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FDA Clears Use of Rotavirus Vaccine, Rotarix

Also endorses continued use of RotaTeq; RotaTeq linked to lower hospitalization rates in new study

MONDAY, May 17 (HealthDay News) -- The introduction of the RotaTeq (RV5) vaccine is associated with a reduction in hospitalizations for acute gastroenteritis in children under 5, according to research published in the June 1 Journal of Infectious Diseases. And the U.S. Food and Drug Administration (FDA) has announced that health care professionals can resume using the vaccine Rotarix, and continue using RotaTeq, to prevent rotavirus in children.

Aaron T. Curns, of the U.S. Centers for Disease Control and Prevention in Atlanta, and colleagues compared hospitalization rates for acute gastroenteritis among U.S. children younger than 5 years of age during pre-RV5 rotavirus seasons from 2000 through 2006 with the post-RV5 2007 and 2008 seasons. The researchers found that the median rate for the 2000 through 2006 rotavirus seasons was higher than the rates for 2007 and 2008 (101.1 hospitalizations per 10,000 children compared with 85.5 and 55.5, respectively).

In other news, on March 22, the FDA recommended that use of the rotavirus vaccine Rotarix be temporarily suspended due to concerns over the presence of porcine circovirus type 1 (PCV1). The FDA was also aware of DNA from PCV1 and PCV2 in RotaTeq. On May 14, the agency announced revision of its rotavirus vaccine recommendations and that it is appropriate for health care professionals to resume the use of Rotarix and continue the use of RotaTeq.

"FDA has no evidence that either PCV1 or PCV2 poses a safety risk in humans, and notes that neither is known to cause infection or illness in humans," according to a May 14 posting by the agency. "In addition, both rotavirus vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of recipients."

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