Italians ban Hib vaccine in BSE scare(Feb 1997)
The police were called in to seize batches of HibTITER from the Italian outlets of the US manufacturer Wyeth-Lederle on 17 January. The vaccine was used in the Italian national vaccination programme, but the use of bovine heart-brain infusion agar to promote bacterial growth early in the manufacturing process has worried the Commissione Unica per il Farmaco, which is part of the ministry of health.
Last year the ministry was given new powers to minimise the risk of transmission of BSE to humans after the possibility of a link between BSE and the new form of Creutzfeldt-Jakob disease was raised. It has subsequently closely monitored the manufacturing processes of all drugs and vaccines used in Italy.
Don Barret, a spokesman for Wyeth in the United Kingdom, said: "We are aghast, we do not know why the Italian government has taken this action. There is no scientific basis for it. We strongly disagree and remain thoroughly convinced of the safety of our product."
The European Agency for the Evaluation of Medicinal Products, the key advisory body overseeing safety of medicinal products for the European Union, discussed the issue on 22 January. Its Committee for Proprietary Medicinal Products (CPMP) concluded that it "remains confident about the safety of HibTITER and is reassured that the manufacturing process complies with all relevant CPMP guidelines on prevention of the risk of transmission of animal spongiform encephalopathy."
The committee said that careful examination of materials used in the manufacture of vaccines was carried out, including a review of the sources of bovine material, before the vaccine was licensed. Bovine material was used only in the first step of the manufacturing process and was not an ingredient in the finished product. The bovine material came from herds in countries free of BSE such as Australia and the US. There had been no breeding from outside the herds, and the material was obtained under veterinary supervision.
The Italian ministry of health said that there was little or no risk to the public and that people who had received the vaccine should not worry, but that under Italian law even the remotest risk of transmission of BSE was a reason to act. The ministry added that there was another Hib vaccine which was not made using bovine heart-brain infusion and that it would be used in the national vaccination programme.