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New Vaccine Subject to Anti-Vaccine Propaganda – Shock!

Just over a week ago, a new vaccine was approved by the FDA to prevent rotavirus gastroenteritis in infants. And, in a move that was completely expected by all, the anti-vaccine movement has set its sights on it.

A story on the curiously named “What Doctors Don’t Tell You” website makes the finger pointing in what, at first, may appear to be a regular news story.

Our children will soon have to receive yet another vaccine on top of the cocktail they already get – and it’s one that may cause convulsions and even death.

The Rotarix vaccine – designed to prevent the rotavirus infection that causes gastroenteritis – has just been approved by America’s drug regulator, the Food and Drug Administration (FDA), even though a new study has discovered that it may increase the rate of convulsions and even pneumonia-related deaths.

Rotarix is an oral vaccine by GlaxoSmithKline recently approved by the FDA. And is indicated for the prevention of rotavirus gastroenteritis and is administered as a 2 dose series in infants and children.

Rotavirus is the leading cause of severe diarrhea in infants and young children. There are 7 species of the virus, A through G, rotavirus A being the most common. Rotavirus infects nearly every child in the world by the time they reach the age of five.

Rotavirus is transmitted by the faecal-oral route. Mostly through contact with contaminated hands and other surfaces. It infects cells that line the small intestine and produces an enterotoxin, which induces gastroenteritis, which, in turn, leads to severe diarrhea and sometimes death through dehydration.

Treatment of the virus is done through management of symptoms, most importantly, maintenance of hydration.

The story from the “What Doctors Don’t Tell You” (WDDTY) website mentions a study that allegedly discovered a possible link between the Rotarix vaccine and increased rates of convulsion and infant deaths.

The most recent study, involving 31,673 infants, inadvertently discovered the possible link to increased rates of convulsions and deaths while it was assessing the new vaccine’s risk of causing intussusception, or intestinal folding, which can lead to life-threatening intestinal blockage. The previous rotavirus vaccine was withdrawn from the market in 1999 because of its intussusception risk.

So I checked this out on the FDA’s website on Rotarix and here’s what I found. The “study” described by the WDDTY website is actually a metanalysis of 8 different studies. In these studies, 36,755 children were given the Rotarix vaccine while 34,454 were given placebo.

During the entire course of 8 clinical studies, there were 68 (0.19%) deaths following administration of ROTARIX (N = 36,755) and 50 (0.15%) deaths following placebo administration (N = 34,454). The most commonly reported cause of death following vaccination was pneumonia, which was observed in 19 (0.05%) recipients of ROTARIX and 10 (0.03%) placebo recipients (Relative Risk: 1.74, 95% CI: 0.76, 4.23).

So, to put this in perspective, the difference between the Rotarix group and the placebo group is 18 deaths following the administration of the vaccine. That’s a 0.04% difference. And although when you look at it as 18 children dying, it does seem like a lot, too much even. It is hardly statistically significant. And yet the headline on the WDDTY website reads like a warning for everyone to be afraid of. “New Childhood Vaccine: It may cause convulsions – and even kill – but it still gets approved”.

Rotarix was approved by the FDA on April 8th, 2008. And, although 0.04% may be statistically insignificant, the vaccine was approved with the following condition.

Therefore, based on appropriate scientific data, you are required to conduct the following study:

1. A large-scale observational post-licensure safety study in the U.S to assess the potential serious risk of intussusception and other serious adverse effects (specifically Kawasaki disease, hospitalizations due to acute lower respiratory tract infections, and convulsions) in recipients of ROTARIX®.

The study will include approximately 44,000 vaccinated subjects (adjustments to the sample size will be made based on the background rate of intussusception). The study will be designed to detect an increased relative risk of intussusception due to vaccine with a relative risk of 2.5 or greater and with 80% power.

The moral of the story? Be critical of what you read. One group’s statistical insignificance is another group’s raison d’être*.

* – French for “reason for being” or “reason to exist”… barbarians**
** – Recycled Mark Crislip joke, thanks Mark.

9 comments to New Vaccine Subject to Anti-Vaccine Propaganda – Shock!

  • SJC

    “It is hardly statistically significant.”

    Not just hardly – NOT statistically significant. The 95% confidence interval is 0.76 to 4.23. This says that there’s a pretty big chance there is no change, and even a small chance that the vaccine decreases risk compared to placebo.

