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FDA Approval for CERTIVA(TM) Issued to North American Vaccine
Company is First Independent Vaccine Manufacturer to Enter U.S. Pediatric
Vaccine Market in More Than a Decade
BELTSVILLE, Md., July 30 /PRNewswire/ -- North American Vaccine (Amex: NVX) announced today that it received U.S. Food and Drug Administration ("FDA") approval to manufacture and market CERTIVA(TM), a combined diphtheria, tetanus and acellular pertussis ("DTaP") vaccine. The FDA approval of CERTIVA establishes North American Vaccine as the first independent vaccine manufacturer to clear the many hurdles required to enter the U.S. pediatric vaccine market in more than a decade and one of only a handful of FDA approved vaccine manufacturers for U.S. infants and children. Moreover, North American Vaccine becomes the first and only U.S.-based manufacturer of the acellular pertussis component used in combined DTaP vaccines.
Under the FDA approval, CERTIVA is indicated for active immunization against diphtheria, tetanus and pertussis (whooping cough) in infants and children six weeks to seven years of age. CERTIVA will be marketed and distributed in the United States by the Ross Products Division of Abbott Laboratories Inc. to private physicians and managed care markets, and by North American Vaccine to government purchasers, including state governments and the Centers for Disease Control and Prevention ("CDC").
"We are extremely excited about the FDA's approval of CERTIVA, which represents a significant milestone for the company and is a tribute to the enormous effort of each and every one of the company's dedicated employees. This FDA approval, along with approvals for the European formulation of CERTIVA and other company products in select European countries, firmly establishes North American Vaccine as a long-term player in a rapidly expanding vaccine market," stated Sharon Mates, Ph.D., President of North American Vaccine. "We firmly believe that these approvals, along with the over 15 other vaccines in our pipeline, will serve as a solid foundation from which the company will grow to become a recognized leader in the research, development, manufacturing and marketing of innovative vaccine products intended to prevent infectious diseases, improve the quality of life for children and adults, and lower total health care costs."
The acellular pertussis component of CERTIVA consists of a monocomponent purified pertussis toxoid that has been detoxified with hydrogen peroxide. In U.S. safety studies, local and systemic adverse events commonly associated with whole-cell DTP vaccination occurred less frequently after vaccination with CERTIVA. "We anticipate that CERTIVA, based on its safety and efficacy profile, will make a strong entry into a growing pediatric vaccine market and will be well received by physicians and parents alike," stated Dr. Stephen Keith, Vice President-Marketing and Sales at North American Vaccine.
"Surveillance and epidemiologic studies in Goteborg, Sweden for more than a decade, and the results from clinical trials and the mass vaccination program, have shown that pertussis toxoid confers immunity to vaccine recipients. These data also demonstrate that it may be possible to eliminate pertussis by vaccination with a single component of Bordetella pertussis," stated Dr. John Robbins of the National Institute of Child Health and Human Development ("NICHD") of the National Institutes of Health ("NIH").
The detoxification technology used in the manufacture of the pertussis toxoid contained in CERTIVA was developed by scientists at the 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 Beltsville, Maryland.
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 NICHD, and U.S. safety studies involving 3,715 infants and children sponsored by the Company, the NICHD and the National Institute of Allergy and Infectious Diseases ("NIAID") of the NIH. "We applaud the commitment and dedication of both the NICHD and the NIAID to improving the public health and welfare of U.S. infants and children, which have contributed greatly to the clinical development of CERTIVA," added Dr. Mates.
Dr. John Taranger of the University of Goteborg, and co-principal investigator in the Goteborg efficacy study employing the European formulation of CERTIVA ("CERTIVA(TM)-EU") stated: "None of the infants and children who received the vaccine in the efficacy study experienced hypotonic-hyporesponsive (collapse) episodes and the rates of local reactions, such as soreness, redness and swelling, were quite low." Dr. Birger Trollfors of the University of Goteborg, and co-principal investigator in the study added: "The demonstrated efficacy for CERTIVA-EU in Sweden was especially significant since the clinical study was conducted during an epidemic of pertussis."
According to one of the U.S. clinical investigators, Dr. Fernando Guerra, Director of the San Antonio Health District, San Antonio, Texas, "The results of the U.S. clinical trials of CERTIVA clearly demonstrate a superior safety profile as compared to the whole-cell pertussis vaccine, with significantly fewer mild reactions compared to the experience with the whole-cell pertussis vaccine."
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