NEW DATA SHOWS GSK’S ROTAVIRUS VACCINE HIGHLY EFFICACIOUS IN PROTECTING ASIAN INFANTS

New data from a multi-centre trial presented at the recent 13th International Congress on Infectious Diseases (ICID) demonstrates that two doses of GlaxoSmithKline’s (GSK) oral rotavirus vaccine, are highly efficacious (96.1%) against severe rotavirus gastroenteritis (RVGE), offering sustained protection during the first two years of life when the disease burden is highest. A total of 10,708 infants were enrolled in the double-blind, placebo-controlled trial in an urban Asian setting. These data are in line with data from other settings, including Europe, where the rotavirus vaccine has shown high levels of efficacy and up to 100% reduction in hospitalizations caused by RVGE. European data have shown that GSK’s oral rotavirus vaccine offers statistically significant protection against the five most commonly circulating rotavirus strains: G1, G2, G3, G4 and G9.3 Rotavirus (RV) disease is the leading cause of severe gastroenteritis among children below five years of age and diarrhea-related illness including dehydration, hospitalization and death among infants and young children.

In addition, new data from a multi-centre survey revealed at the congress shows hospitalization of a child for acute gastroenteritis has a significant impact on parents as well in terms of level of anxiety, impact on daily living and time off work. Working parents miss work for three days on average due to the child’s illness.

Data from a survey of 763 parents of children hospitalized for acute gastroenteritis from the Philippines, Malaysia, Thailand, Argentina, Columbia and Egypt further showed that parents were greatly concerned that their child would suffer from fever, vomiting, diarrhea and dehydration as a result of rotavirus infection. This concern for the child also impacted the parent’s quality of life with the majority reporting feeling ‘very worried’ (69.6%) or ‘extremely heartbroken’ (58.7%) to see their child ill. These data are in line with other studies which have shown a major impact on the economic burden to affected families and society as a whole.

Jean Stéphenne, President of GSK Biologicals said: “Immunization is the only effective intervention to reduce rotavirus disease burden in infants and young children. GSK’s oral rotavirus vaccine has now been studied in more than 100,000 infants and over 27 millions doses of the vaccine have been distributed in the past three years. The new data adds to the growing body of evidence on the efficacy and safety of the vaccine in the prevention of rotavirus gastroenteritis. This also shows that with only two doses of our live attenuated-human rotavirus vaccine, a high and sustained protection is provided during the first two years of life against rotavirus gastroenteritis in Asian infants, which also leads to a reduction in hospitalizations.” RV is a major disease burden in developing countries, particularly South Asia. It is estimated that over 661,000 children die of rotavirus gastroenteritis each year, a child per minute worldwide; Of these deaths, 90% occur in Asia and Africa.

Additional studies presented at ICID demonstrate that GSK’s oral rotavirus vaccine is also well tolerated when co-administered with routine vaccinations in Latin America and does not affect the immune response to oral polio vaccine (OPV). With a simple dosing schedule, GSK’s two-dose oral rotavirus vaccine allows completion of the course by 10 weeks of age, which is up to one month earlier compared to the other rotavirus vaccine.

Miguel O’Ryan, Professor and Director of the Microbiology and Mycology Programme, Institute of Biomedical Sciences, University of Chile said: “Globally there are 25 million physician visits every year as a result of rotavirus infections. Rotavirus gastroenteritis kills more than half a million children annually, mostly in developing countries and accounts for one third of hospitalizations for diarrhea worldwide. Efficacy data obtained from studies worldwide clearly demonstrate that vaccination against rotavirus before six months of age significantly prevents associated hospitalizations during the first two years of life, the age at which rotavirus disease burden is highest. The emotional and financial burden for parents associated with the occurrence of a severe rotavirus infection in their child can be prevented by early vaccination.”

GSK’s rotavirus vaccine is currently licensed in more than 100 countries around the world and sold in 62 countries. It has been approved by the U.S. Food and Drugs Administration (FDA) and is the only rotavirus vaccine that received a pre-qualification status by the World Health Organization. In the Philippines, GSK’s live oral rotavirus vaccine is registered and approved by Bureau of Food and Drugs (BFAD). It is the only two-dose oral rotavirus vaccine that provides early protection to infants by 3 months of age.

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