A discolored dose of an Adimmune influenza vaccine was found in Keelung from a batch of 183,000 doses that have already been distributed to six cities and counties, the Centers for Disease Control (CDC) said on Saturday.
The Keelung Health Bureau on Saturday reported that one dose of the vaccine manufactured by Adimmune Corp was found to have discoloration before being administered at Cidu District Public Health Center, the CDC said in a news release.
The dose was immediately withdrawn for further investigation, it said.
Photo courtesy of the Centers for Disease Control
The batch containing the discolored flu vaccine consisted of about 183,000 doses, which had been distributed to health bureaus in six cities and counties: Taipei, Keelung and Taoyuan, and Miaoli, Hualien and Taitung counties, CDC Deputy Director-General Philip Lo (羅一鈞) said.
From the batch, 75,000 doses had already been administered, while 108,000 doses in stock have been temporarily withdrawn, he said.
The Cidu District Public Health Center inspected more than 70 doses from the same batch (FSZA2408) produced by the Taiwan-based vaccine maker, but no others were found to have discoloration, he added.
Six years ago, a similar situation arose with a dose of a flu vaccine manufactured by French pharmaceutical company Sanofi, Lo said, adding that the incident led to the establishment of a protocol that includes immediately halting the administration of remaining doses from the same batch.
The Food and Drug Administration (FDA) has asked Adimmune to investigate the cause of the discoloration and determine if it is an isolated case or a systemic issue, he said.
The incident would not affect an ongoing free influenza and COVID-19 vaccination program, which began on Oct. 1, Lo said, adding that 6.254 million doses of flu vaccines from five different brands are still available for this year’s program.
Discoloration is usually due to issues with in the cold chain — the temperature-controlled process for storing and transporting vaccines — or improper sealing, leading to abnormalities, said Hwang Kao-pin (黃高彬), deputy head of China Medical University Hospital’ infection control center.
The discoloration could be caused by storing the vaccine at an incorrect temperature, a faulty cap that failed to seal the vaccine or an issue with how it was stored in the Keelung public health center, Hwang said, adding that it was important for health authorities to quickly check other batches to determine the cause.
Medical experts and representatives from the FDA, Keelung City Health Bureau and Adimmune are to meet today to discuss vaccine quality and administration safety, the CDC said.
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