GlaxoSmithKline’s Rotarix vaccine, which is given to infants to inoculate them against the rotavirus, may be contaminated with viral DNA that should not be there and federal regulators are warning pediatricians not to use the vaccine.
The FDA issued the Rotarix warning on Monday, recommending that health care practitioners stop using the vaccine until the agency further examines the situation. However, the agency indicates that there is no evidence at this time that the extraneous viral DNA found in the vaccines poses a safety risk to infants.
The FDA says that an independent U.S. academic research team discovered genetic material from the porcine circovirus 1 (PVC1) in Rotarix. The FDA then confirmed through it’s own tests that extraneous viral DNA was in Rotarix. However, the virus is not known to cause illness in humans, the FDA stated.
Rotarix is an oral vaccine given to infants six weeks or older to prevent rotavirus, which can cause vomiting, diarrhea and fever. Most adults are protected against rotavirus due to immunities acquired during childhood, and it is generally considered to be most dangerous among children two years old and younger.
The first rotavirus vaccine, Merck & Co.’s RotaTeq, was approved in 2006, and GlaxoSmithKline’s Rotarix was approved in 2008. About 55,000 children were hospitalized annually in the United States due to rotavirus before the vaccinations began.
“We are making clinicians aware of information recently received by FDA about the Rotarix vaccine,” said Dr. Margaret A. Hamburg, Commissioner for Food and Drugs. “There is no evidence at this time that there is a safety concern. FDA is recommending that clinicians temporarily suspend use of Rotarix until we can learn more about the situation. We will keep the public and the clinical community updated on our findings.”
Beyond the warning, FDA is taking no action at this time. However, the agency announced it will hold an expert advisory committee meeting and determine what other recommendations should be made.