PHILADELPHIA, May 14 GlaxoSmithKline (NYSE: GSK) announced that the Food and Drug Administration (FDA) has determined that U.S. healthcare practitioners can resume the use of Rotarix® (Rotavirus Vaccine, Live, Oral), effective immediately. This action supersedes the FDA's recommendation from March 22, 2010 and reflects the agency's assessment that the presence of porcine circovirus type 1 (PCV-1) in the vaccine poses no safety risk.
The FDA stated that the benefits of rotavirus vaccination are substantial, and include prevention of death in some parts of the world and hospitalization for severe rotavirus disease in the United States. The FDA further concluded that these benefits outweigh the risk, which is theoretical.
Barbara Howe, MD, Vice President, Director, North American Vaccine Development, GlaxoSmithKline stated: "We appreciate the swift and thorough review conducted by both the FDA and an expert advisory committee into the recent findings related to PCV-1 and the benefit/risk profile of Rotarix. We will continue to work with the FDA and other regulatory authorities on next steps as we maintain our commitment to helping protect infants from rotavirus disease in the U.S. and around the world."
Notes to Editors
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. This is consistent with the body of literature that has not shown any evidence of PCV-1 infection in humans, or any other animals, including pigs.
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
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.
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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.
-- 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.