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1993.03.30 :  Combination Childhood Vaccine 
 
Contact: Monica Revelle - (301) 443-3285 (Home) -- (410) 290-6575
March 30, 1993

    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.
David A. Kessler, M.D. "We're satisfied that the combination
vaccine is safe and gives children the protection they need."
     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.     ###