July 30, 1998
The National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health today joined North American Vaccine in announcing that the U.S. Food and Drug Administration has given its approval to manufacture and market a new DTaP (diphtheria-tetanus-acellular pertussis) vaccine for use in immunization against these diseases. The vaccine, marketed as CERTIVA, uses as the pertussis component the vaccine developed in the NICHD laboratory of Dr. John Robbins, one of the world's leading scientists involved in vaccine research and development. The NICHD licensed its patent for producing this pertussis vaccine to North American Vaccine.
The pertussis vaccine consists of a single antigen, pertussis toxoid, which is pure pertussis toxin detoxified by treatment with hydrogen peroxide. It differs from all other marketed pertussis vaccines in that the others contain multiple pertussis antigens, and in the way the pertussis toxoid is prepared. The trials of the NICHD/North American Vaccine product demonstrated its efficacy and safety.
"Approval of this vaccine represents the culmination of years of NICHD research, intended to produce a safe toxoid for a vaccine," said Dr. Duane Alexander, MD, Director of the NICHD.
The extensive trials of the vaccine were conducted in the United States (primarily North Carolina and Texas) and in Sweden, initially by NICHD, and later by North American Vaccine.
"Surveillance and epidemiologic studies in G?teborg, Sweden, were ongoing for more than a decade," said Dr. Robbins, Chief of the Laboratory of Developmental and Molecular Immunity at NICHD where the vaccine was developed. Dr. Robbins shared the 1996 Albert Lasker Clinical Research Award in recognition of his pioneering role in developing the vaccine against Hemophilus influenzae type b meningitis.
"The results from clinical trials and the mass vaccination program have shown that pertussis toxoid alone confers immunity both to vaccine recipients and the unvaccinated population at large, i.e., 'herd' immunity," Dr. Robbins added. "These data also demonstrate that it may be possible to eliminate pertussis by vaccination with a single component of Bordetella pertussis. FDA licensure of the product allows for the availability of this acellular pertussis vaccine for administration to infants and children."
"The extensive studies done on this vaccine clearly show safety and protection against pertussis from a single antigen. Its availability in the U.S. brings to our children the benefits of this important research advance," said Dr. Alexander.
The NICHD is one of the Institutes of the National Institutes of Health, the world's premier biomedical research organization, located in Bethesda, Maryland. NICHD supports and conducts basic, clinical, and epidemiological research on the reproductive, developmental, and behavioral processes that determine and maintain the health of children, adults, families, and populations.