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 The previous rotavirus vaccine was withdrawn from the market in 1999 because of its intussusception risk.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.