Answers
01/28/1994

<TITLE>ADVISORY COMMITTEE DISCUSSES CHICKENPOX VACCINE</TITLE>
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T94-9                                             Monica Revelle
Jan. 28. 1994                                     (301) 443-3285

         ADVISORY COMMITTEE DISCUSSES CHICKENPOX VACCINE

     An advisory committee to the FDA yesterday concluded that an
experimental chickenpox vaccine is safe and effective but advised
FDA to look into several issues before making a final decision on
approval. 
     The committee, a group of outside experts, considered data
collected over the past decade in more than 10,000 healthy
patients.  They determined that the data showed the vaccine to be
safe and effective with only minor side effects.  
     Questions that remain a concern of the committee were
whether the vaccine provides long-term immunity; whether extensive
vaccinations in children will shift the disease to adults where it
is more severe; whether to give children one inoculation or two;
and whether chicken pox immunizations should be given
simultaneously or with other vaccines.  Another question about the
vaccine is how it will affect the occurrence of shingles, a painful
rash caused when the chickenpox virus continues to live within its
victims and resurfaces in nerve endings later in life.      
     Chickenpox, a highly contagious disease, affects nearly 3.9
million Americans each year.  An estimated 33 percent of these
cases occur in children ages 1 to 4 years and 44 percent occur in
children ages 5 to 9 years.  
                             -MORE-
                                    Page 2, T94-9, Chickenpox
     Chickenpox is transmitted to others through fluid from broken
blisters as well as by coughing or sneezing.  The average
incubation period for chickenpox is 10 to 20 days (the time between
exposure to the virus and the onset of illness).  A child is
contagious from 1 or 2 days before the rash appears until all the
lesions are dried -- usually 4 to 5 days.
     Fortunately, chickenpox, while highly contagious, is generally
mild and not normally life-threatening.  Some individuals, such as
adults and immunosuppressed people are at higher risk of serious
illness.  It is estimated that there are about 9,600 chicken-pox
related hospitalizations annually, with 50 to 100 deaths.
     The proposed labeling permits vaccination of persons older
than 12 months of age.  Children 12 months to 12 years of age would
receive one dose, while persons 13 years and older would receive
two doses separated by 4 to 8 weeks.  
     The clinical trials also revealed that the adverse reactions
include pain and redness at the injection site, fever, itching,
bruising, hardened or firm skin, stiffness, and a rash.
     The varicella zoster virus vaccine is manufactured by Merck,
Sharp and Dohme.  
     Advisory committee recommendations are not binding on FDA.
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