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Recommendations for Use

For EPI

In 2008 as many as 551 cases of polio (481 P3, 70 P1) have been reported in India of which 530 are in UP and Bihar. This scenario of continuous P1 transmission and resurgence of P3 has been attributed to neglect of routine immunization, poor efficacy of OPV, extremely high force of transmission of wild polio virus in UP and Bihar and operational/political issues.

The polio eradication committee of the IAP (IAP-PEC) has suggested certain corrective measures including improvement of routine immunization coverage, utilization of IPV in a campaign mode in the hotbeds of wild polio, improving performance of the NID’s/SNID’s, reducing the frequency and shortening the durations of SIA’s, prompt outbreak response immunization, sensitive surveillance to pick up cVDPV, greater transparency on VAPP cases, rehabilitation of polio victims, conduction of appropriate research, social mobilization, adequate attention to other EPI vaccines and improvement of environmental sanitation.

The IAP-PEC has further opined that it will be unsafe to stop vaccination in the post eradication era due to risks of cVDPV and bio terrorism and thus switch to IPV is inevitable. Such a switch cannot happen overnight due to requirement of large number of doses and logistic issues. It therefore, recommends incorporation of IPV as DTPIPV combination in addition to OPV in the routine immunization of states that are currently free of polio so that a gradual switch to IPV is facilitated.

For Office Practice

IAPCOI recommends continuing OPV use for birth dose, for routine immunization at 6,10 and 14 weeks, 15-18 months and at 5 years and on all NID’s and SNID’s. The IAPCOI also recommends offering additional use of IPV with OPV in all children who can afford the vaccine (Category 2) in the schedule discussed below. Any of the currently licensed brands may be used. The recommendation for wider use of IPV is for the following reasons:

Excellent immunogenicity, efficacy and safety of IPV
IAP-PEC has already recommended that the government gradually introduce IPV in polio free states to facilitate the switch to IPV in post eradication era. By promoting use of IPV in the private sector, the committee hopes to create a demand base for the vaccine, increased supply and lower cost of the vaccine.

OPV use should be continued at present for the following reasons:

In concordance with the government policy of using OPV for polio eradication
Better mucosal immunity of OPV and IPV combination schedule as compared to IPV alone
By not giving OPV we might create confusion in the minds of the parents whose children receive only IPV about the efficacy and safety of OPV and interfere with OPV uptake on the NID’s and SNID’s. Also as a cascade effect there might be some individuals who may refuse immunization with OPV due to fear of side effects and neither give IPV due to non-affordability.
The risk of VAPP with this combined OPV and IPV schedule is extremely low as the child receives OPV at the time when he/she is protected against VAPP by maternal antibodies. Subsequently he/she is protected from VAPP by IPV. Even if we adopt an all IPV schedule the child may still be at a small risk for VAPP through exposure to the oral polio vaccine virus through contacts/environment before he/she receives his/her first dose of IPV.

The IAPCOI feels that in the current scenario where polio eradication in India is at the cross roads and a highly sensitive issue, the combined OPV and IPV schedule strives to provide the best of protection to an individual child while not deviating from the national immunization policies.

The Inactivated Poliomyelitis
Vaccine (IPV)

Recommendations of the IAP Committee on Immunisation

Background

The availability of two effective vaccines against poliomyelitis for the past five decades has ensured remarkable decline in the global burden of disease. The Global Polio Eradication initiative was launched in 1988 using oral polio vaccine (OPV) as the eradication tool and employing a four pronged strategy comprising high routine immunization coverage, supplementary immunization activities (SIAs)/pulse immunization, acute flaccid paralysis (AFP) surveillance and outbreak response/“mopping up” immunization.

The initiative was hugely successful with reduction of polio cases from 350,000 in 1988 to less than a 1000 cases in 2007. Only four countries including India, Pakistan, Nigeria and Afghanistan remain endemic today and wild virus type 2 has not been isolated since 1999. However, the last leg of the journey has been difficult consisting of challenges of eradication of polio from the last remaining pockets (especially UP and Bihar), occurrence of cVDPV (circulating vaccine derived polio viruses) and meeting the funding gap.

Inactivated Polio Vaccines (IPV)

IPV is formaldehyde killed poliovirus grown in monkey kidney cell/human diploid cells. Old IPV contained 20, 8 and 32 D antigen units of type 1, 2 and 3 polioviruses respectively. All currently used IPV vaccines are enhanced potency IPV (eIPV) which contain 40, 8 and 32 D antigen units of type 1, 2 and 3 respectively. Currently the term IPV means eIPV.

The vaccine should be stored at 2 to 8°C and dose is 0.5 ml intramuscularly/ subcutaneously. It is highly immunogenic. Seroconversion rates are 90-100% with two doses given after the age of 2 months and at 2 months interval or in the EPI schedule of three doses at 6,10 and 14 weeks. It produces excellent humoral immunity as well as local pharyngeal and, possible intestinal immunity and thus offers herd protection. IPV can be administered along with all other childhood vaccines and can be used in combination with DTwP/DTaP, Hib and Hep B vaccines without compromising seroconversion or increasing side effects.

The vaccine is very safe. As IPV contains trace amounts of streptomycin, neomycin and polymyxin B, allergic reactions may be seen in individuals with hypersensitivity to these antimicrobials.

Several countries have shifted from all OPV to sequential OPV-IPV schedules and all IPV schedules with elimination of wild polio. IPV will be indispensable in the post eradication era when OPV has to stop but “vaccination against polio” cannot stop.

Dose and Schedule

Child who has not received any polio vaccination so far: OPV at birth, OPV and IPV at 6, 10 and 14 weeks. OPV and IPV at 15-18 months and OPV at 5 years. OPV on all NID’s and SNID’s. An alternative to this schedule is birth dose of OPV, OPV at 6 weeks, OPV and IPV at 10 weeks, OPV at 14 weeks and IPV at 18 weeks, OPV and IPV at 15-18 months, OPV at 5 years and OPV on all NID’s and SNID’s.

In this schedule though the number of IPV doses have reduced from 4 to 3 but it
(a) is logistically more demanding as number of visits increase
(b) is not feasible if combination vaccines are chosen
(c) delays the introduction of IPV and thus lowers protection against VAPP.

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 2 month interval. OPV need not be given with these IPV doses. OPV should be given with the 1st and 2nd boosters of DTP and on all NID’s and SNID’s.

Immunodeficient children and their close contacts: IPV should be the preferred vaccine especially in patients with B-cell immunodeficiency if resources permit. OPV should be avoided. The schedules are as discussed earlier with the exception that a second booster dose of IPV at 5 years is also recommended. Combination vaccines containing IPV are discussed separately.