FDA suspends Glaxo rotavirus vaccine as precaution

[Guest guest]

FDA suspends Glaxo rotavirus vaccine as precaution - Yahoo! News

" contaminated with bits of an apparently benign pig virus. " -

BENIGN BITS??????????????

" 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. "

NOW Offit gets to sell more of his Merck vaccine

and lower down lies about SV40 in polio vax being just fine too

Sheri

http://news.yahoo.com/s/ap/20100322/ap_on_bi_ge/us_med_vaccine_warning

By LAURAN NEERGAARD, AP Medical Writer n Neergaard, Ap Medical

Writer – 2 hrs 41 mins ago

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 GlaxoKline'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. 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. "

Sheri Nakken, R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

Vaccines -

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