Introduction
Polio (poliomyelitis) mainly affects children under five years of age. The Polio virus invades the nervous system and can cause total paralysis in a matter of hours. Polio is mainly passed through person-to-person (i.e., fecal-oral) contact, and infects persons who do not have immunity against the disease.
Polio Eradication Campaign
In 1988, the forty-first World Health Assembly, consisting then of delegates from 166 Member States, adopted a resolution for the worldwide eradication of polio. It marked the launch of the Global Polio Eradication Initiative, spearheaded by the World Health Organization (WHO), Rotary International, the US Centers for Disease Control and Prevention (CDC), and UNICEF. The primary strategies for achieving this goal are:
- high infant immunization coverage with four doses of oral poliovirus vaccine (OPV) in the first year of life;
- supplementary doses of OPV to all children under five years of age during national immunization days (NIDs)
- surveillance for wild poliovirus through reporting and laboratory testing of all acute flaccid paralysis (AFP) cases among children under fifteen years of age;
- targeted "mop-up" campaigns once wild poliovirus transmission is limited to a specific focal area.
Polio cases have decreased by over 99% since 1988, from an estimated 350,000 cases then, to 1604 reported cases in 2009. However, the polio eradication campaign is way behind where its planners hoped it would be at this stage. There are still four countries (Nigeria, India, Pakistan, and Afghanistan) in which transmission has never been interrupted. Furthermore, 14 countries in which poliomyelitis had been eradicated have reported re-introduction, admittedly small numbers of cases, but showing that the threat is still quite real. Persistent pockets of polio transmission in northern India, northern Nigeria, and the border between Afghanistan and Pakistan are the current focus of the polio eradication initiative.
National Immunization Days/Pulse Polio Immunization
Pulse Polio Immunization (PPI) involves providing additional OPV doses to every child aged <5 years at intervals of 4-6 weeks. The aim of PPI is to "flood" the community with OPV within a very short period of time, thereby interrupting transmission of the virus throughout the community. In 2005, new monovalent polio vaccines (OPV type 1 and type 3) were licensed and used to enhance the impact of supplementary immunization activities (SIAs) in the key remaining reservoirs of wild polio. Despite the use of OPVs and the intensification of the global eradication efforts in 2007, indigenous wild poliovirus type 1 (WPV1) and 3 (WPV3) transmission has continued.
ContraIndications of Polio Vaccine
IPV is only contraindicated in children who have experienced a severe allergic reaction to a previous dose of IPV or to streptomycin, polymyxin B, or neomycin. OPV is contraindicated in children who have immunosuppressive conditions due to congenital immunodeficiency (agammaglobulinemia or hypogammaglobulinemia), cancer (leukemia or lymphoma), immunosuppressive chemotherapy, or acquired immunodeficiency syndrome (AIDS). OPV also is contraindicated for family and other close contacts of immunocompromised people because of the risk of the spread of OPV to the affected person.
Indian Academy of Pediatrics Committee On Immunization (IAPCOI) Recommendation For Polio Vaccine
A child who has not received any polio vaccination so far: OPV at birth, IPV at 6, 10 and 14 weeks, OPV at 6 months and 9 months, IPV at 15-18 mths and OPV at 5 years. OPV on all pulse polio immunization days.
A child who has completed primary series of OPV: IPV may be offered as catch up vaccination for children less than 5 years of age who have completed primary immunization with OPV. IPV can be given two doses at a 2-month interval. OPV need not be given with these IPV doses.
Polio Vaccine Storage and Dosing
OPV is a very heat sensitive vaccine having a shelf life of 2 years at a temperature of -20oC, 6 months at 2 to 8oC, and 1-3 days at room temperature. OPV should be stored at -20oC at the state and district level and in the freezer at the clinic level. The vaccine must reach the outreach facility at 2 to 8oC in vaccine carriers. The dose is 2 drops orally. IPV should be stored at 2 to 8oC and the dose is 0.5 ml intramuscularly/subcutaneously.
Polio Vaccines
Oral Polio vaccine (OPV):
Oral polio vaccine has been the choice for routine immunization in over 120 countries that have eliminated poliomyelitis. Following the same experience, India is also using OPV as routine immunization and pulse polio immunization as well in order to become polio-free. OPV has few advantages like low cost, an event to administer, inducing gut immunity, and herd effect, which interrupts wild poliovirus circulation. OPV is constituted from three Sabin strains of polioviruses, types 1, 2, and 3, in concentrations of 10,00,000, 1,00, 000, and 6,00,000 infective units (TCID50) per dose, respectively.
However, by using OPV India was able to control the disease but failed to achieve the target of polio eradication by the year 2000. So few questions were raised regarding its efficacy, administration strategy, safety concerns, choice of vaccine for individual protection, eradication & vaccine schedule, etc.
Efficacy concerns:
Various studies from developing countries suggest that after 3 doses of OPV, the mean proportion of infants with detectable serum neutralizing antibodies level was only 73% (36-99%) for type-1, 90% (71-100%) for type-2 & 70% (40-99%) for type-3 poliovirus. Data suggests that there is a wide variation among OPV vaccines in developing countries. These findings were later confirmed by randomized trials in Brazil & Gambia. A study from India found that with 5 doses of OPV at an interval of 4 weeks, seroconversion rates are 88.7%, 93.5% & 96.5% for type 1, 2 & 3 respectively. This sub-optimal seroconversion was related to many factors including - interference with other enteroviruses, inhibition of type 1 & 3 virus from type 2 virus, diarrheal illnesses & presence of maternal antibodies. In spite of routine use of OPV supplemented with mass immunization achieving, immunization coverage of 85-90%, Gaza & Wert banks continued to experience polio outbreaks indicating its inefficiency in controlling the disease.
