From: Robert Hamilton [rhamilto@jhmi.edu]
Sent: Friday, November 15, 2002 12:23 PM
To: fdadockets@oc.fda.gov
Subject: Please use synthetic stoppers in small pox vaccination vials

RE: Comment Docket #02N-0466

Based on the results of our research (ref 1), we believe that natural
rubber latex proteins can be eluted from natural rubber stoppers into
aqueous solutions in pharmaceutical vials during storage or the process
of puncturing.  

It is our believe that natural rubber containing closures should not be
used vials containing vaccine to minimize the prospect of exposure of
any latex allergic child or adult to rubber allergen exposure. 
Alternative synthetic closures are widely available and effective.

Ref 1: Primeau M, Adkinson NF, Hamilton RG. Natural rubber
pharmaceutical vial closures release latex allergens that produce skin
reactions. J Allergy Clin. Immunol 107:958-962, 2001.

Sincerely yours,


Robert G. Hamilton, Ph.D.
Professor of Medicine and Pathology
Johns Hopkins University School of Medicine

Johns Hopkins Asthma and Allergy Center
Room 1A20
5501 Hopkins Bayview Circle
Baltimore, MD 21224 USA
410-550-2031 Tel
410-550-2030 fax
rhamit@jhmi.edu