Rotavirus Rotarix vaccine contaminated with pig virus!

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Rotarix rotavirus vaccine contaminated, officials say

By Tom Watkins, CNN

March 22, 2010 4:22 p.m. EDT

About 1 million children in the United States and about 30 million

worldwide have gotten Rotarix vaccine, the FDA says.

STORY HIGHLIGHTS

Doctors have been advised to suspend use of Rotarix rotavirus vaccine

Another vaccine, RotaTeq, is still OK to use, officials say

GlaxoKline, maker of Rotarix, says the contamination is not harmful

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(CNN) -- Federal health authorities recommended Monday that doctors

suspend using Rotarix, one of two vaccines licensed in the United States

against rotavirus, saying the vaccine is contaminated with material from a

pig virus.

" There is no evidence at this time that this material poses a safety

risk, " Food and Drug Administration Commissioner Dr. Margaret Hamburg told

reporters in a conference call.

Rotarix, made by GlaxoKline, was approved by the FDA in 2008. The

contaminant material is DNA from porcine circovirus 1, a virus from pigs

that is not known to cause disease in humans or animals, Hamburg said.

About 1 million children in the United States and about 30 million

worldwide have gotten Rotarix vaccine, she said.

Rotavirus disease kills more than 500,000 infants around the world each

year, primarily in low- and middle-income countries, she said. Before

rotavirus vaccine became available, the disease was blamed for more than

50,000 hospitalizations and several dozen deaths per year in the United

States, she said.

The FDA learned about the contamination after an academic research team

using a novel technique to look for viruses in a range of vaccines found the

material in GlaxoKline's product and told the company, Hamburg said.

The drug maker confirmed its presence in both the cell bank and the seed

from which the vaccine is derived, suggesting its presence from the early

stages of vaccine development, she said. The FDA then confirmed the drug

maker's findings.

GlaxoKline emphasized Monday that the pig virus is not known to

cause illness in humans, saying " it is found in everyday meat products and

is frequently eaten with no resulting disease or illness. "

" No safety issue has been identified by external agencies or GSK, "

Breuer, the drug maker's chief medical officer, said in a written

statement. " GSK is committed to patient safety and to the highest

manufacturing standards for all our vaccines and medicines. We are already

working closely and discussing this finding with regulatory agencies around

the world. "

Another vaccine, RotaTeq, is made by Merck and was approved in 2006.

There is no evidence that the Merck product is affected, Hamburg said. Both

vaccines are given by mouth to infants to prevent rotavirus disease, which

is marked by severe diarrhea and dehydration.

Asked whether Merck would be able to meet the nation's demand, Merck

spokeswoman Pam Eisele said, " Obviously, we will work with the ... FDA to

evaluate supply needs. "

In the next four to six weeks, the drug agency will convene an advisory

committee to make recommendations and seek input on the use of new

techniques for identifying viruses in vaccine, Hamburg said.

" We're not pulling it from the market, we're just suspending its use

during this period while we're collecting more information, " she said. " It

should not be in this vaccine product and we want to understand how it got

there. It's not an easy call and we spent many long hours debating the pros

and cons but, because we have an alternative product and because the

background rates of this disease are not so severe in this country, we felt

that the judicious thing to do was to take a pause, to really ask the

critical questions about what this material was doing in the vaccine, how it

got there. "

Dr. Fauci, director of the National Institute of Allergy and

Infectious Diseases at the National Institutes of Health, said " a

substantial amount " of the DNA was found in the vaccine. But, he stressed,

" there is no evidence that it causes any disease. ... There is no evidence

that it ever does anything. "

The research group that discovered the contamination has asked not to be

identified pending its paper's publication in a scientific journal, Hamburg

said.

Anyone who has already received a dose of Rotarix should switch to the

Merck product for the next two doses, Hamburg said. Preliminary testing of

the Merck product has found no evidence of the porcine circovirus 1 DNA, she

said. Doctors should be able to tell parents which of the two products their

children received, she said.

Hamburg stressed that the suspension applies only to the United States.

Public health officials in countries where the incidence of rotavirus is

more severe may decide that the benefits of continuing to use the vaccine

outweigh any concerns raised by the contamination, she said. " Such a

decision would be very understandable, " she added.

A similar virus, porcine circovirus 2, also does not cause disease in

humans, but it does cause disease in its pig host, Hamburg said.