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| |  FDA Approves RotaShield Vaccine For Use In The Prevention of Rotavirus PHILADELPHIA, PA -- Aug. 31, 1998 -- The United States Food and Drug Administration today announced that it has granted licensure to Wyeth-Ayerst Laboratories’ RotaShield(R) rotavirus vaccine, live, oral, tetravalent, the first vaccine for use in the prevention of rotavirus gastroenteritis, the most common cause of severe and sometimes fatal diarrhea in children. The approval of RotaShield was based on positive evaluation of efficacy data from three, large-scale clinical efficacy trials conducted in the U.S. and Europe. The vaccine is intended for oral administration to infants in a three-dose series at two, four and six months of age. Rotavirus causes a highly-contagious disease that infects nearly every child by the age of four. It causes diarrhea, cramps and vomiting and results in the dehydration and death of up to a million children world-wide every year. In the U.S. rotavirus infects 3.5 million children each year at a total cost to society of approximately $1.4 billion US. It is estimated that an immunisation program may prevent 1.08 million cases of diarrhea, avoiding 34,000 hospitalisations, 95,000 emergency room visits and 227,000 physician visits in the first five years of life. The Centers for Disease Control and Prevention (CDC) advisory committee on immunisation practices (ACIP) recommends routine use of RotaShield for all healthy infants. Authorisation is currently being sought to market the vaccine outside the U.S. A dossier has been filed in Europe and discussions with health authorities are underway in a number of other countries to make the vaccine available as soon as possible. As with all vaccines, serious reactions might rarely occur after administration of RotaShield. When compared to placebo, the most common adverse event was fever after the first dose. Administration to infants with persistent diarrhea or vomiting or to those who are known or suspected to be immunocompromised is contraindicated. It is not to be given to infants who are hypersensitive to latex or to any component of the vaccine, including aminoglycoside antibiotics, amphotericin B, or monosodium glutamate.
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