FDA panel backs Rotarix.An FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. committee of vaccine experts recommended the approval of Rotarix, a GlaxoSmithKline vaccine designed to help protect infants from a gastrointestinal illness caused by rotavirus rotavirus /ro·ta·vi·rus/ (ro´tah-vi?rus) any member of the genus Rotavirus. ro´taviral Rotavirus /Ro·ta·vi·rus/ (ro´tah-vi?rus , "The Wall Street Journal" reported Feb. 21. The panel unanimously said it believed the vaccine was effective and voted 11-1 in favor on the question of whether the vaccine was safe. The votes amount to a recommendation that the agency approve the vaccine. FDA is expected to decide whether to approve Rotarix by April 3. Rotavirus infection rotavirus infection Virology RI is usually mild, but may be severe in children ≤ 2 yrs due to intense vomiting Morbidity > 870,000 children < age 5 die of rotavirus infection in developing countries, in contrast to 75 to 150 in the US Epidemiology hits most children before age 5. Although rotavirus deaths in the U.S. are rare, the infection still causes about 50,000 to 70,000 hospitalizations each year. Rotarix, like a similar vaccine by Merck called RotaTeq, is designed to protect infants against rotavirus during their first two years of life, when the infection's symptoms are most likely to be severe. Merck's vaccine has been on the U.S. market since 2006, and health officials have been monitoring it for links to a rare bowel problem called intussusception Intussusception Definition Intussusception is the enfolding of one segment of the intestine within another. It is characterized and initially presents with recurring attacks of cramping abdominal pain that gradually become more painful. . A Wyeth vaccine was pulled off the market in 1999 after it was linked to the ailment ail·ment n. A physical or mental disorder, especially a mild illness. , which is marked by a twisting or obstruction of the intestine that can be fatal. About a year ago, FDA issued a public-health advisory discussing 28 reports of intussusception seen among infants who were given Merck's vaccine. The Centers for Disease Control later cleared the vaccine, saying intussusception rates among vaccinated infants were lower than what would be found in the general population. Still, federal health officials continue to monitor RotaTeq and would do the same for Rotarix, assuming it is approved, The Journal reported. So far, 11 clinical studies of Glaxo's vaccine, involving more than 75,000 children, do not show an increased risk of intussusception, with six cases reported among children receiving the vaccine in clinical studies compared with seven cases seen among patients receiving a placebo. However, Steven Rosenthal, an FDA medical officer who presented the agency's review of the vaccine, said there was a higher rate of pneumonia-related deaths and convulsions Convulsions Also termed seizures; a sudden violent contraction of a group of muscles. Mentioned in: Heat Disorders among vaccinated infants in one of the main studies. The overall death rate from any cause, however, was similar between infants given the vaccine and those in placebo groups. In total, there were 118 deaths among all infants in the studies, with 19 pneumonia related-deaths among those receiving the vaccine and 10 among those not receiving it. Clare Kahn, Glaxo's North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. vice president of regulatory affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: |
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