LONDON (Reuters) - Rotavirus vaccines made by GlaxoSmithKline and Merck & Co are safe to use despite being contaminated with a pig virus, Europe’s drugs watchdog said on Friday.
The decision echoes a similar ruling from the U.S. Food and Drug Administration last week.
Glaxo’s Rotarix and Merck’s Rotateq, which is sold in Europe via a joint venture with Sanofi-Aventis, target rotavirus, which can cause fatal diarrhea. DNA from porcine circovirus (PCV) had been found in both vaccines.
The European Medicines Agency said there was no evidence that the PCV in the oral vaccines presented a risk to public health, noting PCV was not known to cause disease in humans.
The agency said it was awaiting further information from the manufacturers on steps being taken to rid their vaccines of PCV and would consider the need for further recommendations in its meeting in July, as further data emerge.
Sales of Merck’s vaccine were $522 million in 2009, while Glaxo’s rotavirus sold around $440 million.
Reporting by Ben Hirschler, editing by Will Waterman