Prevnar 13's Added Strains, Extra Studies Help Insulate Pfizer's U.S. Position
Executive Summary
By picking up serotype 19A, Pfizer's next-generation pneumococcal disease vaccine Prevnar 13 is armed to protect against the most prevalent strain of Streptococcus pneumoniae left in the U.S
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In Brief
Further delay for Prevnar 13: FDA has not yet completed its review of Pfizer's Prevnar 13 vaccine for pneumococcal disease and therefore the review will continue beyond the Dec. 30 user fee deadline. It's not clear how much longer the review will take and there was no explanation for the delay, but there was no indication that additional information was sought, according to the drug maker's Dec. 30 statement. The vaccine is under priority review and FDA already used its one-time extension of the user fee period to move the original action date of Sept. 30 to the December date, after additional manufacturing data was submitted. An FDA advisory committee voted 10 to 1 on Nov. 18 to recommend the product, although the panel did not endorse a broad claim for otitis media (1"The Pink Sheet," Nov. 23, 2009). European marketing authorization was granted on Dec. 11
In Brief
Further delay for Prevnar 13: FDA has not yet completed its review of Pfizer's Prevnar 13 vaccine for pneumococcal disease and therefore the review will continue beyond the Dec. 30 user fee deadline. It's not clear how much longer the review will take and there was no explanation for the delay, but there was no indication that additional information was sought, according to the drug maker's Dec. 30 statement. The vaccine is under priority review and FDA already used its one-time extension of the user fee period to move the original action date of Sept. 30 to the December date, after additional manufacturing data was submitted. An FDA advisory committee voted 10 to 1 on Nov. 18 to recommend the product, although the panel did not endorse a broad claim for otitis media (1"The Pink Sheet," Nov. 23, 2009). European marketing authorization was granted on Dec. 11
No Non-Inferiority, No Problem: FDA Advisory Committee Endorses Prevnar 13
Panel votes 10-1 to recommend next-generation pneumococcal vaccine for prevention of invasive disease, but says claim for further protection against otitis media should await post-market study data.