Reactions 1301 - 15 May 2010

Rotavirus vaccines: benefits stilloutweigh risks

A US FDA advisory committee has acknowledged thatthe benefits of the rotavirus vaccines, RotaTeq andRotarix, continue to outweigh any potential risks.

The advisory committee convened in a meeting todiscuss the recent discovery of DNA fragments ofporcine circovirus (PCV) in the rotavirus vaccines.Although no formal recommendations were issued,committee members indicated that the benefits ofvaccinating infants against rotavirus outweighed anytheoretical risks associated with the presence of PCVmaterials in the vaccines.

The agency recommended a temporary suspension ofthe use of Rotarix, as a precautionary measure, whenPCV-1 DNA was detected in the vaccine* This wasfollowed by the discovery of PCV-1 and PCV-2 DNA inthe RotaTeq vaccine.* see Reactions 1294 p2; 801075614

GlaxoSmithKline Inc. GSK Statement on FDA Advisory Committee Meeting onRotavirus Vaccines. Media Release : 7 May 2010. Available from: URL: http://www.gsk.com 809112326

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Reactions 15 May 2010 No. 13010114-9954/10/1301-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved