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Report says defective stopper caused vaccine discoloration: FDA

2018/11/16 19:51:28

Taipei, Nov. 16 (CNA) French pharmaceutical Sanofi Pasteur has reported that the change in color of one of its vials of flu vaccine distributed in Taiwan was caused by a defect in the vial's rubber stopper, Taiwan's Food and Drug Administration (FDA) said Friday.

Hung Kuo-teng (洪國登), section chief of FDA's Division of Medical Devices and Cosmetics, said the Sanofi Pasteur report on the problematic flu vaccine suggested impurities from the defective stopper may have found their way into the vaccine.

The problem could have stemmed from the sulfur vulcanization process, make the rubber more durable and provide a tight seal, Hung said.

The French company believes the vulcanization process may have repeated itself or the temperature was too high during the process, generating sulfur compounds that may have come in contact with the vaccine and changed its color, the FDA official said.

Hung said that according to the report, Taiwan was the only country to detect such a problem with the vaccine.

The Taipei Department of Health received a report on Oct. 26 of a suspicious dose of the vaccine after local hospital workers noticed that what should have been a clear liquid had turned a brown coffee color.

No other vials of vaccine made by Sanofi belonging to the same lot number -- R3J803J -- produced a similar problem, according to the Centers for Disease Control (CDC).

The CDC immediately ordered medical facilities in seven counties and cities to stop administering the batch of 270,000 doses of the Vaxigrip vaccine as a precaution, and the problem vial was sent to the manufacturer in France to determine the cause of the discoloration.

The FDA will further study the 50-page report to determine whether the discolored vaccine was an isolated case or whether the entire batch of vaccine will have to be dumped, Hung said.

The Sanofi vaccines have currently been put on hold until further examination, he said.

(By Chang Min-hsuen and Ko Lin)