Abbott Announces CERTIVA(TM) Launch
Company Anticipates Solid Reception into U.S. Pediatric Vaccine Market
For New Combined Diphtheria, Tetanus and Acellular Pertussis Vaccine
ABBOTT PARK, Ill., Oct. 15 /PRNewswire/ -- Abbott Laboratories (NYSE: ABT) announced today the market introduction of CERTIVA(TM), a combined diphtheria, tetanus and acellular pertussis (DTaP) vaccine developed and manufactured by North American Vaccine of Columbia, Maryland (Amex: NVX). Abbott will market CERTIVA to private physicians and managed care markets in the United States under a distribution agreement with North American Vaccine.
"The launch of CERTIVA fits extremely well with the current product offerings of Ross Products," stated Joy Amundson, senior vice president of the Ross Products Division of Abbott. "The introduction of CERTIVA in the U.S. means that pediatricians have an important new option in immunizing infants and children against serious childhood diseases."
Abbott is planning launch symposia throughout the U.S. and will utilize its 500-person Ross pediatric sales force to educate physicians and others on the benefits of CERTIVA in the immunization of infants and children. In the U.S., CERTIVA is indicated for active immunization against diphtheria, tetanus and pertussis (whooping cough) of infants and children six weeks to seven years of age. Under current immunization policies, virtually all children in the U.S. are required to receive four doses of a combined diphtheria-tetanus- pertussis vaccine during the first two years of life with a fifth dose administered prior to entering grade school. It is currently estimated that the U.S. market for combined diphtheria-tetanus-pertussis vaccines is between $250-$300 million per year. Since 1997, acellular pertussis vaccines have been preferred for all doses in the pediatric immunization schedule recommended by the Advisory Committee on Immunization Practices of the U.S. Center for Disease Control and Prevention (CDC) and the American Academy of Pediatrics.
Gary Harmon, general manager, Pediatric Pharmaceuticals at the Ross Products Division, stated: "Acellular pertussis vaccines have been recognized to provide a significant improvement over the whole-cell vaccines previously used in the market."
The acellular pertussis component of CERTIVA consists of a monocomponent purified pertussis toxoid that has been detoxified with hydrogen peroxide. The detoxification technology used in the manufacture of the pertussis toxoid contained in CERTIVA was developed by scientists at the National Institutes of Health (NIH) and is the subject of U.S. and foreign patents licensed exclusively to North American Vaccine. North American Vaccine produces the monocomponent acellular pertussis toxoid and formulates the final product at its manufacturing facilities in Maryland. In U.S. safety studies, local and systemic adverse events commonly associated with the whole-cell DTP vaccination occurred less frequently after vaccination with CERTIVA.
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 conducted in Goteborg, Sweden, involving 3,450 Swedish infants sponsored by the National Institute of Child Health and Human Development of the NIH. It was also supported by U.S. safety studies involving 3,715 infants and children sponsored by North American Vaccine, the National Institute of Child Health and Human Development, and the National Institute of Allergy and Infectious Diseases, both of the NIH. In addition, approximately 60,000 infants and children received more than 150,000 doses of a European formulation of CERTIVA in a mass vaccination project conducted in Goteborg that began in June 1995.
Pertussis is a highly contagious bacterial infection of the respiratory tract caused by the bacterium Bordetelle pertussis. Most reported pertussis cases occur in infants and young children. In the first stage of pertussis, an infant or child will often have mild respiratory symptoms. Within two weeks, the disease usually progresses and the infant or child will develop prolonged series of rapid coughs followed by a quick, deep breath -- a "whoop." These whooping episodes can persist up to two months and can cause vomiting, choking, inability to breathe and injury to the brain due to lack of oxygen, especially in those individuals under twelve months of age. For 1997, the CDC reported that provisionally there were over 5,500 cases of pertussis in the U.S. In addition, surveillance data in the U.S. from 1992-1994, as reported by the CDC, indicate that in children aged less than one year with pertussis, 66% were hospitalized, 15% had pneumonia, and 2% had seizures. |
