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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE T99-6

Consumer Media: 888-Info-FDA
January 29, 1999

RECALL OF ONE LOT OF TRIPEDIA BECAUSE OF SUBPOTENT DIPHTHERIA COMPONENT

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The FDA is announcing that one lot of Tripedia, (lot number 0916490) a U.S. licensed vaccine that immunizes children against diphtheria, tetanus and pertussis, has been voluntarily recalled because the diphtheria component of the vaccine was recently found to be subpotent. The lot was distributed nationally between February and June, 1998, by Pasteur Merieux Connaught of Swiftwater, Pa. The subpotent lot was discovered by routine testing of retained samples by the company.

No problem exists with the potency of the tetanus and pertussis components of this lot, and no adverse reactions related to the subpotent diphtheria component would be expected. However, health professionals may advise parents that some children should receive a supplemental vaccine dose.

Because diphtheria is very rare in the United States, (largely due to the routine immunization of children,) the risk to most children who received the subpotent lot is extremely low. The risk may be higher for children traveling to a country with a higher risk for the disease. For some of these children who will be traveling outside the U.S., supplemental immunization may be needed.

In addition, any child who received a dose from the subpotent lot of Tripedia should receive subsequent scheduled doses on a regular, timely basis to ensure the optimum level of immunity against diphtheria.

Diphtheria is a serious disease usually spread from the respiratory tract that causes a thick covering in the back of the throat that can lead to breathing problems. Heart problems and other serious complications are also possible. From 1980 through 1996, only 43 cases of diphtheria were reported in the United States.

Diphtheria occurs worldwide, but clinical cases are more prevalent in temperate zones during colder months (winter and spring). Risk to travelers increases with prolonged travel, extensive contact with children, or exposure to less than optimal hygiene conditions. Individuals who will be traveling abroad and who may be affected by this recall should contact their health provider. Information from the Centers for Disease Control and Prevention (CDC) is available on their website at www.cdc.gov.

Five doses of a vaccine containing a diphtheria component are recommended for preschool aged children in the U.S. and provide optimal protection against diphtheria. Currently, most children are vaccinated against diphtheria with a combination vaccination such as Tripedia, which includes components that protect against tetanus and pertussis, in addition to diphtheria. Tripedia is given at 2, 4, and 6 months of age, with additional doses for added protection at 12-18 months and before going to school. The first three doses are considered the primary series of vaccinations.

If parents need further information they should contact their physicians. FDA and CDC will be advising physicians about further, more specific, recommendations for supplemental immunization of children who have received doses of the subpotent lot. Health professionals can also call Pasteur Merieux Connaught at 1-800-325-7709 for further information.

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.