FDA Advises Clinicians To Suspend Rotarix Use


The Food and Drug Administration is advising clinicians to temporarily suspend use of the oral rotavirus vaccine Rotarix because of the unexpected finding of DNA from porcine circovirus type 1 in the product, FDA Commissioner Margaret A. Hamburg said in a teleconference

“There is no evidence at this time that this material from PCV1 in Rotarix poses any safety risk,” she said.

“We are not taking the vaccine off the market, we are just asking clinicians to suspend using it in their practices during the 4- to 6-week period when we are collecting additional information,” Dr. Hamburg added.

PCV1 is a virus that is often found in meat and other foods, and it is not known to cause disease in humans or animals.

The virus was identified in Rotarix (manufactured by GlaxoSmithKline) as part of an academic research exercise, and the finding was unanticipated, Dr. Hamburg said.

The rotavirus vaccine is typically given orally to children aged 6 weeks and older to protect them against the diarrhea and vomiting associated with a rotavirus infection.

“PCV1 is a virus, not an animal product, and this has nothing to do with food safety,” Dr. Hamburg emphasized.

The FDA conducted its own studies and confirmed that PCV1 has been present in Rotarix since its initial development, said Dr. Hamburg.

The FDA is reviewing the data and will convene an advisory committee in approximately 4–6 weeks to make recommendations about the use of Rotarix, she said in the teleconference.

Rotarix was studied extensively before and after its 2008 FDA approval and has an excellent safety record, Dr. Hamburg said.

But the FDA is obtaining additional information about the presence of PCV1 DNA in Rotarix, including whether DNA fragments or an intact virus is present. The agency is also studying how the virus came to be in the vaccine.

Meanwhile, the FDA recommends continuing vaccination of children in the United States using RotaTeq, a separate rotavirus vaccine manufactured by Merck & Co. that uses a different process from the one used by Rotarix. Studies of RotaTeq had not shown any evidence of PCV1, said Dr. Hamburg, adding that the take-home message for clinicians is to reassure parents and continue to vaccinate children on schedule with RotaTeq.

“We are definitely recommending that if you have given one dose of Rotarix, you follow that with two doses of RotaTeq in order to provide the full regimen to protect against rotavirus, and we are definitely encouraging ongoing rotavirus vaccination,” she said.

Dr. Hamburg noted that the FDA recommendations apply to clinicians in the United States only, because of the relatively low burden of disease and the availability of an alternative product.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) reviewed the Rotarix findings and concluded that no action is necessary at this time, according to a statement issued by CHMP.

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