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DAPTACEL™ has not been approved for the 5th DTaP dose. What are the ramifications and/or implications of using it for this dose?

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DAPTACEL™ has not been approved for the 5th DTaP dose. What are the ramifications and/or implications of using it for this dose?

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From time to time ACIP will make “off-label” recommendations for a vaccine based on data the committee has available beyond the data that was obtained during clinical trials and presented to the FDA when the vaccine was licensed. This is one such case. ACIP recommends that it is preferable to complete the 5-dose DTaP series with the same vaccine based on available safety and efficacy data. ACIP also recommends that if DAPTACEL is the only DTaP you have on hand and a child presents for the 5th dose, it is better to use the vaccine you have on hand than to miss the opportunity to vaccinate.

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