Temporary Suspension in Use of Rotarix Recommended by FDA

March 24, 2010

After independent academic researchers, using a new technology, found DNA from porcine circovirus 1 (PCV1) in GlaxoSmithKline’s Rotarix vaccine, the FDA has recommended that clinicians temporarily suspend administration of the vaccine. The recommended suspension is a precautionary measure, put into effect while the FDA reviews the data and conducts further investigations.

After independent academic researchers, using a new technology, found DNA from porcine circovirus 1 (PCV1) in GlaxoSmithKline’s Rotarix vaccine, the FDA has recommended that clinicians temporarily suspend administration of the vaccine. The recommended suspension is a precautionary measure, put into effect while the FDA reviews the data and conducts further investigations.

The FDA has emphasized that there is no evidence that the presence of PCV1 DNA in the vaccine poses a safety risk. PCV1 is not known to cause illness in animals or humans. Moreover, the FDA scientists who confirmed the findings of the independent researchers also found that PCV1 components have been present in the vaccine since the early stages of its development and throughout clinical trials-and the safety record of Rotarix, both in clinical trials and in post-marketing surveillance data, has been excellent. Because of this excellent safety record, the FDA has not recommended medical follow-up for children who have received the Rotarix vaccine.

While the temporary suspension is in place, practitioners are advised to use the Rotateq vaccine (Merck) to vaccinate against rotavirus infection; preliminary tests have found no traces of PCV1 in Rotateq. Rotateq should also be used to complete the vaccine series in children who have received one dose of Rotarix. The FDA anticipates that supplies of Rotateq in the United States will be adequate to meet the increased need.

Because the FDA expects to be able to issue new recommendations on rotavirus vaccines in 4 to 6 weeks, clinicians are advised to hold onto current supplies of the vaccine for possible future use. For updates on the situation, healthcare providers can visit the FDA’s Update on Rotarix Vaccine page.