A recent study, published in the journal Pediatrics in December 2010, provides further evidence that the pentavalent rotavirus vaccine is effective in reducing hospitalization and emergency visits attributable to rotavirus gastroenteritis, without increased risk of intussusception or other serious adverse events, among infants aged 6-12 weeks of age.
Pentavalent Rotavirus Vaccine in Developing Countries: Safety and Health Care Resource Utilization
Summary - A total of 1804 Jamaican infants, 6 to 12 weeks, and primarily from low/middle-income families of African heritage, received ≥1 dose of either the vaccine or a placebo. The two groups were followed for a period of time of 1 year after dose #1. Rates of hospitalization, or emergency visits, due to rotavirus related gastroenteritis, rates of intussusception and deaths were compared between the children that received the vaccine and those that received the placebo.
Results - During the 1 year follow up period there were:
- 2 hospitalizations/emergency visits due to rotavirus induced gastroenteritis out of 831 evaluable vaccine recipients
- 11 hospitalizations/emergency visits due to rotavirus induced gastroenteritis out of 809 evaluable placebo recipients
- 82% rate of reduction in hospitalization/emergency visits
- All 8 gastroenteritis events occurring 2 weeks after the 3rd dose were in the placebo group (100% reduction rate)
- Intussusception was confirmed for 1 vaccine recipient and 3 placebo recipients
- 1 vaccine recipient and 3 placebo recipients died during the follow-up period
Conclusion – This study adds to the existing evidence supporting the conclusion that rotavirus vaccines have a significant effect in reducing rotavirus induced gastroenteritis hospitalization/emergency visit events, without increasing the rate of intussusception or deaths in the recipients. The vaccines appear to be highly effective and safe. The study’s authors concluded as such:
In this posthoc subgroup analysis, the vaccine reduced health care resource utilization attributable to rotavirus gastroenteritis, without increased risk of intussusception or other serious adverse events, among infants in a resource-limited country.
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[...] This post was mentioned on Twitter by Ljiljana, Skepacabra and The Vaccine Times, Leart. Leart said: Study: Rotavirus vaccine 82% effective in reducing hosp rates with no side effects http://bit.ly/h5NmGA #stopAN #vaxfax #VaccineTimes #1SOL [...]
What was the placebo? An actual inert placebo, or just a different rotavirus vaccine?
I’m pretty sure this is an adverse effect:
Intussusception
1 vaccine recipient and 3 placebo recipients died
And does the study also say none of the following occurred?
The following were reported more often in infants who received RotaTeq, when compared to those who received placebo; diarrhea (24.1% in vaccine recipients vs 21.3% in those receiving placebo), vomiting (15.2% in vaccine recipients vs 13.6% in those receiving placebo), ear infection (14.5% in vaccine recipients vs 13.0% in those receiving placebo), runny nose and sore throat (6.9% in vaccine recipients vs 5.8% in those receiving placebo), wheezing and coughing (1.1% in vaccine recipients vs 0.7% in those receiving placebo).
Technically, these are also considered adverse effects.
Citation required.
Oh, sorry. You were going on what was written. Hard to notice when you comment on an old article.
The four cases of intussusception were mostly from the placebo group. That means it happens to kids without the vaccine, which more than likely means that the child who had the vaccine also would have had suffered an intussusception without a vaccine. In other words, they were not really caused by the vaccine.
And the same thing can be said for the four children who died. There is no reason given for the deaths, it could have been car accidents, another disease, drowning, etc.
As far as the second paragraph, that does require a citation. It is not mentioned in the abstract, and the full article requires a subscription.
But let us break down the results in vaccine versus placebo:
______________________vaccine ________placebo
diarrhea _______________24.1% ________ 21.3%
vomiting _______________15.2% ________13.6%
ear infection ____________14.5% _______ 13.0%
runny nose and sore throat _6.9% _________5.8%
wheezing and coughing ____1.1% ________ 0.7%
For those of us who have done statistical studies those numbers show something we like to call “No Statistical Difference.” Since kids get at least one of those symptoms multiple times per year for all kinds of reasons (my favorite being one kid vomiting, followed by another one doing the same thing for no particular reason), you’ll have to argue harder why the vaccine is the cause of all of them!
So what you are trying to say is that it has to be the vaccines fault, no matter what. Kind of like people who tried to convince me my son’s first seizures were due to vaccines. Except he was a newborn and had not even been poked for the PKU test.
If a different Rotavirus vaccine had been used to compare the one being studied, they wouldn’t have used the term “placebo”. Without the full study it’s hard to say conclusively, but generally when they use the words “placebo-controlled” it means an inert substance was used. You can feel free to find the PDF of this article and send it to me as well at admin@vaccinetimes.com for further review.
Adverse effects have to meet the test of “statistical significance”. All of the differences in your list are under 3%, which statistically speaking is dead even.
I would love to send the pdf, but it’s locked behind the pediatrics pay wall.
And I should point out, the article itself doesn’t say no adverse effects, just the misleading title of the blog post.
The study itself says “CONCLUSIONS: In this posthoc subgroup analysis, the vaccine reduced health care resource utilization attributable to rotavirus gastroenteritis, without increased risk of intussusception or other serious adverse events, among infants in a resource-limited country. ”
Big difference between none and no increased risk.
So quoth the guy who thought that if three kids one the placebo had intussusception, then the one child who had the same but because he/she had been vaccinated: it had to be the vaccine.
Or thinks that 3% is significant.
You might understand better if you took a basic course in statistics at your local community college.
It’s not misleading at all. The study did not show a difference in adverse events between the vaccine and placebo. Therefore no risk can be attributed to the vaccine itself. To claim that the study supports “no adverse effects” from the vaccine is appropriate.
We are all at risk of intussusception by virtue of having intestines alone. But this study shows no risk from the vaccine. I.E. the vaccine causes no adverse effects, at least that this study could find.