tell me about the rotavirus vaccine - Page 2

[kiara7]

I think that pretty much sums it up. Live virus (even weakened) can make a child and others sick, whether it's on someone's hand or in a vial.

[tmaue]

Here is some info I put together about rotavirus for some other people. I cut and pasted so not how well it will turn out looking:

RotaTeq is one of the rotovirus vaccines (approved in 2006) and
below is the package insert link. There is another one that just
came out called Rotarix (approved in 2008).


http://www.merck.com/product/usa/pi_...rotateq_pi.pdf

It says "Most common adverse events included diarrhea, vomiting,
irritability, otitis media (ear infection), nasopharyngitis, and
bronchospasm."

Below is the link to VAERS and if you search under the vaccine
ROTHB5 you can see what has been reported to VAERS on this vaccine.

http://www.medalerts.org/vaersdb/



http://www.merck.com/product/usa/pi_...rotateq_pi.pdf

From the package insert:
"5.4 Shedding and Transmission
Shedding was evaluated among a subset of subjects in REST 4 to 6
days after each dose and among
all subjects who submitted a stool antigen rotavirus positive sample
at any time. RotaTeq was shed in the
stools of 32 of 360 [8.9%, 95% CI (6.2%, 12.3%)] vaccine recipients
tested after dose 1; 0 of 249 [0.0%,
95% CI (0.0%, 1.5%)] vaccine recipients tested after dose 2; and in
1 of 385 [0.3%, 95% CI (<0.1%,
1.4%)] vaccine recipients after dose 3. In phase 3 studies, shedding
was observed as early as 1 day and
as late as 15 days after a dose. Transmission was not evaluated.
Caution is advised when considering whether to administer RotaTeq to
individuals with
immunodeficient close contacts such as:
• Individuals with malignancies or who are otherwise
immunocompromised; or
• Individuals receiving immunosuppressive therapy.
RotaTeq is a solution of live reassortant rotaviruses and can
potentially be transmitted to persons who
have contact with the vaccine. The potential risk of transmission of
vaccine virus should be weighed
against the risk of acquiring and transmitting natural rotavirus."


http://jama.ama-assn.org/cgi/content/full/279/17/1371

" Finally, about 20 deaths occur each year due to rotavirus diarrhea
among children younger than 5 years,1, 6 for a cumulative incidence
by age 5 years of 0.000005 (1 in 195000 children)."

I also found this interesting, from:
http://www.ncbi.nlm.nih.gov/sites/entrez?
db=pubmed&uid=11069230&cmd=showdetailview&indexed= google

"To determine whether naturally acquired serum IgA and IgG
antibodies were associated with protection against rotavirus
infection and illness, a cohort of 200 Mexican infants was monitored
weekly for rotavirus excretion and diarrhea from birth to age 2
years. Serum samples collected during the first week after birth and
every 4 months were tested for anti-rotavirus IgA and IgG. Children
with an IgA titer >1:800 had a lower risk of rotavirus infection
(adjusted relative risk [aRR], 0.21; P<.001) and diarrhea (aRR, 0.
16; P=.01) and were protected completely against moderate-to-severe
diarrhea. However, children with an IgG titer >1:6400 were protected
against rotavirus infection (aRR, 0.51; P<.001) but not against
rotavirus diarrhea. Protective antibody titers were achieved after 2
consecutive symptomatic or asymptomatic rotavirus infections. These
findings indicate that serum anti-rotavirus antibody, especially
IgA, was a marker of protection against rotavirus infection and
moderate-to-severe diarrhea."

What I got from this is that the body gains
immunity from rotovirus infection and the diarrhea after having a
couple exposures to rotovirus, regardless of whether they get sick
from the rotovirus. So like with many other sicknesses, allowing the
body to deal with rotovirus, actually helps the body with future
sicknesses.

Also some good info to know. There is alot of info to learn here (so I would
read from the following link if you have time), but I will just
include a little bit here. It also says at the beginning that they
estimate that acute diarrhea accounts for 300 deaths per year in the
US, and from earlier in my post, only 20 of those would be from
rotovirus.

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5216a1.htm

"Home Management of Acute Diarrhea

Treatment with ORS is simple and enables management of uncomplicated
cases of diarrhea at home, regardless of etiologic agent. As long as
caregivers are instructed properly regarding signs of dehydration or
are able to determine when children appear markedly ill or appear
not to be responding to treatment, therapy should begin at home.
Early intervention can reduce such complications as dehydration and
malnutrition. Early administration of ORS leads to fewer office,
clinic, and emergency department (ED) visits (37) and to potentially
fewer hospitalizations and deaths."

*ORS being oral rehydration solutions such as pedialyte. Breastfed
infants should continue nursing on demand.

So the bottom line on rotavirus, in my opinion, is that while there are alot of cases of rotavirus, very few children die from it, and most will not even need to go to the hospital if proper precautions are taken at home. The symptoms of the disease are almost the same as the common adverse events from the vaccine. The vaccine can shed to others.

