of women given these vaccines during pregnancy (see Refer to ). Vaccines now in use do not contain SV40 as they are not manufactured using monkey cell cultures.

(last reviewed 2010-09-03; last modified 2008-07-24)

References

1. Stratton K, et al.. Immunization Safety Review. 2003; online

Effects on the nervous system

There have been several case reports of the isolation of poliovaccine virus from the CSF after use of oral poliomyelitis vaccine. A 7-year-old girl who had previously been vaccinated with inactivated poliomyelitis vaccine in infancy was given oral vaccine and developed prolonged headache, vomiting, and fever but no paralysis;1 poliovirus was subsequently isolated from her CSF 34 days after she had received the oral vaccine, and it was concluded that her previous immunisations had been ineffective. In a further report,2 poliovirus was isolated from the CSF of 2 infants with ventriculoperitoneal shunts who had developed aseptic meningitis without paralysis after oral poliomyelitis vaccination. A neurovirulent variant of Sabin type 2 oral poliomyelitis vaccine virus was detected in both the CSF and stools of an infant with transient hypogammaglobulinaemia who developed meningoencephalitis, retinitis, and irreversible hearing loss after oral poliomyelitis vaccination.3A 6-year-old girl given oral poliomyelitis vaccine at 1 and 2 years developed acute disseminated encephalomyelitis and a mutated form of poliovirus was isolated from her CSF;4 it was thought that she had been infected with the mutated virus from extrafamilial contacts and that the cause of her condition may have been related to her HLA type.

(last reviewed 2010-09-03; last modified 2010-06-11)

References

1. Rantala H, et al.. Poliovaccine virus in the cerebrospinal fluid after oral polio vaccination.J Infect. 1989; 19: 173–6. PubMed

2. Gutierrez K, Abzug MJ. Vaccine-associated poliovirus meningitis in children with ventriculoperitoneal shunts.J Pediatr. 1990; 117: 424–7. PubMed

3. Inaba H, et al.. Polio vaccine virus-associated meningoencephalitis in an infant with transient hypogammaglobulinemia.Scand J Infect Dis. 2001; 33: 630–1. PubMed

4. Ozawa H, et al.. Acute disseminated encephalomyelitis associated with poliomyelitis vaccine.Pediatr Neurol. 2000; 23: 177–9. PubMed

Guillain-Barré syndrome

A small cluster of cases of Guillain-Barré syndrome was seen1 in children after a mass oral poliomyelitis vaccination campaign in Finland in 1985. An increased frequency of Guillain-Barré syndrome was also seen in adults. However, a direct link with poliovaccine virus infection could not be established and no link between Guillain-Barré syndrome and oral polio vaccine was found by a subsequent, epidemiological study in California.2

(last reviewed 2010-09-03; last modified 2008-07-29)

References

1. Uhari M, et al.. Cluster of childhood Guillain-Barré cases after an oral poliovaccine campaign.Lancet. 1989; ii: 440–1. PubMed

2. Rantala H, et al.. Epidemiology of Guillain-Barré syndrome in children: relationship of oral polio vaccine administration to occurrence.J Pediatr. 1994; 124: 220–3. PubMed

Vaccine-associated paralytic poliomyelitis

Although generally considered safe and effective, in extremely rare cases the live attenuated virus in oral poliomyelitis vaccines can cause vaccine-associated paralytic poliomyelitis (VAPP) in either the vaccine recipient or in a close contact. There is no such risk associated with inactivated poliomyelitis vaccines. The incidence of VAPP is about 1 case in every 2.5 million doses of vaccine and may be increased in immunocompromised patients. A case control study1 identified intramuscular injections given within 30 days of vaccination as a risk factor in the development of VAPP. This phenomenon, known as provocation paralysis or provocation poliomyelitis, has been described with the wild virus2 and has been recognised as a factor in vaccine-associated paralysis in the UK and USA.3Paralytic poliomyelitis in contacts of vaccine recipients can be further reduced by ensuring that parents without evidence of previous immunisation receive the vaccine at the same time as their children. The benefits of oral poliomyelitis vaccination are considered to greatly outweigh the small risk involved, however, and many countries where the risk of wild virus-caused poliomyelitis has been reduced to zero are now considering combined immunisation schedules with both oral and inactivated poliomyelitis vaccines. It has been suggested that inactivated poliomyelitis vaccine should be introduced globally.4

(last reviewed 2010-09-03; last modified 2011-01-02)

References

1. Strebel PM, et al.. Intramuscular injections within 30 days of immunization with oral poliovirus vaccine—a risk factor for vaccine-associated paralytic poliomyelitis.N Engl J Med. 1995; 332: 500–6. PubMed

2. Anonymous. Provocation paralysis.Lancet. 1992; 340: 1005–6. PubMed

3. Wyatt HV. Vaccine-associated poliomyelitis.Lancet. 1994; 343: 610. PubMed

4. Heinsbroek E, Ruitenberg EJ. The global introduction of inactivated polio vaccine can circumvent the oral polio vaccine paradox.Vaccine. 2010; 28: 3778–83. PubMed

Precautions

As for vaccines in general, Refer to .

