Serum Institute's vaccine demonstrates significant efficacy against severe rotavirus

September 26, 2017, PATH
Transmission electron micrograph of intact rotavirus particles, double-shelled Transmission electron micrograph of intact rotavirus particles, double-shelled. Credit: CDC

Results from a Phase 3 efficacy study in India of the Serum Institute of India Pvt. Ltd.'s rotavirus vaccine BRV-PV (known as ROTASIIL) were published in the journal Vaccine. The study showed the vaccine to be safe, well tolerated, and to provide significant efficacy against severe rotavirus gastroenteritis. In 2013, an estimated 47,100 rotavirus deaths occurred in India, 22 percent of all rotavirus deaths that occurred globally.

ROTASIIL reduced severe rotavirus diarrhea by more than a third - 39.5 percent over two years. Significantly, the 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, under whose leadership this vaccine has been developed, commented, "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 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 of India 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.

"This is great news for India," noted Dr. David Kaslow, PATH's vice president for Essential Medicines and global head of the Center for Vaccine Innovation and Access. "The results and successful licensure of this rotavirus vaccine is an exciting and encouraging milestone toward the public health goal of improving the supply of affordable rotavirus vaccines, both in India and worldwide."

Médecins Sans Frontières and Epicentre are also evaluating the efficacy and safety of ROTASIIL in a separate Phase 3 study 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.

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 used in the Niger study.

Explore further: New low-cost rotavirus vaccine could reduce disease burden in developing countries

More information: Vaccine, DOI: 10.1016/j.vaccine.2017.09.014 , http://www.sciencedirect.com/science/article/pii/S0264410X17312306

Related Stories

New low-cost rotavirus vaccine could reduce disease burden in developing countries

March 22, 2017
A new vaccine for rotavirus was found to be 66.7% effective in preventing severe gastroenteritis caused by the virus, according to a new study from researchers at Harvard T.H. Chan School of Public Health and Epicentre, Paris. ...

Rotavirus vaccines continue to reduce diarrhea hospitalizations, medical costs in US kids

August 10, 2017
Following the introduction of routine childhood vaccination against rotavirus, a common cause of diarrheal illness, more than 380,000 children avoided hospitalization for diarrhea from 2008 to 2013 in the U.S., thus saving ...

Gaps in vaccine coverage highlighted with new report and online tool

May 24, 2016
As the 69th World Health Assembly discusses progress on the Global Vaccine Action Plan, a new data visualization platform—from the International Vaccine Access Center (IVAC) at the Johns Hopkins Bloomberg School of Public ...

India announces low-cost rotavirus vaccine (Update)

May 14, 2013
The Indian government announced Tuesday the development of a new low-cost vaccine proven effective against a diarrhea-causing virus that is one of the leading causes of childhood deaths across the developing world.

Rotavirus vaccine given to newborns in Africa is effective

June 17, 2013
Mayo Clinic and other researchers have shown that a vaccine given to newborns is at least 60 percent effective against rotavirus in Ghana. Rotavirus causes fever, vomiting and diarrhea, which in infants can cause severe dehydration. ...

Research identifies causes and possible treatments for deadly diseases affecting children

September 11, 2017
Each year, more than half a million deaths among children under five years of age around the world are caused by diarrheal diseases—largely due to insufficient access to adequate hygiene, sanitation and clean drinking water. ...

Recommended for you

Study identifies how hantaviruses infect lung cells

November 21, 2018
Hantaviruses cause severe and sometimes fatal respiratory infections, but how they infect lung cells has been a mystery. In today's issue of Nature, an international team including researchers at Albert Einstein College of ...

Scientists shed new light on infection process of the gastrointestinal pathogen C. difficile

November 21, 2018
Scientists from the VIB-UGent Center for Inflammation Research identified the mechanisms by which the bacterial pathogen Clostridium difficile kills intestinal epithelial cells (IECs), thus destroying the protective mucosal ...

As antibiotic resistance grows, researchers find new targets for fighting deadly staph infections

November 21, 2018
A new look at the inner-workings of bacterial cells could help researchers overcome deadly antibiotic resistance and save the lives of tens-of-thousands of people every year.

Can liver disease be linked to heart failure? Study highlights liver-heart interaction

November 21, 2018
Virginia Commonwealth University researchers have collaborated on a clinical trial that identifies indicators for nonalcoholic fatty liver disease—a typically asymptomatic disease caused by fat buildup in the liver and ...

Researchers find infectious prions throughout eyes of patients with deadly sporadic Creutzfeldt-Jakob disease

November 20, 2018
By the time symptoms of sporadic Creutzfeldt-Jakob disease (sCJD) are typically discovered, death is looming and inevitable. But, in a new study, researchers at University of California San Diego School of Medicine with colleagues ...

Researchers a step closer to understanding how deadly bird flu virus takes hold in humans

November 19, 2018
New research has taken a step towards understanding how highly pathogenic influenza viruses such as deadly bird flu infect humans.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.