Vaccines produced by French maker Sanofi show impurities again: FDA

11/26/2018 09:33 PM
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Photo courtesy of Food and Drug Administration
Photo courtesy of Food and Drug Administration

Taipei, Nov. 26 (CNA) Two batches of influenza vaccine produced by French manufacturer Sanofi Pasteur have been put on hold after several doses were found to contain impurities, Taiwan's Food and Drug Administration (FDA) said Monday.

Wang Po-yu (王博譽), a senior specalist at the FDA, confirmed the decision, saying the problematic vials, which came in two separate batches imported from France in October, contained suspicious white and black suspended matter.

The batches -- R3J711V, R3J71 containing 438,000 doses and R3J721V, R3J72 with 80,000 doses -- are scheduled to be returned to Sanofi, Wang said.

The impure doses have been sent back to the French firm for testing, he said.

According to the FDA, the problematic doses were discovered when FDA workers opened the sealed batches to perform delivery inspections on the imported vaccines.

Four doses which contained black suspended matter were found in the first batch, while nine with suspicious white matter were found in the second lot, all of which were supposed to be transparent liquids with no impurities, Wang said.

This is the second time products supplied by Sanofi have been found to contain impuritues, after reports of problematic vaccines on Oct. 26.

On Monday, the vaccine supplier expressed regret over the problematic vaccines, saying in a statement that it will investigate the matter once it receives the samples at its laboratory in France.

A report on its findings will be released in three weeks, Sanofi said.

Meanwhile, Centers for Disease Control (CDC) Deputy Director-General Chuang Jen-hsiang (莊人祥) also confirmed that none of the vaccines from the two batches have been distributed to local health centers.

A total of 6 million flu vaccines have been bought from Sanofi and Taiwan-based vaccine maker Adimmune Corp. this year, as part of the government's annual free flu vaccination program made available for people aged 50 and over, pregnant women, mothers with babies younger than six months, children between the ages of six months and preschool years, nursing home residents, patients with rare or acute diseases, health care workers, and people with high-risk chronic illnesses.

According to CDC statistics, a total of 4.12 million doses had been administered to the public as of Nov. 22.

(By Chen Wei-ting, Chang Ming-hsuen and Ko Lin)


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