One of the United States' Rotavirus vaccines has been tainted. Federal health authorities released a report on Monday that claims investigators found Rotarix to be contaminated with material from a "pig virus." FDA Commissioner Dr. Margaret Hamburg held a press conference Monday and suggested that doctors suspend the use of Rotarix, one of the two vaccines licensed for use against rotavirus within the United States. Hamburg insisted, during the press event, that "there is no evidence at this time this material [pig virus] poses a safety risk."
A student group researching vaccines and viruses stumbled across the Rotarix contamination, identified as porcine circovirus 1, found generally in pigs and not known to affect other species, including humans or other animals. The student group reported the contamination to GlaxoSmithKline, and the company in turn reported it to the FDA. GlaxoSmithKline found the contamination in its "cell bank" and "seed from which the vaccine is derived." This finding may indicate that the contamination has been present since the "early stages of vaccine development" per Hamburg. The FDA investigated the company's findings and came to the same conclusion. GlaxoSmithKline insists that porcine circovirus 1 "is found in everyday meat products and is frequently eaten with no resulting disease or illness." GlaxoSmithKline's chief medical officer, Thomas Breuer, issued a written statement that maintains "No safety issue has been identified by external agencies or GSK. GSK is committed to patient safety and to the highest manufacturing standards for all our vaccines and medicines. We are already working closely and discussing this finding with regulatory agencies around the world."
The Rotarix vaccine was administered to approximately 1 million children within the United States and an estimated 30 million children worldwide. The vaccine will be suspended from use until further research is collected.