FDA takes brakes off GSK's Rotarix

Rotavirus vaccines are in the clear. The FDA has decreed that both GlaxoSmithKline's (NYSE: GSK) Rotarix and Merck's (NYSE: MRK) Rotateq are safe despite their contamination with DNA from a pig virus known as porcine circovirus, or PCV. The decision reversed FDA's stance on Rotarix, which was the first of the two vaccines to test positive for PCV genetic material.

The agency's decision follows a May 7 recommendation from an FDA advisory panel, which said the PCV contamination didn't appear to be harmful to humans and the vaccines' benefits outweighed any "theoretical" risk the products might pose.

In announcing its decision, FDA said that both vaccines have strong safety records, including clinical trials of the vaccines in tens of thousands of patients, plus clinical experience with their administration in millions more. PCV isn't known to cause illness in humans, whereas the rotavirus these vaccines ward off can cause severe illness and even death. Indeed, the virus kills more than 500,000 infants every year.

- read the FDA release
- see the news from Reuters

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