Vaccine Contamination: Pig Virus DNA Found in Rotarix

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[NVIC Vaccine News] Vaccine Contamination: Pig Virus DNA

Found in Rotarix

 

 

 

Wed, 7 Apr 2010 16:51:08 -0400 (EDT)

 

 

 

National Vaccine Information Center <newsnvic

 

 

 

newsnvic

 

 

 

 

 

[NVIC Vaccine News] Vaccine Contamination: Pig Virus DNA Found

in Rotarix

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

April 7, 2010 Issue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NVIC Vaccine News

 

 

 

 

 

 

 

 

 

 

 

 

Vaccine Contamination: Pig

Virus DNA Found in Rotarix

by Barbara Loe Fisher

 

 

On March 22, 2010, Food and Drug Administration (FDA) officials

adhering to the precautionary principle advised American doctors to

suspend use of Rotarix vaccine until the agency finds out why DNA from

a swine virus (porcine circovirus 1 or PCV1) was found in the live

rotavirus vaccine. The FDA said there is "no evidence at this time"

that the vaccine manufactured by GlaxoSmithKline and given to babies at

2,4 and 6 months of age to prevent diarrhea poses any safety risk.

 

 

Independent Lab Using New Technology Found

Contamination

 

The discovery that viral DNA is contaminating Rotarix vaccine was made

by a team of scientists at an independent research lab in San

Fransisco, California, where they used new technology to detect

fragments of viral genetic material in vaccines using genetic

sequencing.

 

More testing confirmed that many copies of DNA from the pig virus were

present in all Rotarix vaccine lots released since the vaccine was

licensed in 2008 because the pig virus DNA also contaminated the

working cell bank and the original viral "seed" stock, from which

Rotarix vaccine was first produced.

 

 

Two Other Live Virus Vaccines Contaminated

 

The surprising discovery reportedly was made after the independent lab

used new technology to evaluate the purity of eight live virus vaccines

for polio, rubella, measles, yellow fever, human herpes 3 (varicella or

chicken pox), rotavirus (Rotarix and RotaTeq) and MMR. In addition to

pig viral DNA found in Rotarix vaccine, low levels of DNA fragments

from avian (bird) leukosis virus (a retrovirus) was found in measles

vaccine and DNA fragments of a virus similar to simian (monkey)

retrovirus was found in RotaTeq vaccine.

 

 

FDA Looking For Answers

 

After the team double checked their findings, researchers notified

GlaxoSmithKline (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. 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.... click

here

to read the entire commentary and watch a video.

 

 

NVIC's updated

Rotavirus and Rotavirus Vaccines information with references on www.NVIC.org.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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NVIC E-News is a free service of the National Vaccine Information

Center and is supported through donations.

 

NVIC is funded through the financial support of its members and does

not receive any government subsidies. Barbara Loe Fisher, President and

Co- founder.

 

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