Was Rotavirus Vaccine Prematurely Recalled?

In 1998 Wyeth Laboratories introduced Rotashield, a vaccine against the common rotavirus, whose main symptoms are severe, sometimes fatal diarrhea. An estimated 600,000 to 800,000 infants around the world die annually from rotavirus-related complications.

A rotavirus vaccine would be an important advanced, but Wyeth’s vaccine was quickly withdrawn after the U.S. Centers for Disease Control conducted studies suggesting that the vaccine increased the risk of intussusception, a rare type of bowel obstruction.

When Wyeth voluntarily withdrew the vaccine, the CDC estimated that the risk of an infant receiving the vaccination contracting intussusception was one in 2,5000. But in February 2001 the CDC announced that the results of a more thorough study reduced the risk to one in 10,000, and a further refinement of the data suggests that the risk is even smaller than that.

In fact, researchers looking at data from 10 states concluded that the rate of intussusception actually declined during the period when the vaccine was on the market.

Even with a one in 10,000 risk, however, this vaccine would be a godsend in many parts of the developing world, but the damage has already been done. Wyeth, almost certainly concerned about its potential liability over the vaccine, say that it has no intention to resume production of Rotashield.

Source:

Rotavirus vaccine may have been prematurely withdrawn. Lauren Morello, New Scientist, October 12, 2001.

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