RotaTalk Newsletter March 2023

Rota Talk

Rotavirus vaccine: Updates in the country

Though it has been more than three years of RVV expansion nation-wide and the Post Introduction Evaluation completed for the vaccine, a lot many activities, updates and news are ongoing regarding the Rotavirus Vaccine. One major activity in our focus is the product switch in select states. Few states have already witnessed the product switch (from Rotasiil lyophilized to Rotasiil liquid) but more states are going to do the same in the coming months. This issue mostly focuses on the major findings of the RVV PIE and the past and current status of the RVV product switch.

India’s Universal Immunization Programme (UIP), launched in 1985 is the largest immunization programme in the world, catering to 2.6 crore newborns in the country, with over 1.2 crore immunization sessions planned each year.

To expand the basket of vaccines under the immunization program, Government of India has introduced a number of new vaccines in the UIP in the past few years including Rotavirus Vaccine (RVV) in 2016. India became the first country in the WHO Southeast Asia region to introduce the RVV in the UIP in the year 2016.

The introduction of the Rotavirus vaccine (RVV) is a milestone in the history of vaccination in India as it was for the first time that a novel, low-cost ‘Made in India’ vaccine was introduced in the country with domestic funds.

In September 2019, rapid scaleup of RVV in the remaining 25 states

Rotavirus vaccine: Product switch

In India, the RVV introduction and scale up was done with two types of products- a liquid frozen RVV and a lyophilized RVV. In 2021, a new liquid RVV product was licensed and was introduced in the Universal Immunization Programme (UIP). As of January 2023, the RVV lyophyilized product has been completely phased out from the UIP. Currently, the two products used are RVV liquid frozen (Rotavac) and RVV liquid (Rotasiil). Both the products are indigenously manufactured.

was achieved as a part of the ‘100 days agenda’ covering the entire birth cohort of 26.7 million using two different indigenous RVV products namely Rotavac® and Rotasiil®. The introduction was carried out under the stewardship and ownership of the Central Government along the shortest timeline.

In 2021, the manufacturer of Rotasiil® informed MoHFW about the change of Rotasiil lyophilized product to Rotasiil liquid, following which a decision of product switch was taken for all 11 states using Rotasiil lyophilized and five select states using Rotavac®.

As recommended by World Health Organization (WHO), RVVPIE has been conducted in 14 states to provide an understanding of the operational aspects of the immunization programme at different levels of the health system of the country in March 2022.

Since its roll-out and up until February 2023, 27.48 crore doses had been administered. Government of India is making constant efforts to improve the access, coverage and quality of immunization and thus ensure that all children are protected from the vaccine preventable diseases.

Message from Dr. Veena Dhawan, AC Immunization, MoHFW

RVV Findings: Post Introduction Evaluation (PIE) RVV PIE

In 2016, India became the first country in the WHO South East Asia Region (SEAR) to introduce the rotavirus vaccine (RVV) in the routine immunization programme. The expansion happened in phases and between 2016-2018, 11 states introduced RVV, covering 56.4% of India’s birth cohort. In 2019, under the “100 days agenda” of the National Government, RVV was expanded to the remaining 25 states/UTs.

The Ministry of Health and Family Welfare (MoHFW), decided to conduct the RVV PIE from 21st - 29th March

KEY FINDINGS

2022, to assess the programmatic experience and impact of the introduction of rotavirus vaccine under UIP.

The field teams had a total of 64 evaluators from 16 immunization partner agencies including WHO, UNICEF, UNDP, BMGF, CDC, ITSU, NCCVMRC, INCLEN, RTI International, PATH, JHPIEGO, CHAI, CHRD-SAS, Plan India, CMC Vellore, and JSI. Under the guidance of the Immunization Division, MoHFW, JSI coordinated with all stakeholders for the successful conduct of the PIE.

a. Strengths:

• Political commitment at all the levels including strong national and state level programme leadership.

• Well-planned preparedness assessment and other pre introduction activities (cold chain space

• Assessment and gap mitigation, strengthening of AEFI surveillance, job aids for FLWs, etc) and clear implementation guidelines.

• Availability of domestic RVV products, securing vaccines well ahead of roll out and close monitoring of immunization supply chain.

• Support from immunization partners in the vaccine roll out.

• Use of standard training packages for the frontline workers, supervisors and programme managers and close monitoring of training quality.

• Intensified communication and advocacy activities which included ceremonial launches by political leaders and senior government officials, media sensitization workshops, use of social media platforms (WhatsApp and Facebook), key stakeholders mapping and interaction, use of posters, banners, IPC by FLWs, etc.

• Many innovations at the national level such as obviating the need for buffer prior to actual vaccine (Rotavac®) administration based on scientific evidence, change in the position of VVM from body of the vial to cap to ensure that opened vials are not used beyond recommended time, change in the size and colour of RVV dropper to avoid confusion with the OPV dropper, provision of two syringes with Rotasiil®.

• No disruption of supply of RI vaccines during the COVID 19 pandemic.

b. Challenges:

• Shortage and lack of rational deployment of ANMs.

• In few areas there is lack of awareness of the community for immunization.

• Fear of AEFI amongst caregivers.

