FDA Temporarily Suspends Use of Rotarix Vaccine

From Medscape Medical News > Alerts, Approvals and Safety Changes > Medscape Alerts

Allison Gandey

Posted: 03/22/2010

March 22, 2010 — The US Food and Drug Administration (FDA) announced today viral contamination of GlaxoSmithKline's Rotarix vaccine.
The agency is recommending that doctors stop using the vaccine until further investigations are complete.

An independent academic research team testing the product recently identified porcine circovirus 1 in the vaccine and notified regulators.

Follow-up tests by GlaxoSmithKline and FDA scientists reportedly confirmed the academic team's findings and suggested that viral components have been present since the early stages of the vaccine's development, including during clinical studies.

FDA commissioner Margaret Hamburg, MD, emphasized to reporters attending a press conference that the virus is not known to cause illness in humans or animals. She also noted that the viral contamination is not the result of animal or other food safety issues.

"We do not believe there is a clinical risk," Dr. Hamburg told Medscape Medical News. "However, as with all vaccines, we recommend that clinicians watch for any serious adverse events and report them."

Porcine Circovirus 1

The Rotarix vaccine is administered by mouth to young infants to prevent rotavirus, which can cause severe diarrhea and dehydration. Dr. Hamburg noted that the vaccine, which has been on the market in the United States since 2008, has an excellent safety record to date.

An estimated 1 million children have already received Rotarix in the United States alone.

Preliminary testing of another rotavirus vaccine by both academic researchers and FDA scientists has not detected any viral contamination. Regulators are recommending that clinicians continue using Merck's RotaTeq, which has been available in the United States since 2006. Most children vaccinated in the United States already receive RotaTeq.

Regulators report they will continue to gather more information about the porcine circovirus found in the vaccine. Scientists are studying whether intact virus is present, as opposed to DNA fragments.

In about 5 weeks, the FDA will convene an expert advisory committee and will make additional recommendations on the use of rotavirus vaccines.