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 FDA suspends Glaxo rotavirus vaccine as precaution
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Posted - 03/22/2010 :  21:41:57  Show Profile  Send Rosemary an AOL message  Reply with Quote

FDA suspends Glaxo rotavirus vaccine as precaution

By LAURAN NEERGAARD, AP Medical Writer Lauran Neergaard,

WASHINGTON – U.S. health officials told pediatricians Monday to temporarily quit using one of two vaccines against a leading cause of diarrhea in babies, after discovering that doses of GlaxoSmithKline's Rotarix were contaminated with bits of an apparently benign pig virus.

Glaxo's vaccine has been used in millions of children worldwide, including 1 million in the U.S., with no signs of safety problems — and the pig virus isn't known to cause any kind of illness in people or animals, said Dr. Margaret Hamburg, commissioner of the Food and Drug Administration.

But vaccines are supposed to be sterile, and because there is a competing vaccine against diarrhea-causing rotavirus that has tested clean — Merck's RotaTeq — the FDA decided to err on the side of caution.

"We don't want to scare parents," Hamburg told reporters. "This was a difficult decision for us to make because there is no evidence at this time that there is a risk to patients who have received this vaccine, and we know there are real benefits for children to be vaccinated against rotavirus."

Rotavirus causes severe diarrhea and is a leading child killer in developing countries. In the U.S., with better health care, about 55,000 children a year were hospitalized for rotavirus infections and several dozen died each year before vaccination began — with Merck's vaccine in 2006 and Glaxo's in 2008.

Glaxo said Monday that regulators abroad have decided not to change how Rotarix is used while scientists probe the relevance of the discovery.

A group of scientists testing a new way to detect viruses in a variety of products stumbled onto fragments of genetic material — broken pieces of DNA — from what's called porcine circovirus-1 in Rotarix and alerted Glaxo, which confirmed the findings and in turn alerted FDA, Hamburg said.

Rotarix, an oral vaccine, is made from a weakened strain of human rotavirus that has to be grown inside living cells before being purified into a vaccine dose. Glaxo uses a line of monkey kidney cells, or vero cells. Hamburg said the pig virus DNA fragments have been found in Glaxo's cell bank, meaning they were present from the vaccine's earliest development. How the original contamination occurred is under investigation.

Merck's competing rotavirus vaccine RotaTeq is made by a very different process, and FDA's testing showed no sign of the pig virus in it.

It's not the first time unwanted viruses have been discovered in vaccines. Best known is a monkey virus that contaminated some polio vaccine in the 1950s; years later, scientists investigated if the SV40 virus might have increased vaccine recipients' risk of later-in-life cancer but concluded it didn't.

"We live in a world that's teeming with microbes," Hamburg said, but until now this particular pig virus is not one that FDA thought vaccine makers needed to check their products against.

Parents should switch to the Merck vaccine for now — it requires three doses instead of Glaxo's two — because rotavirus is too serious a disease to ignore, said Dr. William Schaffner, a vaccine specialist at Vanderbilt University who was briefed on FDA's decision.

He's bracing for calls from worried parents and will tell them that "this has been an extraordinarily safe vaccine," and that the discovery is "a consequence of our improved science and ability to detect things that we never could before."


United Kingdom
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Posted - 04/07/2010 :  18:10:29  Show Profile  Send Rosemary an AOL message  Reply with Quote

Is circovirus DNA infectious?
by Vincent Racaniello on 26 March 2010

The US Food and Drug Administration does not want Rotarix, the rotavirus vaccine, to be used because it contains porcine circovirus 1 DNA. If complete copies of the circovirus genome were present, would they constitute a potential threat to recipients? Put another way, is circovirus DNA infectious?

Here is the information you need to answer this question.

The circovirus genome is a circular, single stranded DNA molecule (pictured).
To infect a cell, the two viral proteins encoded in the DNA must be produced.
To produce proteins, mRNA must be synthesized from the viral DNA.
Single-stranded DNA cannot be copied into mRNA; the DNA must be double-stranded.
The circovirus particle consists of a protein shell surrounding the viral DNA. There are no other components in the virion.
During infection of cells by circoviruses, the particles enter the nucleus where the viral DNA is released
If naked DNA is added to cells, a good fraction ends up in the nucleus.
Knowing these facts, can you determine whether introduction of circovirus DNA into cells would lead to viral replication?
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Posted - 04/08/2010 :  16:09:27  Show Profile  Send topaz an AOL message  Reply with Quote
Vaccine Contamination Pig Virus DNA Found in Rotarix April 7, 2010
Barbara Loe Fisher, National Vaccine Information Center, NVIC


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.
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United Kingdom
2068 Posts

Posted - 04/09/2010 :  17:16:25  Show Profile  Send Rosemary an AOL message  Reply with Quote
" Some individuals have told me they do not want to know what is in their vaccines. Their logic is that even if we do identify a contaminating virus, we might not know if it is of any consequence to human health. But we would nonetheless worry about its presence and unnecessarily spend millions of dollars to remove it. The contrary view is that, although infection with porcine circovirus 1 might be benign, who can be confident that in 20 years the infection will not lead to dire consequences? "

Do you want to know what is in your vaccines?

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