FDA says rotavirus vaccines are safe
pharmafile | May 17, 2010 | News story | Manufacturing and Production | drug safety, rotarix, rotateq
The US Food and Drug Administration has taken the advice of its advisors and given its backing to resume the use of GlaxoSmithKline’s rotavirus vaccine Rotarix, which was temporarily suspended after it was found to be contaminated with a pig virus.
The FDA also said that Merck & Co’s Rotateq, another rotavirus vaccine with a contamination issue which had escaped suspension in March, can also continue to be used.
Last week, an FDA advisory committee looked into the contamination issue and concluded that the benefits of the vaccines in preventing rotaviral diarrhoea in infants outweighed any ‘theoretical’ risks of suffering an adverse event from exposure to the pig virus, known as porcine circovirus-1 (PCV-1).
The virus is thought to be derived from a pig-derived ingredient (trypsin) used in the early development of the vaccines.
The FDA has concurred with this view, saying that “an evaluation of laboratory results from the manufacturers and its own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts” had answered its safety concerns.
The European Medicines Agency (EMA) said in March that Rotarix should not be used to vaccinate children, but after a few days reversed that stance. Meanwhile, the World Health Organization recommended no change to the way that health care practitioners in the developing world use Rotarix or Rotateq, although the authorities in Hong Kong asked for a recall of Merck’s vaccine.
The FDA said considered that both vaccines have “strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of recipients”.
It also said there was no evidence that PCV-1 or the PCV-2 variant also found in Rotateq is known to cause infection or illness in humans.
“The benefits of the vaccines are substantial, and include prevention of hospitalisation for severe rotavirus disease in the USA and of death in other parts of the world,” commented the agency.
Phil Taylor
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