Remember that pig-virus DNA that turned up in GlaxoSmithKline's vaccine against the diarrhea-causing rotavirus? Well, DNA from the same pig germ has surfaced in Merck's rotavirus preventive. And both vaccines are up before an FDA advisory panel today as the agency solicits expert opinion on the DNA contamination.
The good news: The FDA doesn't consider the viral DNA to be a safety risk. There's no evidence that the pig virus--known as porcine circovirus, or PCV--poses a risk to humans. "Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients and clinical experience with millions of patients," the agency says in a statement.
When the pig was found in GSK's Rotarix, the company and the FDA advised doctors to suspend its use; since then, the company has been working to replace the cell bank and virus seeds used to make it, Reuters reports. Even so, the World Health Organization said at the time that it viewed the risk of rotavirus to be more severe than any risk posed by the PCV genetic material, and said it would continue using Rotarix in developing countries. In Merck's case, neither the FDA nor the company has suggested that Rotateq shouldn't be used.
The FDA's position could change, however, after today's advisory committee meeting. "After considering the input of the Committee's experts and the available scientific information, FDA will make further recommendations on the use of the licensed rotavirus vaccines in the United States," the agency says in a statement. Stay tuned.
- here's the FDA's announcement
- read the Reuters story