The Centers for Disease Control (hereafter referred to as CDC) received a notification from the New Taipei City Health Bureau on March 24 this year (115) that one dose of GSK (GlaxoSmithKline) influenza vaccine from the Taiwan branch of the Dutch company GlaxoSmithKline displayed a white cloudy appearance upon visual inspection, and the vaccine was not administered. After checking the inventory of the same batch number (AFLUA915AA) within the bureau, no other vaccines showed similar conditions. The CDC immediately reported to the Food and Drug Administration, which activated the relevant mechanism to investigate and clarify. Based on the FDA's preliminary assessment, it is recommended that the vaccines of the same batch be temporarily suspended as a precaution. To ensure public vaccination safety, the CDC has notified the health bureaus of 14 counties and cities that still have inventory of this batch to temporarily suspend and retrieve the batch, and also informed contracted medical institutions in the jurisdictions; if they have inventory of this batch, they should cooperate in temporarily suspending, retrieving, and inspecting the vaccine appearance, and if cloudiness or similar conditions are found, proactively report to the health bureau and the CDC. The CDC has not received any other similar reports so far. Additionally, there have been three reported adverse events after administration of this batch, all in individuals in their 60s, occurring from the day of vaccination to 20 days post‑vaccination, including Guillain‑Barré syndrome (GBS), generalized urticaria, and systemic fatigue with muscle pain requiring hospitalization; all three cases have recovered.
The CDC stated that a total of 545,280 doses of this batch were received, and according to data from the National Immunization Information System (NIIS), the current inventory totals 2,642 doses, distributed across 14 counties and cities, including Taipei City, New Taipei City, Keelung City, Yilan County, Taoyuan City, Hsinchu County, Taichung City, Nantou County, Yunlin County, Chiayi County, Chiayi City, Pingtung County, Hualien County, and Taitung County. The CDC will ask the health bureaus to reconfirm the actual inventory; if stock is confirmed, all unused vaccines will be retrieved and centrally stored by the health bureaus. Regarding this incident, the FDA has required the manufacturer, in accordance with the drug adverse product reporting mechanism, to promptly investigate and clarify.
Source: Centers for Disease Control
Data compiled: Epidemiology Management Office
