TFDA confirms discolored Adimmune flu vaccine as 'isolated incident'

Taipei, Nov. 27 (CNA) The Taiwan Food and Drug Administration (TFDA) confirmed on Wednesday the previous conclusion of the Centers for Disease Control (CDC) that a discolored dose of Adimmune Corp.'s influenza vaccine reported in October was an "isolated incident."

After a dose of flu vaccine manufactured by Adimmune Corp. was found discolored in Keelung on Oct. 12, the CDC offered initial findings on the issue on Oct. 14 based on an initial report by the vaccine maker.

The agency said the discoloration was caused by a defective rubber stopper that had a small brown mass on it and had come into contact with the vaccine solution, and felt that it likely was an isolated incident.

Adimmune was then required to submit a final report on the incident by the deadline of Nov. 12.

Eight days later, on Nov. 20, an expert committee reviewed the company's report and ultimately agreed with the CDC's findings on the cause of the discoloration and that it was an isolated incident, said TFDA Deputy Director-General Wang Der-yuan (王德原) at a press briefing.

As the rubber stoppers used by Adimmune are supplied by outside manufacturers, the vaccine maker has agreed to increase the frequency with which it manually inspects the stoppers for foreign objects and will strengthen inspections of its suppliers, Wang said.

The TFDA will also increase the number of visual inspections conducted on samples of Adimmune's vaccine sent to the agency for testing, Wang said.

In addition, it has asked Adimmune to complete factory operation improvements and implement quality control measures for its suppliers by the end of this year.

Wang said the TFDA will verify the implementation of improvement measures at Adimmune's factory during subsequent inspections and will continue monitoring reports of defective products.

The TFDA did not offer any follow-up on the health of those who received vaccines from the FSZA2408 batch that included the discolored vaccine.

The CDC previously said on Oct. 24 that 89,000 doses from the batch in question had been administered before the discolored vaccine was discovered, while the remaining 94,000 doses were temporarily suspended on Oct. 12 and later destroyed.

CDC Deputy Director-General Lo Yi-chun (羅一鈞) told CNA on Wednesday that the center has received six reports of people who had adverse reactions from FSZA2408 batch vaccines to date, all involving mild symptoms such as finger numbness, elbow pain, and an arm rash.

The symptoms were all brought under control, and there have been no serious complications, Lo said.