12:00 AM
 | 
Nov 04, 1996
 |  BioCentury  |  Strategy

Lining up the acellular pertussis competition

WASHINGTON - Beyond the immediate spotlight put on North American Vaccine Inc.'s Certiva acellular pertussis vaccine, last week's meeting of the FDA's Vaccines and Related Biological Products Advisory Committee focused attention on the coming competition between similar vaccines manufactured by several companies.

The impetus for development of these products, which are combined with diphtheria and tetanus toxoids to form a DTaP vaccine, has come from the relatively high incidence of adverse effects associated with whole-cell vaccines. The side-effects have caused some countries to abandon universal vaccination programs and has limited compliance in other countries. Acellular pertussis vaccines include only the parts of the bacterium believed to induce immunity to whooping cough. The greater purity is believed to be responsible for the lower incidence of adverse effects compared to whole-cell vaccines.

Assuming all five acellular pertussis products make it to market, they presumably will be judged on some combination of safety and efficacy. To date, two DTaP vaccines have been approved in the U.S.: Connaught Laboratories' Tripedia received FDA approval in July for use in infants two, four and six months of age and for the first booster dose at 15 to 20 months;...

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