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The Department of Health (DH) today (March 4) ordered a licensed drug company, GlaxoSmithKline Ltd. (GSK), to recall from the market 144 units of three of its vaccines because of suspected quality defect.
The products to be recalled are 115 units of Fluarix vaccine (Registration No.: HK-43003; Batch No.: AFLUA510AB) from eight private practitioners and two units from Hong Kong Baptist Hospital (HKBH); 20 units of Infanrix-IPV/Hib vaccine (Registration No.: HK-47367; Batch No. A20CA598A) from Hong Kong Sanatorium and Hospital Ltd (HKSH); and two units of Synflorix vaccine (Registration No.: HK-58098; Batch No. ASPNA023DC ) from DH's Anne Black Maternal and Child Health Centre (MCHC) and five units from Ap Lei Chau MCHC.
GSK reported to DH today that earlier on this January, a total of 260 units of the above three products were collected from a private practitioner via its distributor, Zuellig Pharma Ltd, a licensed wholesaler, because of possible breakage in the cold chain while the items were in his custody. The vaccines were being quarantined in Zuellig's store, pending assessment by GSK before disposal. However, they were mistakenly released in February because of staff oversight.
Fluarix is a vaccine for use in adults and children above six months for the prevention against influenza.
Infanrix-IPV/Hib is for immunisation against diphtheria, tetanus, pertussis; poliomyelitis and Haemophilus influenzae type B in clients aged two months, while Synflorix is a vaccine against pneumococcal disease.
Investigation into the records of GSK and Zuellig showed that the suspicious vaccines were released by GSK and distributed by Zuellig to DH¡¦s Anne Black and Ap Lei Chau MCHCs, eight private practitioners' clinics and two private hospitals, HKSH and BH, between February 16 and 23.
Further tracing revealed that 116 units had already been administered, comprising 38 units of Synflorix to clients of Anne Black Maternal and Child Health Centre between February 23 and 24; 73 units of Fluarix to clients of the eight private practitioners after February 16; and five other units of Fluarix to clients of HKBH after February 16. There was no record of Infantrix-IPV/Hib ever having been given out by HKSH, nor has DH received any report of related adverse event thus far.
A spokesman for DH remarked that inappropriate storage temperature could reduce or even destroy the effectiveness of vaccines, resulting in inadequate or no immune response. According to most international authorities, the World Health Organisation included, re-vaccination would likely be required.
GSK will be in contact with the affected healthcare providers and will also set up a hotline, 3189 8765, to answer enquiries. DH's Pharmaceutical Service will be closely monitoring the recall besides investigating further into the modes of product distribution in both GSK and Zuellig. Indicated prosecution will be initiated in consultation with the Department of Justice.
Meanwhile, DH's Anne Black MCHC will call back its involved clients for assessment besides providing reassurance to those not affected. A designated telephone line 2125 1133 will also be set up tomorrow for related enquiry.
The spokesman urged that healthcare providers in reception of the affected batches must stop supplying the products further and get in touch with GSK.
"People who have been contacted by their healthcare providers for assessment ought to discuss their need for re-vaccination for adequate protection, although safety is unlikely a concern in this incident," he stressed.
Ends/Friday, March 4, 2011
Issued at HKT 21:36
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