The discovery of a pig virus in a vaccine for babies did not trigger any action by Europe's medicines authority although its American counterpart called on paediatricians to stop using the immunisation.
The Federal Drugs Administration asked US doctors to temporarily stop using GlaxoSmithKline's rotavirus vaccine Rotarix, which is given to infants as young as six weeks, even though there was no evidence of risks to babies.
Switzerland has also called on doctors to temporarily stop using GSK's vaccine.
Rotavirus, a form of tummy bug, is the leading cause of severe diarrhoea in infants and young children and which can lead to dehydration. It is believed to be responsible for more than half a million infant deaths around the world every year, mostly in developing countries.
The two-dose, orally-transmitted vaccine was found to be contaminated by PCV-1, a DNA virus that infects pigs but is not known to cause illness in humans. According to GSK, the virus is regularly found in meat products and frequently eaten with no resulting disease or illness.
Although FDA commissioner Margaret Hamburg said there was no evidence the contamination posed a risk to children, the agency recommended a temporary suspension of its use until its experts discussed the issue in the next weeks. The FDA pointed out that Merck's rotavirus vaccine, Rotateq, did not contain the DNA fragment.
In contrast, the European medicines agency has decided no action was necessary for the time being because the findings did not represent a public health threat. At a meeting on Thursday, the European Medicines Agency concluded that the presence of the viral strain did not present a risk to public health and there was no need to restrict the use of Rotarix.
"It is nonetheless clear that viral DNA should not be present in the vaccine and its source is unclear," the European agency said, adding that its committee for medicinal products for human use had asked GSK for more information "as a matter of urgency".
Similarly, WHO urged countries using the vaccine to consider the "significant benefits of continued use", adding it did not present a threat to public health.
"Moreover, rotaviruses are the most common cause of severe diarrhoeal disease in young children throughout the world. Therefore, WHO does not recommend any change to the use of the vaccine," it said. Worldwide sales of Rotarix exceeded €300 million last year. A local spokesman for GSK said "a few hundred" vaccines were sold in Malta annually.
Although the local authorities said no statistics were available on the number of rotavirus infections, almost 100 positive cases were registered in 2005.
A Health Ministry spokesman said the authorities were constantly in touch with the European medicines authority and the risk-benefit analysis of the vaccine was expected to be discussed at tomorrow's meetings.
"The local authorities will take all action necessary in line with what will be decided," the spokesman said.