    Of course there is also a decent chance that if could actually increase the risk, but this data is inconclusive when it comes to that. More testing is required. Oh! they’re doing more testing? Well then, they’re doing their job.

    I’d like to see the stats on gastroenteritis, and see what the possible payoff is for this vaccine, but my suspicion is that it will be much larger than the possible ill effects it can elicit. From a population standpoint, its sometimes better to risk some side effects than to leave the population unprotected against potential pathogens.

  • Ginger Taylor

    Inside Vaccines, which usually has pretty balanced information, has a good discussion on the necessity of a vaccine for the virus in general given that there are only about 20 deaths attributed to rotavirus in the US per year. His analysis was done in Feb before the more serious intussusception/convulsions/pneumonia questions were raised, only using the adverse reactions from the vaccine, vomiting, diarrhea, nasopharyngitis, and fever.

    His basic conclusion was, ‘why are we vaccinating for something that only causes 20 deaths per year in this country?’ I think that question is made all the more important given the serious safety question that rotarix brings up.


    And that 20 deaths per year is further put into perspective by the fact that 95% of US children have had rotavirus by the time they are 5 years old. Almost everyone gets it and almost no one dies from it.

    Further, once a child has had the illness twice, they are apparently inoculated against serious diarrhea:

    “…the study titled Serum antibody as a marker of protection against natural rotavirus infection and disease (6) which was published in the Journal of Infectious Disease in 2000. Apparently, children are gaining natural immunity from rotavirus after 2 consecutive infections whether or not they demonstrated symptoms.

    “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.”

    This is supported by documents at the CDC showing that 95% of children have had rotavirus by age 5 and that after just one natural infection, 88% of children are protected against severe diarrhea.”

    This is a vaccine that may have important use in third world countries where children don’t have access to potable water, basic medical care and live in unhygienic conditions, but for American kids?

    And just as importantly, when a mom is in the doctors office, will she be told that the FDA has not ruled out that there may be an increased risk of death to her child from these serious side effects and that they have not actually finished safety testing it?

    Because after all… this is just diarrhea we are talking about. The CDC web site recommends treating it a home with pedialyte.

  • Ginger Taylor

    Going back and reading this again:

    :During the entire course of 8 clinical studies, there were 68 (0.19%) deaths following administration of ROTARIX (N = 36,755) and 50 (0.15%) deaths following placebo administration (N = 34,454).”

    There is your 20 deaths from the vaccine, and that is only in a population of less than 37,000. Looks like if that number holds up we would be trading up in deaths if this was given to the whole population.

  • kidsdoc

    Speaking on behalf of most pediatricians, we are all thrilled with Jenny McCarthy, Oprah, Don Imus et al for making our days significantly longer trying to discuss all of this nonsense. My favorite line I use is “I can’t speak for Jenny McCarthy’s medical degree or her molecular biology studies program, however…”

    As far as what roto vaccine can help avoid, here are the number: 400,000 doctor visits, 200,000 emeergency room visits, 55,000-70,000 hospital admissions and 20-60 deaths. All of those statistics are for the United States only and the nubers come from the CDC and their vaccine information statement sheets that we are legally obligated to give to every patient that recieves any vaccine.

  • Ginger Taylor

    I noted that you have not approved my comment. Does it some how violate the comments policy on the site?

    If I have not adhered properly to it is some way, please let me know so that I can correct that.

    Thank you.

  • madeingermany

    @Ginger: “Looks like if that number holds up we would be trading up in deaths if this was given to the whole population.” – Have you actually read the article above?

    @kidsdoc: Thank you for putting the numbers in perspective.

    @All: Has anybody seen studies about the new “spacing out vaccinations” strategy, that seems to be all the rage among new parents these days?

  • SJC

    “There is your 20 deaths from the vaccine”

    I argue that this isn’t a significant enough result to draw any real correlation here. The difference could be simply statistical noise and normal variation. There is also a chance you’d see just as many less die when receiving the vaccine. More testing is required to show if a real effect is occurring.

  • Scotty B

    If Ginger is right about the number of deaths, why do we need this vaccine? I think I may be missing some information here.

    Note: I am not an antivaccinationist and in the interest of full disclosure, I work for a major company which produces vaccines.

  • Manstorm

    I second SJC on that.

    18 deaths is of no statistical consequence.

    Don’t be silly.

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