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Published Date: 2012-08-29 20:40:20
Subject: PRO/EDR> Rabies - India (07): (HA) vaccine withdrawn
Archive Number: 20120829.1271575

RABIES - INDIA (07): (HARYANA) VACCINE WITHDRAWN
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Date: Wed 29 Aug 2012
Source: Hindustani Times [edited]
http://www.hindustantimes.com/Punjab/Chandigarh/Rabies-vaccine-withdrawn-after-boy-s-death-in-Karnal/SP-Article1-921450.aspx

Following the death of a 6-year-old boy after being administered an anti-rabies vaccine (ARV) here on Wednesday [29 Aug 2012], the Haryana health department has alerted all civil hospitals to temporarily discontinue using the vaccine. The incident took place at Karnal Civil Hospital, and doctors termed it a case of vaccine reaction. Karnal civil surgeon Dr Shiv Kumar said that the vaccine, AbhyaRab, manufactured by Human Biological Institute, Tamil Nadu, has been withdrawn.

The vaccine is available at all government hospitals, and following suspicion about its quality, its use has been suspended with immediate effect. "The vaccine stock in Karnal has been sealed, and the civil surgeons across the state have been informed telephonically to stop using the vaccine till it gets a quality clearance," Dr Kumar said. He said that the patient from Panipat was undergoing treatment at the local civil hospital after being bitten by a stray dog. He had been referred here to undergo a treatment of 5 ARVs in a row. "The patient was administered the vaccine on 3 earlier occasions, and he responded well. But after being administered the ARV at the hospital today [29 Aug 2012], his condition deteriorated suddenly. Despite the best efforts of the team of doctors attending on him, the patient died within 20 minutes of being injected the vaccine," the civil surgeon added.

District drug controller Parvinder Malik confirmed that the stock of Human Biological Institute ARV had been sealed and samples would be sent to the Central Research Laboratory at Kasauli in Himachal Pradesh. Meanwhile, the parents of the boy have not lodged any complaint and have declined a post-mortem.

[Byline: Vishal Joshi]

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[The AbhyaRab vaccine is produced by Human Biological Institute. It is a purified Vero cell rabies vaccine. It is a freeze dried preparation that should be reconstituted with 0.5 mL of a diluent supplied with the vaccine. The reconstituted vaccine should be administered immediately and should not be stored for administration later. Abhayrab vaccine should be administered intra-muscularly in the deltoid region in both adults and children. Under no circumstances should it be administered intravenously.

The tolerance of the child to the 1st 3 inoculations followed by abrupt deterioration of his condition following the 4th administration of the vaccine suggests that there may been some error in preparation or administration of the vaccine rather than a defect in the vaccine itself. The outcome of the investigation of this incident is awaited.

Karnal is a district in the Indian state of Haryana. The interactive HealthMap of Haryana can be accessed at: http://healthmap.org/r/3cXh. - Mod.CP]

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