The Centers for Disease Control (CDC) yesterday reported finding a second discolored flu vaccine dose and issued an emergency call to stop administering shots from the same lot number until an investigation is complete.
The CDC said it received a report on Sunday from the Kaohsiung Department of Health that a clinic in Kaohsiung had discovered white suspended matter in a trivalent flu vaccine on Saturday.
The vaccine — manufactured by Taiwan-based Adimmune Corp (國光生技) — was from lot number FKAE1802.
Photo: CNA
The lot contained about 82,000 vaccines in 0.25ml doses, which are recommended for children aged six months to three years, CDC Deputy Director-General Chuang Jen-hsiang (莊人祥) said yesterday.
About 48,000 vaccines from the lot had been distributed to health bureaus in Taichung, Chiayi City, Tainan, Kaohsiung and Pingtung, as well as Hualien, Taitung, Penghu and Kinmen counties.
The first case of a discolored flu vaccine dose was reported on Friday last week in Taipei. Use of doses from that lot, which was manufactured by Lyon, France-based Sanofi Pasteur, has been suspended until further investigation.
The CDC has instructed Adimmune to investigate the case and report to the Food and Drug Administration (FDC) within three days, Chuang said, adding that each case was immediately reported by the healthcare worker working with the vaccines, so people should not worry.
Families who live in one of the nine cities and counties can ask the clinic that administered their child’s flu shot — if the shot was given between Oct. 15 and Sunday — whether the dose came from the same Adimmune lot number and have a doctor examine their child if any signs of illness occurred after the vaccination, the CDC said.
Adimmune said in a news release yesterday that a preliminary inspection showed that the suspended matter might have been clear plastic material from the aseptic packaging.
Similar problems in Taiwan or other countries have not been reported, so the discoloration could have been an isolated incident, it said.
Adimmune said it is continuing to investigate and will report its findings to the FDC.
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