Poliomyelitis vaccine may contain trace amounts of antibacterials such as neomycin, polymyxin B, and streptomycin and should be used with caution in patients with severe hypersensitivity to these antibacterials.

Oral poliomyelitis vaccines should not be given to patients with diarrhoea or vomiting.

Because the vaccine virus of oral poliomyelitis vaccines is excreted in the faeces for up to 6 weeks, the contacts of recently vaccinated babies and infants should be advised of the need for strict personal hygiene, particularly hand washing after napkin changing, in order to reduce the possibility of infection in unimmunised contacts. Unimmunised adults can be immunised at the same time as their children.

Immunocompromised patients are at increased risk of developing vaccine-associated paralytic poliomyelitis. Oral poliomyelitis vaccines should not be given to immunocompromised patients or their household contacts and in these persons an inactivated vaccine should be used. Asymptomatic HIV-positive persons may receive oral poliomyelitis vaccines but faecal excretion of the vaccine virus may continue for longer than in uninfected individuals. For symptomatic HIV-positive persons the use of inactivated poliomyelitis vaccine may be considered.

Intramuscular injections given after the oral vaccine may also increase the risk of vaccine-associated paralytic poliomyelitis (see Refer to ).

(last reviewed 2010-09-03; last modified 2008-08-04)

Porphyria

The Drug Database for Acute Porphyria, compiled by the Norwegian Porphyria Centre (NAPOS) and the Porphyria Centre Sweden, classifies trivalent inactivated poliomyelitis vaccine as not porphyrinogenic; it may be used as a drug of first choice and no precautions are needed.1

(last reviewed 2010-09-03; last modified 2011-11-08)

References

1. The Drug Database for Acute Porphyria. Available at: Link (accessed 26/10/11)

Pregnancy

Live vaccines such as oral poliomyelitis vaccines are generally contra-indicated in pregnancy because of a theoretical risk to the fetus. Population-wide mass vaccination programmes become impossible, however, if pregnant mothers and women of child-bearing age are to be excluded.1 In February 1985, mass vaccination with live oral poliomyelitis vaccine was started during a poliomyelitis outbreak in Finland.1 Pregnant women were advised to take the vaccine. An analysis of all reported congenital malformations in the years 1982 to 1986 suggested that oral poliomyelitis vaccine had no harmful effects on fetal development as measured by overall prevalence of malformations or by the incidence of either CNS or orofacial defects. The results did not, however, exclude an effect measurable by other criteria of fetal development.

The incidence of spontaneous abortions was measured during a mass poliomyelitis vaccination campaign in Israel.2 The number of spontaneous abortions did not differ between controls and women vaccinated during the first trimester of pregnancy; the percentage of spontaneous abortions in relation to live births was also similar. Microscopic examination of placentas from spontaneous abortions indicated no effect of oral poliomyelitis vaccine on the frequency or type of pathological changes. In addition, subsequent epidemiological study3 found no increases in congenital malformations or in premature births during the period of and immediately after the vaccination campaign compared with those born before the campaign.

The Collaborative Perinatal Project (CPP) in the USA4followed up 50 897 pregnancies to examine risk factors for the development of malignancies in offspring born between 1959 and 1966. In 18 342 children whose mothers were vaccinated during pregnancy withinactivated poliomyelitis vaccines, there were 14 malignancies (7.6 per 10 000), while in 32 555 non-exposed children there were 10 malignancies (3.1 per 10 000). There were 7 tumours derived from neural tissue in the exposed children (3.8 per 10 000) and one in non-exposed children (0.3 per 10 000). Thus there was an excess of neural tumours but not of leukaemias or other malignancies in children exposed in uteroto inactivated poliomyelitis vaccine. No malignancies occurred among the children born to 3056 women who received oral poliomyelitis vaccine. Serum samples collected from mothers on entry into the CPP and at delivery were subsequently analysed5for the presence of antibodies to Simian virus 40 (SV40). None of the serum samples from 8 mothers of infants with neural tumours had antibodies to SV40. Two of the 7 mothers of infants with leukaemia had SV40 antibodies, but only one had conversion during pregnancy. None of the samples from the 7 mothers of children with other types of cancer had antibodies. Three of 36 controls had antibodies, but in both the first and second samples. The association between use of inactivated poliomyelitis vaccine in mothers and neural tumours in their offspring could not be attributed to contamination of vaccine with SV40. A later analysis6 of 54 796 children enrolled in the CPP found an increased risk of neural tumours and of haematological malignancy in children whose mothers were given pre-1963 poliomyelitis vaccine, but concluded that this was unlikely to have been due to transmission of SV40.

