FDA reviewers question some results from Prevnar 13 study

11/17/2009 | Reuters · Google

FDA reviewers plan to ask the advisory panel that evaluated Pfizer and Wyeth's Prevnar 13 about clinical-trial findings showing the pneumococcal vaccine missed "noninferiority" goals compared with the original version of the vaccine. Pfizer said the results demonstrate "a real and substantial benefit given [the vaccine's] demonstrated ability to elicit immune responses" to each of the 13 forms of Streptococcus pneumoniae.

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Reuters · Google

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