Posted on 02/04/2006 2:28:54 PM PST by neverdem
FOR IMMEDIATE RELEASE P06-16 Media Inquiries: Stephen King, 301-827-6242 Consumer Inquiries: 888-INFO-FDA
The Food and Drug Administration (FDA) today announced the approval of RotaTeq™, a live, oral, vaccine for use in preventing rotavirus gastroenteritis in infants. It is the only vaccine approved in the United States that can help protect against rotavirus, a viral infection that may cause diarrhea, vomiting, fever, and dehydration.
"This vaccine gives health care providers an important new tool that can effectively prevent an illness that affects almost all children within the first few years of life," said Jesse L. Goodman, MD, MPH, director of FDA’s Center for Biologics Evaluation and Research.
Infection with rotavirus is a leading cause of severe diarrhea in infants and young children in the United States and worldwide. The Centers for Disease Control and Prevention (CDC) has estimated that rotavirus infection results in approximately 55,000 hospitalizations annually of infants and young children in this country. Death from rotavirus is rare in the United States. However, in developing countries, rotavirus gastroenteritis has been estimated to cause up to several hundred thousand deaths annually in infants and young children.
Overall, approximately 72,000 healthy infants were studied in the United States and other countries in randomized placebo-controlled studies to look at the safety of RotaTeq™. Of these infants, almost 7,000 from the United States and Finland were also studied for efficacy. In these studies, RotaTeq™ prevented 74 percent of all rotavirus gastroenteritis cases and 98 percent of the severe cases. In addition, RotaTeq™ prevented approximately 96 percent of hospitalizations due to rotavirus gastroenteritis.
In 1998, FDA approved a different live vaccine against rotavirus that was later withdrawn from the market because of its association with an increased risk of intussusception, a rare, life-threatening type of blockage or twisting of the intestine. Intussusception occurs spontaneously in approximately 1 in 2,000 healthy young infants and children per year, but occurred at an increased rate during the first week or two following vaccination with the previous rotavirus vaccine.
The risk of intussusception for RotaTeq™ was evaluated in a large-scale trial of over 70,000 children, of whom half received vaccine and the remaining half received placebo. In this study, RotaTeq™ was not associated with an increased risk of intussusception when compared to placebo. In addition, RotaTeq™ was not associated with an increased risk of other serious adverse events when compared to placebo.
"Although this large study did not show an increased risk of intussusception associated with RotaTeq™, given the experience with the previous vaccine, safety of this vaccine will be closely monitored in additional studies conducted after licensure," said Dr. Goodman. The manufacturer has committed to conducting a post-licensure study of approximately 44,000 children. CDC will also conduct a large study designed to rapidly detect any association of intussusception with RotaTeq™ through its Vaccine Safety Datalink Program, which evaluates vaccine safety in approximately 80,000 U.S. infants every year. In addition, for the first three years of licensure, the manufacturer will report cases of intussusception and all serious and unexpected adverse events to FDA within 15 days of receiving them, and all other side effects on a monthly basis.
RotaTeq™ is a liquid vaccine that is given by mouth in three doses, between the ages of 6 and 32 weeks. The following were reported more often in infants who received RotaTeq™ when compared to infants who received placebo; diarrhea (24.1 percent in vaccine recipients vs 21.3 percent in those receiving placebo), vomiting (15.2 percent in vaccine recipients vs 13.6 percent in those receiving placebo), ear infection (14.5 percent in vaccine recipients vs 13.0 percent in those receiving placebo), runny nose and sore throat (6.9 percent in vaccine recipients vs 5.8 percent in those receiving placebo), wheezing and coughing (1.1 percent in vaccine recipients vs 0.7 percent in those receiving placebo).
The vaccine is manufactured by Merck & Co., Inc.
I wonder if only vaccinated children get rotavirus? This will make, what 23 vaccinations children under 2 receive?
