H5N1 Flu Vaccine Proven Safe

December 14, 0005
ePT--the Electronic Newsletter of Pharmaceutical Technology

H5S1 Flu Vaccine Proven Safe

Preliminary results from a clinical trial of Sanofi Pasteur's (Lyon, France, www.sanofi.com) H5N1 prepandemic influenza vaccine indicate the vaccine is safe and well-tolerated in 300 healthy volunteers. This study is the first trial of an H5N1 prepandemic influenza vaccine candidate that compared vaccines with and without adjuvants.

The 30 microgram-dose vaccine (with adjuvant) is given in two doses, but the company also noted that immune responses were detected in several volunteers who received smaller doses. Follow-up studies still under development will be performed using a scaled-up production method that will mimic the manufacturing scale that would be used during a true pandemic.

-Kaylynn Chiarello-Ebner