Printer Friendly

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


(610) 971-5823


Jeff Hoyak


(800) 477-9626
COPYRIGHT 1996 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:May 8, 1996
Previous Article:JCP&L races in/sponsors Tour de Sol Electric Car Road Rally.
Next Article:Ocal Announces First Quarter Results.

Related Articles
Nothing exceeds like success.
Vaccine confers pertussis protection.
Reemergence of Pertussis in the Highly Vaccinated Population of the Netherlands: Observations on Surveillance Data.
Vaccine Verity.
Checkmate for a child-killer? Vaccine researchers close in on rotavirus.
New vaccines can keep whooping cough in check.

Terms of use | Privacy policy | Copyright © 2019 Farlex, Inc. | Feedback | For webmasters