The US Food and Drug Administration recently recommended that administration of Glaxo SmithKline’s Rotarix vaccine, which protects against rotavirus infection, be suspended after an independent research group found that the vaccine contains DNA of porcine circovirus type 1. Now the FDA reports finding circovirus DNA in the rotavirus vaccine made by Merck:
FDA recently received information from Merck & Co, Inc. that its preliminary studies have identified fragments of DNA from PCV1 and from a related porcine circovirus type 2 (PCV2) in its RotaTeq vaccine. Merck’s findings suggest that the number of PCV DNA fragments in its vaccine may be smaller than what has been found in Rotarix.
FDA has so far not recommended suspension of RotaTeq use. The Vaccines and Related Biological Products Advisory Committee meets today, after which FDA will make further recommendations on the use of the licensed rotavirus vaccines in the United States.
The source of porcine circovirus type 1 DNA in both Rotarix and RotaTeq is likely to be trypsin used during propagation of the cell cultures necessary for vaccine production. The enzyme is produced from porcine pancreas.
Update 10 May 2010: The FDA has posted a briefing document for the VRBPAC meeting that was held this past Friday. The Los Angeles Times reports on the outcome of the meeting:
Members of a Food and Drug Administration advisory committee meeting Friday urged physicians to continue using both commercial rotavirus vaccines despite evidence that both carry trace contaminants from a harmless pig virus. The panel did not take a formal vote on a recommendation, but a majority of participants said they thought the benefits of the vaccine far outweigh any potential risk. An agency spokeswoman said it would make no immediate recommendation on the vaccines, but would act expeditiously to come to a decision.
Finally, there are some good quotations from committee members in the article at Medscape Today.