Polio: Off-label use of IPV vaccine to tide over shortage

IPV vaccine

The manufacturers have confirmed that they will not raise objections to the use of IPV off-label for intradermal use.

Due to shortage of Inactivated Polio Vaccine (IPV) globally, India and a few other countries are stretching the supply of the vaccine to cover all children. The IPV vaccine was introduced into the routine immunisation programme in India from November 30, 2015.

To tide over the shortage, children in Puducherry and seven States (Andhra Pradesh, Karnataka, Kerala, Maharashtra, Odisha, Tamil Nadu and Telangana) will get two doses of 0.1 ml each at 6 and 14 weeks and administered intradermally. Children in the rest of the country will get 0.5 ml of the vaccine at 14 weeks administered intramuscular.

The vaccine has been licensed by the manufacturers only for intramuscular use and not for intradermal administration. The Global Polio Eradication Initiative (GPEI) has, however, permitted the use of the vaccine intradermally as only one-fifth of the vaccine will be required to vaccinate a child.

“The manufacturers have confirmed that they will not raise objections to use of their product off-label. The final decision, however, on the use of IPV intradermally will need to be made by each country and its respective regulatory agencies,” says an April 7 Information Note of GPEI. Both the companies have been “requested to fast-track their efforts to file for a licence revision to include a provision for intradermal use.”

The February 26, 2016 meeting of the mini India Expert Advisory Group (IEAG) recommended that in the absence of sufficient IPV supply, the Government of India “should consider implementing a routine immunisation schedule of two fractional doses [of 0.1 ml each] of IPV, administered at 6 weeks and 14 weeks, in six or seven of the high performing States/Union Territories”. The main objective of IEAG in using IPV intradermally was to ensure administration of IPV to all infants.

As of February 2016, Gavi has assured 28.14 million doses of IPV. Domestic procurement from the Hyderabad-based Shantha Biotechnics for the period October 2016 to March 2018 will provide another 24 million doses, leaving a shortfall of 23.42 million doses, notes the IEAG.

“India has no shortage of IPV vaccine but it is a hand-to-mouth supply,” said Dr. Pradeep Haldar, Deputy Commissioner – Immunisation, Ministry of Health and Family Welfare, Government of India. “The supply has to be managed properly till March 2018 by making sure that all 27,000 cold-chain points [across the country] have only one month’s supply”.

The “rapid scale-up of IPV production required has encountered multiple challenges, leading to a global shortage”, according to the Global Polio Eradication Initiative. As a result, about 20 countries that are at low risk for type 2 VDPV will get their first shipment only in the fourth quarter of 2017. And nearly 25 countries that have already introduced IPV and considered at low risk for type 2 VDPV outbreak will not receive additional supply before the fourth quarter of 2017.

The IEAG has recommended reassessment of the use of fractional dose of IPV in seven States and Puducherry after one year and take a decision to either continue in these States and Puducherry or expand it to more States based on the “lessons learnt from the experience and the supply position at that point in time.” It has also asked for studies to be carried out to understand the immunogenicity and protection conferred by two doses of 0.1 ml vaccine in the Indian setting and to guide future continuation or expansion of the use of fractional dose of IPV.

Published in The Hindu on April 26, 2016


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