Vaccine Contamination: Pig Virus DNA Found in Rotarix

[Guest guest]

Please take the time to read and listen to the following from the NVIC.

Vaccine Contamination: Pig Virus DNA Found in Rotarix

http://www.nvic.org/NVIC-Vaccine-News/April-2010/Vaccine-Contamination-Pig-V

irus-DNA-Found-in-Rota.aspx

Brief excerpt below:

After the team double checked their findings, researchers notified

GlaxoKline (GSK) on February 9, 2010 and GSK notified the FDA on March

15, 2010, which prompted the FDA's action on March 22, 2010 to suspend use

of Rotarix. The FDA says it " does not know how DNA from PCV1 came to be

present in Rotarix " or whether " this means that intact virus is present.

Additional studies are being conducted. "

Rotavirus Vaccines Use Monkey, Cow, Pig Materials for Production

Rotarix is a genetically engineered vaccine that GSK created by isolating

human rotavirus strain infecting a child in Cincinnati and using African

Green monkey kidney cells to produce the original viral seed stock from

which all Rotarix vaccine has been made. 7 In the FDA licensing process,

Rotarix had to meet certain FDA standards, that included demonstrating the

vaccine was not contaminated with, for example TSE (Transmissable Spongiform

Encephalopathy or " mad cow " disease, a brain wasting disease) or with cow

viruses because bovine (cow) serum was used to prepare the original viral

seed stock. Porcine trypsin, an enzyme in the pancreatic juice of a pig,

was also used to make the viral seed stock.

RotaTeq is a genetically engineered vaccine containing five human-cow

reassortment strains of rotavirus that were created at the Children's

Hospital of Pennsylvania (CHOP), where strains of rotavirus that give cows

diarrhea were combined with strains of rotavirus that cause diarrhea in

humans. The reassortment viruses were transported to Merck, where master

seeds were produced using African Green Monkey kidney cell cultures. Fetal

bovine (cow) serum and porcine trypsin was used to make the " seed " stock.

There are small amounts of bovine serum and cell culture media (monkey viral

DNA) that remain in RotaTeq vaccine.

Using Cancer Cells to Produce Vaccines?

Vaccine manufacturers have long used cell material that comes from the

bodies of mammals, including humans, monkeys, cows, pigs, dogs and rodents,

as well as birds or insects to make vaccines now in use or to make

experimental vaccines. There is an inherent risk of contamination with

viruses and other microbes (or DNA from those microbes) that can escape

detection during the vaccine development, testing, licensing, manufacturing

and oversight process. There has even been discussion among vaccine

manufacturers and the FDA in the last decade about using neoplastic (cancer)

cell substrates to make vaccines but the risk of contamination with cancer

cell DNA is a big risk.

New Influenza Vaccines: Is Contamination Possible?

In searching for ways to make seasonal influenza vaccines in a faster,

easier and less expensive way than relying on chicken eggs for production,

drug companies have experimented with using dog kidney cells and human fetal

retinal cells. However, these cell lines have been documented to cause

tumors in animals, especially dog kidney cells (MDCK).

At a November 19, 2009 meeting of the FDA Vaccines & Related Biological

Products Advisory Committee, a vaccine manufacturer asked for permission to

use insect (caterpillar) cells to make pandemic influenza shots. But insect

cells can be contaminated with insect viruses that are hard to detect. The

FDA Committee, on that day, voted " no. "

Be Well

Dr.L