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FDA Licenses ACEL-IMUNE For Five Dose DTaP Series.

ST. DAVIDS, Pa.--(BUSINESS WIRE)--December 30, 1996-- Wyeth-Lederle Vaccines and Pediatrics, a unit of Wyeth-Ayerst Laboratories, announced today that the Food and Drug Administration (FDA) for the first time has licensed an acellular pertussis vaccine, Wyeth-Lederle's ACEL-IMUNE(R) Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed,(1) for all five doses in the diphtheria, tetanus, and pertussis (DTP) immunization series. This licensure expands the vaccine's use to include infants at two, four, and six months of age in addition to its current indication for the fourth and fifth doses in older children.

ACEL-IMUNE is currently the only DTP with an acellular pertussis vaccine component which is licensed in the U.S. for all five doses of the recommended DTP immunization series. "The fact that ACEL-IMUNE is licensed for all five doses is extremely important to both health care professionals and parents," says Ronald J. Saldarini, Ph.D., President of Wyeth-Lederle Vaccines and Pediatrics. "The ability to use one vaccine product, such as ACEL-IMUNE, for the complete five-dose DTaP immunization schedule will simplify vaccine administration and record keeping."

In 1991, ACEL-IMUNE was the first DTP containing an acellular pertussis vaccine component to be licensed in the U.S. Until now, it has been indicated for the fourth and fifth doses, typically administered to children at approximately 15 to 20 months of age and between four and six years of age.

A Four-Antigen Acellular Pertussis Component

ACEL-IMUNE has an acellular pertussis vaccine component with the following four antigens: agglutinogen (FIM 2), pertactin (PRN), filamentous hemagglutinin (FHA), and pertussis toxin (PT).

"The four-antigen component is an important feature of ACEL- IMUNE because each antigen contributes to the development of antibodies," says Marc W. Deitch, M.D., Senior Vice President of Medical Affairs and Medical Director of Wyeth-Ayerst Laboratories.

A large-scale clinical trial was conducted with ACEL-IMUNE in Germany, involving approximately 10,000 infants who received either ACEL-IMUNE, whole-cell DTP vaccine, or diphtheria and tetanus (DT) vaccine. Infants in the ACEL-IMUNE arm of the study experienced significantly fewer local (injection site) reactions and less fever, drowsiness, continuous crying, and fretfulness than those in the whole-cell DTP vaccine group.

The efficacy results with ACEL-IMUNE were comparable with those reported for whole-cell DTP vaccine. ACEL-IMUNE was also demonstrated to be effective when administered with other vaccines routinely used in infants such as Haemophilus influenzae type b, Hepatitis b, and oral polio.

Unlike the DTP vaccines that contain killed, whole pertussis bacteria, the acellular pertussis vaccine component of ACEL-IMUNE is a combination of antigens, believed to be important for immunity, derived from the pertussis bacteria.

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

Since its licensure in 1991 for use with the fourth and fifth doses, more than 8.5 million doses of ACEL-IMUNE have been distributed in the U.S. ACEL-IMUNE has been the market leader in private pediatrician offices for booster-dose use.

"ACEL-IMUNE set a new standard for pertussis immunization," says Dr. Saldarini. "We are pleased that health professionals and parents can now look forward with confidence to the use of this innovative vaccine, which safely and effectively helps to protect infants as well as older children against three serious childhood diseases."

An established leader in developing vaccines to protect families against disease, Wyeth-Lederle also provides:

-- HibTITER(R) Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate), the first Haemophilus influenzae type b vaccine licensed for infants;

-- TETRAMUNE(R) Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed and Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate), the first combination vaccine to help prevent four serious childhood diseases with half the number of shots;

-- ORIMUNE(R) Poliovirus Vaccine Live Oral, Trivalent, an oral polio vaccine;

-- FLU-SHIELD(R) (Influenza Virus Vaccine, Trivalent, Types A and B, purified subvirion), to help protect against influenza; and

-- PNU-IMUNE(R) Pneumococcal Vaccine, Polyvalent to help protect against pneumococcal pneumonia.

Wyeth-Ayerst Laboratories 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 generic pharmaceuticals. American Home Products is one of the world's largest research-based pharmaceutical and health care products companies and is a leading developer, manufacturer, and marketer of prescription drugs and over-the-counter medications. It is also a leader in vaccines, biotechnology, crop protection products, animal health care, and medical devices. -0-

There are risks associated with all vaccines. Please see Prescribing Information for indications and usage, dosage and administration, and safety information. -0- (1) Acellular pertussis component manufactured by Takeda Chemical Industries, Ltd.

CONTACT: Doug Petkus


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Publication:Business Wire
Date:Dec 30, 1996
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