Game-changing rotavirus vaccine from India gets WHO nod

September 27, 2018 by Dr. Tushar Tewari

Mother and infant in Indian. Photo: Richard Franco

A mother in India holds her infant. Photo: Richard Franco

The thermostable vaccine ROTASIIL® is now available for procurement by United Nations agencies and Gavi, the Vaccine Alliance.

India has long been a leader in developing safe, effective, and affordable vaccines for the global market, so it should really come as no surprise that, for the second time this year, the World Health Organization (WHO) has prequalified a new rotavirus vaccine produced in India. But, Serum Institute of India’s ROTASIIL® is the very first thermostable rotavirus vaccine to reach this milestone, which could be a real game-changer.

As a Senior Medical Officer with PATH’s Center for Vaccine Innovation and Access, I had the privilege of serving as the Team Leader for the ROTASIIL® Phase 3 efficacy study in India that PATH helped conduct, which led to the vaccine being licensed in India in 2017, and now reaching this new milestone of WHO prequalification.

Back during my medical school days, when today’s avenues to diagnose rotavirus were not available, I was intrigued by continuing deaths in children due to diarrhea in spite of antibiotic treatment. Rotavirus is the most common cause of severe diarrheal disease in children worldwide, and vaccines are the best way to prevent this terrible illness. Unfortunately, 57 percent of all children—over 70 million infants—still lack access to rotavirus vaccines. Achieving WHO prequalification means the vaccine is now available for procurement by United Nations agencies and Gavi, the Vaccine Alliance, for use in low-resource countries, and it’s a key step for vaccine manufacturers to reach global markets.

ROTASIIL®, which prevents severe rotavirus diarrhea in infants, provides an innovative and practical option to many countries since it can be stored outside the cold chain. This holds a tremendous amount of promise for lots of low-resource settings, particularly in sub-Saharan Africa and southern Asia, where there are still many countries that have not yet introduced rotavirus vaccine.

In Sinafala village, an infant sleeps on her mother's lap

In Sinafala village, Zambia, an infant sleeps on her mother's lap. Photo: Gabe Bienczycki

“ROTASIIL®, which prevents severe rotavirus diarrhea in infants, provides an innovative and practical option to many countries since it can be stored outside the cold chain.”

All other globally available rotavirus vaccines need to be refrigerated. But, ROTASIIL® is unique in that it does not require refrigeration and can remain stable for up to 30 months at temperatures below 25°C. Having witnessed, on multiple occasions, losing vaccines because of erratic power supply especially in rural areas, the need for a thermostable vaccine cannot be overemphasized. Having access to heat-stable vaccines can make a huge difference in places where electricity is unreliable or nonexistent, and it eliminates the need for cold storage boxes when delivering vaccines to rural health clinics. Simplifying transport for that critical “last mile” of the vaccine supply chain can make a valuable difference in reaching those who need vaccines most and saving more children’s lives.

ROTASIIL® is already being rolled out to millions of infants here in India through the government’s national immunization program, and it’s exciting to think that now children worldwide will have access to this new rotavirus vaccine. I’m truly proud of the role that PATH played, in partnership with Serum Institute and many others, to evaluate the vaccine’s efficacy in India and contribute to the hard work that helped ROTASIIL® achieve this pivotal milestone. And, I’m also proud that India is, once again, contributing to the toolbox of interventions needed to fight diarrheal disease with this innovative new rotavirus vaccine.

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