Rotarix™ significantly reduced severe rotavirus gastroenteritis in African babies during their first year of life

The New England Journal of Medicine (NEJM) today published the first study demonstrating that Rotarix™, GlaxoSmithKline’s rotavirus vaccine, significantly prevented severe rotavirus gastroenteritis during the first year of life in African babies. In the study Rotarix prevented the disease in 61.2% of these infants. The study also showed that Rotarix. provided broad protection against diverse circulating rotavirus strains.

“Rotavirus disease has caused more than five millions deaths in infants and young children over the last decade. It is time to act to avoid these unnecessary deaths and hospitalisations from rotavirus gastroenteritis. GSK is committed to working with our partners to help ensure that Rotarix reaches those in need, wherever they live,” commented Thomas Breuer, Head of Global Clinical R&D and Chief Medical Officer of GSK Biologicals.

Rotavirus is a contagious infection that kills an estimated 1,600 children under the age of five every day, most of these deaths are in Africa and Asia.¹ In addition, six of the seven countries with the highest rotavirus diarrhoea mortality rates are located in Africa.² The high number of severe rotavirus gastroenteritis cases and associated deaths in Africa means that Rotarix vaccination may have an even greater public health impact than in developed countries where parents have easy access to hospitals.

“Measures to prevent rotavirus diarrhoea are urgently needed for African children,” commented study author Professor Shabir Madhi, Professor of Vaccinology, University of the Witwatersrand, South Africa. “We have shown that immunisation during early infancy can significantly reduce the burden of gastroenteritis, even in the most challenging of settings, such as Africa.”

The trial was designed to accumulate data from Africa and include populations that would be broadly representative of those in developing countries. These data suggest that, when introduced into standard childhood vaccination schedules in similar settings across Africa, Rotarix is expected to have a considerable public health benefit.

Rotarix is generally well-tolerated. The most common adverse events after vaccination are fever, fatigue, irritability and gastrointestinal disorders.

In April 2009, the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) recommended that rotavirus vaccination be included in all national immunisation programmes. Based on this decision, the WHO awarded global prequalification to Rotarix. These decisions have opened the door to making rotavirus vaccines available to children worldwide.

Notes to editors

About the study

In South Africa and Malawi, more than 4 900 infants were enrolled in clinical trials examining the efficacy of Rotarix. Healthy babies were randomized (1:1:1) to receive placebo followed by 2 doses of Rotarix, 3 doses of Rotarix or 3 doses of placebo, respectively, at 6, 10 and 14 weeks of age with routine childhood vaccines including oral poliovirus vaccine. Episodes of gastroenteritis caused by circulating wild-type rotavirus during the first year of life were assessed through active follow-up and graded for severity using the Vesikari scale. The clinical trials were conducted by the Rotavirus Vaccine Trials Partnership (RVTP), a collaboration between PATH, the WHO and US Centers for Disease Control and funded by the GAVI Alliance. Clinical research sites in South Africa and Malawi also partnered with RVTP to conduct the trials, along with GSK, who provided co-funding for the research.

Rotarix

Rotarix is a two-dose, orally-administered vaccine that offers early protection against rotavirus to infants. Rotarix. is indicated for the active immunisation of infants from the age of 6 weeks for prevention of gastro-enteritis due to rotavirus infection. The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks.³ Since 80% of rotavirus infections in developing countries occur in infants less than one year old, early administration of the first dose at six weeks helps protect the most vulnerable population as early as possible.

The global clinical development program has spanned five continents and demonstrates that Rotarix protects against the most common circulating strains (G1 and non-G1 rotavirus strains) including the emerging G9 strain.⁴ Rotarix is also able to significantly reduce hospitalisations for all gastroenteritis, regardless of cause. Today, Rotarix. is available in more than 116 countries around the world.

On 5^th June 2009, the World Health Organization (WHO) awarded global prequalification to Rotarix.This WHO prequalification is necessary for UN agencies and the Global Alliance for Vaccines and Immunisation (GAVI) to purchase Rotarix. on behalf of developing countries. The global designation accelerates access to the vaccine in Africa, as well as Asia, and expands on a 2007 decision by the WHO to prequalify the vaccine for Europe and the Americas.

Rotavirus gastroenteritis

Rotavirus (RV) is the leading cause of severe gastroenteritis (GE) among children below five years of age and a major disease burden in developing countries.^5,6Although the disease is endemic worldwide, more than 90% of these deaths occur in developing countries. The effects of rotavirus are especially severe in Asia and Africa, where a lack of clean water and limited healthcare infrastructure contribute to the spread of the disease.¹

It is estimated that more than half a million children die of rotavirus gastroenteritis each year, a child a minute worldwide.⁷ Of these deaths, 90% occur in Asia and Africa. More than 100,000 deaths each year occur in India and sub-Saharan Africa and 35,000 in China.¹

Globally, 25% to 55% of all children under the age of five hospitalized with diarrhoea or acute gastroenteritis are infected with rotavirus.¹

GlaxoSmithKline Biologicals (GSK Biologicals), GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 13 manufacturing sites strategically positioned around the globe. In 2008 GSK Biologicals distributed 1.1 billion doses of vaccines to 176 countries in both the developed and the developing world – an average of three million doses a day.

Through its accomplished and dedicated workforce, GSK Biologicals applies its expertise to discover innovative vaccines that contribute to the health and well-being of people of all generations around the world.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com

References

1. Glass RI, Bresee JS, Turcios R, Fischer TK, Parashar UD, Steele AD. Rotavirus vaccines: targeting the developing world. The Journal of infectious diseases. 2005 Sep 1;192 Suppl 1:S160-6.

2. WHO. Rotavirus deaths under 5 years of age per 100,000 population under five (and number of deaths) by country. Accessed August 2009, 2004.

3. Rotarix Summary of Product Characteristics. 2006.

4. Vesikari T, Karvonen A, Prymula R, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007 Nov 24;370(9601):1757-63.

4. Vesikari T, Karvonen A, Prymula R, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007 Nov 24;370(9601):1757-63.

5. Parashar UD, Bresee JS, Gentsch JR, Glass RI. Rotavirus. Emerg Infect Dis. 1998 Oct-Dec;4(4):561-70.

6. Bresee JS, Hummelman E, Nelson EA, Glass RI. Rotavirus in Asia: the value of surveillance for informing decisions about the introduction of new vaccines. The Journal of infectious diseases. 2005 Sep 1;192 Suppl 1:S1-5.

7. Parashar UD, Hummelman EG, Bresee JS, Miller MA, Glass RI. Global illness and deaths caused by rotavirus disease in children. Emerg Infect Dis. 2003 May;9(5):565-72.