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.
20).
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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