TFDA Confirms Discolored Adimmune Flu Vaccine as ‘Isolated Incident’.

Taipei: 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. According to Focus Taiwan, the agency attributed the discoloration to a defective rubber stopper that had a small brown mass on it and had come into contact with the vaccine solution, deeming it likely an isolated incident. Adimmune was then required to submit a final report on the incident by Nov. 12. An expert committee reviewed the company's report on Nov. 20 and concurred with the CDC's findings that the incident was isolated, said TFDA Deputy Director-General Wang Der-yuan at a press briefing. As the rubber stoppers used by Adimmune are supplied by o utside manufacturers, the vaccine maker has agreed to increase the frequency of manual inspections for foreign objects and 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. Additionally, Adimmune has been asked to complete factory operation improvements and implement quality control measures for its suppliers by the end of the year. Wang mentioned that the TFDA will verify these improvements during subsequent inspections and continue monitoring reports of defective products. The TFDA did not provide any updates on the health of individuals who received vaccines from the FSZA2408 batch, which included the discolored vaccine. The CDC previously reported that 89,000 doses from the batch 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 stated that the center has received six reports of mild adverse reactions from the FSZA2408 batch vaccines, involving symptoms such as finger numbness, elbow pain, and an arm rash. These symptoms were controlled, and no serious complications were reported, Lo added.