Oral rotavirus vaccine Rotarix receives FDA approval

ST LOUIS (MD Consult) – On April 4, 2008, the US Food and Drug Administration (FDA) and GlaxoSmithKline announced the approval of Rotarix (rotavirus vaccine, live, oral), the second oral US-licensed vaccine for the prevention of rotavirus infection. Rotarix is indicated for the prevention of gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9). The approved vaccine will be available in liquid formulation and is to be orally administered in a 2-dose series to infants aged 6 to 24 weeks.

In infants and children, infection with rotavirus causes gastroenteritis. Although the disease is usually self-limiting, rotavirus causes about 2.7 million cases of gastroenteritis in American children each year. Without vaccination, nearly every child in the United States would likely be infected with rotavirus at least once by the age of 5 years.

The FDA approval of Rotarix was granted on the basis of data collected from nearly 75,000 infants. Clinical trials of the vaccine were conducted in the Americas, Europe, Asia, and Africa and reflect an ethnically diverse population. Clinical data published on the 2-dose series of Rotarix show that protection for rotavirus infection was sustained through the first 2 years of life and was highly efficacious against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%). In addition, Rotarix was effective against rotavirus gastroenteritis of any severity (79%). Specifically, significant protection was demonstrated against severe rotavirus gastroenteritis during 2 rotavirus seasons caused by types G1 (96%), G2 (86%), G3 (94%), G4 (95%), and G9 (85%), the most commonly circulating rotavirus types in the United States. The most common adverse reactions reported during clinical trials were fussiness, irritability, cough, rhinorrhea, fever, vomiting, and loss of appetite.

The US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians recommend that infants receive routine rotavirus vaccination and complete the vaccine series by the age of 6 months. Rotarix will be commercially available in the United States in the second half of 2008.


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