• Local issues with the guidelines for Alternate Vaccine Delivery (AVD) for the last mile vaccine supply to the session sites.

Message from SEPIO Maharashtra

Rotavirus spreads easily among infants and young children and Rotavirus Vaccine protects the child from this potentially severe disease. Rotavirus vaccine was introduced in state of Maharashtra on 20th July 2019.

The introduction of Rotavirus vaccine has increased immunity in children and decreased death due to diarrhea. It is seen though decreased OPD cases and hospitalization cases for the severe diarrhea among the infants and children.

Further, the switch to single dose tube has ensured the minimal wastage of RVV and the coverage has also improved. The inclusion of RVV has strengthened the Universal Immunization Program and has made it more profound and complete.

Last year, the Post Introduction Evaluation (PIE) for the RVV roll out was also conducted in Maharashtra. The evaluation was done in Pune and Nagpur districts. Maharashtra is one of the states which has transitioned from Rotasiil Lyophilized product to Rotasiil Liquid one. The PIE report will inform the programme to take necessary corrective measures.

Dr Sachin Desai, State Immunization Officer, Maharashtra

Overcoming Challenges: Bagnan, West Bengal

In India, Rotavirus vaccine (RVV) was expanded to all states in 2019. Two types of RVV products were useda oral liquid frozen RVV and a oral lyophilized RVV. In the state of West Bengal, the lyophilized product was introduced in August 2019.

Bagnan-1 is a remote block in Howrah district of West Bengal. It has a higher prevalence and incidence of vaccine preventable diseases and also had history of wild polio virus transmission. There are a lot of areas in the block which are diarrhoea prone. However, the health seeking behaviour of the community is sub optimal and the diarrheal cases are brought to the Block PHC only when the condition of the patient deteriorates and becomes critical. Acceptance to new vaccine was traditionally low here. What

became even more challenging for RVV was that for the first time an oral vaccine was to be administered via a syringe.

At the time of RVV launch, Dr. Palash Kumar Mallick was Block Medical Officer Health (BMOH), Ms Shyamoli Roy was Block Public Health Nurse (BPHN) & Ms Madhumita Roy was the Public Health Nurse (PHN). This dedicated team along with the other health staff of the block took various steps to ensure a smooth introduction and uptake of the RVV.

Teams were formed in the identified diarrhoea prone areas. They visited every house in those areas to create awareness about diarrhoeal diseases & importance of RVV. VHND sessions were also utilized to create awareness about diarrhoea & other VPDs. RVV introduction was utilized as an

opportunity to create awareness not just about diarrhoea & RVV but about all other VPDs & how they can be easily prevented by giving all doses of all the vaccines available in UIP in time. It was done through extensive IPC, mothers meeting, meeting with key influencers & making them move in the community for awareness generation.

Block level Task Force (BLTF) was held at regular interval in presence of Block Development Officer (BDO), Sabhapati & Swasthya Karmadhakya. This ensured that under the leadership of respective Panchayat Pradhans in the block, PRI members work in close coordination with the HWs to create awareness not just at the time of new vaccine introduction but work throughout the year for better coverage of all UIP vaccines.

State wise Cumulative RVV-1 Coverage (%) January 2022 – December 2022

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State wise Cumulative RVV-3 Coverage (%) January 2022 – December 2022

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ROTA QUICK FACTS

 In India, Rotasiil prevented 48% and 44% of Severe Rotavirus Gastroenteritis (SRVGE) during the one-year and two-year follow-up periods, respectively, and it prevented ≈28% of cases of rotavirus diarrhea with efficacy increasing with the severity of the diarrheal episode (39% against SRVGE) during one year follow-up.

Reference: Varghese, T., Kang, G. and Steele, A.D., 2022. Understanding rotavirus vaccine efficacy and effectiveness in countries with high child mortality. Vaccines, 10(3), p.346

 The seroresponse rate in the mixed vaccine regimen group (33·5% [95% CI 30·9–36·2]) was non-inferior compared with the single vaccine regimen group (29·6% [26·1–33·4]); the seroresponse rate difference was 3·9% (95% CI −0·7 to 8·3). The proportion of participants with any type of solicited adverse events was 90 9% (95% CI 88 4–93 0) in the single vaccine regimen group and 91 1% (89·5–92·6) in the mixed vaccine regimen group.

Reference: Kanungo, S., Chatterjee, P., Bavdekar, A., Murhekar, M., Babji, S., Garg, R., Samanta, S., Nandy, R.K., Kawade, A., Boopathi, K. and Kanagasabai, K., 2022. Safety and immunogenicity of the Rotavac and Rotasiil rotavirus vaccines administered in an interchangeable dosing schedule among healthy Indian infants: a multicentre, open-label, randomised, controlled, phase 4, noninferiority trial. The Lancet Infectious Diseases, 22(8), pp.11911199.

Editorial Board

RVV Total Doses (January to December

For details, please contact:

Dr. Veena Dhawan, MoHFW

Dr. Ashish B. Chakraborty, MoHFW

Dr. Arindam Ray, Bill and Melinda Gates Foundation

Dr. Arup Deb Roy, JSI

Dr. Amanjot Kaur, JSI

Acknowledgements: State officials, JSI State and National team

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