Protein Sciences "Dumbfounded" After Committee Votes Down FluBlok
This article was originally published in The Pink Sheet Daily
Executive Summary
Cell-based seasonal influenza vaccine needs both additional safety data in general and considerably more efficacy data in older patients, FDA advisory panel says.
You may also be interested in...
Protein Sciences To Begin Selling Novel Flu Vaccine; Flublok Has Virus-Free Appeal
The trivalent vaccine can be produced much faster than traditional vaccines and could be modified to compete with quadrivalent formulations.
GSK’s Bird Flu Vaccine Approval May Hinge On Pandemic Postmarketing Study
FDA will ask its Vaccines and Related Biological Products Advisory Committee to talk about how to verify and describe the clinical benefit of the vaccine under the accelerated approval regulations.
Pediatric Meningococcal Vaccine's Approval Pathway May Work For Other Disease Areas
FDA suggests serum bactericidal antibody measurements to predict protection from meningococcal diseases in children under age 2.