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May 2008 The FDA recently announced the licensure of the new live, oral, attenuated rotavirus vaccine for protection against rotavirus gastroenteritis strains G1, G3, G4 and G9 in infants aged 6 to 24 weeks. The newly licensed vaccine (Rotarix, GlaxoSmithKline) is the second oral rotavirus vaccine licensed in the United States and is offered in a two-dose liquid form series. “With only two doses, [the new vaccine] allows infants to complete the vaccination series earlier than ever before. This may prevent many of the emergency department visits and hospitalizations that are a burden on families and the health care system,” Barbara Howe, MD, vice president and director of North American vaccine development at GlaxoSmithKline, said in a press release. “This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children,” Jesse L. Goodman, MD, director of the FDA’s center for biologics evaluation and research, said in an FDA press release. Data from studies that included more than 24,000 infants suggested the vaccine is effective for the prevention of both severe and mild forms of rotavirus gastroenteritis during the first two years of life. Reported adverse events included irritability, cough, runny nose, fever and vomiting. The manufacturer also conducted a study to ensure that the vaccine did not increase the risk for intussusception that resulted in the 1999 voluntary withdraw of a different rotavirus vaccine (RotaShield, Wyeth-Ayerst). The study of the new vaccine involved more than 63,000 infants, and results indicated no increase in intussusception occurred among the vaccine group (n=31,673) when compared with the placebo group (n=31,552). However, an increased incidence for convulsions and pneumonia-related deaths were observed among the vaccine-recipient group, but were not observed in other studies conducted by the manufacturer. According to the FDA, “Available data do not establish that these events are related to the vaccine. The agency has requested the manufacturer conduct post-marketing safety studies involving more than 40,000 infants to provide additional safety information.” The vaccine is expected to be available in the United States during the second half of 2008.
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