Several doses from two batches of imported flu vaccines have been taken for further examination after abnormal floating substances were found in them, the Food and Drug Administration (FDA) said on Monday evening.
The agency said two batches from Sanofi Taiwan Co were being examined: No. R3J711V, R3J71, a trivalent vaccine for government-funded vaccinations, and No. R3J721V, R3J72, a quadrivalent vaccine available for purchase.
Four trivalent vaccines were found to contain abnormal black particles and nine quadrivalent vaccines had white particles, failing a visual inspection, it said.
The batches had not been approved and did not reach the market, the agency said, adding that they have been sealed and would be returned or destroyed within a given timeframe.
The black particles appeared to be of the same substances as the vaccines’ rubber stopper, FDA Division of Research and Analysis official Wang Der-yuan (王德原) said, adding that there are about 438,000 vaccines in the trivalent batch and about 80,000 in the quadrivalent batch.
However, the white particles are not of the same material as the stopper, he said, adding that both types were returned to the pharmaceutical company for examination.
Sanofi Taiwan said in a news release that it regretted the incident and that it has sent the abnormal vaccines to its headquarters in France for further examination.
There are still about 910,000 vaccines for adults and 140,000 vaccines for young children available this year, Centers for Disease Control Deputy Director-General Chuang Jen-hsiang (莊人祥) said yesterday.
The centers have asked the company to provide additional vaccines to make up for the supply shortage, he added.
National Taiwan University Hospital pediatrician Lee Ping-ing (李秉穎) said the incident showed that Taiwan has very strict examination standards to ensure public safety, so people do not have to be worried about flu vaccine quality.
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