The Centers for Disease Control (CDC) yesterday ordered the suspension and recall of 2,642 doses of a government-funded influenza vaccine after a discolored vial was discovered at a clinic in New Taipei City.
The dose, manufactured by GlaxoSmithKline (GSK), was found to be cloudy and white during a routine pre-vaccination inspection.
The vial was reported and later classified as a defective product by the Food and Drug Administration (FDA) and was not administered.
Photo courtesy of the Centers for Disease Control
Following the report, the CDC traced the batch and found that 2,642 doses remained unused across 14 jurisdictions, including Taipei, New Taipei City, Taoyuan and Taichung, as well as counties in central, southern and eastern Taiwan, CDC spokesperson Lin Ming-cheng (林明誠) said.
Lin said about 545,280 doses from the same batch have already been administered.
Since this season’s government-funded flu vaccination program began on Oct. 1 last year, three adverse events have been reported: Guillain-Biarre syndrome, systemic urticaria and fatigue with muscle pain requiring hospitalization.
All three patients, aged in their 60s, have since recovered, Lin said.
He said the adverse event rate remains below the seasonal average of 1.6 cases per 100,000 doses.
The cause of the discoloration is under investigation, with the FDA asking the manufacturer to conduct a prompt probe under defective product reporting mechanisms.
Similar incidents have occurred in the past.
In 2018, Sanofi flu vaccines were found to contain suspended particles, while in 2024, a single discolored dose of a domestic Adimmune vaccine led to the disposal of the entire remaining batch.
Taiwan procured about 6.83 million doses of publicly funded flu vaccines for the current flu season, supplied by multiple manufacturers, including Adimmune Corp and GSK Taiwan.
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