FDA backs rotavirus vaccine despite contamination
pharmafile | May 13, 2010 | News story | Sales and Marketing | GSK, Rotavirus, Vaccine, drug safety, rotarix
FDA advisors have recommended two rotavirus vaccines licensed in the US should continue to be used, despite contamination with a pig virus.
The advisory committee panel 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).
Rotavirus is estimated to cause more than half a million childhood deaths each year around the world from gastroenteritis, diarrhoea and associated dehydration.
In March, the FDA advised physicians to suspend dosing of GlaxoSmithKline’s Rotarix after fragments of PCV-1 DNA were found in some batches of the vaccine.
A few weeks later, the same viral contaminant was identified in Merck & Co’s rival vaccine Rotateq although the vaccine remained on the market in advance of the advisory committee meeting.
With the expert panellists endorsing the safety of the vaccines, it is now up to the FDA to decide whether Rotarix and Rotateq can continue to be sold. Both are sizeable products, with Merck selling $522 million-worth of Rotateq last year, while Rotarix added $440 million to GSK’s coffers.
The panel also discussed the likely source of the contamination, which was identified using new molecular testing techniques and is thought to affect the products right back through their development. It has been suggested that the culprit may have been a pig-derived ingredient (trypsin) used in the early development of the vaccines.
GSK said it would work to develop a version of Rotarix without the viral contaminant.
Despite the committee’s support for the vaccines, the US Coalition for Vaccine Safety (CVS) called on FDA Commissioner Margaret Hamburg to “re-assess the panel’s hastily-considered risk-benefit analysis and suspend the use of both rotavirus vaccines” on the basis of “a safety first agenda”.
The CVS is asking for additional testing on the pig virus’ potential risks, and also a Congressional hearing on the wider topic of vaccine safety.
News of the FDA panel verdict came alongside the publication of a new meta-analysis in the May 2010 edition of The Cochrane Library, which found Rotarix and RotaTeq were not linked to increased numbers of serious adverse events and reduced all cases of rotavirus diarrhoea by 76% and 73% respectively at one year of age.
Severe rotavirus disease was reduced by 72% and 93% respectively at one year and 67% and 89% respectively at two years, according to the paper.
Phil Taylor
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