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Safety of Varivax

Richard Spaete spaete at biomail.aviron.com
Thu Apr 27 15:51:58 EST 1995

                       Subject:                               Time:9:53 AM
  OFFICE MEMO          Safety of Varivax                      Date:4/27/95
     More than 11,000 adults, adolescents and children participated in Merck's Varivax
trials over a ten year period.  Adverse reactions were mild.  Eight cases of
zoster were reported in children (44,994 person-years of follow-up).  These
project a calculated incidence of 18 cases per 100,000 person years.  One case
of zoster was reported in the adolescent/adult group (7,826 person-years of follow-up).
 All nine cases were mild and without sequelae (SCRIP No 2011 march 28, 1995, p.
     The Japanese experience has been similar.  In a twenty year follow-up of a
small number of patients (n=96), no cases of zoster were reported and all showed
positive skin reaction.  Therefore, boosters may not be required.   The sum of
their data indicates long-lasting protective immunity (reported at the 19th
Intl. Herpesvirus Workshop in Vancouver B.C. 30 jul-5 aug, 1994).  
     This vaccine has been approved in Japan and several European countries for
years.  By all measures it is safe and effective (and cost-effective to use that
buzz word).   You virologists in the group should be leading opinion toward
widespread useage of this vaccine. 

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