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Is the RotaTeq Vaccine Cost Effective As We Rein In Healthcare Costs?

Rotateq By Kim Stagliano

As President Obama looks at revamping out of control health care costs in The United States, this study calls into question the cost of RotaTeq, Dr. Paul Offit's rotavirus vaccine (from Merck) which is on the AAP schedule as a routine vaccination.

Pediatrics. 2007 Apr;119(4):684-97.  Links
Comment in:
Evid Based Med. 2007 Oct;12(5):153.

Cost-effectiveness and potential impact of rotavirus vaccination in the United States.

Widdowson MA, Meltzer MI, Zhang X, Bresee JS, Parashar UD, Glass RI.
Respiratory and Enteric Virus Branch, Mailstop A34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333, USA. [email protected]

OBJECTIVE: In February 2006, a safe, efficacious, orally administered pentavalent human-bovine reassortant rotavirus vaccine was licensed and recommended for routine immunization of all children in the United States. We assessed the health and economic impacts of a national rotavirus immunization program in the United States.

METHODS: Monte Carlo cost-effectiveness analyses, from health care and societal perspectives, of vaccination of a hypothetical US birth cohort of 4,010,000 children monitored from birth to 59 months of age were performed. We compared the disease and economic burden of rotavirus infection in an unvaccinated cohort of children with one vaccinated at 2, 4, and 6 months with pentavalent human-bovine reassortant rotavirus vaccine.

RESULTS: A routine rotavirus immunization program would prevent 13 deaths, 44,000 hospitalizations, 137,000 emergency department visits, 256,000 office visits, and 1,100,000 episodes requiring only home care for children <5 years of age in the United States. Assuming costs of administration of $10, the break-even price per dose of vaccine was $42 from the societal perspective and $12 from the health care perspective. From the societal perspective, at the manufacturer's price of $62.50 per dose, vaccination would cost $138 per case averted, $3024 per serious case averted, and $197,190 per life-year saved, at a total cost of $515 million to the health care system and $216 million to society.

Key variables influencing the results were parental workdays lost, costs of hospitalization, emergency department visits, and child care.

CONCLUSIONS: Despite a higher burden of serious rotavirus disease than estimated previously, routine rotavirus vaccination would unlikely be cost-saving in the United States at present. Nonetheless, rotavirus vaccination may still be considered a cost-effective intervention.

Kim Stagliano is Managing Editor of Age of Autism.


apple bottom genes

SteveD, I actually agree with your original assessment that clinical testing is superior to passive surveillance - which is why I picked at it. Passive surveillance sucks, plain and simple. So it’d be interesting to ask why passive surveillance outperformed clinical testing for RotaShield?

Perhaps it’s because clinical tests are primarily marketing tools: they are hoops the vaccine manufacturer has to jump through in order to market their product. Of course the advantages are immense: the vaccine manufacturer gets third party approval (the FDA) and they get a guaranteed market (addition to the vaccine schedule).

I would contend that the overwhelming financial imperative to pass clinical testing corrupts the vaccine manufacturer’s ability to produce reliable results. Merck’s goal during clinical testing is not to find out whether the vaccine is safe, their goal is to report that the vaccine is safe (so the product can get on the market and start making money for them).

Exclusion criteria in clinical testing are designed to minimize the potential for catching adverse events. Why exclude children from clinical testing who are intended to get the vaccine once it is licensed? Because if they’re included, Merck lowers its chances of getting the results necessary for product approval.

Every decision Merck makes is financial: if they can make money from a safe product that prevents disease – great! But regardless, they intend to make money, and if that means the product isn’t as safe or as effective as advertised, oh well. Sure that’s just my opinion, no point in arguing about it I suppose.

So this time around there’s a bunch of additional passive surveillance set up to catch problems with the new rotavirus vaccine. Unfortunately we shouldn’t have to rely on parents bringing their damaged kids into the hospital in order to discover vaccine-associated adverse events. Clinical testing is superior to passive surveillance. The only drawback is that you have to actually do it right. And the fact that the vastly inferior passive surveillance outperformed clinical testing in finding the association between RotaShield and intussusception tells us that clinical testing is not being done right.

D.D. Carlson, PhD

Look at the cost of Gardisil - another boondoggle. $350 million per quarter for Merck. In the U.S. cervical cancer cases represent 7/1000ths of 1% of the female population. If all cases were eradicated it could not possibly impact women's health even 1%. And Merck/CDC would have us believe all should be vaccinated - what a waste. If only people could COUNT - 9,000 cases out of 151 million women does not a program create.

