Sat, Nov 03, 2018 - Page 3 News List

Health authorities discard flu shots

WHITE MATTER:Authorities said discoloration in two vaccines was due to incidents while the syringes were being filled, in one of the cases due to plastic fragments

Staff writer, with CNA

The Ministry of Health and Welfare has decided not to use two batches of influenza vaccine in the national vaccination program, after doses with the same lot numbers were found to be flawed over the past week.

The decision was made on Thursday during a ministry meeting on flu control, which was to decide about the two discolored doses reported on Wednesday last week and on Monday.

Flaws were found in one dose of Vaxigrip flu vaccine made by French manufacturer Sanofi Pasteur and a dose of children’s flu vaccine manufactured by Taiwan-based vaccine maker Adimmune Corp.

Upon the discovery, the ministry ordered an immediate suspension of all doses with the same lot numbers and launched checks in cooperation with the manufacturers.

“Nothing unusual was detected,” said Lee Ping-ying (李秉穎), a pediatrician at National Taiwan University Hospital and convener of the inoculation consultant team serving the ministry.

The checks found that the flaws were not due to production problems, but resulted from unexpected incidents during the syringe-filling process or the syringe production process, Lee said.

The two problematic doses — one of which was discolored, the other appeared to contain white suspended matter — were determined to be “one-off abnormalities” during the meeting, he added.

Experts nevertheless suggested that the batches be shelved, Lee said.

Adimmune in a statement on Thursday said that the flaw in its product was as an “accident.”

An investigation found no other problematic vaccines in the same lot, the company said, adding that all the doses it produces meet good manufacturing practice standards.

The white suspended matter spotted in its product was confirmed to be a cloud of plastic fragments from the syringe itself, it said.

Sanofi Pasteur said that no further anomalies in its vaccine were found during an inventory check conducted with local health officials.

Centers for Disease Control (CDC) data showed that by Wednesday, 2.38 million doses of flu vaccine had been administered as part of the national inoculation program this year.

Nationwide, 31 cases of people having reactions after receiving the inoculation had been reported, only one of which involved vaccine from the problematic batch FKAE1802, CDC Deputy Director-General Chuang Jen-hsiang (莊人祥) said.

That case was a 22-month-old infant who developed symptoms of diarrhea, throat inflammation and fever one day after getting a flu shot, Chuang said, adding that the patient was later diagnosed with bronchitis and an upset stomach.

The infant has recovered after treatment, he added.

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