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濱田 福三郎 NAF01626 at NIFTYSERVE.OR.JP
Thu Mar 2 19:38:49 EST 1995

TO:INET:virology at net.bio.net
FROM:NAF01626 at niftyserve.or.jp
SUB:Live flu vaccine

Cold adapted live flu vaccine is probably the best vaccine. However,
when think of regulatory issue, it would be controvercial.  Because of
nature of influenza virus, antigenic shift or drift, we have to generate
new reassortants almost every year.  Under the conditions, clinical 
study should be done for all new vaccine strains to know the efficacy 
and safety.  However, limited time do not allow us to do so.  Practically,
NDA is going to be applied only once with a certain amount of clinical data.  
What is the most elegant design to show the efficacy and safety of vaccine 
strains used in a clinical study and to guarantee the property of vaccines 
coming in the future?

I would appreciate any comments.

Yoichiro Kino, Ph.D., The Chemo-Sero-Therapeutic Research Institute

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