John Stone

Steve D

So why have the CDC and FDA not acted on the approximately 60 reported associated deaths on VAERS in the past year? How many would it take to have "triggered any alarms"?

Steve D

Hi ABG -
You are correct, and I misspoke. Thank you for clarifying that RotaTeq and the occurrence of intussusception are unrelated according to the pre-marketing clinical safety trial.
As to "passive surveillance", by which I assume you mean VAERS and VSD, the Rotashield occurrence validates the sensitivity of the system and provides a good example of the resulting response (removal from the market).
It is notable that RotaTeq has not triggered any alarms since its licensure, despite the following precautions:
" How will safety of this vaccine be monitored after licensure?

Following licensure and use of all vaccines in the United States, safety is closely monitored by the FDA and CDC through the Vaccine Adverse Event Reporting System (VAERS). This will also occur for RotaTeq®. These agencies will be closely monitoring for any intussusception cases reported to VAERS. Additionally, in order to further observe RotaTeq® for the potential that it could be associated with increased rates of intussusception or other serious adverse events, the manufacturer, Merck and Co., Inc., has committed to conducting another study after licensure of approximately 44,000 children, and CDC will also conduct a large study in its Vaccine Safety Datalink Program (VSD), which evaluates vaccine safety among approximately 80,000 U.S. infants every year. Also, for the first three years of licensure, the manufacturer will report cases of intussusception to FDA within 15 days of receiving them, and all other serious side effects on a monthly basis. Although there is no evidence to date that RotaTeq™ causes intussusception, this aggressive post-licensure monitoring should enhance our ability to detect this risk."


Steve D,

My link does work. It's an Acrobat file, so you have to download it to read it.

As for the worldwide impact of the vaccine, it appears that you're suggesting that the CDC and the various state governments that have added RotaTeq to their vaccination schedules have done so, at least in part, to stop the spread of rotavirus from American children to African children. This is beyond ludicrous. Kim's original post concerns the cost-effectiveness of RotaTeq in the US, where (as bensmyson noted) clean water and nutrition are not the overwhelming problems that they are in developing nations, where the vast majority of rotavirus deaths occur. Is it really likely that children in developing nations are catching rotavirus from American schoolchildren? (Just imagine the government in a developing nation hauling out the old saw that "death is just a plane ride away"...)


Steve buddy, I looked at your CDC link about your claim that half a million kids died as the result of rotavirus.

The CDC report said that the researchers examined the "studies published from 1986 to 2000 on deaths caused by diarrhea and on rotavirus infections in children."

First of all they estimate that 82% these deaths are from impoverished countries where health care concerns fall a few notches below clean water and starvation. Diarrhea, the lack of hygiene and an open sewer system sort of go hand in hand.

How many deaths from diarrhea and/or rotavirus have been prevented from any rotavirus vaccine in these countries with 82% of the deaths?

And while you are at it, how many children die every year from starvation? In 2006, there were 41 countries in which at least 10% of children under five died. All but three were in Africa. Ten of the 41 had higher rates of child mortality than in 1990, and four were exactly the same.

Undernourishment negatively affects people’s health, productivity, sense of hope and overall well-being. A lack of food can stunt growth, slow thinking, sap energy, hinder fetal development and impact a weakened immune system.

An estimated 82% of the deaths (if not all) caused by diarrhea and rotavirus certainly came from these 41 countries. Show me how the vaccines are more effective at saving lives compared to food and proper nutrition.

And how much money does WHO or whoever spend every year vaccinating these poor children compared to nurturing them, feeding them?

John Stone

Steve D

I don't apologise for expressing expressing outrage at negligence. You are also trying to have your cake and eat it. The deficiencies of a passive recording system, and the fact that even then the asociated death toll is more than 4 times higher than for the disease (and presumably it isn't even mandated for all states), makes this association deeply troubling. If you are simply going to disregard the information because it doesn't meet your preconceived notions about the safety of the medicine then your views can scarcely be respected.

You then dodge by referring me to the global impact of the illness, and we move into quasi racist territory because you seem to be arguing that what might not be good enough for US children might be simply great for the children of the developing world. Indeed, I would point out that pre-marketing trials were carried out on only on "healthy" infants (none of whom were given oral polio vaccine concurrently) admittedly in many countries, but then of course rolled out for everybody. We haven't got the protocol for what constituted a healthy infant but check out this post by Hilary Butler which gives such a protocol for testing a small-pox vaccine ('Why were in this position in the first place') with an absolutely mind-boggling list of exclusions:

So, in fact no one has the remotest clue what the risk-benefit ratio is globally and for all children, and frankly the original trials were worthless.


