US okays six vaccines for 2008/09 influenza season
This article was originally published in Scrip
Executive Summary
The US FDAhas approved six seasonal influenza vaccines for the 2008/09 season. There are five injectable inactivated vaccines – CSL's Afluria,GlaxoSmithKline's Fluarix and Flulaval,Novartis's Fluvirin, Sanofi Pasteur's Fluzone – and AstraZeneca's (formerly Medimmune) live intranasal vaccine Flumist. All three strains in the vaccine have changed from last season's formulation. The new influenza A virus strains are Brisbane/59/2007 (H1N1) and Brisbane/10/2007 (H3N2), while the B virus strain is Florida/4/2006. The H3N2 and B virus strains are currently used in the vaccine formulated for the southern hemisphere.
You may also be interested in...
US FDA, Industry Share Early Lessons From Complex Innovative Trial Designs Program
Timelines in the CID program are tight, and sponsors should have a ‘fully baked’ trial design before heading into their first meeting with the agency, industry reps say; agency needs more simulation data from participating sponsors earlier and is working to ensure continuity for firms after the second of two meetings allowed under the program.
US FDA Will Leverage Current Clinical Trial Data In Deciding On Post-COVID Flexibilities
Oncology Center of Excellence’s Paul Kluetz says agency intends to explore the effects of decentralization, remote assessments and other approaches adopted mid-stream on safety evaluations, missing data and endpoint variability.
Decentralized Trials Guidance May Reflect US FDA’s Lessons Learned During COVID-19
Work on guidance that was originally expected in 2020 continues as the agency and industry learn more about the utility and spectrum of decentralized trials as a result of the novel coronavirus pandemic.
Need a specific report? 1000+ reports available
Buy Reports