We could add to this list products such as the Rotashield
rotavirus vaccine, withdrawn only one year after FDA approval because of so many severe reactions in children, including the death of a five-month-old infant.
The first licensed vaccine (RotaShield
), a live oral tetravalent vaccine, was withdrawn following an association with intussusceptions.
Routine vaccination against rotavirus began in 1998 with the FDA approval of RotaShield
vaccination was then voluntarily withdrawn from the market in 1999 when it was found to have an increased risk of intussusception of 1 to 2 cases per 10,000 recipients .
Three vaccines against rotavirus have been developed: Rotashield
(Wyeth-Lederle Vaccines and Pediatrics, ), RotaTeq (Merck, ), and Rotarix (GlaxoSmithKline, ).
Remember the Wyeth rotavirus vaccine, RotaShield
, which was withdrawn after a little more than a year on the market?
Reassortment of animal rotavirus segments onto human strain backbones has been documented (28), and experimental insertion of human rotavirus strains onto animal strain backbones was the basis for construction of reassortant rotavirus vaccines Rotashield
and RotaTeq (29).
The first, RotaShield
, was removed from the market in 1999 because of a detected increase in intussusceptions.
The greatest risk for intussusception was noted after the first dose of RotaShield
More on RotaShield
and intussusception: the role of age at the time of vaccination.
The best example for this is the RotaShield
vaccine for rotavirus, which was pulled from global circulation in 1999 by Wyeth-Ayerts Labs, the holder of the exclusive license, following the reporting of a small number of cases of intestinal blockage.
(14) The withdrawal of RotaShield
by the FDA led to an intense international debate over whether the apparently small increase in the risk of intussusception should prevail over what would likely have been a much larger reduction in morbidity and mortality in the developing world.