Ringing in 2018 with an exciting rotavirus vaccine milestone

Jan 24, 2018


Allison Clifford
Communications Manager, PATH's Center for Vaccine Innovation and Access

Rotavirus vaccines are starting off the new year with a bang! Bharat Biotech just announced that ROTAVAC® has achieved prequalification by the World Health Organization (WHO), making it available for procurement by United Nations agencies and Gavi, the Vaccine Alliance, for use in low-resource countries. This marks the first new rotavirus vaccine to achieve WHO prequalification since 2009, bringing a new affordable option to the table for low-resource countries.


Rotavirus is the most common cause of severe diarrheal disease in children worldwide, and vaccines are the best way to prevent this terrible illness. Although more than 90 countries have already introduced rotavirus vaccines into their national immunization programs, 67 percent of all children—more than 90 million infants—still lack access to rotavirus vaccines. While current manufacturers play an important role in meeting the global demand for the existing rotavirus vaccines, additional vaccine options and manufacturers are critical to ensuring a sustainable, affordable supply.


When I joined PATH in 2007 to provide communication support for our work developing vaccines against the leading causes of diarrheal disease, the vaccine (then known simply as 116E, in reference to the neonatal strain upon which it is based) was just finishing up a Phase 1b/2a study in India with support from PATH and a consortium of international partners. Results from that study were reviewed in February 2008 and showed the vaccine to be safe with a robust immune response in 89 percent of infants, which led to the consortium’s approval to move the vaccine to Phase 3 efficacy studies.


Fast-forward 10 years, and 116E successfully completed Phase 3 testing and achieved licensure in India, and it’s currently being rolled out to millions of infants in India through the government’s national immunization program. And now, it will also be available for children all over the world, putting us one step closer to reaching the ultimate goal of 100 percent access to rotavirus vaccines.


List of three WHO prequalified rotavirus vaccines, ending with ROTAVAC
Help us spread the good news with these tweets and graphics.


It’s so remarkable and rewarding for me to see how far this vaccine has come over the last decade, and it’s exciting to think about where we could be in 10 more years. Let’s aim to make rotavirus a thing of the past!