Birth defect vaccine on the horizon (Gov't says CMV is a major public health crisis) - Mothering Forums

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#1 of 88 Old 02-22-2007, 01:05 AM - Thread Starter
 
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I can't link directly from Reuters - will try to find alternative link. Here's a snippet:

An experimental vaccine for a common virus that can cause mental retardation and deafness in some newborns yielded encouraging results in guinea pigs and may someday lead to a human vaccine, scientists said on Wednesday.

Cytomegalovirus (CMV) is transmitted to a fetus through the mother's placenta. Women can carry the virus without being aware. Congenital CMV is the second-most common cause of mental retardation in infants, behind only Down syndrome, and also can cause deafness.

"Congenital cytomegalovirus infection is a major public health crisis in the United States today, and the average person on the street doesn't know anything about it," Schleiss said.

"I have these moms come into my practice," Schleiss said, "and invariably what they say to me is, 'I've never heard of this before it happened to me and my baby.'"


About 1 percent of U.S. babies are born with the virus, amounting to 40,000 per year, researchers said. Medical experts advising U.S. policymakers have deemed development of a vaccine to prevent cytomegalovirus during pregnancy a high priority.

AlphaVax said it was seeking U.S. Food and Drug Administration approval for the vaccine.
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#2 of 88 Old 02-22-2007, 01:16 AM
 
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So they are looking to vaccinate 100% of the population for a risk that only occurs in 1%? That is just so stupid, really.
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#3 of 88 Old 02-22-2007, 03:04 AM
 
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Okay, so 1% are born with the virus. How many of those are actually damaged from it? I don't care how many are born with it. I want to know how many suffer deafness or mental retardation. What do I care if my baby is born with positive CMV tests, as long as she's healthy?
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#4 of 88 Old 02-22-2007, 03:05 AM
 
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Is this the bug that's shed in cat poop, or am I getting my germs mixed up?

Ruth, single mommy to Leah, 19 (in Israel for another school year), Hannah, 18 (commuting to college), and Jack, 12(homeschooled)
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#5 of 88 Old 02-22-2007, 03:05 AM - Thread Starter
 
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Okay, so 1% are born with the virus. How many of those are actually damaged from it? I don't care how many are born with it. I want to know how many suffer deafness or mental retardation. What do I care if my baby is born with positive CMV tests, as long as she's healthy?

Every year in the U.S., 4,000 to 8,000 children are born with serious HCMV disease.

http://www.slu.edu/publications/gc/v6-10/news_23.shtml
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#6 of 88 Old 02-22-2007, 03:07 AM
 
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Is this the bug that's shed in cat poop, or am I getting my germs mixed up?
Is that toxiplasmosis?

Mama to my spirited J, and L, my homebirth: baby especially DTaP, MMR (family vax injuries)
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#7 of 88 Old 02-22-2007, 03:10 AM
 
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Is this the bug that's shed in cat poop, or am I getting my germs mixed up?
That is toxoplasmosis.

CMV I think causes flu like symptoms in adults.

BTW, I have a client who is a CMV baby. His mom thinks she got it at work. He is SEVERLY disabled. His parent call him a "pillow angel". He does not move, talk, feed himself. He smiles and grunts. He is 13 now.

CMV is one of the things they tested for when I was having complications with DD.

I'm not taking a stand on the vax, just stating my experience with CMV effects.
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#8 of 88 Old 02-22-2007, 03:10 AM - Thread Starter
 
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According to the article, the NIH states that the virus infects between 50 to 80 percent of all U.S. adults by age 40 and it causes few if any symptoms.

The virus is transmitted through close personal contact (kissing, sex or sharing eating utensils), and through blood transfusions and nasal secretions.

TRANSLATION: We're going to vaccinate the boys too.
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#9 of 88 Old 02-22-2007, 03:11 AM
 
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Is that toxiplasmosis?
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#10 of 88 Old 02-22-2007, 03:12 AM
 
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Every year in the U.S., 4,000 to 8,000 children are born with serious HCMV disease.

http://www.slu.edu/publications/gc/v6-10/news_23.shtml
OK, they don't define "serious HCMV disease"- how badly are these babies affected, are these babies otherwise immuno-compromised, etc?

And the study is asking for women who are surgically sterile and men. So they're studying a vaccine to prevent birth defects on a population that can't conceive?

Ruth, single mommy to Leah, 19 (in Israel for another school year), Hannah, 18 (commuting to college), and Jack, 12(homeschooled)
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#11 of 88 Old 02-22-2007, 03:15 AM - Thread Starter
 
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And the study is asking for women who are surgically sterile and men. So they're studying a vaccine to prevent birth defects on a population that can't conceive?

Along with the "sterilization" criteria, here's the other trial conditions which lead me to believe this is going to be a live vaccine:

*Volunteers must not live in the same house with a person who has a weakened immune system.

*Must not live in the same household with children less than 18 years old.

*Household contacts must also agree to enroll in the study although they will not receive vaccine.
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#12 of 88 Old 02-22-2007, 03:17 AM
 
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Now that is scary! Lets create a live vaccine for CMV so it can shed all over the place! YIKES!

