GSK Statement on FDA Advisory Committee Meeting on Rotavirus Vaccines

GAITHERSBURG, Md., May 7 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today participated in a U.S. Food and Drug Administration (FDA) advisory committee meeting convened to discuss recent findings of porcine circovirus (PCV) in rotavirus vaccines. Although the committee did not issue any formal recommendations, members widely acknowledged that the benefits of vaccinating infants worldwide against rotavirus disease clearly outweigh the theoretical risks associated with the presence of porcine circovirus type 1 (PCV-1) in the vaccines.

The advisory committee also discussed current and emerging techniques to detect viruses and the implications of using such techniques to test vaccines currently licensed or in development.

GSK presented data from investigations conducted since the finding of material from PCV-1 in Rotarix® (Rotavirus Vaccine, Live, Oral). GSK had previously informed worldwide regulatory authorities of the finding. According to the FDA and other regulatory agencies around the world, there is no evidence that these findings pose a safety risk. As a precautionary measure, on March 22, 2010, FDA recommended that US healthcare practitioners temporarily suspend the use of Rotarix.

The European Medicines Agency (EMA) and the World Health Organization (WHO) have not recommended any change to the way that healthcare practitioners in Europe and the developing world use Rotarix.

According to scientific literature, PCV-1 is a common virus that has been found in pork products. It is not known to cause illness in humans or any other animals, including pigs. Testing of clinical samples conducted by GSK has not shown any indication of PCV-1 infection in infants who received Rotarix. This is consistent with the body of literature that has not shown any evidence of PCV-1 infection in humans.

GSK stands behind the safety profile of Rotarix. The company will work with regulatory authorities to continue to provide the vaccine to help protect children from rotavirus disease. GSK is committed to producing Rotarix that does not contain PCV-1.

Thomas Breuer, Head of Global Development, GSK Biologicals stated: "Evolving technologies can lead to new findings that were not known at the time of licensure. Decisions on the application of these new technologies must continue to be based on sound science and consideration of the benefit/risk profile of the respective vaccine. GSK is committed to an ongoing dialogue to ensure the worldwide availability of life-saving vaccines."

After considering the input of the committee's experts and the available scientific information, FDA will make further recommendations on the use of the licensed rotavirus vaccines in the United States.

Notes to Editors

About PCV-1

Porcine circovirus 1 (PCV-1) is a small circular virus composed of a single strand of DNA. According to scientific literature, PCV-1 is a common virus that has been found in pork products. It is not known to cause illness in humans or any other animals.

About Rotarix®

Rotarix is a two-dose, orally-administered vaccine that offers protection against rotavirus to infants and children. More than 69 million doses of the vaccine have been distributed globally, with 2.5 million in the United States.

In the U.S., Rotarix is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9). It is approved for use in infants 6 weeks to 24 weeks of age.

The safety profile of Rotarix is based on extensive clinical data from the largest vaccine clinical trial program conducted by GSK, enrolling more than 90,000 participants in Europe, Latin America, Asia, Africa, and the U.S.

Important Safety Information Based on the Rotarix US Prescribing Information

• In clinical studies, common adverse events were fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting. 
• Contraindications include a history of any of the following: Hypersensitivity to any component of the vaccine including latex rubber (contained in the oral applicator), uncorrected congenital malformation of the gastrointestinal tract, or Severe Combined Immunodeficiency Disease (SCID). 
• Administration in infants suffering from acute diarrhea or vomiting should be delayed. 
• Safety and effectiveness in infants with chronic gastrointestinal disorders, or with known primary or secondary immunodeficiencies, have not been evaluated.
• Vaccination may not provide 100% protection to all recipients.

About Rotavirus

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

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

Before rotavirus vaccination was introduced in the U.S, each year an estimated 2.7 million children younger than five years of age experienced rotavirus disease, resulting in hundreds of thousands of emergency room visits and more than 55,000 hospitalisations.

GlaxoSmithKline Biologicals

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. For further information please visit www.gsk.com

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

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2009.

SOURCE GlaxoSmithKline