Shortage: Vaccine Worries - Pharmaceutical Executive

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Shortage: Vaccine Worries


Pharmaceutical Executive

United States-At this time last year, the United States’ supply of tetanus vaccine was easily met by the two companies licensed to produce it there, Aventis Pasteur and Wyeth-Ayerst. But in June 2000, the latter ran into regulatory problems, and FDA seized thousands of substandard doses of acellular pertussis vaccine from the company’s Marietta, Pennsylvania, plant.

Aventis Pasteur, Strasbourg, France-based Aventis SA’s vaccine unit, stepped up production of Tripedia, its acellular pertussis vaccine, to satisfy what it thought would be a temporary rise in demand. Its worst fears were realized, however, when Wyeth Lederle announced in January of this year that

it had no intention of continuing the manufacture of its product, leaving Aventis the sole licensed manufacturer of tetanus vaccine in the country.

US Center for Disease Control officials were surprised by the announcement, saying they had expected the shortage to end by now. But Aventis has been unable catch up, because making and inspecting the vaccine takes an average of 11 months. The worst is yet to come––demand for immunizations for tetanus, which carries a 30 percent fatality rate, typically soars in the spring and summer because of the increase in outdoor injuries and does not subside until mid-fall, after the back-to-school vaccine rush.

In the meantime, Aventis is rationing its supplies of tetanus toxoid and tetanus diphtheria vaccines, stockpiling tens of thousands of doses for emergencies, and attempting to double vaccine production. Hospitals are currently allowed to purchase 100 doses per week, and health clinics are limited to 50 doses per week.

Although supplies for adults will be severely limited , the company says infant tetanus immunizations and combinations containing the vaccine will not be affected. People traveling to countries where tetanus and pertussis are endemic are the highest priority for receiving the adult vaccine, followed by those with wounds that put them at risk for tetanus infections. Those requesting the recommended ten-year tetanus booster are at the bottom of the waiting list.

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