Rotarix, An Oral Rotavirus Vaccine, Approved By The FDA

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Main Category: Immune System / Vaccines
Also Included In: Pediatrics / Children's Health;  GastroIntestinal / Gastroenterology;  Regulatory Affairs / Drug Approvals
Article Date: 04 Apr 2008 - 11:00 PDT

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The FDA (Food and Drug Administration, USA) has approved Rotarix, an oral vaccine for the prevention of rotavirus - an infection in children and infants which causes vomiting and diarrhea (gastroenteritis).

The vaccine, which is presented in liquid form, is given in two doses to infants aged 6 and 24 weeks. It protects against gastroenteritis caused by the G1, G3, G4, and G9 strains of rotavirus.

There are approximately 2,700,000 gastroenteritis cases among US children each year, of which 55,000-70,000 need to be hospitalized. Between 20 and 60 children/babies die each year as a result of gastroenteritis annually in the USA. Health experts say that virtually every American kid will be infected with rotavirus by the age of 5 at least once if they are not vaccinated.

Jesse L. Goodman, M.D., M.P.H., Director, Center for Biologics Evaluation and Research, FDA, said "This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children."

Studies involving over 24,000 infants showed that Rotarix is effective in preventing rotavirus-caused gastroenteritis during the first two years of a baby's life.

The following adverse events were reported during the clinical trials - fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting.

A different rotavirus vaccine was voluntarily withdrawn by the manufacturer in 1999 because it was linked to a raised risk of intussusception, or intestinal folding, which can lead to potentially life-threatening intestinal blockage.

Intussusception can occur in non-vaccinated children spontaneously, but to help ensure that Rotarix does not raise the risk of intussusception, GlaxoSmithKline (GSK) conducted a study of more than 63,000 infants. The study compared 31,673 children who received Rotarix to 31,552 children who received a placebo - Rotarix was found not to increase a child's risk of intussusception.

The FDA has asked the manufacturer (GSK) to conduct post-marketing safety studies involving over 40,000 infants- because during the intussusception study a higher rate of convulsions and pneumonia-related deaths were observed. However, this was not observed in other studies.

-- Rotarix

Written by - Christian Nordqvist


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