Ingredients and BSE (bovine spongiform encephalophathy)

[LongIsland]

While trying to find out why Wyeth recently stopped production of it's HibTITER vaccine (based on information in the "vaccine shortages" section of the CDC website, I came across this 1997 BMJ article (below).

Does anyone know if bovine heart-brain infusion is currently used in the vaccine manufacturing process for vaccines produced for the United States?

http://bmj.bmjjournals.com/cgi/conte...314/7078/393/j


The Italian ministry of health has suspended the use and marketing of a vaccine against Haemophilus influenzae type b (Hib) because of fears that it could transmit bovine spongiform encephalopathy (BSE) to humans.

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.

[HeatherHeather]

I don't know anything about "heart-brain infusion", but many us vaccines contain fetal bovine serum, which theoretically could transmit BSE to humans.

[~member~]

Now, how come our government can't/won't care about us the way Italy's does?

[Gitti]

Originally Posted by LongIsland

Does anyone know if bovine heart-brain infusion is currently used in the vaccine manufacturing process for vaccines produced for the United States?

This is from the FDA from 2002

Bovine Protein in vaccines - from the CDC

[Gitti]

Originally Posted by MamaInTheBoonies

Now, how come our government can't/won't care about us the way Italy's does?

Don't be fooled into thinking that the Italian government cares any more for their people. They may make a show of it, but the whole thing smacks of politics. If they have a chance to say we need to make our own vaccines because of this, that creates jobs, business, taxes.

Don't forget some years ago they enforced a vaccine to be given every school age child and it was revealed that the only reason why it made the mandated list was because of the vaccine manufacturer's connection to the government. Officials went to jail over it, but the vaccine remained on the 'must do' list.

They are just as corrupt as our government. If not, you can be sure they aspire to be so.

Last year in Germany they took the 6-in-1 vaccine off the market. The reason they gave: The Hep B in it was not effective enough.

The truth: Several children died very shortly after getting the injection.

What did people believe? Their government cared so much about them that they were concerned about the ineffective Hep B.

Isn't it ironic that each country in Europe has their own vaccine(s) that 'must be given'. All depends on political connections and who manufactures what in each country. It has absolutely nothing to do with protecting children.

[LongIsland]

Thanks Gitti!



Vaccines that use bovine-derived materials from countries on the USDA list include:

Aventis Pasteur, S.A.’s Haemophilus Influenzae Type b Conjugate Vaccine, ActHIB (ActHIB is also marketed as OmniHIB by SmithKline Beecham Pharmaceuticals)


Scary, but not surprising:

In 2000, CBER learned that its recommendations regarding the sourcing of bovine materials for the manufacture of vaccines had not been followed in at least one instance. As a result of this finding, CBER requested all vaccine manufacturers to review the source for all bovine-derived materials used in the manufacture of their vaccines. This review identified additional vaccines manufactured with bovine-derived materials that had been obtained from European countries on the USDA list.

[HeatherHeather]

There has actually been a big rush to develop an artificial bovine serum medium since mad cow hit the mainstream news several years ago. In fact, I'm pretty sure several companies make it now, but it is not cost effective . . . yet.

I guess their waiting for a bombshell and a lawsuit.