ETA: The hospital I worked at before I became a SAHM tried to make me care for a CMV patient while I was pregnant with DS. I refused! SCARY!
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#13 of 88 Old 02-22-2007, 03:24 AM - Thread Starter
 
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And the study is asking for women who are surgically sterile
By the way, this is how pharma will be able to claim in the product insert that they "don't know how this vaccine affects fertility."

But then they'll set up a pregnancy registry once it's licensed.

.
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#14 of 88 Old 02-22-2007, 03:28 AM
 
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Now that is scary! Lets create a live vaccine for CMV so it can shed all over the place! YIKES!
CMV is all over the place, though.

Quote:
Children typically become infected with the virus in early childhood, especially those in child-care and preschool settings. CMV infections are rarely serious in otherwise healthy children and adults; they usually cause only mild symptoms, if any. When symptoms do appear, they are similar to those seen in mononucleosis ("mono") and only last a few weeks.

CMV is mainly a problem for certain high-risk groups, including:
  • unborn babies whose mothers become infected with CMV during the pregnancy
  • children or adults whose immune systems have been weakened by disease or drug treatment, such as organ transplant recipients or people infected with HIV
http://www.kidshealth.org/parent/inf...galovirus.html

Basically, CMV is like rubella. Most people catch it in childhood, so most pregnant women are protected.
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#15 of 88 Old 02-22-2007, 03:31 AM
 
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i continue to be astounded at how soulless Big Pharma is.
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#16 of 88 Old 02-22-2007, 03:34 AM - Thread Starter
 
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i continue to be astounded at how soulless Big Pharma is.

But they'll probably just add it to the MMRV vaccine and all will be well.
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#17 of 88 Old 02-22-2007, 03:46 AM - Thread Starter
 
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http://clinicaltrials.gov/ct/show/NCT00125502?order=6

Mothers, 14 to 40 years of age (inclusive), who have delivered a newborn infant within the previous 12 months.

Subjects will have an equal chance of either receiving the vaccine or a placebo, and neither the subjects nor the investigators will know. Participants will receive 3 doses of the vaccine or placebo. They and their children born during the trial will be examined over 3 years to see if they have been infected with CMV.
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#18 of 88 Old 02-22-2007, 03:51 AM - Thread Starter
 
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There are more than a dozen other trials going on.
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#19 of 88 Old 02-22-2007, 03:53 AM
 
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So there are two trials going on? One for women of childbearing age and one for everybody else?

Ruth, single mommy to Leah, 19 (in Israel for another school year), Hannah, 18 (commuting to college), and Jack, 12(homeschooled)
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#20 of 88 Old 02-22-2007, 06:27 AM
 
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here's what I know about CMV.

I am CMV positive. I have read statistics about prevalence from http://www.journals.uchicago.edu/cgi...10.1086/508173

"CMV seroprevalence increased gradually with age, from 36.3% in 6-to-11-year-olds to 90.8% in those aged >80 years. "

I don't know when I got it but I tested positive in a routine bloodwork when I was a teenager. Looks like an awful lot of people have CMV.

As an adult, I always donated blood and there was a HUGE "CMV+" marked in red on my form, always. I have 2 babies, both healthy and normal.

My guess is that this is like any other virus. That if a woman gets it young, her babies are not at risk, really, due to getting the antibodies in utero. It's the woman who has NEVER had CMV and seroconverts during pregnancy who is at risk? (or is it the newborn who seroconverts who is at risk? help me out folks)

Liora. Best way to reach me is FACEBOOK, search for "LioraP2". Jewish and Frum In Beijing, Mom of Three (mother of 3: #1 was vaccine injured at age 2m later dx with PDD-NOS, healed in 3 years with biomed. #2 unvaxed and healthy boy. #3 unvaxed amazing girl with Down syndrome using Targeted Nutritional Intervention (TNI) since infancy)
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#21 of 88 Old 02-22-2007, 11:35 AM
 
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<<<It's the woman who has NEVER had CMV and seroconverts during pregnancy who is at risk? (or is it the newborn who seroconverts who is at risk? help me out folks)>>>

Sounds like they will do as they did with the rubella vaccine and give it to teens who have not had the disease(first girls then both sexes),and then bump it down to the toddlers to just avoid the disease all together(and catch 'em while you can-with the shot).

MMRVCMV sounds about right.After all combo vaccines are proven to be safe. What next? Perhaps a roseolla vaccine
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#22 of 88 Old 02-22-2007, 12:23 PM
 
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Hmmmm... a live, vax eh? When my nephews were born (preemies) and it looked like they'd need transfusions, it was very important that they get CMV neg. blood (supposedly had to be from someone who had never had it)..... SOOOOOO if there's a live vaccine and we give it to everyone, how on earth will they get blood from someone without exposure?

hmmmm.....

-Angela
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#23 of 88 Old 02-22-2007, 01:02 PM
 
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Quote:
Originally Posted by LongIsland View Post
But they'll probably just add it to the MMRV vaccine and all will be well.






