GAITHERSBURG, Md. The benefits of vaccinating babies against rotavirus outweigh the theoretical risks of porcine circovirus found in rotavirus vaccines, the Food and Drug Administration and GlaxoSmithKline acknowledged at a recent advisory committee meeting.
The committee also discussed techniques to detect viruses and the implications of using them to test vaccines.
The drug maker presented data from investigations that it had conducted since material from porcine circovirus was found in the Rotarix vaccine, though according to the FDA and regulatory agencies in other countries, there is no evidence that the material poses a safety risk. Nevertheless, the FDA recommended in March that healthcare professionals in the United States temporarily suspend use of the vaccine.
Rotavirus is estimated to cause more than half a million childhood deaths from gastroenteritis each year around the world.