North American Vaccine Inc. said it plans to submit a productlicense application with the FDA for approval of its combineddiptheria, tetanus and acellular pertussis (DTaP) vaccine in the firstquarter of 1995 following Phase III trial results showing thetreatment was safe and effective in preventing whooping cough.
The National Institutes of Health, which sponsored the three-yearstudy in Sweden, reported the DTaP vaccine was 71 percent effectiveagainst whooping cough and did not produce adverse side effectsassociated with currently available diptheria, tetanus and pertussisvaccines, which use whole pertussis bacteria. The North AmericanVaccine product employs a detoxified pertussis toxin.
The promising trial results, a North American Vaccine spokesmansaid, will enable the company to seek approval of DTaP for allvaccine doses used to immunize children. Vaccinations in the U.S.are administered to infants at two, four and six months, followed bytwo boosters, one at between 15-18 months and the other prior toentering grade school. No DTaP vaccine is approved by the FDA forthe first three doses.
The Phase III trial, involving 3,335 infants, was conducted inSweden because adverse side effects from pertussis vaccines forcedthe country to stop vaccinating children against whooping cough in1979. In the study, about half of the children received the DTaPvaccine and the other half were given a diptheria and tetanusvaccine.
Following Tuesday's release of the Phase III results, BioChemPharma Inc., of Laval, Quebec, said it withdrew its registration withthe Securities and Exchange Commission to sell 4.25 million NorthAmerican Vaccine shares. BioChem Pharma owns about 10.9million shares, or 38 percent, of Beltsville, Md.-based NorthAmerican Vaccine. _ Charles Craig
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