Quote:
Originally Posted by LongIsland View Post
http://clinicaltrials.gov/ct/show/NCT00125502?order=6

Mothers, 14 to 40 years of age (inclusive), who have delivered a newborn infant within the previous 12 months.

Subjects will have an equal chance of either receiving the vaccine or a placebo, and neither the subjects nor the investigators will know. Participants will receive 3 doses of the vaccine or placebo. They and their children born during the trial will be examined over 3 years to see if they have been infected with CMV.
... but they at least know they're participating.... right??
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#24 of 88 Old 02-22-2007, 01:12 PM
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[B][COLOR="Red"]"Congenital cytomegalovirus infection is a major public health crisis in the United States today, and the average person on the street doesn't know anything about it," Schleiss said.

About 1 percent of U.S. babies are born with the virus, amounting to 40,000 per year, researchers said. Medical experts advising U.S. policymakers have deemed development of a vaccine to prevent cytomegalovirus during pregnancy a high priority.

AlphaVax said it was seeking U.S. Food and Drug Administration approval for the vaccine.[/I]
Since when is 1% or 40,000 a major public health crisis in a country of 100's of million people?? I'm sure if I was an unfortunate mom whose baby was that 1% I'd feel different but still. : Just because you can create a vax for it doesn't mean you should.
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Every year in the U.S., 4,000 to 8,000 children are born with serious HCMV disease.

http://www.slu.edu/publications/gc/v6-10/news_23.shtml
Sounds awfully similar to the rates of people who get cervical cancer from HPV....
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#26 of 88 Old 02-22-2007, 01:20 PM - Thread Starter
 
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Since when is 1% or 40,000 a major public health crisis in a country of 100's of million people?? I'm sure if I was an unfortunate mom whose baby was that 1% I'd feel different but still. : Just because you can create a vax for it doesn't mean you should.

Look at rubella. Prior to the vaccine's introduction there were a few dozen annual cases of congenital rubella syndrome (and not all cases cause birth defects), yet they considered it a major public health crisis and EVERYONE needed to be vaccinated.

A CMV "Tell Someone"-ish promo blitz should soon be making it's debut in Baby Talk and American Baby, among other baby rag mags.
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#27 of 88 Old 02-22-2007, 01:21 PM
 
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Since when is 1% or 40,000 a major public health crisis in a country of 100's of million people?? I'm sure if I was an unfortunate mom whose baby was that 1% I'd feel different but still. : Just because you can create a vax for it doesn't mean you should.
One of the midwives I work with lost her baby to congenital CMV infection last year. It is different when it's personal. She'd have been interested in any way to prevent CMV infection ahead of time.

I tested CMV negative during my pregnancy, despite having a preschooler, and it was terrifying every time he got cold symptoms. Not everyone is CMV positive, and those of us who are negative can and do seroconvert at the most inappropriate times.

mama to Max (2/02) and Sophie (10/06); wife to my fabulous girl
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#28 of 88 Old 02-22-2007, 01:26 PM
 
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Since when is 1% or 40,000 a major public health crisis in a country of 100's of million people?? I'm sure if I was an unfortunate mom whose baby was that 1% I'd feel different but still. : Just because you can create a vax for it doesn't mean you should.
:

[sarcasm]oh come now, what a fantastic way to claim a "community service" ("but we're eradicating birth defects!") whilst also increasing profits! i'm *sure* they're more motivated by saving babies though . . . . [/sarcasm]

Obstruct livery vehicles!

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#29 of 88 Old 02-22-2007, 01:36 PM - Thread Starter
 
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One of the midwives I work with lost her baby to congenital CMV infection last year. It is different when it's personal. She'd have been interested in any way to prevent CMV infection ahead of time.

I tested CMV negative during my pregnancy, despite having a preschooler, and it was terrifying every time he got cold symptoms. Not everyone is CMV positive, and those of us who are negative can and do seroconvert at the most inappropriate times.
Your concern was understandable, however, when this vaccine is licensed for children (and it will be), the vaccine will not only be universally recommended, but it will be mandated for school entry. There is no doubt about that.

I would imagine none of us has a problem with the vaccine being made available to childbearing women if they want it, but it becomes a problem when mass immunization is implemented and it morphs into a larger-than-life "do it for the country's unborn babies" issue like rubella (and now varicella) because a vaccine exists.
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#30 of 88 Old 02-22-2007, 01:59 PM
 
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This is just one of many viruses that can cause birth defects, right? And, like rubella, it seems like most babies born of mothers who are infected during pregnancy are fine. It really seems that those involved in public health could figure out what factors cause different outcomes. A link from a recent thread about rubella talks about nutrition, and specifically vitamin A, as important in successfully fighting off viruses of all sorts--not a one-at-a-time, need to vaccinate everyone for this to work, sort of approach. This would help with everything at once--I know, I know, no profit motive, and control/responsibility would shift from the health care system to the individual.

And I also wonder about how this will affect those who need CMV negative blood. I've gotten calls asking if I can come in, because CMV negative blood is somewhat hard to come by and at the time, I hadn't had it yet (no idea now, but with 2 kids, it seems like my chances of having it have gone up significantly). I was never clear on which babies needed it, and why, but I assumed it was important to this population.
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