Adimmune flu vaccine batch linked to discolored dose to be destroyed: CDC

Taipei, Oct. 24 (CNA) The Centers for Disease Control (CDC) announced Wednesday that a batch of Adimmune flu vaccines in which a discolored dose was found in mid-October will be destroyed.

Use of vaccines from the batch was temporarily suspended on Oct. 12, a suspension which is now permanent, the CDC said.

A dose of flu vaccine manufactured by Adimmune Corp. was found discolored in Keelung on Oct. 12, with the CDC blaming a defective rubber stopper for the "isolated incident."

On Oct. 14, CDC Deputy Director-General Lo Yi-chun (羅一鈞) said that 82,000 doses from the affected FSZA2408 batch had already been administered, while the remaining 101,000 doses were temporarily suspended from use starting Oct. 12.

Lo told the press on Wednesday that the remaining doses from the FSZA2408 batch will be destroyed following a decision made during a joint meeting attended by members of the Advisory Committee on Immunization Practices and CDC officials.

While the discoloration of that dose of flu vaccine was most likely an "isolated incident," Lo said that the "strictest standards" have been adopted for handling the remaining batch to reassure the public about vaccine safety and maintain their trust in the government-funded vaccination program.

The Taiwan Food and Drug Administration will determine whether the discoloration is an "isolated incident" or a "systemic issue" based on Adimmune's final investigation report, which must be submitted by Nov. 12, Lo added.

In addition, Lo updated the number of remaining flu jabs in the FSZA2408 batch to 94,000 doses, saying that the figure was obtained after final inspections on health bureaus in Taipei, Keelung, Taoyuan, Miaoli County, Hualien County, and Taitung County, where the affected batch had been distributed.

He later told CNA that the discrepancy between the number of remaining doses was due to the "time lag" in data entry and that no doses from the affected batch had been administered after the initial suspension date.

Medical institutions can update vaccine administration records several days after the actual vaccination, the CDC thus could only provide the data available in the system at the time of the news conference or news release, he explained.

Asked about reports of individuals feeling unwell after receiving vaccines from the FSZA2408 batch, Lo said that health authorities had received five adverse event reports, all of which were mild symptoms -- including finger numbness, elbow pain, and skin itchiness -- with no reports of serious cases or deaths.

"The health bureaus have followed up with the reported cases, and all five are currently recovering," Lo said.

Since the start of the government-funded flu vaccination program on Oct. 1, a total of 34 mild symptom reports have been received by the health authorities, involving five different brands and 18 batches, he added.

While there are five mild symptom reports related to the FSZA2408 batch, two other flu vaccine batches unrelated to the discoloration incident, manufactured by Adimmune and TTY Biopharm Co., Ltd., also respectively reported five and four such reports, "indicating no unusual increase" in the number of reports from the affected batch, Lo said.

The Keelung City Health Bureau first reported its discovery of the abnormal vaccine dose to the CDC on Oct. 12, saying that the vaccine was withdrawn at the Qidu District Public Health Center the same day.

Citing a report by Adimmune, Lo said that a small brown mass measuring 1 mm x 0.5 mm was found on the rubber stopper inside the vial containing the discolored dose and had come in contact with the vaccine solution.