NEWS

07/31/1996



<TITLE> FIRST ACELLULAR PERTUSSIS VACCINE APPROVED FOR INFANTS

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P96-12                            Food and Drug Administration

FOR IMMEDIATE RELEASE             Lenore Gelb (301) 443-3285

July 31, 1996                                               



     FIRST ACELLULAR PERTUSSIS VACCINE APPROVED FOR INFANTS



     The Food and Drug Administration today announced it has

licensed the first acellular pertussis vaccine for use in infants

and children two months of age and older for the primary series

of immunizations.  The vaccine protects infants against whooping

cough while causing fewer side-effects than whole-cell pertussis

vaccines now on the market. 

     Currently, U.S. children receive a whole-cell pertussis

vaccine in combination with diphtheria-tetanus toxoid, commonly

called DTP, at 2, 4 and 6 months of age, with additional doses of

either a DTP or DT vaccine with an acellular pertussis component

(DTaP) at 12-18 months and before going to school.

     The vaccine approved today for infants is one of two DTaP

vaccines already approved for children to be given as fourth and

fifth doses following three DTP doses.  This approval should give

parents more confidence in the safety of the pertussis vaccine

their infants will receive.        

     Acellular pertussis vaccines contain only the parts of the

pertussis bacterium thought to be important for immunity, while

whole-cell vaccines, such as the DTP vaccines currently used in

the United States for infants, contain the whole, killed

bacterium.

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                     Page 2, P96-12, Acellular Pertussis Vaccine

     "Safety data from several studies show that acellular

pertussis vaccines cause fewer adverse reactions in the primary

series of immunizations than whole-cell vaccines," said

Commissioner of Food and Drugs David A. Kessler, M.D.  "For a

long time there has been concern about side effects with whole-

cell vaccine.  This new acellular pertussis vaccine, the first of

several in the pipeline, represents an important advance."

     Whooping cough is a highly communicable disease of the

respiratory tract that can be especially serious for infants less

than one year old.  It can cause spells of coughing and choking

that make it hard to breathe; the coughing can last several

weeks.  Occasionally, infants can die from the disease. 

According to the Centers for Disease Control and Prevention

(CDC), in 1994 and 1995, a total of approximately 9500 cases of

pertussis were reported in the United States.  The World Health

Organization (WHO) reports that the disease is responsible each

year for approximately 350,000 deaths worldwide in unvaccinated

persons.  

     Several studies, including one randomized, controlled study

of 673 infants sponsored by Connaught Laboratories, Inc.,

indicate that the DTaP vaccines cause fewer adverse reactions

than DTP vaccines.  These can include local reactions, such as

redness or swelling, as well as systemic reactions, such as

fever, drowsiness, irritability, or prolonged, high-pitched

crying.  Studies are in progress to help determine the extent of  

                             -MORE-

                    Page 3, P96-12, Acellular Pertussis Vaccine

these reactions when children receive the acellular pertussis

vaccine for the entire series of immunizations.  Infrequent, 

serious events such as seizures have been reported after

immunizations with both DTP and DTaP vaccines.    

     Two clinical studies were conducted to assess the efficacy 

of the pertussis component of this DTaP vaccine for infants.  The

first placebo-controlled, randomized trial, of the pertussis

component conducted in the mid-1980's, included children 5-11

months old in Sweden, and was supported in part by the National

Institute of Allergy and Infectious Diseases (NIAID).  They were

immunized according to a different schedule from the one

recommended in the United States.  

     The second study, in Germany, used an immunizing schedule

similar to the one used in the United States for the DTaP, and

involved over 16,000 infants.  Parents were allowed to choose the

type of pertussis vaccine their infants would receive, or whether

the vaccine even  contained a pertussis component.  Approximately

75% of the parents chose the DTaP vaccine.  

     In these studies, the acellular pertussis vaccine was

estimated to be between 69 and 80% effective in preventing

pertussis, depending on the way the study was designed and

completed.

     On July 13, 1995, NIAID announced results of two large

European clinical trials showing that three acellular pertussis 

                             -More-                      Page 4, P96-12, Acellular Pertussis Vaccine

vaccines were highly effective in protecting infants while

causing fewer of the common side-effects.  The acellular 

pertussis vaccine licensed today for infants was not studied in

those trials.  

     The application for this first DTaP vaccine for infants was

received July 21, 1995.  Additional clinical data were presented

after the Vaccines and Related Biological Products Advisory

Committee met in January to discuss this application.  

     Children who have begun their immunizations with DTP should

continue to receive their fourth and fifth doses as DTaP.  For

those children who will now receive DTaP at 2, 4, and 6 months of

age, a fourth dose of DTaP is recommended in the second year of

life.  Studies are now being planned to help determine

recommendations for the fifth dose.     

     The acellular pertussis component of the vaccine is being

produced by the Research Foundation for Microbial Diseases of

Osaka University in Japan.  It is combined with diphtheria and

tetanus toxoids by Connaught Laboratories, Inc., Swiftwater, Pa.,

and is sold under the trade name, Tripedia.

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