[Murihiku]

Thanks for that informative post!

I need help deciphering the information in the Rotateq product insert. The reported numbers from the product trial suggest to me that the vaccine is safe.

I wish I could cut and paste from a pdf but I'm a techno-idiot, so I will give this one example:

34,837 infants receiving the vax and 37,788 infants receiving placebo were monitored for intussusception for 7, 14, and 42 days after each dose. Six of the vaxed children and five of the non-vaxed children were treated for intussesception.

To me, that suggests the risk of intussusception because of the vaccine is extremely minimal.

Now I know the test was run by the product-maker (and that there should be more tests and more long-term tests, etc), but that does that mean the numbers in this test are deliberately false (an actual lie), or that the numbers cannot be trusted for some other concrete reason?

Or am I making a false and naive conclusion about this test based on naive reading of numbers?

Or perhaps both?

This is a sincere query; I would like to become a sophisticated reader of the primary information about vaccines, because I'm sure I'm not so at the moment.

[tmaue]

There is actually more to these vaccine trials than you would find from a package insert. One thing to know, which you may already, is they do not use real placebos in vaccine trials, they almost always use a different vaccine or some kind of aluminum solution. You can't always tell from the inserts, especially when they just say placebo. To be complete, they need to tell what the placebo is. But the thing to know is that they are not comparing their vaccine with those of unvaxed people.

From CDC pink book:

http://www.cdc.gov/vaccines/pubs/pin...safety-508.pdf

“Phase III vaccine
trials may last several years. A few hundred to several thousand
volunteers may be involved. Some volunteers receive another
already-licensed vaccine, allowing researchers to compare one vaccine
to another for adverse health effects – anything from a sore
arm to a serious reaction.”

So anyway, in the package insert where you found 6 vaxed getting intussusception and only 5 placebo, all that shows you is that 6 of those given the vaccine got it, but we don't know how many unvaxed would get it.


Another thing to know is that only healthy full term babies are used in the studies. Well, we know that an awful lot of babies with health problems are going to be getting this vaccine, so we do not know what their risks are.

Lastly, according to the CDC, these small trials are no where near large enough to find true adverse events.

“However, while rates of
common vaccine reactions, such as injection site reactions and
fever, can be estimated before licensure, the comparatively small
number of patients enrolled in these trials generally limits detection
of rare side effects or side effects that may occur many months
after the vaccine is given. Even the largest prelicensure trials
(10,000's persons) are inadequate to assess the vaccine's potential
to induce rare side effects. Therefore, it is essential to monitor
reports of vaccine-associated adverse events once the vaccine has
been licensed and released for public use.”

Unfortunetly we do not have a good monitoring systerm here in the US.

[Murihiku]

Thank you so much, Tara, that was extremely helpful!

I'm off to look up the definition of "placebo" in the Oxford English Dictionary . . .

ETA:

4. Med. A drug, medicine, therapy, etc., prescribed more for the psychological benefit to the patient of being given treatment than for any direct physiological effect; esp. one with no specific therapeutic effect on a patient's condition, but believed by the patient to be therapeutic (and sometimes therefore effective). Also: a substance with no therapeutic effect used as a control in testing new drugs, etc.; a blank sample in a test.

So that would seem to mean the manufacturers are lying when they use the word "placebo". Psychology doesn't come into it with an infant, and a different vaccine presumably has some therapeutic effect . . .

[firstkid4me]

Neither of my kids have received this. Emily was born before rotateq came out, and she actually got rotavirus twice when she was 13 months and 15 months. The first time was rough, she was vomiting for awhile, then could keep stuff down and had diarrhea, then no symptoms and a fever. It was really hard to diagnose because she didn't have the symptoms at the same time. Her stupid backup ped at the time (we've moved twice since then, her regular ped was on maternity leave at the time) put in her chart that he thought it was a UTI (I told him it wasn't, she had no issues with urinating and that a kid in her gymnastics class had recently had rotavirus) so when we took her to the ER when she wasn't acting like herself they put her through a catheter and a blood draw. They came back, said it wasn't a UTI (DUH!) but that she was slightly dehydrated and should have an IV. I refused because she was still crying tears and had been put through too much already (it is absolutely painful to hear your baby scream through a catheter.) We spent the entire weekend nursing on the couch watching cartoons and we followed up with a different doc in the practice that Monday. She knew just from the smell of the diaper I brought in (I tried to get one tested at the ER but they said no) that it was rotavirus and said it was almost done because it had been about a week since symptoms started. She also said there were no signs that she'd ever been close to dehydration, that I must have done a great job keeping her hydrated (stupid back up ped told me, "It won't hurt anything for you not to nurse for a few days." He was a flipping idiot!)

The second time she had it I gave her 3 doses of infant probiotic in a sippy cup of orange juice, she sucked it down, and was better the next day.

It's inconvenient, but if you stay on top of it it's not scary.