NEWS
03/30/1993

<TITLE>The Food and Drug Administration today announced approval of a combination vaccine against four serious illnesses that affect small children</TITLE>
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P93-9                                       Food and Drug Administration
FOR IMMEDIATE RELEASE                       Monica Revelle - (301) 443-3285

    The Food and Drug Administration today announced approval of a combination  
vaccine against four serious illnesses that affect small children.  When        
started in infancy, the new combination vaccine will allow immunization         
against the diseases using four injections, instead of the eight injections     
which are currently needed.
    The diseases are diphtheria, tetanus, whooping cough (pertussis) and        
Haemophilus influenza type b, the leading cause of meningitis.
    "As secretary of HHS, I call this good news.  If I were an infant about to  
get four fewer shots, I'd call it great news," said HHS Secretary Donna E.      
Shalala.
    The new vaccine is composed of diphtheria and tetanus toxoids and           
pertussis vaccine adsorbed (DTP), and Haemophilus b conjugate vaccine.  A       
series of four injections of the combination vaccine has been found to be as    
effective as the eight injections of the DTP and Haemophilus b conjugate        
vaccines that have been used to provide protection against the same diseases    
for almost a decade.
    "Any new product that reduces the need for medical procedures without a     
loss of effectiveness is a step in the right direction," said FDA Commissioner  
David A. Kessler, M.D. "We're satisfied that the combination vaccine is safe    
and gives children the protection they need."
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                                                Page 2, P93-9, Vaccine
     The new vaccine is recommended for use in children at 2, 4, 6 and 15       
months of age.  The clinical trials included 6,793 children who were immunized  
with the combination product and 4,232 children who were immunized separately   
but simultaneously with the two older vaccines.
    The results showed no significant difference in antibody response between   
the two groups. The vaccines were comparable in the frequency and types of
adverse reactions reported, the most common of which were fever, redness and    
inflammation at the injection site, and irritability.
    The combination vaccine is manufactured by Lederle Laboratories and Praxis  
Biologics, Inc., subsidiaries of American Cyanamid Co. in New York, N.Y.  The   
product will be marketed under the name Tetramune.
    Most children have their required vaccines by the time they enter school.   
But since many infectious diseases are particularly dangerous in very small     
children, public health officials have sought to get children immunized before  
age 2.
    To be appropriately immunized by the age of 2 years, a child often will be  
given three of the following four shots -- DTP, Haemophilus influenza type b,   
hepatitis B and measles-mumps-rubella vaccine -- at the same time, at sessions  
at two months, four months, six months and 15 months.  (Polio vaccine is given  
orally at three of these times as well.)  Combining Haemophilus influenza type  
b in a single vaccine with DTP could reduce the shots to as few as two at each  
session -- and also reduce the total number of injections needed during this    
period.
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