One should also look at the spike in Kawasaki Syndrome VAERS reports after the re-introduction of the rotavirus vaccine. It spiked when the first one came out, dipped when it was withdrawn, and has spiked once more. I think it was in the Geiers' study...

Whose playing God?

The Offit does not seem to realize that diarrhea is the body's natural defense to get rid of bacteria that it does not like. This vaccine is another example of messing up a person's immune system. Nobody can count the cost of THAT.

apple bottom genes

RotaTeq did NOT result in a decreased risk of intussusception. You can't just add the "no statistical significance" qualifier in parenthesis and pretend that makes the previous inaccuracy okay. The results differed only by chance, which means they didn't differ at all. Therefore no cause and effect, which means the vaccine did not cause a decrease in intussesception.

So what are we left with? Clinical trials found no significant difference in the risk of intussusception.
So what. Neither did the clinical trials for RotaShield. It took passive surveillance to discover the problem.

Stop Offit's Disease

Steve D

nhokkanen -
I am a parent as I assume you to also be, and I am very concerned about the safety of my own children as well as others. In this case, however, you needn't second-guess my definition in order to discredit me, as the context is very specific to the safety standards as described in the study. John Stone upthread was nice enough to link to the study.

You said: "Brilliant move Paul selling your royalities rights for guaranteed cash before the axe falls for your Rotateq off the mandatory schedule."
According to this,, Dr. Offit sold his share in October 2007. I think your presumed timeline doesn't bear out in terms of a relation to this study or to the economic downturn.
Oh, and RotaTeq actually resulted in a decreased risk for intussusception (though not statistically significant). See here:
"The 34,035 infants in the vaccine group and 34,003 in the placebo group were monitored for serious adverse events. Intussusception occurred in 12 vaccine recipients and 15 placebo recipients within one year after the first dose including six vaccine recipients and five placebo recipients within 42 days after any dose (relative risk, 1.6; 95 percent confidence interval, 0.4 to 6.4)."

Steve D

Theresa -
Unfortunately, your link does not work. Regardless, I agree that clinical safety trials are not perfect, but the relative strength as compared to VAERS data creates an apples-to-oranges comparison. For example, in VAERS reports there are utterly zero controls on the data.

John -
You are misrepresenting my position. I fully support post-marketing surveillance and believe in its efficacy to do that which it was designed to do. Both VAERS and the vaccine safety datalink are important aspects of this safety system.
Your last statement about "dead infants have to be added to the heap" is a striking example of ignoring the reality of the situation and appealing to emotion. But let's play your game and discuss infant mortality.
"Each year, rotavirus causes approximately 111 million episodes of gastroenteritis requiring only home care, 25 million clinic visits, 2 million hospitalizations, and 352,000–592,000 deaths (median, 440,000 deaths) in children <5 years of age."
But perhaps you aren't concerned about the potential positive worldwide impact of this particular vaccine?

Not Paul's Buddy

To Dr. Paul Offit:

1. Down Economy
2. Marginal Cost:Benefit
3. Unknown concommitant use long-term risks
4. Increased risk of intusseception and Kawasaki disease probable

Brilliant move Paul selling your royalities rights for guaranteed cash before the axe falls for your Rotateq off the mandatory schedule.


Vaccinated again Paul's BS


The problem with the clinical trials is that they generally exclude the very kinds of infants that might be most susceptible to vaccine injury -- premature or low birthweight babies, those with underlying health issues, comorbid conditions or family histories of autoimmune disorders, etc.. It's all well and good to test the vaccine on 70000 of the healthiest babies, but that does nothing to predict adverse events in the real world.


good point Kim, hit them where it hurts-the economic side of things. I love it. Steve, I don't believe there was any mention of adverse effects from the vaccine. That would be another story. One that the doctors don't even want to look at.


Steve D's definition of "safety" differs from Webster's Dictionary... and reality.


I don't get this article. what about vaccine adverse effects - where are these? and over a million "home" episodes? you mean infants who get a gastro-intestinal illness and have to have someone watch them at home? where does the study get that info and who evaluated whether these 'episodes' were due to rotavirus or to too much apple juice, travel plans or side effects of a runny nose?

and as for varicella - only 20 of those 100 deaths/year prior to vaccination were in kids younger than 18. so if the vaccine wears off and chicken pox is more deadly in adults, the varicella vaccine will lead to more susceptible adults and more deaths as the first generation of varicella-vaccine recipients age.

apple bottom genes

When talking about rotavirus, you don't have to look very far to find confirmation of the failure of clinical testing: there was a rotavirus vaccine before this one. It was associated with intussusception and death.
Clinical trials did not catch the problem.
Post-marketing surveillance did.

