FDA Backtracks On Glaxo Rotavirus Vaccine

Two months after urging doctors to forego GlaxoSmithKline Rotarix vaccine, the FDA has done an about face and now agrees with one of its own panels, which last week decided the vaccine’s benefits outweigh its risks. The agency, you may recall, took its initial step after extraneous DNA fragments of PCV1 virus were found in two lots of Rotarix vaccine, which is used to combat rotavirus.
As the FDA acknowledged, porcine circovirus type 1, which is common among pigs, is not known to cause disease in animals or humans. Yet the FDA urged docs not to administer Rotarix until more research was completed. The FDA stopped short of a product recall, since there was no new info to contradict earlier evidence that Rotarix is safe and effective.
Instead, the FDA encouraged docs to administer Merck’s RotaTeq, which accounts for about three-quarters of rotavirus vaccines administered annually, while the agency geared up for the recent advisory meeting. But on the eve of the meeting, Merck found PCV1 and PCV2 in its RotaTeq vaccine , although the panel determined both vaccines offer more benefits than risks. Having left Glaxo at a disadvantage and, moreover, raising questions about whether agency officials were too hasty in addressing an unknown, the FDA is now trying to correct the record.