Vaccination has greatly diminished death, illness and suffering in the world. But no other medical technology has been so dogged with controversy. The book chronicles the development of the key lifesaving vaccines since the 18th century. It tells the stories of great scientists and their discoveries, of the protests and pain along the stumbling path of progress. This is the first book to tell the whole story of vaccination for a general audience. In light of controversies about flu vaccine and autism, it will be of particular interest to parents, pediatricians, public health workers and anyone fascinated by medical history. Read More>>

Also Available: Table of Contents and Index

Arthur Allen is a Washington DC-based journalist who has written on vaccine issues in The New York Times Magazine, the Washington Post Magazine, The New Republic, Atlantic Monthly, Salon and Slate.

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Rotateq trouble?

The AP and Reuters are reporting tonight that the FDA has issued guidance asking pediatricians and parents to be on the lookout for cases of intussusception--a paintful twisting of the bowels--in infants who receive Mercks' Rotateq vaccine. 28 cases of intussusception have been reported over the past year to VAERS, the Vaccine Adverse Events Reporting System, which is run by the CDC and FDA. Intussusception can be deadly; in 16 of the 28 cases children had to be hospitalized for surgery following the obstruction, which occurs when a part of the bowel telescopes into another. It's believed to be caused by viral infections, and the Rotateq, like all rotavirus vaccines, is a live viral vaccine that's given orally. The previously marketed rotavirus vaccine, Wyeth-Ayerst's Rotashield, was withdrawn from the market in 1999 because it caused the bowel problem--at a rate, studies later determined, of about 1/20,000.

The wire stories failed to record a key point in the FDA letter, which is that the 28 cases post-Rotateq are below the expected background rate of 18-43/100,000 cases in an unvaccinated population. 3.5 million doses of Rotateq have been distributed in that year. Though not all of them have been used, if only half had been given to children, 28 intussusceptions would still be far lower than one would expect in an unvaccinated population. On the other hand, VAERS is generally considered to underreport reactions associated with vaccines. This may be why FDA has asked pediatricians et al to look more carefully for intussusceptions. Merck and the CDC have been conducting post-marketing safety studies of Rotateq since it was licensed in 2005.

I have a slight conflict of interest in reporting this issue, which is that Paul Offit, one of the inventors of the Rotateq vaccine and a champion of the need for a rotavirus vaccine for American and the world, is a friend of mine and blurbed my book. I obviously hope that eventually his vaccine's name is cleared. If it isn't, I won't hesitate to report on it. I don't imagine that Paul will shirk the evidence either. Maurice Hilleman, the world's leading vaccine maker (at Merck) before his death a few years ago, use to say that he was never sure one of his vaccines was really safe until it had been given to 3 million children. Vaccines are a tough business. But since rotavirus kills hundreds of thousands of children each year, mainly in the Third World, and hospitalizes thousands of American children, it's obviously worth having a vaccine to prevent it.

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Comments

jre

You haven't linked to your excellent Slate article[1] published just two weeks after Rotateq's approval. In it, you mention that 72,000 children in the US and Finland participated in clinical trials, of whom 36,000 got the vaccine and 36,000 a placebo. Going by your numbers, between 13 and 31 cases of intussusception would be expected in an unvaccinated population of 72,000. If the test population saw 15 or fewer incidents of intussusception during clinical trials, it would have been reasonable to say that no causal link had been demonstrated. Do you know how many cases of intussusception were reported during Rotateq trials? It would have been a hot issue, given the Rotashield experience, and the trial population (unlike VAERS') was actively monitored, so we shouldn't have to guess on this one.

[1] You'll need to link; I see that links are automatically stripped from comments.

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