Fractional-Dose Inactivated Poliovirus Vaccine, India/Inde-Vaccin Antipoliomyelitique Inactive En Doses fractionnees/Vacuna Inactivada del Poliovirus De Dosis Fraccionada, India

By Haldar, Pradeep; Agrawal, Pankaj et al. | Bulletin of the World Health Organization, May 2019 | Go to article overview

Fractional-Dose Inactivated Poliovirus Vaccine, India/Inde-Vaccin Antipoliomyelitique Inactive En Doses fractionnees/Vacuna Inactivada del Poliovirus De Dosis Fraccionada, India


Haldar, Pradeep, Agrawal, Pankaj, Bhatnagar, Pankaj, Tandon, Rajiv, McGray, Sarah, Zehrung, Darin, Jarrahian, Courtney, Foster, Jennifer, Bulletin of the World Health Organization


Introduction

In early 2016, the World Health Organization (WHO) announced a global shortage of inactivated poliovirus vaccine, (1,2) which was estimated in 2017 to last until 2020 and potentially beyond. (3) In response, WHO's Strategic Advisory Group of Experts on Immunization recommended that countries with good immunization systems and coverage consider administering two fractional inactivated poliovirus vaccine doses of 0.1 mL each intradermally instead of a single, intramuscular, full dose of 0.5 mL. (4,5)

The use of fractional doses has important implications for immunization systems, including the supply chain. When a vial intended for full-dose vaccination is used to deliver fractional doses, the number of doses it contains increases by a factor of five: a vial containing 5 or 10 full doses becomes a 25- or 50-fractional-dose vial, respectively. Moreover, as the number of doses available at a facility increases, the supply frequency must change to accommodate the slower consumption of individual vials. Staff must undergo training on procedures for new vaccine delivery schedules and on the different route of administration. Vaccinators may, therefore, need to be refamiliarized with the Mantoux method. Finally, close monitoring is essential to ensure that injection quality, vaccine wastage and supplies of both vaccine and injection equipment are appropriate and that coverage meets set targets.

India was the first country in the world to introduce fractional-dose inactivated poliovirus vaccine into its immunization programme. A phased introduction started in 2016 and coverage was expanded throughout the country in 2017. This paper describes the background to the introduction of fractional-dosing in India and highlights aspects of the country's immunization programme that were critical for success. We provide information about immunization programme features, such as training health-care workers, monitoring the introduction of fractional-dosing and vaccine usage, and updating vaccine supply and distribution plans, that could be useful for other countries considering the use of fractional-dose inactivated poliovirus vaccine.

Introducing fractional-dosing

Following publication of the global Polio Eradication Endgame and Strategic Plan 2013-2018 and of recommendations by WHO's Strategic Advisory Group of Experts on Immunization, (6,7) the Indian government decided to introduce inactivated poliovirus vaccine into its routine immunization programme in preparation for the planned global switch from trivalent to bivalent oral poliovirus vaccine in April 2016. For the first year, the government requested 40 million doses of inactivated poliovirus vaccine from Gavi, the Vaccine Alliance. However, Gavi agreed to supply only 28 million doses. Consequently, the government decided to phase in the introduction of inactivated poliovirus vaccine and full-dose vaccination began in six states in November 2015 (Fig. 1). To supplement vaccines supplied by Gavi, the government started to procure vaccines using its domestic budget. Since the first quarter of 2017, all inactivated poliovirus vaccines used in India has been paid for by the Indian government. However, due to global shortages, domestic manufacturers were not able to provide an adequate supply despite their best efforts.

Even with the staggered introduction of inactivated poliovirus vaccine in India, supply challenges remained. In February 2016, the India Expert Advisory Group on polio convened an interim meeting to discuss the impact of supply constraints on the scheduled switch to bivalent oral poliovirus vaccine in April that year. (8) Based on the evidence that two fractional inactivated poliovirus vaccine doses yields equivalent or greater immunogenicity as a single full inactivated poliovirus vaccine dose, (5,9-11) the advisory group recommended that the government continue with the planned switch to bivalent oral poliovirus vaccine and consider implementing a routine immunization schedule of two fractional doses, at 6 and 14 weeks of age, as a risk-mitigation strategy. …

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Fractional-Dose Inactivated Poliovirus Vaccine, India/Inde-Vaccin Antipoliomyelitique Inactive En Doses fractionnees/Vacuna Inactivada del Poliovirus De Dosis Fraccionada, India
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