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Article: FDA panel backs rotavirus vaccine.(Infectious Diseases)
- Article from:
- Family Practice News
- Article date:
- January 15, 2006
- Author:
CopyrightCOPYRIGHT 2006 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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BETHESDA, MD. -- A Food and Drug Administration advisory committee has given unanimous backing to a rotavirus vaccine, Merck and Co.'s RotaTeq.
In two 10-0 votes, the Vaccines and Related Biological Products Advisory Committee said that RotaTeq is both effective and safe. If the agency follows the advice of its panel, which it generally does, the vaccine could be approved by February 2006, the legal deadline for FDA action on RotaTeq.
Panelists were mostly concerned with the vaccine's safety, particularly whether it was linked to intussusception, a potentially fatal condition in which the bowel telescopes in on itself. The only previously approved ...