Updated GlaxoSmithKline statement on European regulatory guidance relating to manufacture of Rotarix

GlaxoSmithKline (GSK)GlaxoSmithKline (GSK) confirmed that the European Medicines Agency (EMA) has maintained its position that it "sees no safety concerns with the Rotarix oral vaccine" and healthcare practitioners in the European Union should continue to use Rotarix™ as indicated. This follows a meeting of the Committee for Medicinal Products for Human Use (CHMP) held on 25th March 2010 to further review all available data relating to the presence of material from PCV-1 in the vaccine. Having done so, the CHMP has reconfirmed its position which is in line with previous communications by WHO, FDA, other national regulatory agencies as well as GSK that the presence of the material does not present a safety risk.

PCV-1 does not multiply in humans and is not known to cause any illness in humans.(1,2) It is found in everyday meat products and is eaten with no resulting disease. CHMP also confirmed that after reviewing the documentation from the company that material from PCV-1 has not been found in GSK Biologicals other live attenuated vaccines.

Thomas Breuer, Head of Global Clinical R&D and Chief Medical Officer of GSK Biologicals stated: “We remain confident in the safety profile of Rotarix. GSK has over fifty years experience of research & development in producing high quality vaccines and is committed to patient safety and to the highest manufacturing standards for all our vaccines. We are committed to reviewing our manufacturing process and in particular to replacing, in a timely manner, the source material used in production of Rotarix."

In the meantime, the company will continue to manufacture Rotarix in accordance with the approved production methods and quality standards agreed with regulatory authorities worldwide in order to help meet public health needs in fighting against rotavirus infection.

Rotarix is a two-dose, orally-administered vaccine that offers 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 safety profile of Rotarix is based on extensive clinical data from the largest vaccine clinical trial programme conducted by GSK, enrolling more than 90,000 participants in Europe, Latin America, Asia, Africa and the US. Additionally, the post marketing surveillance data represents more than 69 million doses of Rotarix vaccine distributed globally.

Rotavirus is the leading cause of severe gastroenteritis among children below five years of age and it is estimated that more than half a million children die of rotavirus gastroenteritis each year- a child a minute worldwide. It is predicted that rotavirus vaccination could prevent more than 2 million rotavirus deaths over the next decade.

The continued availability of rotavirus vaccines around the world remains critical from a public health perspective to protect children from rotavirus disease.

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.

1. Linlin Li, Journal of Virology, Feb. 2010, p. 1674–1682
2. Hattermann, Kim. Xenotransplantation 2004: 11: 284–294