The remaining 94,000 doses of state-funded influenza vaccine from a batch found with a discolored dose earlier this month would be destroyed, the Ministry of Health and Welfare said yesterday.
The Centers for Disease Control (CDC) said that on Oct. 12 it received a report from the Keelung Health Bureau that a dose of the vaccine at the Cidu District’s (七堵) Public Health Center was discolored.
Personnel at the Cidu center immediately ceased vaccinations, retrieved the vial and reported the incident to the bureau, it said.
Photo: Lin Hui-chin, Taipei Times
CDC Deputy Director-General Philip Lo (羅一鈞) said the remaining 94,000 doses of the vaccine of the same batch number would also be retrieved and destroyed by Adimmune Corp, the vaccine manufacturer.
To maintain public trust in state-funded vaccines, the ministry decided at a meeting of its Advisory Committee on Immunization Practices that was attended by the vaccine maker to take the strictest measures, he said.
The decision was in line with the ministry’s response to a similar incident in 2018, when a defective rubber stopper caused discoloration in influenza vaccines made by Sanofi Taiwan Co, Lo said.
Vaccines from the same batch were distributed to public health bureaus in Taipei, Keelung and Taoyuan, as well as Miaoli, Hualien and Taitung counties, which were informed to suspend and retrieve the doses shortly after the incident occurred, he said.
Adimmune is required to submit an inspection report by Nov. 12 to the ministry, he said, adding that the CDC would decide whether it was an isolated incident or part of a systemic problem based on the company’s final report.
A recent report from Adimmune said that an unusual dark brown protuberance was found in the rubber stopper of the vial containing the discolored vaccine.
The defective stopper was in contact with the vaccine for a long time, resulting in its color washing into the fluid, it said.
As the vaccine’s light yellow fluid did not contain impurities, the color change was likely not caused by microbial contamination, it said.
The incident appears to be isolated, as none of the vaccines from the same batch showed color changes or other peculiarities, the report said, adding that the company would commission a third party to further examine the matter.
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