The World Health Organization (WHO) pre-qualification allows for expanded access to Rotateq and provides a greater opportunity to help protect millions of babies from rotavirus gastroenteritis, said Merck.
Because Rotateq is pre-qualified by the WHO, the vaccine is eligible for procurement by the Pan American Health Organization, UNICEF and other United Nations agencies for use in national vaccination programs. Rotateq is said to be the only ready-to-use oral liquid rotavirus vaccine to receive WHO pre-qualification.
In the US, Rotateq is indicated for use in infants and children for the prevention of rotavirus gastroenteritis caused by serotypes G1, G2, G3 and G4 and is administered orally as a three-dose series between the ages of six and 32 weeks.
The WHO pre-qualification of Rotateq is based on quality, safety and efficacy data generated in the US, Latin America and Europe. Merck has committed to provide additional safety and efficacy data from Africa and Asia and is currently conducting clinical trials in these regions in partnership with the Rotavirus Vaccine Program (RVP) of PATH, an international, nonprofit organization.
Mark Feinberg, vice president of medical affairs and policy at Merck vaccines and infectious diseases, said: “WHO pre-qualification of Rotateq is an important milestone in expanding the global availability of Rotateq, and importantly, for facilitating efforts to accelerate the introduction of the vaccine in the world’s poorest countries.
“Merck’s pledge to provide Rotateq to The Global Alliance for Vaccines and Immunization-eligible countries at prices at which we do not profit is another step to make this vaccine accessible to all who need it in every part of the world.”