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Tuesday, January 30, 2007

Sanofi 5-in-1 pediatric vaccine receives FDA recommendation

News late last week that Pentacel, a 5-in-1 vaccine manufactured by Sanofi Pasteur, received a recommendation from an FDA advisory committee that typically signals imminent licensure in the U.S. Here's the story from Bloomberg.com and the Sanofi press release. According to it, the vaccine could reduce the total number of recommended pediatric vaccine doses by seven.

Pentacel provides protection against diphtheria, pertussis, tetanus, polio, and Haemophilus influenzae type B (Hib). It has been licensed and used in nine countries, including Canada, since its introduction in 1998. If licensed for U.S. use, the vaccine would be the second 5-in-1 vaccine available, joining GSK's Pediarix, which contains four common constituents to Pentacel (Pediarix includes hepatitis B vaccine instead of Hib).

For advocates of vaccination, there is great value in these kinds of combination vaccines, which reduce the number of doses (and office visits) necessary to complete the increasingly longer pediatric vaccination schedule. More visits mean an increased likelihood of missed appointments, missed doses, and incomplete vaccination series. Critics of U.S. vaccination policy, however, express concern about 'overloading' infants' immune systems with multiple vaccines at a single visit, and resulting in a variety of known and unknown adverse effects. At present, there isn't evidence that supports this hypothesis.

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