ROCKVILLE, Md. - A fourth diphtheria-tetanus-acellular pertussis vaccine (DTaP) was recently licensed by the Food and Drug Administration (FDA) for use in infants and children.
North American Vaccine received approval to manufacture and market CERTIVA, which uses the pertussis component of the vaccine developed in the National Institute of Child Health and Human Development (NICHD) laboratory of John Robbins, MD. The NICHD licensed its patent for producing this pertussis vaccine to North American Vaccine in Beltsville, Md.
The vaccine is recommended for administration at 2 months, 4 months and 6 months, with a fourth dose given at 15-20 months. If a child has received one or more doses of whole-cell pertussis vaccine, CERTIVA can be used to complete a five dose series, said Stephen Keith, MD, vice president of marketing and sales at North American Vaccine.
"Approval of this vaccine represents the culmination of years of NICHD research, intended to produce a safe toxoid for a vaccine," said Duane Alexander, MD, director of the NICHD. "The extensive studies done on this vaccine clearly show safety and protection against pertussis from a single antigen."
CERTIVA will be marketed and distributed in the United States by the Ross Products Division of Abbott Laboratories Inc. to private physicians and managed care markets, and by North American Vaccine to government purchasers, including state governments and the Centers for Disease Control and Prevention (CDC). The vaccine will be available in the fall.
This DTaP vaccine differs from the other licensed DTaP vaccines because it includes a single antigen, pertussis toxoid, which is pure pertussis toxin detoxified by treatment with hydrogen peroxide.
The FDA license for CERTIVA was supported by a number of U.S. and foreign clinical studies, including a double-blind, randomized, placebo-controlled efficacy trial sponsored by the NICHD and conducted in Göteborg, Sweden, involving 3,450 Swedish infants. U.S. safety studies sponsored by the manufacturer, the NICHD and the National Institute of Allergy and Infectious Diseases involved 3,715 infants and children.
One of the safety and immunogenicity studies involved 1,303 infants who randomly received CERTIVA or a licensed whole-cell pertussis vaccine.
Most of these infants were immunized concurrently with a Haemophilus influenzae type b (Hib) vaccine, a hepatitis B vaccine (HepB), and a trivalent oral polio vaccine. The incidence of fever, redness, pain, irritability and swelling were all significantly lower after vaccination with CERTIVA than after immunization with the whole-cell vaccine.
The most common adverse events reported during the study were irritability and redness and pain at the injection site. CERTIVA has also been given as the fourth and fifth doses in clinical studies and was well tolerated and immunogenic.
"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," said Robbins, chief of the NICHD Laboratory of Developmental and Molecular Immunity.
These data also demonstrate the possibility of eliminating pertussis by vaccination with a single component of Bordetella pertussis, Robbins added.
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