Combatting Rotavirus in India: Rotavirus Vaccine Product Switch — Experiences Under the Universal Immunization Program in India

The rotavirus vaccine (RVV) was one of the first vaccine that underwent a product switch, under the Universal Immunization Programme of India, where two different products were used and a single-dose vaccine presentation was introduced in the routine immunization schedule. The timeline below details the introduction of RVV and the series of switches that were made between 2016–2023.

JSI has been providing technical assistance to the rotavirus vaccine (RVV) introduction in India since 2015. As the New Vaccine Introduction Team reflects on the journey of the RVV product switch, several key takeaways were apparent that enabled the successful RVV product switch.

1. Strong leadership and systematic planning and guidelines from the Ministry of Health & Family Welfare (MoHFW), Government of India (GOI). On June 2, 2021 the MoHFW released guidance that all 11 states who were currently using Rotasiil® lyophilized will be switched to Rotasiil® liquid. On September 15, 2021 they issued additional guidance to the 5 states where Rotavac® was being used, and directed a switch to Rotasiil® liquid. Prior to these declarations, the GoI issued guidance to ease and sensitize all stakeholders. These guidelines mandated that new products were only used when old RVV products were exhausted (Early Expiry First Out — EEFO), ensured that all session sites had at least one type of RVV available at all times, instructed that no session site had both the new and old product at the same time, and that no PHC was given a new product if >21 days’ supply of the old product was available.
2. Indigenous vaccine produced in India. Rotavac®, Rotasiil® lyophilized, and Rotasiil® liquid vaccine were all indigenously manufactured in India, which allowed for the vaccines to effectively address the high burden of rotavirus diarrhea in India at an affordable price.
3. Robust planning, guidelines, and job aids developed and deployed. Careful planning at all levels, with clearly defined responsibilities, activities, and timelines, was imperative to the RVV product switch. New Job Aids were developed for health workers and Cold Chain Handlers to discuss key facts about the switch, interchangeability of vaccine products, product schedule, route, placement at the session sites, transportation, contraindications, recording and monitoring, and reporting of AEFI.
4. Leveraged virtual platform for hybrid/ refresher training during the pandemic. One of the crucial components of a new vaccine introduction or product switch is training of program managers and frontline health workers. However, in-person training for the RVV product switch was not possible in many places/states because of the restrictions on gatherings due to COVID-19 pandemic. A hybrid (online and in-person) training model was adopted in both synchronous and asynchronous modes to allow flexibility for facilitators and participants to join during/ post-working hours. The use of digital media was pivotal for the successful product switch.
5. Intensive monitoring of the supply chain through an electronic vaccine intelligence network (eVIN). A well-defined cold chain network was crucial in the product switch, as it ensured that the Rotasiil® liquid vaccine reached the states/UTs well in advance of the planned state readiness, even during COVID-19. The performance and efficiency of the cold chain system at different levels were continuously monitored, through supervisory visits and review meetings at state/UTs.

JSI in collaboration with MoHFW, GoI, was able to contribute in the successful implementation of new guidelines and guidance of the 5.57 million healthcare workers in India. Every country’s context is unique, requiring localized and meticulous planning before implementing a product switch; however, experiences from India’s RVV product switch can be adapted and learned from.

This piece is part of a series on Combatting Rotavirus in India:
Part 1: Combatting Rotavirus in India: Many Firsts in Vaccine Introduction