vax contamination: Pig virus DNA found in Rotarix

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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

GlaxoKline 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

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. 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.