Reports of Iymphadenitis following administration of BCG Vaccine SSI

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(852) 2803 49E2
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28 December 2011
PRIE/7-30/15
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(TI REPLY PLEASE QUOTE THIS FILE REF,)
Dr. Rayrnond LIANG
President
Hong Kong Academy of Medicine
(FatNumber:2505 5577)
Dear Dr, LIANG,
Singapore Health Sciences Authority (HAS) would like to update healthsare professionals on
the suspected reports of lymphadenitis following the administration of the Bacillus Calmette-Gudrin
(BCG) Vacoine Staten Serum Institute (SSD@, the sole BCG vacoine registered in Singapore since June
2003. BCG vaccine is used for the immunisation against tuberculosis.
In Singapore, BCG vaccine is routinely given to newboms as part of the National Childhood
Immunisation Scniaute. From January to October this year, HSA receivod a total of 53 reports of
lymphadenitis, out of whioh 27 cases presented as suppurative lymphadenitis. The cases of suppruative
tympnaaenitis appeared to have doubled compared to 2010. Studies have rcvealed that the incidence of
suppurative lymphadenitis is dependent on a number of fbctors inoluding the srain of BCG vaccine and
its constituents" host-related factors as wEIl as administration techniques'
Healthoare professionals are reminded that intadermal administrative technique Plays an
important role in minimising BCG-associated complications such as suppurative lymphadentitis. This
consideration is important when administering reactogenic vaccines such as the BCG Vaccine SSi@. It
is also advisable for healthcare profbssionals to inform parents of possible suppurative lymphadenitis
following vaccination so that early treatment can be sought. The median duration of symptoms prior to
patient's presentation at the clinic is two months. For details, please refer to HSA's website:
http://www.hsa.eov.se/oUblisly'hsapoftayep/health oroducts regulation/safetv information/pr
oduct safetv_alertVsafety alerts 2011/reports of lvmphadenitis.html
In Hong Kong, BCG Vaccine SSI Powder for Inj 0.75mgiml (HK-a4952) is registered by
Mekin Ltd. and manufastured by Staten Serum Institute. It is a prescription-only medicine. BCG
vaccine is part of the Hong Kong Childhood Immuisation Programme- Drug OfEce hgs reoeived onc
adverse drug reaotions repot on a 4-month old boy who developod lyrnphadenitis and the patient had
recovered after aspiration. Department of Health wilt keep vigilant against any updated safety news of
the dnrg.
Please remind your members to report any adverse events caused by the drugs to the Adverse
Drug lbaction Monitoring Unit of Department of Health (tel. no.: 2319 2920,fax:2147 0457 or email;
[email protected]). For details, please refer to the website: httpr//www,drugoffioe.gov.hk at Drug Office
under "Reporting an Adverse Drug Reaction".
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