Vaccine Associated Paralytic Poliomyelitis (VAPP):
VAPP though rare is a serious complication of OPV. Vaccine virus has the ability to mutate to become neurovirulent & cause paralytic illness in the subject or its contacts. From 1980 to 1998, 152 cases of paralytic polio were reported from the USA of which 95% (144) were related to oral polio vaccine administration. The risk of VAPP was estimated as 1 case per 1.5-2.2 million doses administered from 1989 to 1991. Data from the UK suggested VAPP risk as 1 case per 1.4 million doses of OPV administered from 1985-1991. There is a higher risk of VAPP following the first dose of OPV and in children with B-cell immunodeficiency. Studies in India by Kehler KA et al concluded that the risk of VAPP was 1 per 4.1-4.6 million doses administered. Recipient risk was 1 per 12.2 million doses. 1st dose recipient risk was 1 per 2.8 million doses & subsequent dose recipient risk was 1 case per 13.9 million dose administration which are much lower as compared to other countries.
National polio surveillance project defined VAPP as AFP cases in whom -
- Onset of paralysis
- History of vaccine administration before the onset of paralytic illness
- Residual weakness 60 days after onset of paralysis and
- Single vaccine-related poliovirus was isolated in stool samples without isolation of wild poliovirus.
Solutions put forward:
India has gained remarkable success in controlling poliomyelitis through pulse polio immunization. Recent surveillance reports indicate that most of the wild virus is in circulation in Northern India (esp. UP, Bihar) causing paralytic polio. Kerala is polio-free from some time so epidemiology has changed but the policy & strategy to eradicate polio are still the same across the country. So few strategies have been put forward in order to tackle this situation. It is proposed that, in the areas where poliovirus (wild) is not circulating. IPV (Injectable Polio Vaccine) should be commenced in order to reduce VAPP and areas with a high incidence of polio should continue to use the oral polio vaccine.
Inactivated Polio Vaccine (IPV):
IPV is derived from three wild strains of poliovirus, types 1, 2, and 3, which are inactivated by formalin. IPV is highly immunogenic with > 90% of vaccine recipients developing protecting antibodies following 2 doses of vaccine and > 99% after 3 doses. These antibodies persist for several years after primary immunization with IPV. A study in Tamil Nadu (India) comparing the efficacy of OPV & IPV has shown higher efficacy with the latter (66% Vs 92%). There were initial concerns that IPV induces lower levels of mucosal immunity than OPV & it doesn't get excreted in the stools of vaccines so it may be less efficacious in preventing wild virus circulation. But now studies have shown that enhanced IPV (IPV) induces an adequate amount of IgA formation in nasopharyngeal and intestinal secretions almost equivalent to that induced by the oral polio vaccine.
Schedule of IPV:
Many schedules have been tested e.g. IPV only, sequential IPV - OPV in combination with DPT, and as part of a number of investigational combinations including acellular pertussis, Hib vaccine, Hepatitis B vaccine, etc. A combined schedule of OPV & IPV may be useful to accelerate the eradication of polio in developing countries. Combined schedule with simultaneous delivery of OPV & IPV at 6,10 & 14 weeks had an excellent serologic response in 3 different parts of the world with mucosal immunity equivalent to that provided by OPV alone without the risk of VAPP. Sequential IPV/OPV vaccination trials confirmed its efficacy in polio eradication and safer than OPV by reducing VAPP among recipients. Denmark, Israel has become polio-free only after introducing the OPV-IPV combination. In one study it was suggested that in countries where wild type virus no longer circulates and where general hygiene is good IPV alone might be the vaccine of choice.
Side effects of IPV:
No serious side effects are reported. Rarely anaphylaxis may occur within a few minutes to few hours after vaccination.
Advantages of IPV:
It is safe in immunodeficient hosts, patient on steroids & radiation therapy, in the elderly, and even in pregnancy. It does not require stringent conditions during storage & transport and has a longer shelf life.
Disadvantages of IPV:
There are few limitations of IPV as well. Virus content is 10,000 times more than OPV hence it is costlier. It requires trained personnel to administer. There is no excretion of the virus, hence contacts are not benefited. It is not useful in controlling epidemics.
1. World Health Organization (WHO). Poliomyelitis. Available at URL: http://www.who.int/mediacentre/factsheets/fs114/en/index.html. Accessed on 15th May 2011
2. Dowdle WR, De Gourville E et al. Polio eradication: the OPV paradox. Rev Med Virol 2003;13(5):277-91.
3. Parent du Chatelet I, Merchant AT, Fisher-Hoch S. Serological response and poliovirus excretion following different combined oral and inactivated poliovirus vaccines immunization schedules. Vaccine 2003;21(15):1710-8.
4. Yeh SH, Ward JI, Partridge S et al. Safety and immunogenicity of a pentavalent diphtheria, tetanus, pertussis, hepatitis B and polio combination vaccine in infants. Pediatr Infect Dis J 2001;20(10):973-80.
5. Update on Immunization Policies, Guidelines and Recommendation. Indian Pediatrics2004; 41: 239-244.
6. Mittal SK, Mathew JL. Vaccine associated paralytic poliomyelitis. Indian J Pediatr 2003; 70: 573-577.
7. Thakker N, Shendurniker N. Controversies in Polio Immunization. Indian J Pediatr 2003; 70: 567-571.
8. Core information for the development of Immunization Policy. WHO- Vaccines and Biologicals. 2002 Update.
9. IAP guidebook on Immunization. Available at URL: http://www.iapcoi.com/pdf/IAP%20GUIDE%20BOOK%20ON%20IMMUNIZATION%20INDIVIDUAL%20VACCINES.pdf