What other vaccines use blood products or antibodies as a means of protection?

Answer 1

Scientists Fear Drugs & Vaccines Made from Cow Blood & Bones May Transmit Mad Cow Disease

Proposal Aimed at Reducing Mad Cow Risks
Wed Sep 22, 2004

By DIEDTRA HENDERSON, Associated Press Science Writer

WASHINGTON - The government is taking steps to reduce the already minimal
risk of mad-cow tainted components ending up in childhood vaccines and other
medications.

Pharmaceuticals regulated by the Food and Drug Administration (news - web
sites), including human vaccines and animal drugs used on farms, routinely
use cow products in their manufacture.

The agency this summer strengthened safety measures to reduce the chance of
mad cow-tainted cow parts winding up in such consumer goods as lipstick and
hairspray.

William Egan, FDA (news - web sites) acting director in the office of
vaccine research and review, told pharmaceutical representatives on Tuesday
that the new rule is aimed at reducing even further mad cow risk in human
and animal drugs. He did not offer specifics.

"It's under development. That's all I can say," Egan said during a
conference co-sponsored by PDA, an association of scientists involved in
drug development and manufacture.

There have been no reported cases of mad cow transmitted by medications.
Dozens of people, however, were infected with Creutzfeldt-Jakob disease
(news - websites), related to the human form of mad cow, by taking tainted
human growth hormone between 1963 and 1985, according to the National
Institutes of Health (news - web sites). The method of manufacturing the
growth hormone was changed in response to that risk.

Eating beef from a diseased cow is thought to cause variant
Creutzfeldt-Jakob disease. More than 150 cases of variant CJD have been
reported in the world, primarily in Britain, and most of those people have
died. The one case of variant CJD in the United States was in a young woman
who likely contracted the disease while living in Britain.

In July 2000, the FDA told manufacturers to replace products in their
vaccines derived from cows born, raised and slaughtered in countries with
confirmed mad cow cases. Manufacturers hustled to find replacement materials
from countries whose cows were free of the always fatal brain malady.

At the time, no North American cases of mad cow, formally known as bovine
spongiform encephalopathy, had been confirmed, until May 2003, when a 6- to
8-year-old cow in Alberta, Canada tested positive for mad cow. And, in
December 2003, a second Canadian cow < this one a 6 1/2-year-old imported
into Washington state < also was confirmed with mad cow.

More aggressive surveillance by the Agriculture Department since June 1,
2004, has tested 63,341 American cow samples, said Lisa Ferguson, a USDA
senior staff veterinarian. Two samples initially were suspicious but, upon
further testing, were found not to contain mad cow.

The FDA's Egan said the agency has not yet decided whether manufacturers
will have to replace American and Canadian cow products routinely used in
vaccine manufacturing. Argentina, Australia, Iceland and Uruguay are among
the dwindling list of countries provisionally free of mad cow.

Also not clear is how the FDA would handle licensed vaccines currently on
the market or products progressing along lengthy development pipelines.

Even if American and Canadian sources of bovine-derived products were
prohibited, it's not clear how sweeping the impact might be.

One drug company, GlaxoSmithKline, already found alternate sources of
materials it uses to produce such products as hepatitis A vaccine and
recombinant hepatitis A and B vaccine. While Danielle Halstrom, a
GlaxoSmithKline spokeswoman, won't identify the source countries, she said
they do not include the United States or Canada.

"The entire process was completed more than a year ago ... to ensure we only
use materials from countries" with no mad cow infections, Halstrom said.

Cow remnants left over from slaughter have long been used to manufacture
drugs like vaccines. Serum is drawn from cow's blood and sugars from cow's
milk. Amino acids from cow bones are added to growth media to coax along
viral vaccines grown in living cells.

Egan suggested the companies consider plant-based and synthetic compounds as
substitutes, culturing methods that don't require serum, and "closed" cattle
herds known to be free of mad cow.

A Merck representative lobbied from the stage at Tuesday's conference,
urging the agency to first issue a letter with its intentions so companies
would have more time to prepare for changes that could affect 80 percent of
pharmaceuticals.

"We have lifesaving medicines that we produce," said Taryn Rogalski-Salter,
a director in the company's department of global regulatory policy, warning
about potential supply disruptions.

By: IAN JOHNSTON -- 22-Sep-04