FDA Advisory Committee Concludes ACEL-IMUNE, Acellular Pertussis Vaccine Safe and Effective for Infant Use

Business Wire, Oct 29, 1996

ST. DAVIDS, Pa.--(HealthWire)--Oct. 29, 1996--Wyeth-Lederle Vaccines and Pediatrics, a unit of Wyeth-Ayerst Laboratories, announced today that the Food and Drug Administration's (FDA) Vaccines & Related Biological Products Advisory Committee concluded that ACEL-IMUNE(R) Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed(a) is safe and effective when given to U.S. infants as a primary series at two, four, and six months of age and as a fourth dose given at approximately 18 months.

Wyeth-Lederle also presented a significant package of data to support the safety of ACEL-IMUNE(R) for use in a fifth dose for children four to six years of age. The Committee reviewed the data favorably and suggested that further data be collected from a post-marketing patient population.

"We are pleased with the Committee's review of ACEL-IMUNE(R), which earlier established the standard for pertussis immunization of older children, and has now been shown to be safe and effective for use in infants," says Ronald J. Saldarini, Ph.D., President of Wyeth-Lederle Vaccines and Pediatrics. "We are committed to working with the FDA to finalize the licensure of this vaccine for the full five-dose diphtheria, tetanus, and pertussis immunization series."

Additionally, the FDA Advisory Committee concluded that ACEL- IMUNE(R) will be safe and effective when administered simultaneously with other vaccines recommended for infants, such as Hib, Hep B, and oral polio vaccines.

In 1991, ACEL-IMUNE(R) was the first DTP-containing acellular pertussis vaccine licensed in the U.S. and is currently indicated for the fourth and fifth doses in older children who have received whole-cell DTP vaccine for the first three doses.

A Four-Antigen, Acellular Pertussis Component

ACEL-IMUNE(R), the current market leader in private-purchase pediatrician offices, is the only acellular pertussis vaccine in the U.S. that has an acellular pertussis component with the following four antigens: agglutinogens (FIM), pertactin (PRN), filamentous hemagglutinin (FHA), and pertussis toxin (PT).

"The fact that ACEL-IMUNE(R) contains four antigens is important because each antigen contributes to the development of antibodies believed to protect against pertussis disease," says Ulrich Heininger, M.D., coordinator of the large-scale, clinical trial conducted with ACEL-IMUNE(R) in Germany.

Lederle Laboratories' supplemental product license application is based primarily on the results of the German study which Dr. Heininger coordinated involving approximately 10,000 infants who received either ACEL-IMUNE(R), whole-cell DTP vaccine, or diphtheria and tetanus (DT) vaccine. Infants in the ACEL-IMUNE(R) 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(R) were comparable with those reported for whole-cell DTP vaccine.

Unlike the DTP vaccines that contain whole-cell pertussis bacteria, the acellular pertussis components of ACEL-IMUNE(R) contain only specific parts of the pertussis bacteria believed to be important for immunity.

Over 8.5 Million Doses Distributed

ACEL-IMUNE(R) was introduced in the U.S. in 1991 for use in children at approximately 15 to 24 months of age and between four and six years of age. These ages typically represent the fourth and fifth doses of the recommended five-dose diphtheria, tetanus, and pertussis immunization series.

"Since its licensure, more than eight and a half million doses of ACEL-IMUNE(R) have been distributed in the U.S. and health care professionals have administered ACEL-IMUNE(R) to toddlers and older children with confidence during the last five years. We look forward to the expanded use of this innovative vaccine to help protect infants from disease," says Dr. Saldarini. "Wyeth-Lederle is committed to providing families and the health care professionals who treat them with advances in vaccine technology that are safe and effective, and also to increasing comfort and confidence in the immunization process."

Pertussis or "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.

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- (a) Acellular pertussis component manufactured by Takeda Chemical Industries, Ltd.