[Congressional Record Volume 140, Number 147 (Tuesday, November 29, 1994)]
[Extensions of Remarks]
[Page E]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: November 29, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
                     A NEW VACCINE FOR OUR CHILDREN

                                 ______


                          HON. STENY H. HOYER

                              of maryland

                    in the house of representatives

                       Tuesday, November 28, 1994

  Mr. HOYER. Mr. Speaker, I rise today to pay tribute to the 
outstanding work of the National Institute of Child Health and Human 
Development who treated millions of parents to a special Thanksgiving 
blessing when it announced the promising results of a clinical trial 
involving a new vaccine for pertussis, commonly known as whooping 
cough.
  The NICHD reported that this new ``acellular'' pertussis vaccine is 
effective in preventing whooping cough in infants and children, and 
does so without any significant adverse side effects. In fact, NICHD 
associate director, Dr. Charles Lowe concluded in his announcement 
that, ``the encouraging results of this vaccine trial justify the 
expectation that in the near future, infants will have an acellular 
pertussis vaccine which was not only effective but remarkably safe.''
  That is especially good news for every parent, Mr. Speaker, because 
the currently used ``whole cell'' vaccine, although effective, has been 
associated with a variety of side effects.
  The phase III (human) clinical trails for the new vaccine were 
conducted in Sweden, one of several countries which does not recommend 
whole cell pertussis vaccination because of side effects. As a result, 
a pertussis epidemic occur during a portion of the trial. Yet even 
under these demanding epidemic conditions, the vaccine proved to be 
remarkably safe and highly effective, so much so that the Swedish 
principal investigators plan to go forward and vaccinate those children 
who were part of the trial's control group.
  Mr. Speaker, many American parents with their child's welfare at 
heart, have chosen not to vaccinate against pertussis, exposing 
millions of infants to the possibility of an outbreak such as one we've 
recently witnessed in Washington State. I'm delighted with the results 
of the NICHD trial and especially pleased that the North American 
Vaccine, the Beltsville, MD, Based Company Licensing the Acellular 
Pertussis Vaccine Technology from the NICHD, anticipates filing for FDA 
approval in the near future.
  I would like to include with my remarks a copy of the press 
announcement from the U.S. Department of Health and Human Services.

   Clinical Trial Results Announced for New Vaccine Against Pertussis

       The National Institutes of Health announced today the 
     promising results of a Phase III efficacy study conducted in 
     Goteborg, Sweden, for a new acellular pertussis vaccine to 
     prevent whooping cough. Under epidemic conditions, the 
     vaccine demonstrated an efficacy of 71 percent in protecting 
     infants in the study cohort from contracting pertussis as 
     defined by the World Health Organization (WHO).
       Even more noteworthy was the absence of adverse side 
     effects. The National Institute of Child Health and Human 
     Development (NICHD) at the NIH supported the study. The 
     vaccine was manufactured for the NICHD trial by AMVAX, a 
     subsidiary of North American Vaccine, Inc., and has been 
     under evaluation in Goteborg. For more than 3 years, Drs. 
     John Taranger and Birger Trollfors of the Department of 
     Pediatrics, University of Goteborg, under contract with the 
     NICHD, have conducted the studies.
       The NICHD acellular pertussis (aP) vaccine consists of a 
     single component, pertussis toxoid. It was compounded by 
     AMVAX as DTaP using diphtheria and tetanus (DT) toxoids 
     manufactured by the Statens Seruminstitut, Copenhagen, 
     Denmark. The DTaP was administered to a group of 1692 Swedish 
     infants at 3, 5, and 12 months of age beginning in September 
     1991 in a randomized, double-blind placebo controlled trial.
       Another group of 1687 infants served as controls and 
     received only the diphtheria and tetanus vaccines. On 
     average, the children were followed for about 20 months after 
     their third vaccination by a team of nurses trained in field 
     work who kept the infants and their households under close 
     surveillance and evaluated all coughing episodes lasting 7 
     days or more for possible pertussis.
       During the trial, 312 of the 3335 children completing the 
     study developed pertussis that met the WHO criteria for the 
     disease (at least 21 days of paroxysmal cough plus a positive 
     culture for pertussis or significant pertussis antibody 
     production). Of the children who developed pertussis, 240 
     were enrolled in the control (DT) group versus 72 in the 
     pertussis vaccinated (DTaP) group.
       In addition to a vaccine's ability to prevent disease, the 
     absence of significant side effects is also important from a 
     public health perspective. In this study, no children in 
     either group had any severe adverse reactions attributed to 
     vaccination. In fact, the vaccine proved to be remarkably 
     safe. The incidence of all side effects, local and systemic, 
     was far below that reported when infants receive the 
     currently used whole-cell vaccine. In the United States, the 
     frequency of significant adverse side effects, both local and 
     systemic, with the currently used whole-cell vaccines has 
     caused concern and prompted the search for a safer vaccine.
       ``The results of this trial are significant,'' said Dr. 
     Charles Lowe, Associate Director of the NICHD and project 
     officer and associate investigator for the study. ``The study 
     is important in demonstrating that a vaccine with a single 
     component, a detoxified pertussis toxin, is capable of 
     preventing disease in a substantial proportion of infants 
     receiving the vaccine. The vaccine appeared to perform well 
     in both efficacy and safety. The clinical results reflect not 
     only the inherent attributes of the vaccine but also the 
     commitment and dedication of the Swedish investigators.''
       In the United States, the schedule for routine childhood 
     vaccination calls for five doses of pertussis vaccine as DTP, 
     three in the first year of life and two thereafter. The 
     fourth dose is given at 15 months of age and the fifth is 
     given before school entry at 4 to 6 years of age. Whole-cell 
     pertussis vaccine is currently the only product recommended 
     for the first three doses. At present, acellular pertussis 
     vaccines may be used only for the fourth and fifth doses for 
     children 15 months or older.
       Pertussis or whooping cough is a severe disease with 
     paroxysmal cough which usually lasts about 6 weeks. In 
     infants and in children with underlying diseases, serious 
     complications sufficiently severe to require hospitalization 
     can occur. In 1933, before immunization, there were 250,000 
     cases of pertussis in the United States with over 5,000 
     deaths. The currently available whole-cell vaccines can 
     effectively prevent disease; but when populations in other 
     countries have rejected vaccination because of concerns about 
     safety, the effectiveness of the whole-cell vaccine becomes 
     irrelevant. For example, in Great Britain and Japan, when the 
     use of whole-cell vaccine was discontinued, these countries 
     experienced epidemic pertussis. Since 1979, pertussis 
     vaccination has not been recommended in Sweden and there is 
     no licensed pertussis vaccine available in that country. Most 
     children in Sweden have had pertussis by age 10. Accordingly, 
     it was ethical to have a control group not vaccinated with 
     pertussis in clinical trials performed in Sweden.
       The pertussis toxoid vaccine was developed in NICHD's 
     intramural research laboratories by Drs. Ron Sekura and John 
     Robbins. Pilot studies for safety and immunogenicity were 
     conducted beginning in 1986 in adults, toddlers, and infants 
     both in the United States and Sweden. Additional trials of 
     this DTaP vaccine for safety and immunogenicity are in 
     progress in Charlotte, North Carolina, and San Antonio, 
     Texas.
       The very encouraging results of this vaccine trial justify 
     the expectation that in the near future, infants will have an 
     acellular pertussis vaccine which is not only effective but 
     remarkably safe.

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