Officials from the US Food and Drug Administration (FDA) have advised physicians to temporarily suspend the use of Rotarix, a vaccine used to prevent rotavirus infection.
The FDA is concerned that the vaccine manufactured by GlaxoSmithKline is contaminated with a second virus, called PCV-1, which infects pigs and other species but is not known to cause illness in humans or any other animals.
The virus is believed to have come from the cell cultures used to make Rotarix, and there is no evidence that this finding poses a safety risk.
Because available evidence supports the safety of Rotarix, no medical follow-up is needed for patients who have been vaccinated with Rotarix.
Rotavirus can cause vomiting and diarrhoea in infants and children, causing around 500,000 deaths a year.
There are two licensed vaccines for rotavirus in the US: RotaTeq and Rotarix.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataThe FDA has recommended the precaution while the agency learns more about the situation.