Flu vaccine in same batches as flawed doses to be shelved: ministry

2018/11/02 19:52:40 fontsize-small fontsize-default fontsize-big
CNA file photo

CNA file photo

Taipei, Nov. 2 (CNA) The Ministry of Health and Welfare (MOHW) has decided not to use in the national vaccination program two batches of influenza vaccine with the same lot numbers as two flawed doses found over the past week.

The decision was made during an MOHW meeting on flu control Thursday, in which discussions were conducted about the two discolored doses reported Oct. 24 and Oct. 29, respectively.

The flawed products consisted of 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 MOHW ordered an immediate suspension of all the vaccine doses with the same lot numbers as the problematic ones and launched checks on them in conjunction with the manufacturers involved.

"Nothing unusual was detected," said Lee Ping-ying (李秉穎), a pediatrician at National Taiwan University Hospital and convenor of the inoculation consultant team serving the MOHW, said at a press conference in the wake of Thursday's meeting.

The conclusion was reached that the flaws were not related to production procedures, but resulted from unexpected incidents during the syringe-filling process or the syringe production process, Lee said.

Therefore, the incidents involving the two problematic vaccine doses -- one discolored and the other carrying white suspended matter -- were eventually defined as "one-off abnormalities" during the meeting, he added.

Despite that, experts suggested that the batches in question be shelved, Lee said.

Meanwhile, Adimmune released a statement Thursday describing its flawed product as an "accident."

After an investigation, no other vaccine produced in the same lot number as the flawed one was found to be problematic. Also, all the vaccines produced by the company meet good manufacturing practice (GMP) standards, the biotech company said.

The white suspended matter spotted in its flawed product was confirmed to be plastic fragments from the syringe itself, Adimmune noted.

Sanofi Pasteur, meanwhile, said that after a Taiwan inventory check conducted along with local health officials, no further anomalies in its vaccine were found.

According to Centers for Disease Control (CDC) data, as of Oct. 31, 238.19 million doses of flu vaccine had been administered in 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, said CDC Deputy Director-General Chuang Jen-hsiang (莊人祥).

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, noting that the patient was later diagnosed with bronchitis and an upset stomach.

The infant has since recovered after treatment, he added.

(By Chen Wei-ting and Elizabeth Hsu)
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