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 The previously marketed rotavirus vaccine, Wyeth-Ayerst's Rotashield, was withdrawn from the market in 1999 because it caused the bowel problem--at a rate, studies later determined, of about 1/20,000.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.