(last reviewed 2010-09-03; last modified 2010-06-11)

References

1. Harjulehto T, et al.. Congenital malformations and oral poliovirus vaccination during pregnancy.Lancet. 1989; i: 771–2. PubMed

2. Ornoy A, et al.. Spontaneous abortions following oral poliovirus vaccination in first trimester.Lancet. 1990; i: 800. PubMed

3. Ornoy A, Ben Ishai P. Congenital anomalies after oral poliovirus vaccination during pregnancy.Lancet. 1993; 341: 1162. PubMed

4. Heinonen OP, et al.. Immunization during pregnancy against poliomyelitis and influenza in relation to childhood malignancy.Int J Epidemiol. 1973; 2: 229–35. PubMed

5. Rosa FW, et al.. Absence of antibody response to simian virus 40 after inoculation with killed-poliovirus vaccine of mothers of offspring with neurologic tumors.N Engl J Med. 1988; 318: 1469. PubMed

6. Engels EA, et al.. Poliovirus vaccination during pregnancy, maternal seroconversion to simian virus 40, and risk of childhood cancer.Am J Epidemiol. 2004; 160: 306–16. PubMed

Interactions

As for vaccines in general, Refer to .

(last reviewed 2010-09-03; last modified 1998-06-23)

Normal immunoglobulins

Although the use of live vaccines and immunoglobulins at the same time is generally not recommended, normal immunoglobulin had no effect on the antibody response to oral poliomyelitis vaccine when the 2 preparations were given together to 50 subjects.1

(last reviewed 2010-09-03; last modified 2006-06-01)

References

1. Green MS, et al.. Response to trivalent oral poliovirus vaccine with and without immune serum globulin in young adults in Israel in 1988.J Infect Dis. 1990; 162: 971–4. PubMed

Preparations: Single-Ingredient

The following preparations list represents a compilation of all available salt forms or related substances for this drug product.

The symbol ¤ denotes a preparation which is discontinued or no longer actively marketed.

ARGENTINA: Imovax Polio; Opvero¤; Polioral¤; Sabin¤;AUSTRALIA: Enpovax HDC¤; Ipol;AUSTRIA: Buccapol¤;BELGIUM: Imovax Polio; Sabin¤;BRAZIL: Imovax Polio¤; IPV¤; Vacina Poliomielitica¤;CANADA: Imovax Polio;CHINA: Imovax Polio (爱宝维);CZECH REPUBLIC: Imovax Polio; IPV-Virelon¤; VeroPol¤;DENMARK: Imovax Polio¤;FINLAND: Imovax Polio; VeroPol;FRANCE: Imovax Polio;GERMANY: IPV Merieux; IPV-Virelon¤; Oral-Virelon¤; Polio-Vaccinol¤; Virelon C¤;GREECE: Imovax Polio¤; Poliorix; Vaccin Antipoliomyelitique/Merieux¤;HONG KONG: Buccapol¤; Imovax Polio;HUNGARY: Imovax Polio;INDIA: Imovax Polio; OPV¤;INDONESIA: Imovax Polio;ISRAEL: Imovax Polio; Polio Sabin; Polioral¤;ITALY: Imovax Polio; Polio Sabin¤; Polioral¤; Poliovax-IN¤;JAPAN: Imovax Polio;MALAYSIA: Polio Sabin¤; Polioral¤;MEXICO: Polio Sabin¤; Polioral¤;NORWAY: Imovax Polio;NEW ZEALAND: Imovax Polio¤; Ipol;PHILIPPINES: Imovax Polio; Polio Sabin; Polioral; Poliorix¤; Polprotec;POLAND: Imovax Polio; Polio Sabin¤;PORTUGAL: Imovax Polio;RUSSIAN FEDERATION: Imovax Polio (Имовакс Полио); Poliorix (Полиорикс);SOUTH AFRICA: OPV-Merieux; Polioral;SINGAPORE: Buccapol¤; Imovax Polio; Polio Sabin¤;SPAIN: Opvax¤; Vac Antipolio Or¤; Vac Antipolio Oral¤; Vac Polio Sabin¤; Vac Poliomielitica¤;SWEDEN: Imovax Polio; VeroPol;SWITZERLAND: Poliorix; Poloral¤;THAILAND: Imovax Polio; Opvero; Polio Sabin; Polioral; Polprotec;TURKEY: Buccapol¤; OPV¤; Polio Sabin¤; Poliorix¤;UNITED STATES: Ipol; Orimune¤;VENEZUELA: Imovax Polio¤; Vacuna Sabin¤;

Preparations: Pharmacopoeial

The following preparations list represents a compilation of all available salt forms or related substances for this drug product.

Ph. Eur.: Poliomyelitis Vaccine (Inactivated); Poliomyelitis Vaccine (Oral);

Therapeutic Use

• Vaccines Immunoglobulins and Antisera

Last Updated 1/21/20