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Biotech / Medical : VD's Model Portfolio & Discussion Thread

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To: Vector1 who wrote (5549)9/1/1998 4:46:00 PM
From: Mel Kaplan  Read Replies (1) of 9719
 
V!, I too am struck that the FDA was concerned by quality control of a complex influenza virus vaccine, composed of a mixture of heat-killed and attenuated live viral strains and produced in the UK ,supplied in
bulk to AVIR in CA for assembly and packaging.
Avir has supported the efficacy of the vaccine in terms of antibody response and clinical infection and protection from ear infection in children. In the original report, it was noted that a small number of patients developed fever after the nasal instillation, which was transient but unexplained, and dismissed. The FDA did not apparently cite this. It did not accept for filing the British papers on
the quality of the bulk product.
Rman may be right in tha whole matter can be reconciled by responses of AVIR, but the FDA is doing its job.
Mel
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