(BW) North American Vaccine Announces Update On FDA Advisory Committee Meeting

(BW) North American Vaccine Announces Update On FDA Advisory Committee Meeting

BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - Tuesday, 26 November 1996.

BELTSVILLE, Md.--(BUSINESS WIRE)--Nov. 26, 1996--North American Vaccine (AMEX:NVX) maintains its policy of not commenting on interactions with the U.S. Food and Drug Administration ("FDA") in, or the status of, the FDA's review of the company's products or on rumors or press reports appearing in the media regarding the business operations of the company. However, following the completion of the Advisory Committee review of CERTIVA(TM), there have been numerous inaccurate reports of the conclusions reached by the Advisory Committee which present compelling unusual circumstances for issuing the following update.

After discussions with representatives of the FDA following the October 29, 1996 meeting of the FDA's Vaccines and Related Biological Products Advisory Committee ("Advisory Committee") at which the clinical data for CERTIVA(TM) was reviewed, the Company reaffirms its previously announced assessment, as summarized below, of the views expressed by the various members of the Advisory Committee. CERTIVA(TM) is North American Vaccine's combined diphtheria, tetanus and acellular pertussis (whooping cough) vaccine.

In its October 29, 1996 press release summarizing that meeting, the Company reported that the Advisory Committee concluded the data presented supports that CERTIVA(TM) is safe and effective for administration in infants at 2, 4, 6 and 15-18 months of age and that the data supported concurrent administration with polio, Haemophilus influenzae type b, hepatitis B and measles-mumps-rubella vaccines, which are all recommended for immunization during the first two years of life. In addition, the Company reported that the Advisory Committee concluded that the data supporting the use of CERTIVA(TM) for the booster dose given to children at 4-6 years of age following primary immunization using the whole-cell pertussis vaccine was adequate. Additional data is required to support use at 4-6 years of age following four consecutive doses of CERTIVA(TM).

In connection with the FDA Advisory Committee comments on the adequacy of the data regarding the use of CERTIVA(TM) for the booster dose given to toddlers at 15-18 months of age following primary immunization using the whole-cell pertussis vaccine, the Company may supplement the data presented at the meeting with additional data or this matter may be addressed in post marketing studies.

The current childhood immunization schedule in the United States recommends administering vaccine to protect against diphtheria, tetanus and pertussis at two, four, six months of age and at 15-18 months of age with a fifth dose at four to six years of age.

The views of the Advisory Committee are not binding on the FDA and there are no assurances that the FDA will accept the views of the Advisory Committee. The Company continues to believe that no additional clinical studies will be required in connection with its product license application, other than standard post-licensure testing and surveillance for continued monitoring of the vaccine. There can be no assurances however that FDA will not require additional clinical trials or that CERTIVA(TM) will be approved by the FDA.

North American Vaccine, Inc., is engaged in the research, development and production of vaccines for the prevention of human infectious diseases. North American Vaccine's news releases are available on the Company's web site at http://www.nava.com. For further information contact: Sharon Mates, Ph.D., President, North American Vaccine, 12103 Indian Creek Court, Beltsville, MD Telephone: 301-470-6100

CONTACT: North American Vaccine, Inc. Sharon Mates, Ph.D., 301/470-6100

Keywords: HEPATITIS; CLINICAL TRIAL

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