No Non-Inferiority, No Problem: FDA Advisory Committee Endorses Prevnar 13
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
You may also be interested in...
13 Going On 50: Pfizer Seeks Adult Indication For Prevnar
Advisory committee might closely scrutinize the requested indication for the 13-valent pneumococcal conjugate vaccine for adults age 50 and up; it is now indicated for children under six years old.
13 Going On 50: Pfizer Seeks Adult Indication For Prevnar
Advisory committee might closely scrutinize the requested indication for the 13-valent pneumococcal conjugate vaccine for adults age 50 and up; it is now indicated for children under six years old.
Prevnar 13's Added Strains, Extra Studies Help Insulate Pfizer's U.S. Position
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