The Food and Drug Administration on Friday said that it is safe to resume the use of the Rotarix rotavirus vaccine and to continue the use of the RotaTeq rotavirus vaccine. The agency in March had cautioned physicians to stop using Rotarix because the manufacturer had found trace amounts of a pig virus in the vaccine. Both the FDA and the manufacturer of the RotaTeq vaccine then found traces of the pig virus in it as well.
Following extensive studies by the manufacturers and the FDA, however, the agency said there is no risk from the viruses, called porcine circovirus 1 and 2. The viruses do not infect humans and are not known to cause any diseases, either in humans or pigs themselves. Moreover, "the vaccines have strong safety records, including clinical trials involving tens of thousands of patients, as well as clinical experience with millions of vaccine recipients."
A report from the Centers for Disease Control and Prevention on Wednesday estimated that the vaccines are preventing more than 50,000 hospitalizations of infants in the United States each year. Rotavirus infections, which are thought to kill as many as half a million children worldwide each year, are characterized by diarrhea and severe dehydration. The benefits of the vaccine, the FDA said, far outweigh any risks, which are only theoretical.
-- Thomas H. Maugh II