Rotarix rotavirus vaccine contaminated, officials say

(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 GlaxoSmithKline, 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 GlaxoSmithKline'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.

GlaxoSmithKline 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," Thomas 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. Anthony 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.


Source:
http://www.cnn.com/2010/HEALTH/03/22/rotavirus.vaccine/index.html

Entering the world of fitteds ( part three )

I take part in the everything swap every month on diaperswappers.com, I got a bunch of fleece longies from Heather8183. Here is one of my favorites:



I won another auction on hyena cart, Tessa's Bumwear made this adorable pair:



I did another trade on diaperswappers with slingmama4, here is one of the pairs I got:



I have started collecting wool and fleece for summer so more to come!!

Entering the world of fitteds ( part two )

My mom bought Kairi her first skirtie set, from http://www.etsy.com/shop/Stitchenmama. I love it, so adorable.



I bought some fleece soakers from http://www.etsy.com/shop/londonware to be part of Kairi's Christmas present, this is one of my favorites.




I bought a pair of recycled wool longies from TerraMade Products on hyena cart, she made me a pair with an owl on the bottom, I love owls!



I traded with BigSamsMom on diaperswappers for a pair of cupcake recycled longies, she even sent a cupcake to sew on a shirt to match, ( which I still need to make )



More to come!

Entering the world of fitteds ( part one )

I have been cloth diapering for the last two years now but only now have I entered the world of fitteds. Before I was strictly a pocket or AIO gal. I just did not want to get into a diaper that was going to require a cover, my thinking was it just meant more laundry for me but after months of browsing the extra fluffy forum on diaper swappers and seeing all the adorable fleece and wool longies I decided to give it a try.

Right now in my fitted collection I have:
loveybums
ewe baby
thirties
nanas bottoms
zippidys
sugar peas

I am still looking to buy a few more fitteds. I love trying new diapers.

I won my first pair of woolies on hyena cart, from Born Again Baby $15 and I quickly fell in love.



I tested some fleece longies from littlemunchkie09 on diaperswappers, I really love these, the built in soaker is great!



I tested two fleece snapless body suit from kannondicarpo on diaper swappers, which are adorable, soft and warm.





There is a start of my new collection, more to come!!

Meatball soup

Lately I have been trying to find new things to make, which normally is not that hard but I do have a picky three year old son and a picky 26 year old husband.

Tonight's soup was a great hit.

Meatball soup:
Water
Beef base
v8 juice
italian season
garlic
salt
rotini noodles
frozen meatballs
corn
shredded italian blend cheese

Start with making your base, which is the water, beef base, v8 juice and other spices, after letting that simmer add your noodles, let those cook for about 10 minuets and then add your meatballs and corn. Cook until meatballs are fully cooked and noodles are soft, top with cheese and enjoy!

Our new carseats

Recently I posted about the great trade in event that was going on at babies r us. My husband and I took advantage of this great deal and we got Alexzander and Destiny new car seats. We ended up getting Destiny an Alpha Omega Elite and Alexzander got a nautilus.

We really love our new seats! Alexzander is loving having his own little cup holder and both the seats were easy to install.

If you are looking for new seats I recommend looking into these more.

Here are some links for more information:

http://www.car-seat.org/showthread.php?t=32792

http://www.car-seat.org/showthread.php?t=10452

Chilli beef and noodles

My three year old son has entered the picky stage of eating so it has been interesting to find new things that he will eat. Tonight was a success and I thought I would share with you all.

Chilli Beef and Noodles

Egg noodles
hamburger
canned chili ( with beans )
salsa
tomatoe paste

shredded cheese

Cook the noodles like you normally would. Brown your hamburger, then add the rest of the ingredients, pour over noodles and top with shredded cheese.

It tastes great and only takes about 20 mins to make!