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).

An oral vaccine named “Rotarix” has been approved by The FDA (Food and Drug Administration, USA) for the prevention of rotavirus - an infection in children and infants which originate vomiting and diarrhea

The vaccine has been developed in liquid form, and it is given in two doses to infants aged 6 and 24 weeks. It protects against diarrhea caused by the G1, G3, G4, and G9 lines of rotavirus. There are almost 2,700,000 diarrhea cases among US children every year, out of which 55,000-70,000 need to be hospitalized. Health experts opine that every American kid will be infected with rotavirus by the age of 5 at least once if they are not vaccinated.

According to Jesse L. Goodman, M.D., M.P.H., Director, Center for Biologics Evaluation and Research, FDA, “The vaccine provides another option to fight and decrease a potentially severe illness that affects so many children.” Studies including over 24,000 infants represented that Rotarix was effective in preventing rotavirus-caused diarrhea during the first two years of a baby’s life.

During clinical trials these severe events like fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting have been noted.

In 1999, a different rotavirus vaccine was voluntarily taken back by the manufacturer because it was related to a high risk of intussusception, or intestinal folding, which can cause potentially life-threatening intestinal blockage. The FDA has inquired the manufacturer (GSK) to launch post-marketing safety studies involving over 40,000 infants- because during the intussusceptions study higher rates of convulsions and pneumonia-related deaths have been observed. However, this has not been observed in other studies.

Articles published here are the property of the site only. Copying and publishing contents from this site is strictly prohibited.