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Rotarix Rotavirus Vaccine

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Updated May 19, 2010

Rotarix Basics:

Rotarix is a rotavirus vaccine that was approved by the FDA in April 2008. Its use was temporarily halted by the FDA while they investigated the presence of a non-harmful porcine virus in the vaccine, but was quickly resumed in May 2010 after they determined it was still safe.

What Rotarix Is Used For:

Rotarix protects young children against mild and severe gastroenteritis that is caused by certain strains of rotavirus.

Rotavirus Facts:

Rotavirus is the most common cause of severe gastroenteritis, with watery diarrhea, vomiting, fever, and abdominal pain, in children. Although many children have mild symptoms, they can still linger for up to eight days. Each year, about 50,000 unvaccinated children are hospitalized from complications of rotavirus infections and there are 20 to 40 deaths.

Rotarix Facts:

Rotarix is given as a two-dose series that can be started when an infant is as young as six weeks old. The second dose can be given as early as four weeks later and must be given before the baby is 24 weeks old. Infants will likely get Rotarix at their two- and four-month checkups.

Forms Of Rotarix:

Like Rotateq, Rotarix is a live, oral rotavirus vaccine. It can be given completed with just two doses though, while the Rotateq vaccine series requires three doses.

Rotarix Side Effects:

The most common side effects of the Rotarix vaccine include fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting. Large safety trials have been conducted and have found no associated between Rotarix and intussusception, which was a rare, but serious side effect of Rotashield, the first rotavirus vaccine that is no longer available.

What You Need To Know:

Rotarix is being used in over 100 countries around the world, including Europe, Asia, and many countries in Latin America. A review of Rotarix in the Seminars of Pediatric Infectious Disease found that "large safety and efficacy trials have shown the vaccine is safe, not associated with intussusception, and effective..."

Sources:

FDA News Release. FDA Revises Recommendations for Rotavirus Vaccines. May 14, 2010.

FDA News Release. FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus. April 3, 2008.

CDC National Center for Immunization and Respiratory Diseases. About Rotavirus.

Gershon: Krugman's Infectious Diseases of Children, 11th ed.

Live attenuated human rotavirus vaccine, Rotarix. Bernstein DI - Semin Pediatr Infect Dis - 01-OCT-2006; 17(4): 188-94.

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