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Wyeth-Lederle Files With FDA, Seeking Clearance For Use of Acellular Pertussis Vaccine in Infants.

ST. DAVIDS, Pa.--(HealthWire)--May 8, 1996--Wyeth-Lederle Vaccines and Pediatrics, a unit of Wyeth-Ayerst Laboratories, announced today that it has completed filing with the Food and Drug Administration a supplement for a new indication to the existing product license of its acellular pertussis vaccine, ACEL-IMUNE(R) Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed. Wyeth-Lederle is seeking clearance for use of ACEL-IMUNE in infants at two, four, and six months of age for immunization against diphtheria, tetanus, and pertussis.

Unlike the whole-cell pertussis (DTP) vaccines that contain killed whole-cell pertussis bacteria, the acellular pertussis components of ACEL-IMUNE contain only specific parts of the pertussis bacterium thought to be important for immunity. Research has demonstrated that acellular pertussis vaccines have fewer side effects than the whole-cell pertussis vaccines, commonly referred to as DTP vaccines, currently used in the U.S. to immunize infants. Results of a large-scale clinical trial conducted in Germany, involving approximately 10,000 infants who received either ACEL-IMUNE or a DTP vaccine, showed that infants in the ACEL-IMUNE arm of the study experienced fewer local (injection site) reactions and less fever, drowsiness, and fretfulness than those in the DTP vaccine group with comparable efficacy.

"We look forward to working with the Food and Drug Administration to bring ACEL-IMUNE to the market for use in infants in as timely a manner as possible," said Ronald J. Saldarini, Ph.D., President of Wyeth-Lederle Vaccines and Pediatrics. "We are committed to providing families with innovations in vaccine technology that not only help protect against disease but also improve patient comfort and increase parental and physician confidence in the immunization process."

ACEL-IMUNE was the first acellular pertussis vaccine licensed in the U.S. It was introduced in 1991 for use in children at approximately 15 to 24 months of age and between four and six years of age. These represent the fourth and fifth doses of the recommended five-dose diphtheria, tetanus and pertussis immunization schedule. Pediatricians in the U.S. currently use whole-cell DTP vaccines for the first three doses given at two, four, and six months of age.

Pertussis or "whooping cough," a highly contagious respiratory tract infection that causes about 350,000 deaths worldwide each year, occurs most frequently in infants and young children. Each year, pertussis afflicts more than 50 million people worldwide.

Wyeth-Ayerst Laboratories, a division of American Home Products Corporation (NYSE:AHP), is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular and metabolic disease therapies, central nervous system drugs, anti-inflammatory agents, vaccines, and pediatric and generic pharmaceuticals. American Home Products Corporation is a world leader in the research, development, and marketing of pharmaceuticals and other health care products. It is also a leader in agricultural products, animal health care, medical devices, and food products.

CONTACT: Audrey Ashby

Wyeth-Ayerst

(610) 971-5823

or

Jeff Hoyak

MCS

(800) 477-9626
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Date:May 8, 1996
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