John Stone


On your basis there would be no point in compiling post marketing data, and no point in anyone bothering to report adverse events because it has been proven in advance that they haven't happened - which would be interesting argument coming either from the industry or from government. Another term for it might be "hit and run".

Thanks for offering the insight, anyway. I would like to know how many dead infants have to be added to the heap before anyone becomes concerned?


Steve D, what's unreliable about VAERS data is that vaccine adverse events are (as John Stone noted) vastly underreported to VAERS. Clinical trial data have never really impressed me as reliable, particularly after reading Bloomberg's report, Big Pharma's Shameful Secret (

I'm waiting for the cost-effectiveness analysis of the varicella vaccine. The CDC's own VIS indicates that only 100 deaths per year were associated with varicella prior to the introduction of the vaccine--and how much do we spend (through insurers and Medicaid) on pumping Varivax et al into kids every year?

Managing Editor

Well, Steve, I have no plans to invite Dr. Offit to my Fourth of July picnic - I think he has worked against my children to a mind-numbing degree. I think he has a vendetta against the autism community for daring to call into question the safety of vaccination. I do. But there was no reason to get snarky on this post from my point of view. I guess I'd had enough coffee and chocolate while posting.

Steve D

I am actually quite surprised to see this article posted on Age of Autism. Normally this site is so critical of Dr. Offit, but this seems to be a simple question posed by the editor and supported by a published study of whether the Rotavirus vaccine is ultimately cost effective.
I guess what surprises me is that this site would post information that supports the position that Dr. Offit's rotavirus vaccine is:
a) efficacious, and
b) safe (despite Mr. Stone's protestations)

Mr. Stone is comparing VAERS data to the clinical trials results referenced in the study itself:
"Large clinical trials with 60000 to 70000 children have demonstrated these vaccines to be highly efficacious and without evidence of vaccine-associated intussusception or other serious adverse events.3,4"
Clinical trial data are far more reliable than VAERS data for obvious reasons.

K Fuller Yuba City

Damaging so many to save so few, and make so many millions. Makes my head spin.
Thanks for taking the time to spell it out for everyone.

John Stone

The argument for cost effectiveness of Rotateq relates to its potential for improving health and saving lives. If, however, it costs lives the argument lapses and Dr Offit did well to sell his stake when he did.

The study, which was funded and conducted by the CDC can be read in full here:

I am not sure how they can waive through all these deaths without suspending its use and calling an urgent review. The longer they leave it the more compromised they will be.

Perhaps Dan from Texas would like to give his explanation.


Dan in Tx-- where does the paper factor the costs of vaccine reactions?

I don't think they could factor them-- the government (through the fund paid for by the tax on each vax) doesn't pay for vaccine reactions or vaccine induced deaths unless they win in "vaccine court". What tiny percentage of adverse events are ever compensated?

Indeed, if the adverse reactions always had to be paid for, no vaccine would be cost effective at this point. This might force industry to come up with a safer, less toxic schedule.


The conclusion is inconsistent: "unlikely [to be] cost saving... Nonetheless, rotavirus vaccination may still be considered a cost effective intervention." HUH?

I saw Paul Offit speak at the AAP convention in DC a few years about about the meningococcal vaccine. Even he couldn't justify the "cost per life saved" analysis. "Nevertheless, it may still be cost effective" I guess.

Erik Nanstiel

Offit was paid big bucks for that vaccine... wonder if they take american currency down below???


Okay, Dan, how many vaccine reactions do they factor in? Unless the number is accurate...

Dan, tx

Indeed John Stone, this paper appears to factor in the cost of the vaccine reations.


Maybe they will charge Offit with negligent homicide for inventing a vaccine that caused death. Why not, Law & Order ran a storyline about a women charged in the death of a child after her unvaccinated kid gave the dead child the measels. Anyone else witness that load of dung? NBC must have secured their drug ads for at least another year with this gem.

John Stone

VAERS presently lists for Rotateq:

3956 adverse events

947 events where the patient was hospitalised

119 deaths

In comparison with when I checked this out on 25 March last year this is

1686 new reports

424 new hospitalisations

61 more deaths

In assessing this information you need to balance the fact that though these events are not confirmed as being causally related, it is usually accepted that VAERS only records 10% of cases at most. It does look as if the level of associated death is really troubling - 61 cases in just over a year when projected deaths from the disease itself would be 14-15.

Evidently, the premise in the above article that the vaccine is safe has not necessarily been borne out.

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