Serum Institute’s Vaccine Shows Significant Efficacy Against Severe Rotavirus

Results from Phase 3 efficacy study of rotavirus vaccine manufactured by the Serum Institute of India have shown the vaccine to be safe, well tolerated, and to provide significant efficacy against severe rotavirus gastroenteritis. The results of the vaccine BRV-PV (known as ROTASIIL) were published in the journal Vaccine. 


In 2013, India accounted for 22 percent of global rotavirus deaths. In terms of numbers, this was an estimated 47,100 rotavirus deaths occurred in India. 


ROTASIIL reduced severe rotavirus diarrhea by more than a third – 39.5 percent over two years.  


Significantly, the vaccine efficacy was nearly 55 percent against the most severe and potentially life-threatening cases of rotavirus diarrhea, which represent the highest risk of dehydration,  hospitalizations, and deaths. 


The results demonstrated by ROTASIIL in India appear generally comparable to the performance of RotaTeq and Rotarix in Bangladesh and in some African countries.  


Dr. Rajeev Dhere, executive director of the Serum Institute, who led the team that developed the vaccine, said: “We are delighted with these results, which indicate that ROTASIIL could save the lives of tens of thousands of children each year in India and, potentially, around the world.”    


The international nonprofit PATH partnered with Serum Institute on evaluating this vaccine in the Phase 3 efficacy study. Six study sites across India enrolled 7,500 infants in the trial. ROTASIIL is an oral vaccine administered to infants in a three-dose course at 6, 10, and 14 weeks of age, at the same time as routine vaccinations under India’s Universal Immunization Programme.  


The office of the Drugs Controller General of India, through its subject expert committee, reviewed the Phase 3 safety and efficacy results and subsequently inspected Serum Institute’s manufacturing facilities leading to licensure of ROTASIIL in January 2017.   


The Government has placed an order for 3.8 million doses of ROTASIIL to use in the Universal Immunization Programme, which serves 26 million children. Serum Institute has manufactured the vaccine doses and is awaiting instructions from the Ministry of Health and Family Welfare for their distribution. ROTASIIL will also be available for sale in India’s private market later this year.   


Serum Institute is pursuing World Health Organization (WHO) prequalification to make this vaccine available for global procurement. PATH and Serum Institute partnered to conduct a separate Phase 3 study in India to gather additional data required for WHO prequalification; results from that study will be submitted for publication this year.      


Médecins Sans Frontières and Epicentre are also evaluating the efficacy and safety of ROTASIIL in a separate Phase 3study in Niger. That study is still ongoing, but results from the primary analysis (one year of data) also showed the vaccine to be highly efficacious for the prevention of severe rotavirus diarrhea and to have an excellent safety profile. The efficacy of the vaccine against severe and very severe rotavirus diarrhea in the Niger study was 66.7 percent and 78.8 percent, respectively. These results were published in the New England Journal of Medicine in March 2017, a statement issued by PATH said. 


The ROTASIIL used in the Niger study was stored at less than 25°C and transported for vaccination at ambient temperature, thus bypassing the typically challenging and costly cold chain requirements that apply to most other vaccines.The ROTASIIL used in the India study was from the same lots of vaccine used in the Niger study.   at ambient temperature, thus bypassing the typically challenging and costly cold chain requirements that apply to most other vaccines.The ROTASIIL used in the India study was from the same lots of vaccine used in the Niger study.  


Rotavirus is the most common and deadly cause of severe diarrhea with dehydration in infants and young children. Every child everywhere in the world is at risk of infection. However, in places where access to urgent medical care is limited, severe diarrhea and vomiting caused by rotavirus can lead to lethal dehydration.   


Worldwide, more than half a million children under the age of five years die each year due to diarrhea. In 2013, an estimated 215,000 of these deaths were due to rotavirus, with more than90 percent occurring in developing countries. In 2013, an estimated 47,100 rotavirus deaths occurred in India, 22 percent of all rotavirus deaths that occurred globally.


According to the United Nations Children’s Fund India statistics from 2011, about half of all children in India experienced an episode of rotavirus (for a total of more than 11 million episodes). 


In addition, 1 in every 31 children was hospitalized due to rotavirus (for a total of more than 872,000 hospitalizations).The first year of life is the period of highest risk for death due to rotavirus infection among children in India. 


The Global Enterics Multi-Center Study (GEMS) looked at acute diarrhea in children 0 to59 months of age. It was conducted at seven sites in Africa and Asia, including the National Institute of Cholera and Enteric Diseases in Kolkata, India. Results from GEMS showed that rotavirus was responsible for the highest number of cases of diarrhea at the India study site for children up to 23 months of age.   and Enteric Diseases in Kolkata, India. Results from GEMS showed that rotavirus was responsible for the highest number of cases of diarrhea at the India study site for children up to 23 months of age.  


For children ages 24 to 59 months, rotavirus remained responsible for more than 13 percent of cases of diarrhea at the India site. In January 2016, the Indian Government began a phased introduction of rotavirus vaccine into the publicly funded Universal Immunization Programme.   

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