I'm sure there must be excellent reasons for giving this; but how many vaccinations is an infant supposed to get?
Is it healthy?
If all children were breast fed, their immunity would receive a boost from the mother's immunity, which is a far more natural method of immunizing a child.
Thank you for posting this. Will read it and look for more on the topic later this weekend. The 1998 vaccine was a disaster. The number of vaccines supposedly "required" for our children is outrageous!!!!
Rota-virus, or as Mrs. MWT and I call it, "Roto-rooter" virus is serious stuff.
Most kids get it, followed by mom and dad.
Exorcist vomit and diarreah going from each end, so bad that Pedialite cannot be kept down.
Babies, especially underweight babies, die from it.
Every one of my kids has been in the hospital for this, hooked up to an IV to prevent dehydration.
Wish this was around 5 years ago.
Was it shortly after the other vaccines were given? ( I don't vaccinate my daughter, so I'm always curious about timing of illnesses.)
*and gee, love your tag line* :)
The last of these vaccines produced as a side effect, the protrusion of the bowel.
No thanks.
My daughter had Roto-virus as well.
Puddle diapers, throwing up uncontrolably etc. She lost a pound of her 18 in a week. I would still take that over the damage of the vaccine.
Personally, keep a baby away from other kids for a while, breast feed if you can (I couldn't) and NEVER step into a daycare. The baby will have less of a chance of getting it.
(And even better if you can keep the older kids out of Public Schools)
I wonder what kind of cell lines were used for the growing of the virus.
http://www.fda.gov/bbs/topics/news/2006/NEW01307.html
Consumer Inquiries:
888-INFO-FDA
Wasn't it fatal, too? I'll also pass (I was luckily able to nurse my 3 and hopefully this next one, also.)
The problem is when they make the vaccine mandatory (they were in the process of doing that last time around), so that the US can subsidize the cost of giving it to developing countries. Luckily, my state allows a philosophical objection to vaccines. I took it with my youngest for Hep B and Chicken Pox vaccines.
Maybe I'm misunderstanding you, here, but "If it wasn't for those evil research scientists, there would be no reason for horribly devastating diseases." is wildly wrong. (Though perhaps you were being sarcastic. In that case, ignore me. :D)
Horribly devastating diseases have been around for millenia - for your contemplation I submit the Bubonic plague, polio, TB, typhoid.. The only reason these aren't near as devastating as they were is because of research scientists trying to discover what makes them tick - and then developing a vaccine. Or found a way to eradicate them before they get a foothold, or both.
Sometimes the only thing preventing a deadly epidemic/pandemic of something like.. Ebola, or the Marburg virus, orrrrr.. -whatever-, is scientists working to stop them in any way they can.
Sure, some vaccines are, IMO, highly unneccesary - for example, the Chickenpox one. Some may just need to be re-reasearched and tested. (My parents have long suspected that an MMR shot in my early years may have caused my deafness.)
Disease is a part of life. Some are avoidable, or easily handled (chickenpx, common cold, normal flu..). Some need these things (vaccines, whatever all else) to deal with them.
That said... can't they place some of these vaccines further on in life?? The poor kids have enough to deal with in their early life without being forever stuck with a needle :P
Again, not trying to preach, just pointing it out. And if it was sarcasm.. well Blow me down (a la Captain Feathersword :D)!
~Moshi-chan
Uh, I don't think a dirty diaper crosses the guidelines. That's reality folks, and it was in the middle of our rotavirus stint. But oh well.
DHF
Sarcasm.
Alrighty then. Now I feel stupid for bringing all that up :P
Oh well. Stupidity happens. :P
~Moshi-chan
In my state, if you homeschool you can skip the vaccines or you can say that you are Catholic and get a religious pass. I'm not sure what other religions count.
Some vaccines are made from aborted babies.
Not particularly.
She probably got it in the church nursery. It is EXTREMELY contagious and long-lived.
And thanks re: the tagline.
LOL.
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