2006D-0088 Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
FDA Comment Number : EC1
Submitter : Dr. Mary Johnson Date & Time: 05/08/2006 03:05:53
Organization : Campbell University School of Pharmacy
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Q: Will the yearly flu vaccine production be compromised if a pandemic vaccine is produced using the same manufacturers?
Q: The avian flu causes mutation so quickly in human subjects. How will this rate of mutation affect the effectiveness of the vaccine?
Q: Have there been any reports of human to human transmissions of avian flu?
Q: If there have not been any transmission, why is this such a pandemic concern?
Q: Would vaccine be available for anyone who needed it during a pandemic?